US group Cambridge Major Laboratories (CML) will begin transferring API production to its 125,000 sq. ft. manufacturing plant in Germantown, Wisconsin.

The new facility is part of CML’s bid to be the leading western supplier of active pharmaceutical ingredients (API) and intermediates to the pharma and biotech industries.

While Asia looks set to dominate the sector for the time being, both as a result of lower production costs and available capacity, high profile scandals with APIs sourced in the region have raised questions about manufacturing standards.

As a result producers in Europe and the US have begun to claw back some of the ground lost Asian manufacturers, meaning that completion of CML’s new plant could be very well timed indeed.

Even if CML fails to achieve its lofty ambitions, the facility should still boost CML customer base according to CEO Michael Major.

He said that: “Without this site we would never be considered for large scale commercial manufacturing,” explaining that, in the past, the firm had lost out to rivals with larger manufacturing capacity, despite the innovative processes its chemists developed.

“Now we have the horsepower to take our clients new molecules from concept to full commercialization,” adding that “with all the hype surrounding drug safety and quality from offshore suppliers CML’s model has shown that US-based manufacturing is still alive and well.”

The facility features six good manufacturing practice (GMP) quality production suites that can make multi-ton quantities of both APIs and pharmaceutical intermediates.

Overall output capacity is 18,000 gallons although CML capacity can be increase by another 30,000 gallons for particularly large manufacturing projects.

CML highlighted the plant’s thermal oxidizer and reaction tank that, it claimed, offer both US Environmentally Protection Agency (EPA) air quality standards and optimized solvent usage.

The firm also explained that it will be to funnel projects from its three kilograms-scale development centers to Germantown when industrial production is required.

University of Boulder Proceeds with Biotech Building with Help from Donors

New vaccine developments will be accelerated because of a $2 million gift by CU alumni to pay for a new biotechnology building on the Boulder campus, according to CU’s fundraising arm..

The CU Foundation officially released its end-of-the-year fundraising numbers, showing that the university and foundation together raised $134.5 million, down 18 percent from the year before. The fiscal year ended June 30.

The 2007-08 fiscal year was a record-breaking fundraising year at CU, when the university raised more than $162.4 million. The school has been braced for an 18 percent decrease for the 2008-09 fiscal year, which ranks it as the second-best year in CU history for dollars raised.

Despite the recession, CU said a record number of donors — more than 50,000 — gave gifts to the school.

CU alumni Jack and Jeannie Thompson’s donation helps finance the new biotechnology building, which will remain a fundraising priority for the Boulder campus this year.

UNC-W Gets $15 Million for Marine Biotech Building

The National Institute of Standards and Technology announced that the University of North Carolina-Wilmington would receive $15 million for a new facility for the Marine Biotechnology in North Carolina program.

The award is one of four, totaling more than $55 million, for the construction of new scientific research facilities at universities. The University of Miami, Auburn University and Rice University also received funding.

“These awards mean four major construction projects in these local areas, with the jobs and economic benefits they bring,” U.S. Commerce Secretary Gary Locke said in a statement. “Even more important, these four projects provide a major boost to scientific research at four respected universities, enhancing innovation, public safety and environmental protection for many, many years to come.”

The new research buildings will provide state-of-the-art laboratory facilities supporting academic research across a broad range of topics affecting the Commerce Department's mission, including fundamental physics research, nanotechnology, aquaculture and marine ecology.

Money for the projects comes from the federal economic stimulus package.

New DTC Genetics Firm Pathway Genomics Launches

Pathway Genomics, a new direct-to-consumer genetic testing firm, launched, offering genotyping and analysis for disease risk and heredity for under $250.

The San Diego, Calif.-based company said that its on-site lab has been certified by California regulators and has received CLIA clearance. The company said its testing enables customers to learn about disease risk, adverse drug responses, carrier status, and ancestral history.

Pathway Genomics joins a nascent field of DTC genomics providers, pioneered by 23andMe, Navigenics, and Decode Genetics among others.

The private company received its principal start-up funding from The Founders Fund, Edelson Technology Partners, and Western Technology Investment.

Pathway Genomics was founded by CEO Jim Plante, who has founded four other technology companies in the wireless, automotive, consumer products, and risk-management fields. The company's scientific team is led by CSO David Becker, who has worked in Alzheimer's research at Torrey Pines Therapeutics.

Pathway Genomics is offering its testing service through its website.

Construction Begins at Viva Biopharma's U.S. Plant

Construction of Viva Biopharm USA’s $30m (€21m) drug manufacturing facility is under way in the latest stage of parent Viva Canada’s international expansion program.

The new 200,000 sq. ft. facility in Blaine, Washington State will make both generic pharmaceuticals and over-the-counter (OTC) medications, including hard and soft shell capsules, as well as nutritional and dietary supplements and cosmetics.

The firm also plans to carry out R&D at the site, including the development of new pharmaceutical products and associated technologies.

Viva already has distribution subsidiaries and sales agents in Asia and the Middle East, however its recent focus has been on growing its North American business and the world's biggest drug market in particular.

Burrill Creates $1B Hybrid Fund, Eyes Stimulus Money for Minnesota's Elk Run Project

G. Steven Burrill, the San Francisco biotech investor/analyst who is the main investor behind the 200-acre BioBusiness Park at Elk Run, planned for Pine Island, Minn., told the Star-Tribune of Minneapolis he will complete by year's end a $1 billion hybrid fund intended to finance the project. The fund would divide its assets evenly between real estate and venture capital.

The fund will spend about $500 million to purchase $20 million equity stakes in 15 to 25 companies — ranging from startups to publicly traded businesses — that will move to the bioscience center. The remaining $500 million will go toward the rest of developer Tower Investments' real estate projects on Elk Run, which include a healthier living center, offices, shops and homes.

Burrill, the CEO and founder of Burrill & Co., traveled to Minneapolis to court potential investors. To date, he told the newspaper, he has received a commitment from a large investment firm he declined to name, and is talking to local pension funds, wealthy families, foreign sovereign wealth funds and many of Minnesota's largest corporations, including Piper Jaffray, Cargill, General Mills, 3M, Medtronic, and Boston Scientific. Burrill said he hopes the corporations will either invest in the fund, or spin out technologies into companies that will reside at Elk Run.

Burrill also said that Elk Run developer Tower Investments is close to securing millions of dollars from the $787 billion American Recovery and Reinvestment Act, the economic stimulus measure enacted in February by President Obama, to construct an interchange that would connect Hwy. 52 to the project site.

According to a spokesman for the Minnesota Department of Transportation, however, the state had yet to approve any stimulus money for the interchange, the newspaper reported.

Biomedical Company Would Employ 300 at Planned $80 Million Atlanta Manufacturing Facility

An unidentified biomedical company plans to invest about $80 million in a manufacturing operation near Atlanta and create at least 300 jobs.

The firm has spent several months searching for a site, but has recently focused on locating a high-tech manufacturing plant within a new 200,000-square-foot building in Majestic Realty’s Airport Center project in Union City, Ga., according to the Business Chronicle, citing unnamed "sources familiar with the deal."

Majestic Realty won approval in June from Union City officials for a 202,000-square-foot building to rise as part of the 137-acre Airport Center III site, near Hartsfield-Jackson Atlanta International Airport. Community Development Director Ann Lippmann told the newspaper she had no specific knowledge of the biomedical company.

Jones Lang LaSalle, the commercial real estate firm that represents the biomedical firm, and state economic development officials would not comment to the newspaper on the deal.

The development comes about two months after Atlanta hosted the nation's largest annual life-sciences industry show, the 2009 BIO International Convention, held at the Georgia World Congress Center. And, according to the newspaper, the New Economy Task Force of the Metro Atlanta Chamber is expected to recommend that the region focus on attracting health and biosciences companies, especially those in that focus on global health and communicable disease, medical biotech and medical research.

Samaritan Health Services, WUHS, Join on Plans for New Med School, Mixed-Use Project

Samaritan Health Services has joined with Western University Health Sciences of Pomona, Calif., on plans to build a Pacific Northwest campus for the medical school in Lebanon, Ore., as the anchor of a 55.5-acre mixed-use project that would also include a conference center, hotels, stores, and apartments, according to the Daily Journal of Commerce in Portland, OR.

Ground for the project is set to be broken by year's end.

“This is undoubtedly going to be a major benefit to this community,” Walt Wendolowski, community development manager for the town of Lebanon, told the newspaper.

Once completed, the school will accommodate about 400 students and dozens of faculty and staff members. “The land we have here is intended to provide additional capacity for companies that want to stay in our state in the future,” said Samaritan Community Hospital President Julie Manning.

Ground will be broken on the first phase of the project before year's end, she added.

Samaritan Health Services, based in Corvallis, Ore., has entered into negotiations with other developers to build on the land, but no agreements have been reached yet, the newspaper reported.

Wendolowski said the project's ultimate goal was to attract biotechnology companies to join the mixed-use part of the development — while Manning countered that it’s questionable whether biotech firms will be drawn to the development: “It’s too soon to answer [the biotech] question intelligently."

Before the project can proceed, Samaritan Health Services must clean up the property because it was subjected to use as agricultural land during the 1950s and 1960s, and thus exposed to the cancer-causing pesticide Dieldrin, Bryn Thoms of the Oregon Department of Environmental Quality told the newspaper.

Genzyme Renews Lease for NYC Space

Genzyme has renewed for another 10 years its lease for 98,000 square feet at 521-33 West 57th St., a midtown Manhattan building between 10th and 11th avenues, after exploring options for new office space in three different boroughs of New York City and two of its suburban regions.

The biotech giant headquartered in Cambridge, Mass., occupies the fifth and sixth floors of the building. Asking rent for the space was in the mid-$40s per square foot.

Genzyme looked at 25 different properties in Manhattan, Brooklyn, and the Long Island City section of Queens, over the course of 18 months, David Dusek, a senior managing director for the real estate firm Studley, which represented the biotech company and announced the deal, told Crain's New York Business.

According to the newspaper Genzyme could have been the anchor tenant at one site it was considering — the East River Science Park life-sci campus, whose first phase is under construction by developer Alexandria Real Estate Equities.

“At the end of the day, the cost of capital to recreate their current infrastructure didn’t add up,” Dusek told Crain's. “It was purely economics.”

Genzyme also searched in northern New Jersey and lower Westchester County — where OSI Pharmaceuticals is purchasing the 43-acre, 400,000-square-foot Ardsley Park Science and Technology Center.

Genzyme has been at 521-33 West 57th since 2004, when it acquired a tenant of the building, Impath Technology, in a bankruptcy sale.

Joining Dusek in representing Genzyme for Studley were Peter Capuciati, executive vice president; and Alex Blue, managing director. The building owner, an affiliate of Himmel + Meringoff Properties, was represented in lease talks by Farrell Virga, president, and Mark Stein, senior vice president and director of leasing.

Biotech Startup VitalMedix Bolts Minnesota for Wisconsin; Talks in Progress on Two Sites

VitalMedix, a Minneapolis biotech startup, plans to move within 90 days to either of two Wisconsin sites for which it is in lease, drawn by better incentives than it said were available in Minnesota.

Charlie Goff, lead investor for VitalMedix and general partner of the $10 million NEW Capital Fund in Appleton, Wis., told the newspaper that Wisconsin's investment tax credits "had everything to do with" the pending move. The drug developer said it is in lease talks for sites in Hudson and New Richmond, and expects to move to either site within the next 90 days.

If VitalMedix is successful at developing into a large operational company, the company might move to Madison or Milwaukee, according to the newspaper.

VitalMedix holds an exclusive global license from the University of Minnesota for Tamiasyn, a drug the company plans to combine with a delivery device that first responders and medics can use to treat hemorrhagic shock. The four-employee company has raised $4.5 million from investors and US Defense Department grants, CEO Jeffrey Williams told the Post-Bulletin.

VitalMedix is among companies benefiting from Wisconsin's decision earlier this year to double its cap on tax credits for investors in life-sci and other tech startups, from $4 million to $8 million. The state also raised its cap on eligible angel investments to $4 million, and more than tripled the total credits available each year, from $11.5 million to $37 million, as part of the Act 2 measure signed in to law by Gov. Jim Doyle.

QB3 Expands Incubator into FibroGen's Mission Bay Facility

A University of California institute has joined with three partners to expand the space available for life sciences startups in San Francisco's Mission Bay section — with the goals of accommodating growing tenant demand and, over time, satisfying that demand through additional sites elsewhere in the Bay Area.

The California Institute for Quantitative Biosciences, or QB3 — which includes UC's San Francisco, Santa Cruz, and Berkeley campuses — has partnered with FibroGen, the San Francisco Chamber of Commerce, and the San Francisco Center for Economic Development to open a roughly 10,000-square-foot suite of laboratories within 409 Illinois St., the 239,000-square-foot building to which FibroGen relocated late last year.

The expansion, which will quadruple the amount of incubator space that QB3 currently operates, is designed to quench the growing thirst of Bay Area startups for incubator space at Mission Bay. Demand is strong enough to force QB3 to turn away one to four inquiries from fledgling companies a week, officials said.

Longer term, the partnership, called the QB3 Mission Bay Incubator Network, envisions developing a set of incubators across the region, Douglas Crawford, the institute's director of industry alliances and associate executive director, told BioRegion News.

"The prime driver was the frustration of having to turn away one to four inquiries a week. We love to help entrepreneurs. We want to be the nexus between new companies and the university. We really do feel that space is a critical element in launching successful companies. All of those factors motivated us to want to participate in this initiative," Crawford said in an interview.

"Our long-term ambition would be to undertake a similar venture in the East Bay. We're in various discussions with people right now, but we haven't rolled that out yet. There's been a huge growth in the biotech industry in West Berkeley, Emeryville, and up to Richmond, too. Currently, there no spaces available there for really small companies," Crawford added.

Pursuing such space at a cost startups can afford may compel the network to consider partnerships with developers owning "units that are a little bit further away, but offer larger and less expensive space," even if they are farther from universities than is the case with the network's initial portion of FibroGen space at Mission Bay, Crawford said.

"In the fullness of time, our network will grow to include other providers of space at Mission Bay," Crawford told BRN — especially the developer of Mission Bay's largest R&D campus, Alexandria Real Estate Equities. The network hopes to expand into a portion of the publicly-traded landlord's Alexandria Center for Science and Technology at Mission Bay, located about a quarter-mile northwest of FibroGen's new space.

That cannot take place until at least early 2010, since Alexandria — a publicly traded real estate investment trust based in Pasadena, Calif. — has all but filled the building it has completed at Mission Bay, the 153,000-square-foot 1700 Owens St.

"If they have space available, they have in the past, and would very much in the future, like to participate in renting out small units of space" to startups within the network, Crawford said. "We hope that the Mission Bay Incubator Network will grow to two or three different private developers."

Absent a perfect re-leasing effort, Alexandria next year may have at least part of 105,000 square feet available for startups in a third Mission Bay building it is constructing, 455 Mission Bay Blvd. South. That space had been leased to Pfizer until the pharma giant earlier this month backed out of its nearly year-old lease deal with Alexandria, citing changing space needs due to the economy and its pending $68 billion acquisition of Wyeth. Pfizer had also agreed to an option for another 50,000 square feet in the 205,000-square-foot building.

Space is also expected to be available for the network at Alexandria's next building to come online at its Mission Bay campus, the 158,000-square-foot 1500 Owens St., where all space has been fully leased or committed to UCSF and a "multi-billion-dollar equity-market-cap biotech company" whose name Alexandria has never disclosed.

The new network has one advantage for the life-sci startup tenants it will house at FibroGen: They need not maintain an affiliation with the UC system, unlike the stipulation in place for startups now within the 2,500 square feet of space that comprises QB3's three-year-old incubator, dubbed "the Garage." The FibroGen-based startups also need not have an affiliation with the drug discovery company focused on tissue fibrosis, connective tissue growth factor, and hypoxia-inducible factor, or HIF, biology.

Late last year, FibroGen relocated its headquarters and labs from a South San Francisco, CA, site to all of 409 Illinois St., part of a two-building, 450,000-square-foot complex redeveloped by Shorenstein Properties from its former use as the warehouse site for Esprit. FibroGen maintains an option to lease the second building, the 211,000-square-foot 499 Illinois St.

Four startups moved in quietly in recent weeks, occupying a combined roughly 2,000 square feet at 409 Illinois — small-molecule therapeutics developer Carmot Therapeutics, cardiovascular therapeutics agent developer CV Ingenuity, influenza therapeutics developer Gemmus Pharma, and protein therapeutics developer Osprey Pharmaceuticals USA.

A fifth startup — Solidus Biosciences, a provider of high-throughput, predictive in vitro toxicology services — will move into the new network's FibroGen space by Aug. 1.

At the FibroGen space, as at the Garage, startups can rent labs starting at 120 square feet, as is the case with one recent arrival, the biotherapeutic platform developer Omniox. Companies can then grow in increments of about 150 square feet. FibroGen's startup space will lease for about the same as the $5.50 per-square-foot, per month operated until now by QB3.

That rate includes full janitorial and utility services, as well as the class A lab space itself, but without equipment. As with the Garage, startups at FibroGen's space will typically furnish their labs by tracking down sources of used equipment, Crawford said.

The Garage is home to six startups, including Omniox. Of QB3's first 10 companies, four closed venture capital financing rounds, one company shut down, and one, True Materials, was acquired by Affymetrix last year for $25 million in cash. Companies must grow out of QB3, or move out, within two years.

Garage tenants have access to amenities such as UCSF's library, use of its core facilities at hourly rates, ownership of their data, and university contacts for lawyers and other professionals they will need to hire in order to do business. In addition, QB3 runs monthly seminars led by experienced entrepreneurs and service providers, as well as scientific seminars held at UCSF's campus.

"One of the great advantages in being near a university is that there are lots of law firms, accounting firms, independent people who are all experienced at this, but they're not always well-known to young companies. So we have a playbook, and one of the things that QB3 is happy to do for its own entrepreneurs, and for members of our network, is provide that networking service to those entrepreneurs," Crawford said.

"One of the great advantages for starting a company in the Bay Area is that young companies get to continue to collaborate with investigators, and we'll help broker those collaborations," Crawford added. "Big companies are more autonomous. They have more internal resources. But when you're a tiny company, you really need to be able to network actively to fill the gaps in your own resources."

$3 Million Tax Break Promise Convinces OSI Pharma to Consolidate, Expand in NYC Suburb

OSI Pharmaceuticals was promised $3 million in sales tax breaks from New York state and Westchester County governments to help pay for its $100 million consolidation of its US operations and expansion in Greenburgh, NY.

At the same time, additional details emerged about the tax incentives and about the search that ended in the New York City suburb located less than an hour's drive north of Manhattan.

Westchester’s Industrial Development Agency agreed to preliminarily “induce” OSI’s consolidation/expansion by assisting the pharma company with economic incentives. OSI is seeking an exemption, valued at $3 million, from state and county sales taxes on construction materials and equipment.

Two days later, the state Empire State Development Corp. disclosed another incentive: The state will shoulder the $1.8 million annual cost of OSI's rent to the State University of New York system for its leased 63,500-square-foot building at SUNY Farmingdale State College, located on Long Island, within the Broad Hollow Bioscience Park, spokeswoman Lisa Willner told BioRegion News. It was unclear at deadline if ESD will award additional incentives to OSI.

The subsidy will cover the cost of OSI's lease until the Broad Hollow space is rented out. The company is expected to vacate the bioscience park in 2010, Willner said.

OSI will vacate Broad Hollow, as well as its 60,000-square-foot owned headquarters in Melville, also on Long Island, starting in the fourth quarter, when it begins shifting its total 200 Long Island employees to the Ardsley Park Science and Technology Center, a 43-acre, 400,000-square-foot campus on Route 9A (Saw Mill River Road), which has been mostly vacant since the departure in 2005 of Purdue Pharma.

By 2010, OSI will combine those employees with 145 oncology staffers now located in Boulder, Colo., and 20 employees now based in Cedar Knolls, NJ. The pharma company will also recruit employees for its new Greenburgh campus, promising to boost payroll there to 600 people by 2012.

The job promise has qualified the company for not only the county and state incentives, but the prospect of reduced property taxes through a payment-in-lieu-of-taxes agreement negotiated but not yet approved by Greenburgh and the Ardsley school district.

“We look forward to building a cluster of biotech companies in your area,” Pierre Legault, OSI's executive vice president, chief financial officer and treasurer, told the IDA board, meeting here at the county government’s main offices.

OSI is dipping into its $660 million in available cash to pay for the campus, Legault said, so it won’t need a tax break typical of recent relocation projects in Westchester, an exemption from the mortgage recording tax levied by the state and county. That tax stands at $1.30 per $100 of mortgage value.

Once the sale closes, he said, OSI will begin renovations to labs and pavement, begin talks with a handful of remaining tenants with leases in the campus — notably Supresta, a maker of phosphorus-based flame retardants — as well as start modernizing the campus' power house, the source of heat, air conditioning and steam for the labs, in consultation with the region's utility, Consolidated Edison.

Con Ed is offering OSI its Business Incentive Rate, which offers qualified companies a discount of about 35 percent on the transmission and distribution portion of their bill. That typically results in a roughly 14-percent discount on the overall bill, according to James Hartwick, the utility's economic-development manager.

He said OSI may also qualify for rebates on its renovations from the New York State Energy Research and Development Authority if the renovations meet the agency's energy-efficiency standards.

While OSI has projected the cost of its total spending on the Greenburgh relocation/expansion at $95 million, the actual cost could reach $100 million or more, Legault said, depending on the extent of renovation needed.

Legault also offered some insight into the thinking of OSI executives when they selected Greenburgh over sites within and outside the New York metro area. Within the region, he said, "our number one choice was really to stay in Farmingdale if at all possible, understanding there was some limitations. We have some very specific requirements being a biotech company," he said.

One requirement OSI had insisted on was an animal facility, something local officials balked at approving following opposition from the college community and others. "While we are well aware that animal testing in medical research is controversial, the Food and Drug Administration won't approve new medicines without a certain amount of animal testing. So not supporting an animal facility is incongruous with supporting biotech in the first place," OSI CEO Colin Goddard said in an op-ed column published in the Long Island newspaper Newsday.

In that column, Goddard linked the refusal of officials to approve an animal facility with the defection of another Broad Hollow tenant, Helicon, to San Diego.

Officials also balked at approving an expansion within Long Island that would have allowed OSI to develop part of the Farmingdale campus and lease its site from the state. State Sens. Carl Fuschillo Jr. (R-Merrick) and Kenneth LaValle (R-Port Jefferson) have told Newsday in separate interviews that they objected to the state assisting OSI without soliciting competitive bids for the site, or receiving a payment in lieu of taxes in return, with Fuschillo saying the effort progressed to a "draft" of a 40-acre no-bid lease.

Michael White, executive director of the Long Island Regional Planning Council, told BRN this week the loss of OSI is among issues that have prompted regional economic-development leaders to develop an "economic-development working group."

The group will start with the economic-development directors of Long Island's Nassau and Suffolk counties, the IDA directors of both counties, the IDA directors of various Long Island municipalities, and a representative of ESD. The group will eventually include business group leaders.

While the loss of OSI is significant for Long Island's biocluster, the region's life-sci industry can rebuild through its existing research anchors, such as Cold Spring Harbor Laboratory and Brookhaven National Laboratory, Nathan Tinker, executive director of the New York Biotechnology Association, told BRN.

"Long Island has still got some key and major academic assets to draw upon and to build upon," Tinker said in an interview at a NYBA networking event held in Westchester at the Landmark at Eastview, a life-sci campus owned by BioMed Realty Trust. "The Farmingdale facility is a fabulous facility, and in some ways, to my mind, it may be that having OSI there, taking up so much space, almost held them back. So this may be an opportunity to build up the smaller, emerging company opportunity there, and to develop a stronger, broader sort of cluster.

By the time OSI began its national site search, Greenburgh was originally OSI’s second choice in the New York metro area. Number one on that list was the East River Science Park in New York City, whose first phase is now under construction by developer Alexandria Real Estate Equities.

But the aesthetics of the wooded Greenburgh campus, its potential for cost-saving through the efficiencies of a single site, its availability of additional developable land, and its availability of facilities that would have to be built new elsewhere at higher cost, propelled Ardsley Park past East River Science Park and other NY-area sites — as well as past two regions with larger life-sci clusters, North Carolina’s Research Triangle Park, and greater Philadelphia.

"There's a big cluster of pharmaceutical companies in North Carolina that was very appealing to us, but it would have been very disruptive" to OSI since the company would not have been able to retain as many of its current staffers as it will in Greenburgh, Legault said. "And then, we looked at Philadelphia, which also has a big cluster of pharmaceutical companies, and the state was really willing to do lots of work with us."

Another factor in Greenburgh's favor, Legault said, was the willingness of local and county officials to work with OSI and the state to attract the pharma company. Through its relocation consultant Deloitte, OSI had been in contact with Westchester officials for "several" months, he added.

The first visit of OSI reps to Westchester took place in December, and included dining at Ardsley Park. "We had a luncheon where the County Executive [Andrew J. Spano] brought people from [Westchester] Medical Center and [New York Medical] College to talk about bio in the county, just a chit-chat," said Theresa Waivada, the IDA's executive director.

"They probably had a team of eight people up here. They went by Project Genesis, and all first names," said Waivada, who is also Westchester County's deputy director of economic development. "They also wanted to meet with companies and interview companies," which OSI did with help from the nonprofit Hudson Valley Economic Development Corp.

Waivada and Salvatore J. Carrera, director of Westchester County's Office of Economic Development/Real Estate, said the office shepherded OSI on visits to several Westchester sites, including Landmark at Eastview, a 751,000-square-foot lab-office campus on Greenburgh's border with Mount Pleasant, as well as several sites in the county seat of White Plains.

GenWay Biotech Obtains CLIA Certification

GenWay Biotech Inc., a San Diego-based diagnostic company has become CLIA certified and received a California lab license.

GenWay Biotech, Inc., (www.genwaybio.com) a US-based diagnostic company has become CLIA certified and received a California lab license. Their license currently permits the testing of immunological biomarkers. This is a very important step in the direction of commercialization of the novel innovative diagnostic tests currently being developed at GenWay. In upcoming weeks, GenWay will add new cancer biomarker tests to their portfolio as well as several infectious diseases such as sexual transmitted diseases. GenWay is seeking to obtain CAP accreditation by the end of the year.

Dr. Joe Voland, CLIA Pathologist and lab director, claims that he has never seen a CLIA lab get set up so efficiently and professionally as GenWay has done. GenWay Biotech Inc. is a GMP compliant facility with capabilities for research, development and manufacturing of proteins, antibodies, immunoassays, and diagnostics. Consequently, most quality control and assurance measures were already in place facilitating the transition into a CLIA certified laboratory. Furthermore, GenWay's lab is under construction for the addition of a Class 10,000 clean room which should be complete sometime in August 2009.

Dylan Malayter, Project Manager, who has played a predominant role in guiding the lab through the CLIA certification process, feels "This is an immense step forward for GenWay Biotech, Inc. We are excited to begin accepting patient samples and performing revolutionary tests that may save patients lives and enhance their treatment by monitoring their condition with simple non-invasive blood tests."

The GenWay team is looking forward to the future impact of the cancer biomarker tests they will offer. They have secured exclusive rights to the DR-70 test from AMDL and have secured several other biomarkers in the field of cancer diagnostics.

About GenWay:

GenWay Biotech, Inc. is a diagnostic company based in San Diego, CA that manufactures and supplies key components of diagnostic kits, such as antibodies and antigens. The Company's proprietary technology platform specializes in producing avian IgY antibodies from proteins of human, animal, plant, bacterial and other sources. GenWay also offers single chain recombinant scFv and shark vNAR antibody technologies. More than 40,000 products are available from the Company's catalog. GenWay is also actively developing novel diagnostic tests in the field of cancer and STD diagnostics.

University of Michigan Startups NanoBio and Accuri Nab Additional Private Investment

A pair of Ann Arbor-based University of Michigan biomedical startups said that they have netted some $26 million in private investment between them.

The first company, NanoBio, said that it has closed a $22 million Series B financing round after securing a $10 million investment from majority shareholder Perseus, based in New York; and Venture Investors of Ann Arbor and Madison, Wisc.

The $10 million is in addition to a $12 million Series B funding announced by the company in February. To date, NanoBio said that it has received more than $90 million in equity and grant funding to support development of its anti-infective products and nanoemulsion-based vaccines.

The second company, Accuri Cytometers, said that it has received $4 million in Series D financing from previous investors Fidelity Biosciences, Flagship Ventures, Baird Venture Partners, and Arboretum Ventures; and new backer InvestMichigan!, a program co-managed by Credit Suisse.

Accuri, which last raised $13 million in Series C financing in July 2008, said it will use the funds to manufacture and market its low-cost, benchtop flow cytometer, the C6, as well as the CSampler product for automating the C6.

NanoBio was founded in 2000 by James Baker, director of the Michigan Nanotechnology Institute for Medicine and Biological Sciences, or M-NIMBS, and a professor at UM, to commercialize nanoemulsion technology developed by Baker as a topical anti-infective for cold sores, and nail fungus.

But the company also wants to adapt the technology for use in a variety of vaccines, including for influenza, hepatitis, and pathogens associated with bioterrorism.

In February 2008, NanoBio announced that UM had been awarded a key patent that covered applications of the nanoemulsion technology to vaccines (see BTW, 2/6/2008). NanoBio holds a worldwide, exclusive license to the patent and four others on which Baker is the primary inventor.

Since it spun out of the university, NanoBio and Baker’s lab at M-NIMBS have garnered several rounds of public and private funding to develop applications for the technology, including a $3.2 million contract from the US Department of Defense awarded in 2003 for antimicrobial applications; a $6.3 million Grand Challenges in Global Health Initiative grant awarded in 2005 to M-NIMBS primarily from the Bill and Melinda Gates Foundation; and a $30 million private-equity investment in NanoBio in 2006 by VC management company Perseus.

Most of that money enabled NanoBio to conduct phase 2 clinical trials on its two lead products, topical lotions NB-001 for cold sores and NB-002 for nail fungus; and to conduct extensive animal studies on nasal vaccines against influenza, hepatitis B, and several additional undisclosed pathogens.

In April, the US Food and Drug Administration approved the NanoBio’s Investigational New Drug application for a Phase 1 clinical study of NB-1008, an intranasal delivered seasonal influenza vaccine.

Now, with the new funding in hand, NanoBio said it can support its clinical trials and company operations through early 2011.

"This investment round secures our ability to independently fund the next two years of our operations," Baker, who is also CEO of the company, said in a statement. "Our investors see the tremendous value of our platform technology from both a medical and commercial perspective. There is a clear need for novel topical anti-infective therapies and new vaccine-adjuvant approaches that offer safety, ease of use, and enhanced efficacy."

Accuri's technology is now protected by three US patents assigned directly by the company, as well as a number of pending patents in various countries. All of the IP covers technology that is "completely different" from the original UM IP, Baird said.

Nevertheless, Baird said she considers Accuri "part of the UM family," and said the company has benefitted greatly from the many business relationships it has formed through its close ties to the university. "The company wouldn't exist if the university and its tech-transfer office hadn't existed," said Accuri CEO Jennifer Baird.

When the company introduced the C6, it claimed that it would provide the same if not better performance as larger, high-priced flow cytometers such as those sold by flow cytometry stalwarts Beckman Coulter and Becton Dickinson, as well as other startup firms such as Guava Technologies (now a part of Millipore), for a fraction of the price.

Specifically, in 2006 Accuri said the cytometer would sell for less than $30,000 (see BTW, 12/15/1006). According to its website, that price has inched up to around $40,000 — not including its optional autosampler technology — which is still much less than most commercial flow cytometry systems.

Accuri's last financing round, a $13 million Series C closed in 2008, was also intended to expand commercialization activities for the C6, specifically in the wake of the company's April 2008 launch of the product.

The company also raised $5 million in a 2007 Series B led by Baird Partners, and in 2006 received a $2 million award from Michigan economic development agency 21st Century Jobs Fund.

Pfizer Halts Plans for US Biotech R&D Centre

Shortly after the Irish investment was announced Pfizer reported that it has shelved plans to set up a 105,000 sq. ft. biotechnology research unit at the University of California, San Francisco’s (UCSF) Mission Bay Campus.

Spokeswoman Joan Campion told the San Francisco Chronicle the firm is "in discussions now with the landlord to exit the lease," explaining that it makes more sense to keep its 100 Bay Area employees at Rinat Neuroscience, the South San Francisco start-up it acquired in 2006.

In yet more Pfizer news, the US drug giant announced that it has sold rights to three developmental dermatology drugs to fellow US firm Graceway Pharmaceuticals.

The candidate drugs in question, stearoyl CoA desaturase 1, cholesterol-acyltransferase and activin-like kinase 5 are being developed to treat a variety of skin conditions.

Pfizer will continue to develop the three compounds, one of which is already in Phase II trials, on Graceway’s behalf on a contractual basis under a master services and supply agreement.

The world leading drugmaker said the deal, further terms of which have not been disclosed, is another example of its ongoing efforts to divest research programs that are not essential to its future development plans.

Adeona Completes HartLab Acquisition

Adeona Pharmaceuticals, Inc., a specialty pharmaceutical company dedicated to the awareness, diagnosis, prevention and treatment of subclinical zinc deficiency and chronic copper toxicity in the mature population, announced that it has completed its acquisition of HartLab LLC, an independent Chicago-area CLIA-certified clinical laboratory ("HartLab"). Adeona originally announced its agreement to acquire HartLab on June 1, 2009.

Founded in 2006 and located in Bolingbrook, Illinois, HartLab can serve the same-day clinical laboratory needs of physicians that care for the approximately 9 million residents of the greater Chicago area and can currently provide next-day clinical laboratory services to physicians in most states.

HartLab is a licensed Medicare and Medicaid provider and accepts insurance from most third party reimbursers as well as private payers.

Adeona intends HartLab to remain independent and to support HartLab in expanding its offering of services to include a suite of high precision and proprietary assays and diagnostic panels useful in the diagnosis, monitoring, prevention and treatment of conditions that involve copper toxicity and other types of metal dyshomeostasis. Adeona believes that, if operated as planned, HartLab may satisfy an unmet physician need for a clinical laboratory dedicated and competent in such areas.

Max Lyon, CEO of Adeona, stated, "We look forward to HartLab entering the greater Chicago area market, and eventually the national market, with a clinical diagnostic service that can help physicians and patients cope with the challenges of diseases of aging such as Alzheimer's disease and mild cognitive impairment."

Hamner Institutes Signed Agreement with China Medical City

The Hamner Institutes for Health Sciences has signed an agreement with China Medical City to create the Hamner-China Medical City Institute for International Drug Development. Building on strengths of the two organizations in translational research, business development, and education, the Institute will help to produce new biomedical technologies that benefit the U.S. and People's Republic of China as well as the rest of the world.

During the first phase of this agreement, the Institute for International Drug Development will be established at The Hamner's campus in Research Triangle Park (RTP), NC, and will focus on preclinical drug development and compliance with FDA regulatory standards. After the partners validate research capabilities and new technologies at The Hamner campus, they will transfer them to China Medical City, a new life science park located in the Yangtze River Delta north of Shanghai.

In 2008, The Hamner launched a Bioscience Accelerator on its 56-acre campus in the heart of RTP. There are two initial start-ups: BioMedomics, a diagnostics company started by Chinese-American scientists, and b3bio, a spinout from Duke University.

Newsummit Biopharma, one of China Medical City's premier partners, is establishing its North American business center in The Hamner's Bioscience Accelerator. Newsummit Biopharma is a contract research and technology development company whose service platform includes support for commercialization, intellectual property, funding, and staffing in science and technology parks throughout China.

The partnership with China Medical City and Newsummit Biopharma creates a vital bridge of opportunity between NC and China. Acknowledged worldwide as a major hub of biotechnology, NC is an ideal location for companies from China that seek to enter the U.S. market. After establishing an initial presence in RTP, which already has a strong Chinese community of scientists and business professionals, companies from China can expand around the state as their businesses prosper and grow.

As part of its strategic agreement with China Medical City, The Hamner has worked with the NC Dept. of Commerce and NC Biotechnology Center, a world leader in bioscience development, to create a "North Carolina-China partner network" that supports Chinese business and educational initiatives. Other members of this innovative network include the NC China Center, the NC China Business Association, Council for Entrepreneurial Development, and NC Research Parks Network as well as economic development organizations in counties such as Wake and Durham.

China Medical City and Newsummit Biopharma are actively using their network to assist NC's R&D companies, contract organizations (research, manufacturing, and commercial), and academic institutions that want to establish strategic alliances, research sites, and branch offices in China. The new Hamner Bioscience Center in China Medical City and the NC Dept. of Commerce office in Shanghai are serving as gateways for NC organizations, such as Cirrus, Specialty Operations Solutions, Inc., and SyneCor, that are developing new markets in China.

New Bedford, MA Business Park Wins $1M Federal Grant for Access Road Tied to Expansion

The US Economic Development Administration has awarded a $1 million grant to the city of New Bedford, Mass., and the operator of the New Bedford Business Park, the Greater New Bedford Industrial Foundation, toward the construction of an access road that will open 45 acres of the park to new development.

The grant — to be combined with approximately $1 million secured by US Rep. Barney Frank (D-Newton) — will cover most of the project's cost, Tom Davis, executive director of the industrial foundation, told the New Bedford (Mass.) Standard-Times.

Davis told the newspaper the foundation expects the additional land to draw a major company to the business park, such as a pharmaceutical or biotechnology firm, and create hundreds of jobs — 100 during construction, 500 permanent jobs afterward.

The foundation will likely begin construction in the fall and complete work by the middle of next year, Davis told the Standard-Times. The project would include roadwork, as well as extension of water, sewer, gas, electric and telecommunications services.

The lot is on the western end of the park's New Bedford portion, behind AFC Cable. The 1,000-acre park includes straddles the communities of New Bedford and Dartmouth, Mass.

The 45-acre lot could support a 300,000- to 400,000-square-foot plant or office building, Davis told the newspaper, adding that several companies have already expressed interest in buying large lots for major projects, though the park cannot offer them any land at present.

While inquiries from prospective buyers and tenants slowed down during the latter half of last year and first part of this year, the foundation has boosted its marketing efforts, and there was an increase in leads in June, according to Davis.

That momentum, Davis told the newspaper, should be sustained into next year as a result of the road extension project:

Eli Lilly Division Elanco Plans Groundbreaking for New Corporate HQ in Greenfield, Ind.

Elanco, a division of Eli Lilly, said it will formally break ground on a new global headquarters in Greenfield, Ind., that had been announced when the pharma giant announced it was selling its Greenfield operations to contract research organization Covance.

Elanco, which has approximately 2,000 employees worldwide, will anchor a 52-acre business and life sciences park at I-70 and State Road 9 in Greenfield, to be called Progress Park.

"The new Elanco facility will help our economic base continue to diversify into the rapidly growing life sciences sector," Greenfield Mayor Brad DeReamer said in a news release. "The location of this state-of-the-art facility on the city's north side helps open the door for other companies seeking to join Greenfield's emerging growth."

Eklanco said the new HQ will enable it to centralize operations, and save at least $1 million in annual operating expenses.

The new Elanco site and facility will be developed and built by commercial developer Browning Investments. The global headquarters will encompass about 130,000 square feet on about 20 acres. The first project in the new business park, Elanco's new HQ will leave 32 remaining acres for additional development within the campus.

The park, when completed, could accommodate up to 400,000 square feet of business space

Elanco primarily supports livestock health, but also is in the pet health business through Elanco Companion Animal Health.

Altus Exits One Property, Cuts Space in a Second, as Retrenchment Continues

Altus Pharmaceuticals has disclosed in a filing with the US Securities and Exchange Commission that that it has moved out of the 83,405-square-foot 333 Wyman St. in Waltham, Mass., and will get out of its lease there.

Also, Altus said it will reduce by 24,083 square feet the 63,880 square feet it has rented, and correspondingly by 38 percent, the rent it pays, at a second Waltham property, 610 Lincoln St., which would leave the company with 39,797 square feet.

Leases for both properties end in 2018. Altus has agreed to pay the owner of 333 Wyman more than $1 million as a result, the company said. That payment could increase by another $475,000 by Nov. 2 or earlier if Altus is acquired, merges with another company, or raises more than $25 million in capital, the company disclosed.

The deals are part of a corporate retrenchment that has prompted the company to cut three-quarters of its workforce. Altus eliminated 107 jobs in January and narrowed its focus to an injectable human growth hormone.

Using $2 Million Indiana Grant, West Lafaytte Nanobiomaterials Developer Begins Tests

Nanovis, a startup developer of nanosurfaced implants and nanostructured biomaterials, has begun initial testing of a bone regeneration technology using a $2 million grant it won last year from the 21st Century Research and Technology Fund, the Indiana Economic Development Corp. said.

The company's technology, which combines nanostructured biomaterials with proprietary bone growth factors, is designed to promote bone growth among patients with a high risk of bone fracture, such as people with osteoporosis and other bone disorders. The technology was jointly discovered by Nanovis and researchers at Purdue University and Brown University.

Nanovis said it plans to create up to 42 new research and development jobs as the tissue technology is commercialized over the next three to five years.

Based at the Purdue Research Park at West Lafayette, Nanovis has begun initial testing of its technology, and hired several full and part-time research associates through the state grant. Nanovis is one of 69 businesses awarded a 21st Century Fund grant since January 2006. According to IEDC, the fund has awarded more than $90 million in life sciences and other entrepreneurial companies.

OSI Leaves Long Island

US biotechnology group OSI Pharmaceuticals will move HQ to a facility in Greenburgh, New York due to the high cost of land at its current base in Long Island.

OSI, which developed the oncology drug Tarceva (erlotinib), was originally based at the Cold Spring Harbor Laboratory cancer research center and has been based at the Farmingdale State College for over ten years.

Under the proposed relocation plan, the firm will pay $27m (€19.4m) for the 43 acre, 400,000 sq. ft. Greenburgh laboratory and office space that has been empty since former occupant Purdue Pharma left in 2005.

Speculation about a major OSI move away from Long Island emerged early last month when the Long Island Business News reported that the firm was mulling New York as a potential new base of operations.

Now that the move has been confirmed, OSI expects to begin renovating the facility next month and plans to relocate 350 employees from facilities in Melville and Farmingdale, New York, Boulder, Colorado and Cedar Knolls, New Jersey this year.

The firm expects that the move, coupled with wider synergies provided by its consolidation efforts, will generate annual savings of around $15m a year from the fourth quarter next year.

CEO Colin Goddard said that: “We have recognized that we will only truly capture the full strategic value of our oncology franchise if we simplify our business by bringing together all the elements of our US operations onto a single site.

“After an extensive and highly competitive process involving the exploration of options in multiple different states, we have identified a campus that will represent a first-rate facility for our company and provide for all foreseeable expansion needs over the next several years.”

USU Projects Clear Funding Hurdle

A number of Utah State University projects — including a major new College of Agriculture facility — have passed the first hurdle in gaining millions in Congressional funding.

In total, the Senate Appropriations Committee has approved over $17 million for USU.

Sen. Bob Bennett, R-Utah, a member of the committee, requested the money for the current fiscal year, which began July 1.

“We appreciate Sen. Bennett’s leadership,” said Eric Warren, spokesperson for the Space Dynamics Lab, which would benefit from the request.

Before USU can receive the funds, Bennett’s proposal must pass through several other parts of Congress. During that process the amount of money allocated may change.

The following is a summary of the approved programs:

Agriculture Research Center — $4.527 million

This funding will support the construction of a new USU facility that will provide the space needed to enhance collaborations among USU faculty, USDA and Agriculture Research Service researchers.

The state-of-the-art, high-tech facility will increase opportunities for research with ARS, top university and other federal programs. The new building will be located on the east side of the Quad and will include campus-wide, technology-enhanced classrooms. In March 2008, the Utah State Legislature approved a challenge bond for $43.1 million that provides the entire state share of the building funding, but the release of the funds are tied to the release of federal funding.

Jack H. Berryman Institute for Wildlife Damage Management — $1.5 million

This collaborative program with Mississippi State University researches scientifically based solutions for wildlife disease threats. Created in 1993, the purpose of the institute is to give students opportunities to participate in multi-disciplinary research programs focused on resolving human-wildlife problems. This funding will be jointly used by the institute’s eastern and western divisions.

High Performance Computing Utah — $263,000

This initiative addresses the need for high performance computing education and resources. Through this program, the high performance computing resources at USU will be expanded by improving visualization, storage and networking capabilities. The demand for high performance computing education, in this case for agricultural scientists and students, will be addressed by the development of training material targeting agricultural researchers.

Joint U.S./China Biotechnology Research Programs — $210,000

Utah State will develop joint research programs in agricultural biotechnology, including infectious diseases, livestock cloning and genetics, crop production, and irrigation. A number of Chinese collaborators are involved including the Chinese Ministry of Science and Technology, Xiamen University and the Northwest Sci-Tech University of Agriculture and Forestry. The funding will be used for professional exchange, training and internships to promote greater economic and agricultural development in the U.S. and China.

Alternative Energy Technology — $10 million

These funds will go toward developing technology focused on energy-efficiency, carbon sequestration and carbon-free energy sources. USU plans to develop energy research and establish long-term relationships with the Department of Energy (DOE) national labs and other research universities.

USU Intermountain Center for River Dynamics and Restoration — $600,000

The center will work to integrate river science research to restore riparian environments in the West. The funding will provide educational programs for natural resource scientists and managers in the public and private sector.

Prevention Plus, Utah State University — $170,000

This program for at-risk students is already in place in six high schools in Ogden, Alpine, Nebo and Wasatch school districts. The funding will allow it to expand. According to Richard West, USU professor of education and the executive director of the Center for the School of the Future, the effort targets students who display highly aggressive or violent behavior.

“We are trying to identify these kids earlier and deal with the problems,” said West. “We see a lot of these kids drop out of school.”

The program includes a screening process, collaborative communities among schools and the use of research-based techniques that improve students’ learning and behavior.

Satellite Sensor Calibration for Global Climate Observing System — $400,000

The funding for this project will allow USU’s Space Dynamics Laboratory to work with NASA Goodard Space Flight Center’s Biospheric Sciences Branch to develop a comprehensive record of climate data for analysis.

SDL spokesperson Eric Warren commented that SDL has a long history of developing calibration processes and providing accurate climate data.

University of Miami Plans Biotech Center

The University of Miami is moving ahead with plans to create a 1.4-million-square-foot Life Science Park that campus leaders hope will spark a new biotechnology industry in Miami-Dade County.

UM has selected a developer for the project's $80 million first phase, and construction is set to start this summer.

The university says the completed park eventually will employ 4,500 people and have a $253 million annual impact on the local economy.

But UM officials think the impact could be even greater if the project becomes the nucleus of an entire biotechnology industry for Miami-Dade.

''We still have a long way to go to catch up with cities like Boston, San Diego and San Francisco,'' Dr. Bart Chernow, the project's chief shepherd and UM medical school vice president, said. ``But I'm hopeful and cautiously optimistic that we're on our way to make Miami a hub of biotechnology.''

The idea behind the park is that it would provide offices, laboratories and some shared equipment that biotech companies could use while developing new medicines and medical devices. UM researchers could start new companies there, or collaborate with existing biotech firms.

The park will sit on 7.2 acres near Jackson Memorial Hospital and the UM medical school, between Northwest 17th and 20th streets and between Seventh Avenue and Interstate 95 in Miami.

As a first step, developer Wexford Science + Technology will build a 200,000-square-foot research and development building at the north end of the site. The six-story building will include labs and offices for biotech tenants and several ground-floor retail spaces.

A courtyard ''Rain Garden,'' where workers could gather for lunch, is planned for the project's second phase.

The first building will be ready by the end of next year or early 2011, said Wexford Vice President Jospeh A. Reagan Jr. He said he already has spoken with prospective tenants and is optimistic about filling the place.

''If everyone who has expressed interest so far signs up, we wouldn't have enough space,'' he said. ``We're already looking at Building Two. There's quite a bit of pent-up demand for life sciences.''

One of the tenants will likely be the South Florida Proton Center, a $120 million private cancer treatment and research facility scheduled to open in 2012.

Dropped from UM's early concept drawings is a gigantic rooftop solar panel for the center. However, plans call for getting the first building certified as an environmentally friendly facility.

Reagan talked about the project at a forum that was organized by the City of Miami to introduce small business owners and construction workers to Wexford and the developers and builders of several other planed projects, including the new Marlins stadium and new art and science museums. About 400 people attended the event, said William Porro, of the city's Division of Economic Initiatives.

UM's ambitious goal of creating a new biotech center that would rival hubs such as Boston will put it in stiff competition with other communities across the country whose leaders see biotechnology as a way of bringing in high-paying jobs.

In Florida alone, major biotech developments have been built or are in the works in the Gainesville area, Orlando, Tampa Bay, St. Lucie County and Jupiter.

Phoenix, Buffalo, N.Y., and Huntsville, Ala., have all been talking about biotech projects. Even Kannapolis, N.C., struggling to replace jobs lost in the textile industry, is building a life science park.

On the other hand, UM President Donna Shalala, who headed the U.S. Department of Health and Human Services under President Clinton, has pushed hard to elevate the university's profile and raise money. (She has already set a state record by raising $1.4 billion during a university campaign.)

The medical school's dean, Dr. Pascal Goldschmidt, has brought down a group of leading genetics researchers from his old employer, Duke University, along with millions of dollars in research funding. Chernow also has been a successful researcher and biotech entrepreneur.

And Wexford has developed biotech parks and similar projects at the University of Maryland at Baltimore and the Penn State medical school in Hershey, PA.

Shalala is counting on the biotech center to provide a big stimulus to the local economy: ''The life science park will bring jobs. ...More importantly, it will bring good jobs,'' Shalala says in a video promoting the project. ``You're creating new knowledge, spinning off new companies -- creating a quality of jobs and a job market that we have not seen before in Miami.''

Genzyme Expands Framingham, Mass., Presence with New 17,596 Sq. Ft. Lease

Genzyme has signed a new lease for 17,596 square feet of office space in Framingham, Mass., at the 62,000-square-foot 10 California Ave.

The deal expands Genzyme's presence in the suburban town. Last fall, the company opened a $125 million, 180,000-square-foot science center off nearby New York Avenue in the Framingham Technology Park.

Bill Sullivan & Garry Holmes of R.W. Holmes Realty, which announced the lease deal July 9, represented the building owner, while Chris Tosti and Rob Walles of CB Richard Ellis represented Genzyme, which is based in Cambridge, Mass.

Genentech Adds to South San Francisco Presence; Parent Roche Pulls Out of PhRMA

Genentech, the biotech pioneer headquartered in South San Francisco, Calif., has expanded its presence in its home city by agreeing to lease 156,000 square feet at 500 Forbes Blvd., the space formerly occupied by cancer therapy developer Cell Genesys.

The space became available earlier this year after Cell Genesys terminated its leases for all of its major facilities — including 500 Forbes, which is owned by publicly traded Alexandria Real Estate Equities of Pasadena, Calif. The retrenchment followed Cell Genesys' Oct. 16, 2008, announcement that it was restructuring its business operations following the failure of its GVAX immunotherapy for prostate cancer during two phase 3 clinical trials.

"We would have been obligated to make rental payments of approximately $86 million through the lease expiration in 2018 for South San Francisco" absent a termination, Cell Genesys said in a filing with the US Securities and Exchange Commission.

In connection with the end of the Cell Genesys lease, Alexandria recorded $18.5 million in rental income that "includes the fair value of building improvements and equipment which was received in the modification of the lease and recognized over the remaining term of the applicable lease," according to a 10-Q filing by the real estate investment trust with the US Securities and Exchange Commission.

On a May 7 conference call with analysts, Alexandria disclosed that the space was re-leased, but declined to identify Genentech as its new tenant.

"This opportunity to exit the former tenant, to stabilize the property with a credit tenant, we felt, clearly was the appropriate business decision. It gave us the best economics for the property for the long term," Dean Shigenaga, Alexandria's chief financial officer, told analysts. "We feel pretty comfortable that that property is going to perform well in the long term. At the end of the day, we're ahead on total consideration under the new lease."

The lease is one of the first deals inked by the biotech pioneer since its $47 billion acquisition by Swiss-owned Roche earlier this year.

Roche also made news when the company — which has adopted the Genentech name for its US operations — dropped out of the pharma industry trade group Pharmaceutical Research and Manufacturers Association, or PhRMA, in a reflection of the company's reorientation toward biotech. Roche also plans to end its sponsorship of a special pharmaceutical management program at Rutgers Business School.

Instead, Genentech has become a member of the Biotechnology Industry Organization: "Genentech and Roche believe BIO's purpose is closely aligned with the direction of the new company and, therefore, can represent the company's interest in Washington," company spokeswoman Darien Wilson said in a statement to the Star-Ledger last week.

Sanofi-aventis Plans France Consolidations, Eyes Shifts Elsewhere, in R&D Restructuring

Sanofi-aventis said it will consolidate operations in the Paris and Toulouse regions and may also consolidate operations in the US, Spain, the UK, and Japan as part of a restructuring of R&D operations.

The world's third-largest pharma giant said it will proceed with previously announced transfers of personnel and activities in the Paris area, from the "discovery research" facilities in Bagneux, and Rueil-Malmaison to Chilly-Mazarin — where operations now in Evry will also be shifted. Approximately 300 people may be affected by the consolidations, which may include grouping "tertiary activities" at Chilly-Mazarin as well as Massy, an option Sanofi-aventis said it is now considering.

In the Toulouse area, the company will shift the Labège site’s activities and 150 staffers to the namesake Toulouse site. However, Sanofi-aventis said it is looking into "a divestment solution" for its Porcheville site, which employs approximately 200 people.

Sanofi-aventis said it is also examining selling of converting preclinical research labs in the US, Spain, the UK, and Japan. The company's US facilities include a flu vaccine production site in Swiftwater, Pa., where more than 2,000 people were employed last year, making it among the largest employers in Pennsylvania's Monroe County, according to the Morning Call of Allentown, Pa.

Lab Supply Company Takes 148 Sq. Ft. at Brandywine-owned Radnor, Pa., Building

VWR International, a global laboratory supply and distribution company whose customers include pharmaceutical and biotech companies, has signed a 14-year lease for 148,000 square feet at One Radnor Corporate Center, a 201,980-square-foot office building in Radnor, Pa., owned by publicly traded Brandywine Realty Trust.

Brandywine, which announced the lease deal, said VWR International will occupy the Radnor property in stages beginning in February 2010. The lease will increase occupancy to 90 percent in Brandywine's Radnor portfolio, which consists of 10 buildings totaling approximately 1.7 million square feet.

VWR International was represented by David Binswanger and Scott Gabrielsen of Binswanger. Brandywine was represented by Richard McGuckin and Daniel Palazzo. Brandywine is a real estate investment trust that owns, develops and manages a primarily Class A, suburban and urban office portfolio totaling about 37.3 million square feet.

PPD Drops Plans for 40K Sq. Ft. Building at North Carolina Research Campus

PPD, a contract research organization headquartered in Wilmington, NC, said it has terminated its lease for 40,000 square feet at the North Carolina Research Campus, citing the ongoing economic upheaval and its effect on the development of the Kannapolis, NC, complex spearheaded by billionaire food/real estate magnate David H. Murdock.

“Progress in developing, constructing and recruiting tenants to the North Carolina Research Campus has been much slower than we expected. We understand that this is the result of the economic conditions and the global financial crisis," PPD said in a statement to several North Carolina news outlets. "Construction of the building we intended to lease has not commenced. As a result, we elected to terminate our lease. Despite this development, we have informed NCRC that we would like to continue to work closely with them to evaluate ways in which we can participate in the campus.”

PPD announced its intent to expand into NCNC last year, projecting at the time that it would create as many as 300 new jobs over three years, in positions that included clinical research associates, project managers, and scientific staffers.

Soon after, PPD established a temporary office within The Village, a Kannapolis complex on the outskirts of the campus that was supposed to be supplanted by the permanent space at NCRC. That operation housed about 20 employees before shutting down recently.

PPD was to share space in a new four-floor, 160,000-square-foot building with Carolinas HealthCare, but the project has seen repeated delays, and still has no timetable for starting construction, which was projected to last 14 months. According to the Charlotte Business Journal, the project ran into delays as NCRC developer Castle & Cooke North Carolina worked to secure financing.

Hal Kempson, director of CBRE Capital Markets, told the Business Journal that Castle & Cooke may change the medical building PPD was to occupy, from a single large building that would have required $45 million in financing, to several smaller ones, each likely to need less money to build. Kempson's firm — which financed the building Rowan Cabarrus Community College is now constructing at NCRC — hopes it can finance the medical space as well.

PPD is one of 18 private businesses that have announced plans to locate at the $1.5 billion, 350-acre NCRC, where eight NC universities and the state’s community college system also have a presence on the campus.

PPD's pullout was the second setback for the NCRC in recent weeks. Earlier plans by PepsiCo for a lab at the site are “in flux” because of the economy, the Charlotte Observer reported.

Like NCRC, PPD has also struggled to weather the economic storm. The company cut its guidance for the year in April, citing an “unprecedented” number of project cancellations, and the state of the pharmaceutical industry — though the company has also expanded overseas after acquiring AbCRO.

UMass Medical School Builds Data Center at Worcester Campus

Construction has begun on a new data center and supporting infrastructure to serve the University of Massachusetts Medical School in Worcester, Tishman Construction Corp. of Massachusetts, the project's construction manager, announced.

The project broke ground in May and is scheduled to reach its planned height or "top off" in March 2010, Tishman said in a statement.

“This data center will be extremely energy efficient, utilizing new technologies such as flywheel-backed [uninterruptible power supply] systems and air side economizing. By removing all HVAC components from the Data Center box while providing complete system monitoring, we can essentially turn off the lights,” Paul Hanbury, a professional engineer and senior mechanical project manager at UMMS, said in the statement.

The data center will be part of an existing 225,000-square-foot building where 30,000 square feet of impacted space will be renovated and 7,000 square feet of white space created for the project.

Tishman was hired by a state-created nonprofit affiliated with the med school, the Worcester City Campus Corp.

BioMed Realty Secures $350 Million in Financing for Center for Life Science|Boston

BioMed Realty Trust said it has secured a $350 million loan toward construction of its 700,000-square-foot Center for Life Science|Boston. The company obtained the loan from John Hancock Life Insurance, TIAA-CREF, and Westdeutsche Immobilien Bank AG.

In a statement, the San Diego-based, publicly traded laboratory developer said the $350 million loan carried an interest rate of 7.75 percent, and will mature in June 2014. BioMed Realty said the loan allowed it to pay off part of a $507 million debt that is set to mature later this year. BioMed Realty said it paid down the remainder by drawing on its unsecured line of credit.

Located in Boston's pricey Longwood Medical Area, the CLS has attracted a tenant roster that includes Beth Israel Deaconess Medical Center, Children's Hospital Boston, Dana-Farber Cancer Institute, Immune Disease Institute, and Japanese-based Kowa Company Ltd. The center recently received the "gold" rating for energy efficiency based on the US Green Building Council's Leadership in Energy and Environmental Design standards.

Expansion of NYC's Javits Convention Center Clears Last State Government Hurdle

New York Gov. David Paterson announced that construction of a $463 million expansion of the Jacob K. Javits Convention Center in New York City " will begin immediately" after the state Public Authority Control Board approved the a general project plan for the work.

In a statement, Paterson said the expansion “will generate close to $880 million in direct and indirect sales, as well as 9,000 direct and indirect construction and construction related jobs."

The center would add 40,000 square feet of new exhibition space within a total 100,000 square feet of new construction. The expansion would increase the amount of exhibition space at Javits, which opened in 1986, from the current 675,000 square feet to 715,000 square feet, making it the nation's 18th largest convention center.

The city announced its expansion plan March 20, as part of a bid to host a future Biotechnology Industry Organization international convention. BIO responded by saying it would study the plan; the group last held an annual convention in the Big Apple in 1998.

Dendreon More than Doubling Seattle HQ & Expanding in New Jersey

Dendreon plans to more than double the size of its headquarters near downtown Seattle, and is seeking approximately a quarter-million square feet of office and laboratory space along the city's waterfront or South Lake Union neighborhood, Chief Financial Officer Greg Schiffman has told the Puget Sound Business Journal.

"We’re looking to remain in the downtown region. We are looking at buildings that are in place or could be built within a couple years' time frame," Schiffman told the newspaper. "If we find the right facility, we’re ready to move in the next couple of months to make a decision."

The Seattle office of real estate services firm Jones Lang LaSalle is representing Dendreon in its search for space. The new Seattle headquarters will house the product sales and marketing division, as well as laboratory space for research and development of other promising products in the biotech’s pipeline, Schiffman said.

Dendreon currently leases a total of 95,000 square feet by the Seattle waterfront under two leases at 3005 First Ave. and 3101 Western Ave. The leases are set to expire in 2011.

Seattle isn't the only place where Dendreon is expanding. Last week, the company said in a filing with the US Securities and Exchance Commission it plans to spend up to $50.5 million to expand its therapeutic biotechnology-processing facility in Morris Plains, NJ, to allow for commercial production of its new prostate-cancer immunotherapy, Provenge.

Dendreon has hired the Henderson Corp. to manage construction of a two-phase expansion of the Morris Plains facility. The first phase calls for additional quality-control laboratories, data center, training areas, infrastructure and offices, all of which are scheduled to be done by mid-December. The final phase, with additional manufacturing clean-room work stations, production-support areas, warehouse, infrastructure and offices, is to be substantially complete by late April.

Dendreon finished the initial build-out of its 158,000-square-foot facility in July 2006.

Agency Overseeing Ex-South Weymouth, MA NAS Redevelopment Rejects Developer's $250K Offer

The South Shore Tri-Town Development Corp., a Massachusetts state agency that is overseeing the redevelopment of the former South Weymouth Naval Air Station, has turned down an offer of $250,000 from developer LNR Property to balance its budget for the fiscal year that ended June 30.

Tri-Town Chief Executive Officer Kevin Donovan said the agency could not accept LNR’s financial offer because it had too many conditions attached to it. One stipulation would have prohibited Tri-Town — a joint venture of Weymouth and nearby Abington, MA, and Rockland, MA — from issuing press notices or making statements in the media about its relationship with LNR.

Other conditions included Tri-Town accepting the money in monthly installments, and showing good faith efforts to facilitate the redevelopment proposed by LNR, Bill Ryan, a spokesman for the developer, told the newspaper. He said Tri-Town also had to show LNR a plan for obtaining bonds to cover the cost of constructing new infrastructure, a wastewater treatment plant, and a parkway on the southern tier of the base.

“We recognize that there are market conditions, capacity issues, and technical challenges, but we need to see a structure that meaningfully shows that they are serious about getting these things done," Ryan told the News. “Over the last six years, we have paid Tri-Town $12 million to cover costs, but we can’t keep doing that if the public partner is not performing and we are not seeing evidence of them performing that shows an end gain."

Donovan said Tri-Town is "actively working on" plans to show how it attempting to obtain bonds to finance the construction of amenities connected to the redevelopment.

LNR and Tri-Town have squabbled in recent months over each other's ability to finance the redevelopment — though both have publicly stated they remain committed to the project. The redevelopment would include a 2 million-square-foot commercial complex designed to accommodate a pharmaceutical company or biotechnology firm — part of much broader redevelopment plans for the shuttered military outpost.

LNR is installing new infrastructure on the northern tier of the base to service the first 500 condominiums that will be built at the base. Plans call for 2,855 housing units in a new community called SouthField, through a mix of housing types that include rentals, apartments, condos, townhouses, single-family homes, and senior apartments. LNR's plan also includes a hotel, an 18-hole golf course, a hotel, a conference center, boutique shops, restaurants, hiking baths, walkways, and recreational fields.

The timeline for constructing these amenities has been pushed back because of Tri-Town's difficulty in obtaining bonds, which the agency blames on the ongoing economic upheaval. Some of those bonds will repay a $35 million loan to LNR to cover the cost of installing new infrastructure for the project’s initial phase.

Precision Stability Storage (PSS) is Expanding cGMP Storage Facility in North Carolina

Precision Stability Storage (PSS) is expanding its cGMP storage facility in Wilson, North Carolina, doubling its size and adding a room for bulk powder and liquid sampling and dispensing.

The expansion will add 8500 cubic feet of stability storage space and 2500 cubic feet of sample storage, which will be in compliance with current good manufacturing practices (cGMP).

PSS has undertaken the expansion to increase its temperature and humidity controlled storage capacity, logistical support and sample data management.

Ken Edwards, director of business development, said: “The size and variety of our walk-in stability chambers, allows us to meet customer demands for storage for the most far-reaching clinical studies and commercial products."

Proximity to Biocluster, Grants Persuades Carbon Nanopores to Open its HQ in Philly Suburb

Proximity to the Philadelphia-area biopharma cluster and the availability of grants targeted to the needs of early-stage companies have persuaded a developer of high-resolution probes used for atomic-force microscopy to establish a new headquarters in the Philadelphia suburb of Malvern.

Carbon Nanoprobes produces carbon nanotubes, which are cylindrically shaped carbon molecules 10,000 times thinner than a human hair and mounted on silicon pyramids. It adds the nanotubes to the silicon tips of atomic-force microscopes, which improves their resolution by tenfold and allows them to produce three-dimensional, atomically scaled images of objects.

The company, which had been based in Seattle's Washington Technology Center, has begun shipping its product to customers that include semiconductor companies and basic research labs. Its nanotubes sell for $250 apiece.

CEO Brian Ruby said his company was drawn to its new Malvern HQ in part because of its closeness to some of its potential customers — namely the pharmaceutical and biotech companies that comprise the greater Philadelphia life-sci cluster.

The cluster recently surpassed the San Francisco Bay Area and placed second only to Boston/Cambridge, Mass., in a Milken Institute report that updated its ranking of the nation's top life-sciences clusters.

"On a cultural level, you've got a pretty fervent and fertile startup community, much more so than I had anticipated. We've had a tremendous number of good vendors, some of whom have asked for stock. This is not something I expected on the East Coast," Ruby said. "I saw it a lot on the West Coast, and I think it's absolutely essential toward successfully building one of these firms, because it aligns everybody's interests, and it seems to be very, very much prevalent out here, too."

The company's new headquarters, situated within 4,522 square feet at 363 Phoenixville Pike, part of the single-building, 104,400-square-foot 335-395 Phoenixville Pike owned by BioMed Realty Trust.

Privately held Carbon Nanoprobes is basing nine employees, including Ruby, at the Malvern HQ. That number will grow over time, Ruby said, adding: "I can't get into specifics, but I can say we have a very aggressive growth strategy."

Carbon Nanoprobes has received $500,000 in working capital in two tranches from the Life Sciences Greenhouse for Central Pennsylvania, or LSGPA. One tranche came from LSGPA's Technology Development Fund, which invests up to $250,000 in projects that show commercial promise but need additional development of the business model, proof-of-concept, or prototype.

The other tranche came from the greenhouse's Gap Fund, which makes convertible debt-to-equity or straight equity investments in pre-seed stage companies ranging from $250,000 to $1 million. It also requires companies to match their award from the LSGPA.

The greenhouse is one of three incubators created by the state to nurture startup companies in the life sciences and other technologies, using a portion of the state's share of the 1999 nationwide tobacco settlement.

Michele Washko, the LSGPA's vice president of strategic services, told BRN the greenhouse agreed in 2006 to add Carbon Nanoprobes to its portfolio, subject to scientific and business milestones. Companies whose management, finances, technology, and target market pass muster with the greenhouse are added to its portfolio, which includes developers of new drugs and therapeutics, medical devices, healthcare IT software, and scientific tools.

"That's how we saw Carbon Nanoprobes: as a tool that would advance the life sciences," Washko said.

LSGPA came across Carbon Nanoprobes through the greenhouse's liaison to Pennsylvania State University in State College, Pa., where the company had a working relationship with researchers that included Randen Patterson of the Eberly College of Science. The company had hoped to use the college's nanofabrication facility, but found the equipment and expertise it wanted at the Washington Technology Center in Seattle.

Ruby said the tech center had a piece of needed equipment that produced carbon nanotubes and cost "a few hundred thousand" dollars, "so we had to go there. In my industry, you kind of have to follow the (capital expenditure)," Ruby said.

"They actually let us take state money, bring it out to Washington because of this cap-ex, and then come back. They were very easy to deal with, in that respect, and they were very aggressive about getting us in," he said. "They had enough latitude, and foresight, to realize that because Pennsylvania could not provide what we needed at that moment in time, they let us shoot over to Seattle.

"We went out to Seattle, we proved what we needed to prove," Ruby added. "There was trust that we would [return to Pennsylvania], and we executed on that. We made good on our promise, and [the state] put extra money on the table.

Also putting money on the proverbial table was the Chester County Economic Development Corp. The private, nonprofit agency helped draw Carbon Nanoprobes to the county's state-created Chester County Keystone Industrial Zone, where early-stage life-sci and information technologies in business for eight years or less are eligible for tax credits — as well as grants toward hiring interns and training staffers.

Within the Chester County KIZ, companies are eligible to receive up to $5,000 per person per year for staff training, and up to $4,000 per person per year for the placement of interns within the KIZ company.

Ruby said the grants, which are awarded first-come, first-served, have "enabled us to create jobs we might not normally have." The training grants allowed the company to hire consultants that have helped it by sharing their expertise in better using equipment, he said.

According to its web site, the Chester County KIZ alone is home to about a dozen life-sci companies, including Johnson & Johnson subsidiary Centocor Ortho Biotech, Frontage Laboratories, Melior Discovery, Neuronetics, Molecular Targeting Technologies, Progenra, Promedior, Reaction Biology, and Tetralogic Pharmaceuticals.

Unlike other KIZ zones across Pennsylvania, Chester County's KIZ consists of seven nodes with numerous corporate parks along the US 202 corridor where life-sci and other high-tech businesses are clustered, rather than a single zone anchored by a university or research institute.

"The reason for that is because we have so many life science and biotech companies in this part of the region," Tim Connor, senior director with the Chester County Economic Development Corp., told BRN.

Carbon Nanoprobes had agreed to grow its work force in Pennsylvania in return for the greenhouse funding, a promise it began to fulfill when it relocated the company to the Keystone State six months ago from Seattle.

Carbon Nanoprobes found the home base it wanted at Phoenixville Pike, a property San Diego-based BioMed Realty acquired in 2005 and renovated three years later by creating four suites with offices and labs within what had previously been warehouse space, at an undisclosed cost. One attraction for the company: BioMed Realty built for it a production facility in the space, which had not been occupied since the publicly-traded real estate investment trust acquired the property.

"One of the things that was fabulous about that deal was that BMR's interest with us is long-term. They have enough space to rent us, so if we expand into a bigger space, they'll rip up our current lease. That's a contractual term; that's not a handshake. That's great for both parties," Ruby told BRN.

Richard Howe, a BioMed Realty spokesman, told BRN that the Phoenixville Pike property "has [speculative] lab space available to accommodate the requirements of wide range of life science and biotech tenants, including smaller companies.” As of March 31, the property's occupancy rate stood at 74 percent, he said.

Before moving to Malvern, Carbon Nanoprobes had been based at the Washington tech center for three years starting in 2006, when it moved west from the BioMed Realty-owned lab-office campus The Landmark at Eastview, in the New York City suburb of Tarrytown.

The company occupied a lab within the headquarters of Progenics Pharmaceuticals, where Ruby interned after he was among the winners of the 2001 Intel International Science and Engineering Fair, which the biopharma company sponsored.

Ruby's work with nanoprobes began as a 15-year-old intern at IBM's Thomas J. Watson Research Center in another New York City suburb, Yorktown. He persuaded Progenics to let him use its technology for his job of imaging proteins being used for possible vaccines.

Ruby founded Carbon Nanoprobes in 2003, while a student at Columbia University's School of Engineering and Applied Science, and graduated from the school three years later. Since then, Ruby said, the company has refined the technology, and raised "somewhere between $4 million and $6 million" in multiple rounds of financing.

Carbon Nanoprobes explored locating to New Jersey a few years back, Ruby said. While not wanting to criticize the Garden State, he contrasted that state, and neighboring New York, with the Keystone State when it comes to how far along businesses must be into early stages before they find economic subsidies.

"Many states put themselves in a much less risky position than the state of Pennsylvania, which was a venture investor. They understood, at the time when they made their initial investment, that we were pretty much a concept company. They were comfortable with that risk profile."

Florida Gives $300K Tax Incentives to NeoGenomics

NeoGenomics Laboratories, a molecular clinical lab in Fort Myers, Fla., will use a $300,000 tax incentive to hire 75 new lab techs, lab directors, pathologists, and support personnel — which will more than double the lab's existing headcount.

The tax incentive was announced by the Lee County Office of Economic Development and reported by a local paper. Fort Myers is based in Lee County.

State officials estimate that the new salaries and additional revenue will eventually generate $12.7 million in taxable receipts.

NeoGenomics, which has been in Fort Myers since 2003, offers testing in cancer genetics, flow cytometry, immunohistochemistry, and molecular diagnostics through its network of regional laboratories. The firm currently employs 72 people, according to the economic-development office.

The economic-development department said $240,000 of the incentive will come from the state while the remaining $60,000 will come from Lee County.

The incentives are part of Lee County's Financial Incentives for Recruiting Strategic Targets, or FIRST, Initiative.

The incentive amounts to a $300,000 taxpayer-funded bet placed by the state and Lee County that NeoGenomics will return the favor in the form of taxable salaries and revenue. This is something the state desperately needs: Regional income has been declining for years, and Florida's current budget shortfall is expected to reach $3.8 billion in fiscal 2010.

NeoGenomics generated $6.9 million in revenue during the three-month period ended March 31 — which is 66 percent better than the same time one year ago. The company also recorded more than $33,000 in net profits during the quarter, and closed out the quarter with more than $857,000 in cash and equivalents.

Azopharma Expands Cytotoxics Capacity

US contractor Azopharma has added new GMP quality cytotoxics and high-potency manufacturing capacity at its facility in Hollywood, South Florida in a bid to strengthen its position in the trial materials sector.

The 7,000 sq. ft. expansion includes three dedicated suites stocked with the requisite equipment, including an MG Futura Capsule Filler, a Bausch & Strobel aseptic filling isolator and XcelodoseTM powder microdosing system.

Azopharma now has 29 manufacturing suites, 11 dedicated cytotoxics production units, two good manufacturing practice (GMP) standard aseptic filling plants and two explosion proof production facilities that were completed earlier this year.

Company CEO Phil Meeks said that the new capacity is a key development for the firm and claimed that: “Our capabilities are unique within the industry based on the depth and scope of our development capabilities which range from discovery to commercialization."

Cytoxics Boost for US CMOs

The market for cytotoxic production looks set to continue growing over the next few years as a rise in demand for novel, potent medications to replenish pipelines coincides with Big Pharma’s efforts to cut back on internal manufacturing capacity.

While this will drive demand of all types of contract drug manufacture, the specialized handling skills needed to make cytotoxics and the investment required to develop such capacity is likely to limit the number of companies offering such services.

A recent Frost & Sullivan (F&S) survey predicted that demand for cytotoxics handling, lyophilisation and the production of small volume parenterals (SVP) would see US contract manufacturing organizations (CMO) regain ground lost to rivals.

In the last year alone Cytovance Biologics, PharmaTek and SAFC have increased their US cytotoxic and high-potency active pharmaceutical ingredient (API) handling capacity.

Another factor likely to drive the market for cytotoxic drugs, and hence the need for more outsourced manufacturing services, is the growing incidence of cancer worldwide.

A recent World Health Organization (WHO) report suggested the number of cases of cancer will grow 50 per cent to 15m by 2020

GWC Lands $110K NSF Stimulus Grant to Develop Protein Biochip

The proteomics products company GWC Technologies said that it has received a Small Business Innovation Research grant from the National Science Foundation to continue developing its Carbon-on-Metal protein array analysis technology.

According to an NSF database, the award amount is $100,000 and it was funded under the American Recovery and Reinvestment Act of 2009.

The Madison, Wis.-based company’s imaging systems analyze protein arrays made on gold biochips, which enables label-free analysis that may “accurately reflect how proteins function in real life,” the company said.

“Our first goal is to demonstrate the superior performance of CoM technology in proteomics analysis,” company CSO Voula Kodoyianni, said in a statement. After that, he said, the research “will focus on new products for the pharmaceutical industry.”

According to the NSF grant abstract, "the broader impacts of this research are to reduce costs and improve the speed of analysis in proteomics research, clinical diagnostics and the development of therapeutic antibodies." It adds that potential markets for the platform include "basic research, lab-on-a-chip diagnostics, drug discovery; forensics; detection of bio-terror agents; and food and crop testing."

Despite Cutbacks, Piedmont Triad Research Park Continues Infrastructure Development

The president of the Piedmont Triad Research Park in Winston-Salem, NC, is vowing that recent layoffs and a scaleback in its business attraction effort won't stop the campus from pursuing a long-term expansion intended to cement its role as an anchor of the life sciences cluster taking shape about an hour's drive west of Research Triangle Park.

PTRP laid off Bill Dean, the director of the research park and head of its recruitment operation, and three support staffers, among cost-cutting moves announced by the research park earlier. Those moves included farming out the marketing of available space at the research park to the university's commercial real estate firm, Pleasants Properties, and shifting the center's focus from recruiting new life-sci employers to fill existing space, to carrying out the extensive infrastructure projects needed for the research park to grow over the next generation.

"More infrastructure work needs to be done before we expect large-scale construction" in PTRP's central district, one of the three districts that comprise the 230-acre research park, said Doug Edgeton, PTRP's president.

"We are about three months away from completion of a railroad corridor relocation. We are in the pre-construction stages of a major storm water management project. We have recently completed placing a series of high voltage lines underground and are now in the process of removing the massive towers that formerly supported those lines. All of the projects are continuing on schedule, and we are still planning for buildings in the park with outside companies and other institutions of higher education," Edgeton added. "We continue to actively work through the project development aspects of the park."

The railroad tracks were moved in order to create a "research parkway" thoroughfare through PTRP.

Edgeton also said PTRP is in talks with a new developer, Wexford Science+Technology, to join with the research park in developing a long-planned expansion that another builder was supposed to have begun. Struever Bros. Eccles & Rouse of Baltimore had been selected by PTRP to redevelop 2.19 million square feet of space within 74 acres comprising the park’s northern district.

This past winter, after the economy soured, Struever Bros. pulled out of the project, which envisioned transforming part of a former RJ Reynolds campus into a mix of biomedical, residential, and neighborhood retail space. The project was part of a larger plan completed in 2003 by Sasaki Associates for a total build-out of 5.7 million square feet in three sections or districts totaling 230 acres. The full build-out is projected to create more than 27,000 new jobs over the next 25 to 30 years, with a total economic impact of more than $1.6 billion.

"Discussions with Wexford continue, and we hope to firm up plans later this year for a mixed-use rehab of former RJR buildings in the North District, as was already anticipated," Edgeton told BRN.

PTRP now encompasses six buildings totaling 554,000 square feet of wet lab, office, meeting, and residential space, all within the central district. The research park is home to 763 salaried employees working in 41 life-sci companies and Wake Forest University academic outposts — from Targacept, the park's largest business tenant, to the Armed Forces Institute for Regenerative Medicine and Wake Forest University's Institute for Regenerative Medicine and Lipid Sciences Program.

Bill Dean remains chairman of the North Carolina Research Parks Network, a coalition aimed at helping PTRP, RTP, and the state's five other research parks brand and locate technology resources statewide, and thus boost the life sciences and other tech sectors. Earlier this month he was elected to a two-year term as president of the North American division of the International Association of Science Parks.

"Although the Park is an entity unto itself, it is supported by Wake Forest University Health Sciences, which, like all academic medical organizations, is facing challenges from the current economy," said Edgeton, who is also executive vice president at Wake Forest University Health Sciences.

Days before the PTRP announcement, WFUHS' parent Wake Forest University Baptist Medical Center disclosed some of those challenges in a report highlighting the amount of "community health benefits" or charity care and health outreach, it provided for the fiscal year that ended June 30, 2008.

According to the Community Benefits Report, WFUHS accounted for $41 million of the total $110.6 million in community health benefits provided by the med center, not counting $34.6 million in uncompensated care for patients who did not pay for services and did not pursue charity care status.

More than half of the $41 million in community health benefits attributable to WFUHS, or $21.5 million, reflected research costs for programs ranging from the regenerative medicine institute — whose director, Anthony Atala, has been a key leader in the Triad's development of a life-sci cluster — to the Comprehensive Cancer Center, Heart Center, and Public Health Sciences units.

Wake Forest University Baptist Medical Center is operated by the North Carolina Baptist Hospital and the School of Medicine at Wake Forest University. The university has seen its endowment fall by 24 percent over the last six months of 2008, to $1.27 billion. In January of this year, the school cut its budget by 5 percent and froze hiring for staff, though not faculty.

Wake Forest's research presence at PTRP also includes the Babcock Demon Incubator, which operates under the WFU Babcock School of Management’s Angell Center for Entrepreneurship. In April, the BDI won $70,578 from the state-funded North Carolina Biotechnology Center, matched with $35,739 from the incubator itself, toward equipment allowing for the expansion of the 780-square-foot wet lab announced last year, with an eye to accommodating multiple startup life sciences and nanotechnology companies.

BDI is one of two incubators at PTRP; the other is the Wet Lab LaunchPad, which has accommodated later-stage startups at a cost lower than the research park's standard lab space since opening more than 18 months ago.

Edgeton said the cutbacks at PTRP did not signify that the Triad region — anchored by the cities of Winston-Salem, Greensboro, and High Point — could not build up its own life-sci cluster, as RTP has done successfully over the past half-century.

In interviews with BRN, three business groups that serve life sciences employers in and around Winston-Salem agreed that PTRP's retrenchment from earlier expansion plans doesn't signify a broader retreat from building a biocluster in the Triad region.

Donald Kirkman, president and CEO of the Piedmont Triad Partnership, cited the presence of 87 life-sci companies within the 12 counties served by his group, the region's primary economic development marketing organization, in addition to the Wake Forest departments.

"We have a lot of activity throughout the entire 12-county region that goes far beyond the work of that research park, although the research park is certainly a very important anchor asset for us. I don’t think that will impede the recruitment efforts of Winston-Salem, Forsyth County, or the research park," Kirkman said on Thursday. "The region is continuing to see very robust activity in biotechnology and nanobiotechnology."

He cited Becton Dickinson's June 9 announcement that it would add 20 jobs this fall, and as many as 100 in the near future, in the Alamance County community of Mebane, NC. BD will spend $20 million to buy a 100,000-square-foot building, at 1022 Corporate Park Drive within the North Carolina Industrial Park, where it will base 40 employees — half to be shifted from Burlington, NC, the rest to be hired starting this summer — focused on assembling lab instruments for use in detecting cancer. The building can be expanded by an additional 50,000 square feet. Next to the building, BD bought about 7 acres for a future expansion.

The regional biocluster, he said, may well evolve toward more nanobiotech activity, as three regional academic institutions advance in their development of the North Carolina Center of Innovation in Nanobiotechnology, or COIN. The consortium earlier this month won a $2.5 million, four-year grant from the state-funded North Carolina Biotechnology Center toward the second phase of enabling COIN to establish itself as an independent, self-sustaining entity that will help commercialize nanobiotech research from the state's universities.

North Carolina A&T State University and the University of North Carolina at Greensboro joined with Wake Forest University to develop COIN in 2007, through a consortium formed to advance nanotech collaborations between the schools. COIN's executive director, Brooks Adams, was named earlier this year.

NCA&T and UNCG have established the Joint School for Nanoscience and Nanoengineering, a roughly $60 million, two-campus collaboration focusing on nanotechnology.

"I anticipate, later this summer, announcements of some targeted initiatives to really jumpstart the activity at the park while they work through the physical planning and infrastructure development at the park itself," Kirkman said. "You'll be hearing in the coming months about some significant new initiatives coming out of Winston-Salem that will be very much focused on the research park, and trying to grow the Institute for Regenerative Medicine, the nanobio- and nanomedical competencies of Wake Forest."

He and leaders of two business groups serving the Winston-Salem metro area said they expected Winston-Salem and the Triad to grow their life-sci clusters through a mix of employers already in place and new arrivals to the region.

"I don't think we will lose a step at all in terms of being able to serve a client that has an interest in our park and our community as a bio- or life science location," said Bob Leak Jr., president of Winston-Salem Business, the economic development organization that promotes Winston-Salem and the rest of Forsyth County.

In an interview Tuesday, Leak said that the Triad has attractions for life-sci companies allowing it to stand out from RTP. While the Triad's overall cost is "maybe 8 to 10 percent" below RTP's, and facility costs are just 5 to 10 percent below those of the Research Triangle region, housing costs are significantly cheaper at "15 to 20 percent less," he said.

"We have always seen ourselves as kind of a complementary location to companies that want to be near Research Triangle Park, but maybe don’t want to compete with some of the costs associated with that park, or maybe being a small company in a big pond, if you will," Leak told BRN. "Small to medium sized companies can be players in our park without being under the shadow of the big [GlaxoSmithKlines] and those kinds of [companies]."

"We've really promoted ourselves as a location that provides access to RTP, without some of the congestion and cost issues that are associated with physically being in RTP and Charlotte," Leak added. "There's not a lot of traffic congestion here, compared with around Charlotte and RTP. That's always been a positive for us."

While Winston-Salem Business focuses on marketing Winston-Salem and Forsyth County externally, existing businesses in the region's life sciences and other industries are the focus of the Winston-Salem Chamber of Commerce.

"We are still developing a biotech and a life science cluster here. None of our plans have changed," Peggy Low, the chamber's senior vice president of technology and strategic initiatives, told BRN. "We do have a tougher economy, and a few new challenges, but we're continuing to move ahead. We still have a lot of good companies that are doing very well."

Low said the chamber's Eighth Annual Technology Briefing, which took place March 24, featured presentations from life sciences companies among the 10 tech-based businesses invited. The industry's presence is significant enough within Winston-Salem, Low said, that one of the presenting companies at the briefing, Out of Our Mind Animation Studios, has developed video simulations for life-sci companies.

Also aiding the Triad's cluster development, Low said, has been the ability of companies to find local workers through a pair of community colleges. Alamance Community College is the state's oldest biotech program, with some 275 graduates over the past 24 years. The region is also home to the largest two-year school life-sci program at Forsyth Tech Community College, which has graduated more than 100 students, according to a presentation based on a Tracking Study of Biotech Graduates, published this month.

Genzyme Reports Progress Related to Allston Plant

Genzyme Corporation has provided an update on its progress toward restoring production at its Allston Landing manufacturing facility and in implementing temporary supply management measures. The company recently announced that it had interrupted production of Cerezyme^® (imiglucerase for injection) and Fabrazyme^® (agalsidase beta) at the plant to sanitize the facility, after identifying a virus in a bioreactor used for Cerezyme production. The virus impairs the viability of cells used in the manufacturing process and is not known to cause infection in humans.

Following a collaborative interaction with FDA and EMEA, Genzyme has begun shipping product from finished lots of Cerezyme held in inventory, after PCR testing detected no evidence of Vesivirus 2117. Shipments of Fabrazyme were not put on hold.

“We continue to make strong progress toward resolving this situation as quickly as possible, thanks to a broad group of employees across the company who have been working around the clock,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer. “We are confident that the Allston plant will be back online later next month, that we will be able to minimize the impact of constrained supply, and that the measures we are implementing will prevent this issue from occurring again. The support we have received from regulatory authorities, patients, suppliers, and from our industry peers who have shared their experiences and offered expertise and resources, has been heartening.”

Because Cerezyme and Fabrazyme inventories are not sufficient to avoid shortages during the period of suspended production and recovery, Genzyme has begun working with regulatory authorities, physicians and patient organizations to carefully manage product supply, with the goal of protecting the most vulnerable patients. The company met with the National Gaucher Foundation’s medical advisory board to formulate clinical guidelines for use by U.S. and other physicians during the period of Cerezyme supply constraint. Genzyme will also convene meetings to facilitate the creation of guidelines for managing Fabrazyme supply. In Europe, following the recommendations of the EMEA, Genzyme will issue a letter to health care providers establishing an approach for the use of Cerezyme and Fabrazyme throughout the European Union during the anticipated period of supply constraint.

At the Allston plant, Genzyme is following a well-established and proven method for removing viruses, which includes disassembly and removal of equipment, cleaning, disinfection of cell culture and downstream production suites with vaporous hydrogen peroxide, installation of new air filters and insulation, and other measures. The disinfection process has begun, and the company remains on track to complete this work and restore operations in all cell culture suites and downstream processing areas by the end of July. Once the sanitization of the plant has concluded, equipment will be reassembled, tested and brought back into operation, and production will resume on a rolling basis. Genzyme will not have to perform process validation runs in order to resume production.

Genzyme continues to evaluate the impact of the interruption in production on the timing and magnitude of constraints on Cerezyme and Fabrazyme supply. The company currently expects the period of constraint for each product to last approximately 6-8 weeks. This period is expected to begin in August for Cerezyme and October for Fabrazyme. Genzyme will provide updated financial guidance reflecting the impact of this situation as soon as possible.

Genzyme has now confirmed that the Vesivirus 2117 strain identified at the Allston facility also contaminated production twice in 2008, once at the Allston plant and once at Genzyme’s biologics plant in Belgium. Although Genzyme was not able to detect and identify the virus until this year after it developed a highly specific assay, it took precautionary measures in 2008 and sanitized both facilities at the time. The virus was likely introduced through a raw material used in the manufacturing process, and the company is collaborating with its suppliers to address this issue and implement steps to protect against recurrence. Genzyme is also evaluating adding steps to its raw-materials screening and virus-removal processes to make them more robust, including testing all of its raw materials for the presence of Vesivirus 2117 using the highly specific assay it developed.

In addition, Genzyme is collaborating with other biologics manufacturers to learn from their experience and apply this knowledge to resolve the current situation and implement enhanced safeguards. Genzyme intends to share its own experience with this virus through appropriate mechanisms so that others within the industry may benefit. This includes working to ensure that an assay for Vesivirus 2117 becomes widely available to the industry.

Genzyme has been operating with lower than usual inventories of Cerezyme and Fabrazyme because it has allocated capacity for Myozyme® (alglucosidase alfa) production at the Allston plant. Myozyme’s worldwide growth has been rapid and strong, and the capacity requirements for the product are substantial because its approved dosage is significantly higher than for similar therapies. Genzyme has been executing a plan to provide additional capacity to support the long-term growth of these three products. Recently, the company received approval in the EU for manufacturing Myozyme at the 4000-liter bioreactor scale at its plant in Belgium. The company is in the process of transitioning all Myozyme production to this plant, which is currently being expanded with the addition of a third 4000-liter bioreactor that is scheduled to come on line in 2011. This will bring Genzyme’s total investment in the plant to nearly $500 million since 2001.

In addition, Genzyme is in the late stages of construction on a new plant in Framingham, Massachusetts, for the production of Cerezyme and Fabrazyme. This plant, which will include four 2000-liter bioreactors, will provide substantial additional capacity to support the growth of the two products. Genzyme is investing approximately $300 million to build this facility. It expects to begin qualification runs next year and anticipates regulatory approval for the production of Fabrazyme in 2011 and for the production of Cerezyme in 2012.

Covance Doubled Capacity at Its Facility in Madison, WI

The expanded facility will offer clients preclinical, clinical and chemistry, manufacturing and control (CMC) services, which allows Covance to provide a complete molecule development program.

Expanding the facility’s CMC capacity is seen as an important step by Henry Hummel, vice president and general manager, Madison sites, Covance.

Hummel explained: "Together with our integrated discovery, preclinical and clinical service offerings and dedicated program management team, we can now offer CMC analytical services as part of an entire molecule development program."

The company offers a suite of CMC services, including analytical method development, validation and transfer, stability and product release testing.

Hummel added: "Covance is committed to providing world-class CMC analytical services for our clients to provide the highest quality data and reduce developments timelines.”

The expansion houses upgraded stability chambers equipped with high-density tracked shelving, which Covance claims will significantly increase pharmaceutical analysis service capacity and utilization.

Warnex Lab Gains ISO Clearance

Life sciences analytical testing services company Warnex said that it has received International Organization for Standardization (ISO) certification from the Standards Council of Canada (SCC).

The ISO 15189:2007 accreditation standard covers the quality management of the company's medical laboratory services, test result interpretation, sample handling and analysis, and turnaround time.

The Laval, Quebec-based Warnex offers genetic and biochemical testing and it has expertise in pharmacogenetics, molecular diagnostics, and human identification.

Asterand Ponders Move from Detroit's Tech Town to Ann Arbor, MI

Asterand, the anchor tenant at Detroit's TechTown, is considering relocating from the incubator and technology park associated with Wayne State University to Ann Arbor, Mich., about an hour's drive west, and developing affiliations with the University of Michigan, Crain's Detroit Business reported.

Martyn Coombs, CEO of the tissue bank company, told the newspaper he has rescinded a tentative renewal lease agreement with TechTown, and retained two real estate brokers to scour for sites in Ann Arbor, after concluding that WSU President Jay Noren had neglected the company despite it being the best performer on the London Stock Exchange last year.

“We could benefit from the help of a good research university. I'm not sure Wayne State is interested. We are looking for top-notch research partners and have reached out to Wayne State with little success," Coombs said, adding: "I assume the University of Michigan would be interested.”

One reason for the perception of neglect, Coombs told the newspaper: Asterand leases its space at $27 a square foot, a rate he said was over-market and only served to help subsidize other TechTown operations. TechTown sought to address that concern, he acknowledged, by offering Asterand $25.50 a square foot.

Coombs acknowledged that getting a better lease rate is one reason for the potential move, but told Crain's his major motivation is his feeling of neglect. Coombs hopes to decide on a move by the end of September.

Victoria Blanc, general manager of Asterand's US operations, wrote a letter expressing concerns about the relationship to Noren last Dec. 15. A response was written on March 2 by John Davis, the school's CFO and vice president for finance. Blanc followed up with another letter to Noren on April 3 asking for a meeting, but said she had yet to get a response.

Blanc told the newspaper one attraction Ann Arbor offered Asterand was the prospect of lower rent; she projected about $21 to $22 per square foot, as UM prepares to occupy the former Pfizer campus it recently announced it would acquire.

Coombs offered another attraction of Ann Arbor: the prospect that Asterand may acquire a company now based there.

Coombs disclosed to Crain's another sticking point between his company and TechTown — what the company perceives as Wayne State's not doing enough last year to help it land a $4 million contract, administered through the university, with the National Institutes of Health

to run its Perinatal Research Branch. That contract instead went to Maryland-based Fisher Bioservices, which recruited away an Asterand employee, Abdalla Doleh, to oversee the NIH perinatal branch.

Blanc told the newspaper the real estate brokers have been active “for a period of months” targeting Ann Arbor and looking elsewhere in Southeast Michigan, as well, including the I-94 corridor.

Asterand occupies 14,000 square feet on TechTown's fifth floor, about half of which is office space and half wet and dry labs. Sixty of the company's 90 employees work at TechTown, while most of the rest are based in England. The company's lease expired almost a year ago, Blanc said.

Skanska Signs Contract to Build $220M Nemours Children's Hospital in Orlando, FL

Skanska has signed a SEK 1.7 billion ($220 million) contract to provide construction manager at-risk services to build Nemours Children's Hospital in the Medical City section of the Lake Nona mixed-use master planned community in Orlando, FL.

The 630,000-square-foot hospital, to be built on a 60-acre site, will feature research centers as well as a 95-inpatient bed tower, emergency department, diagnostic and ambulatory programs, education and research centers, and an outpatient clinic on a 60-acre greenfield site. The facility is designed to allow Nemours to provide access to a full line of specialty services, and improve pediatric care to the region.

The facility will seek to achieve certification under the Leadership in Energy and Environmental Design energy efficiency rating system, developed by the US Green Building Council. Site work will commence in June with a scheduled completion date of June 2012.

Stanley Beaman & Sears is the architect of record, while Perkins+Will serves as associate architect.

Dendreon Plans Phased $50 Million Expansion of New Jersey Plant Built in 2006

Dendreon is looking to expand its therapeutic biotechnology processing facility in Morris Plains, NJ, at a projected cost of $50 million, the company said in a regulatory filing.

The Seattle biotech has hired the Henderson Corp. to manage construction of a two-phase expansion of its Morris Plains facility, designed to process the immune cells of patients to boost their ability to fight cancer, before those cells are re-infused into them.

Additional quality control laboratories, data center, training areas, infrastructure and offices are scheduled to be completed by mid-December. The final phase, with additional manufacturing clean-room work stations, production support areas, warehouse, infrastructure and offices, is to be substantially complete by April 23, 2010.

Dendreon finished the initial build-out of the 158,000-square-foot facility in July 2006, before its application to the US Food and Drug Administration for the Provenge prostate-cancer immunotherapy was tabled to await additional clinical results.

BioMed Realty Trust Closes New $18M Loan Secured by San Diego Building

BioMed Realty Trust has closed on a new $18 million loan secured by the laboratory developer's 9865 Towne Centre Drive property in San Diego, an 84,000-square-foot building that is fully leased to Illumina.

Completed in the second quarter of 2008, 9865 Towne Centre Drive earlier this year received certification from the US Green Building Council for the building's core and shell meeting the silver standard of the LEED energy efficiency rating system.

Illumina leases a total of approximately 193,000 square feet through October 2023 at the Towne Centre Drive campus in San Diego.

In a statement, Kent Griffin, BioMed's president and chief financial officer, named the lender as Washington Capital Management and praised it for its participation.

Bill Before Congress Could Aid Redevelopment of Ex-South Weymouth, MA Naval Air Station

The redevelopment of the former South Weymouth, MA Naval Air Station into a mixed-use campus that would include a 2 million-square-foot commercial complex designed to accommodate a pharmaceutical company or biotechnology firm could benefit from a bill pending in the US Congress that would permit the federal government to convey the property titles of surplus military bases at no cost to local communities, the Weymouth News reported.

The House Armed Services Committee on June 18 approved the bill, which will provide the Department of Defense with authority to negotiate land conveyances with local governments, in the hope that they will redevelop more quickly military sites shut down through the Base Realignment and Closure, or BRAC, process.

The bill has been included in the National Defense Authorization Act, which passed the US House of Representatives, but which President Obama has threatened to veto because the measure includes $369 million for more F-22 fighter jets and $603 million for the alternative engine program for the F-35 Joint Strike Fighter Program — a pair of programs he and Defense Secretary Robert Gates have denounced as wasteful.

"As we grapple with the economic recession and troubles in the housing market, the Congress now realizes that it is important to ease the financial burden of local communities in redeveloping former military bases, such as the South Weymouth Naval Air Station," said US Rep. William Delahunt (D-Quincy), a key proponent of the bill, in a written statement. "This legislation will help with the redevelopment of the base and the SouthField project, which is so critical to the economic development of the South Shore."

SouthField, a project of base developer LNR Property, calls for building 2,855 housing units over 14 years, through a mix of housing types that include rentals, apartments, condos, townhouses, single-family homes, and senior apartments. The plan also includes a hotel, an 18-hole golf course, a hotel, a conference center, boutique shops, restaurants, hiking baths, walkways, and recreational fields. LNR is installing new infrastructure on the northern tier of the base to service the first 500 condominiums that will be built at the base.

Construction, however, hinges on the transfer of 835 acres by the Navy to South Shore Tri-Town Development Corp., the state agency that is overseeing the redevelopment of the property. Tri-Town, which has no credit history, has been unable to obtain bonds to complete the sale, delaying the start of work. The Navy has requested $43 million for the parcels, an amount Tri-Town is seeking to lower through negotiations with naval officials; Tri-Town must propose a price for the acres no later than July 31.

While Navy officials have publicly voiced concern about Tri-Town’s ability to fulfill terms for a property transfer, LNR and Tri-Town have sought to reassure local officials they remain committed to the project.

$10 Million Grant from NIMH to Establish Neuroscience Research Center at Stanford U School of Medicine

The National Institute of Mental Health has awarded neuroscientists at the Stanford University School of Medicine a $10 million, five-year grant to establish and operate a Silvio O. Conte Center for Neuroscience Research.

The Stanford Conte Center will be devoted to the study of how the brain's synapses and circuits change during development or when exposed to changing conditions. The center hopes to apply its research on this change, or neuroplasticity, toward better understandings of schizophrenia, autism, bipolar disorder, pain syndromes and other conditions.

Robert Malenka will serve as the center’s director. He will be joined by Stanford professors Thomas Südhof, the Avram Goldstein professor of medicine, and Karl Deisseroth, associate professor of bioengineering and of psychiatry and behavioral sciences; as well as Lu Chen, associate professor of neurobiology at the University of California, Berkeley.

Norwich’s Developmental Expansion Continues

Norwich is continuing to diversify and expand its offering by adding pilot scale production and capacity to develop high potency compounds.

The contract manufacturing organization (CMO) has stated it is taking an aggressive approach, which has seen the company expand beyond its traditional focus on commercial scale manufacturing and packaging.

Norwich believes that biotechs are increasingly seeking full service outsourcing offerings and the CMO has expanded its offering to meet this demand.

Referring to its pilot scale production Chris Calhoun, president of Norwich, said: "Small scale development studies require a broad range of equipment. We invested in new, state-of-the-art particle sizing equipment, tablet compression equipment, high shear granulation, fluid bed and mixers with capacities in line with the requirements of formulation activities.

"Our engineers have been diligently comparing the specifications of equipment making certain that what we were putting in place could be scalable and adaptable to meet the varied requirements of several pilot programs at one time."

The company has also added potent compound development capabilities, investing $3m (€2.2m) in the infrastructure, controls and equipment that is needed.

This includes the installation of a HVAC (heating, ventilation and air conditioning) system capable of 20 room air changes per hour and use of HEPA (high efficiency particulate air) filtration to eliminate the risk of cross contamination

Having added this capacity the CMO will be able to produce highly potent clinical trial material, including fast dissolve and controlled release tablets.

The additions to Norwich’s capacity are part of its attempts to diversify, which began with the expansion of its developmental services.

By making these investments Norwich hopes to equip itself to deal with “any technical service request”. This spans from single, specialized services, such as improving quality control processes, up to complete end-to-end assistance.

Dendreon Sets Aside $50 Million for Provenge Facility Expansion in New Jersey

US biotechnology company Dendreon revealed its confidence in lead drug Provenge for prostate cancer with the announcement it will invest up to $50 million in production facilities for the product.

Dendreon still doesn't have any products on the market but has high hopes that active cellular immunotherapy Provenge (sipuleucel-T) will be its first commercial product, and a blockbuster to boot.

And unlike many biotech companies in these lean times, the company also has financial resources at its disposal, having closed last month on a $221 million financing round that was intended to fund the manufacturing expansion, as well as other operational activities such as the creation of sales and marketing capabilities.

Dendreon says it plans to file for approval of Provenge in the fourth quarter of 2009 based on the results of the recently-unveiled IMPACT trial, which found a four-month increase in overall survival for the drug compared to placebo in men with advanced prostate cancer.

The survival improvement is greater than has been seen in trials of chemotherapy in this patient group and that efficacy, coupled with the fact that prostate cancer is one of the most frequently-diagnosed malignancies in men, has buoyed up product sales forecasts. For example, analysts at Rodman & Renshaw have suggested Provenge could achieve $2 billion in peak sales.

In a filing to the US Securities & Exchange Commission, Dendreon said that it had retained construction firm Henderson to build "phase II and phase III" of its 158,000 sq. ft. therapeutic bioprocessing facility in Morris Plains, New Jersey`

The unit has already been used to make supplies of Provenge for clinical trials, alongside Dendreon's pilot plant in Seattle.

Phase II of the project will see the addition of more quality control laboratory space, a data centre, training areas and offices and is expected to complete by the end of the year the firm said. Phase III is due to end in April 2010 and will add manufacturing cleanrooms, production support areas, warehousing and additional offices.

Maryland Restructures University of Maryland Biotechnology Institute (UMBI)

The Board of Regents of the University System of Maryland announced it will restructure the University of Maryland Biotechnology Institute to align its four research centers and their staffs with other USM campuses, in hopes of boosting research collaboration activity and access to outside research funding.

One key restructuring goal: USM hopes to multiply the $25 million in annual research funding now generated by UMBI.

"It also is expected to yield a higher level of technology transfer, commercialization, and business start-ups, and thereby advance economic development statewide," USM said in a statement.

USM Chancellor William Kirwan added in a statement that the restructuring "has the potential to double the research productivity of UMBI’s current assets within five years.”

Established in 1985, UMBI's areas of research include biotechnology's application to human health, the marine environment, agriculture, and protein engineering/structural biology. The institute currently comprises four centers: Center for Advanced Research in Biotechnology, or CARB, in Rockville; Center for Biosystems Research, or CBR, in College Park; Center of Marine Biotechnology, or COMB, in Baltimore; and the Medical Biotechnology Center in Baltimore. UMBI also includes the Institute of Fluorescence in Baltimore.

The restructuring had been recommended in a study carried out by UM Regents Chairman Clifford Kendall. He cited what he termed flaws with the existing structure: A lack of a critical mass of graduate and undergraduate students involved in UMBI research; isolation among UMBI’s research centers; an inability to scale up UMBI programs for greater efficiency; and administrative inefficiencies.

"With a focus on collaboration — across disciplines and across institutions — and with recognition of the exceptional talent within the UMBI community and the system’s other institutions, this action will position USM to take fuller advantage of its system-wide strengths in the biosciences and to fuel the state’s knowledge economy even more," Kendall said in a statement.

The move isn’t a total surprise, according to the Washington Business Journal, which reported that several schools in the USM had been angling for a piece of UMBI’s real estate, laboratory space, and scientific talent, while the institute had hoped to remain a stand-alone entity.

Under the restructuring:

USM will establish a joint research center at CARB facilities in Rockville. The system’s flagship College Park campus will oversee the facility, then work with the University of Maryland, Baltimore to elevate work in physics, engineering, and computational sciences; as well as structural biology, protein design and drug discovery.

UMBI’s Center for Biosystems Research will also be overseen by College Park.

A joint research center at COMB will be established, with administrative responsibility falling to the University of Maryland, Baltimore County. UMBC will collaborate with the University of Maryland Center for Environmental Science and the University of Maryland, Baltimore to drive research in environmental and genomic sciences.

The Medical Biotechnology Center will fall under the University of Maryland, Baltimore’s purview.

UMBI’s Institute of Fluorescence will be administered by UMBC.

UMBI’s K-12 educational programs will be overseen by Towson University with an eye on enhancing its teaching focus.

UMBI President Jennie Hunter-Cevera is stepping down June 30 after 10 years in the position, to become executive vice president of discovery and analytical sciences and corporate development at the nonprofit R&D organization RTI International, which is based at Research Triangle Park.

Dearth of State Funds Could Stretch Construction Period for CU Boulder Biotech Building

The University of Colorado will leave its $179.8 million biotechnology building an empty shell until it can raise enough funding to complete it, after a subcommittee of CU regents gave preliminary approval to splitting construction of the facility into two projects.

The modification of construction plans comes about two months before an anticipated groundbreaking, and requires approval of the full Board of Regents.

Frank Bruno, the Boulder campus's vice chancellor for administration, told CU leaders that the campus wanted to split the construction into two projects so the university could begin constructing the building sooner, in the absence of state funding.

Of the $148 million in initial funding for the entire biotech project, $66.5 million will be privately raised, with CU Boulder matching that amount, followed by $15 million in federal funds, and — eventually — $31.8 million from the state.

The first phase of the project would be about 262,000 square feet, and include an auditorium and three wings that will house labs and university departments. The second phase would be a 50,240-square-foot wing for undergraduate classes and the Department of Chemical and Biological Engineering.

Construction of the main building could take two years — but no date has been set for when the final wing of the building would be completed, since it hinges on state funding. CU's Boulder campus will ask the state for $26.95 million in 2010-11 and $4.82 million in 2011-12 for the project.

The biotechnology building is designed to bring together researchers now based in labs throughout the campus. The facility is credited with helping return Nobel laureate Tom Cech back to CU; he will be based there.

With $1 Million in Hand from WI, Exact Sciences Moving to Madison from Marlborough, MA

Exact Sciences has received a $1 million loan from the Wisconsin Department of Commerce to relocate its headquarters and operations from 100 Campus Drive in Marlborough, Mass., to University Research Park in Madison, Wis.

The loan and relocation was announced by Wisconsin Gov. Jim Doyle. The molecular diagnostics firm, which has developed a technology to screen for colorectal cancer, will use the funds to purchase equipment and support other relocation costs.

The Department of Commerce said in a statement that the firm will make a significant investment in the relocated operations and could create as many as 150 jobs over five years. As of the end of 2008, Exact Sciences had four full-time employees.

As part of a restructuring last year, Exact Sciences eliminated eight positions, or 67 percent of its staff, to cut costs. A few months ago, the firm brought in Kevin Conroy to serve as president and CEO. Conroy formerly was president and CEO of Third Wave Technologies, a Madison-based molecular diagnostics maker that was acquired last year by Hologic for $582 million. In addition to Conroy, Exact also hired Maneesh Arora, former CFO of Third Wave, to be CFO of Exact.

"The assistance provided by the governor was a critical part of our relocation decision," said Conroy in a statement. "We know from past experience that Wisconsin, and the Madison area, in particular, is a great place to build a biotechnology company."

Tom Wellen, executive director of the nonprofit Marlborough 2010 Corp., told the Worcester (Mass.) Business Journal that while it's disappointing that Exact Sciences is leaving, he knows of companies that have waited years to get space in one of the Campus Drive buildings.

Earlier this year, the cash-strapped firm sold to Genzyme certain intellectual property assets related to the fields of prenatal and reproductive health in a deal that is expected to provide it with a cash infusion of $24.5 million. The agreement with Genzyme ended Sequenom's hostile bid to acquire Exact Sciences for around $41 million.

The firm also announced that it had closed an $8.2 million private placement of 4.3 million shares of its common stock.

Georgia Competing for 1,000-Person Life-Sci Facility Eyed for Metro Atlanta

Georgia is among several states competing for the facility of a biotechnology company that could employ at least 1,000 in metro Atlanta, the Atlanta Business Chronicle reported.

The newspaper described the facility as "what might be a vaccine or pharmaceutical manufacturing operation that could locate on more than 100 acres."

Georgia economic development officials would not comment on the recruitment campaign, which has been dubbed “Project Boss” and headed up by Carol Henderson, director of the Innovation and Technology Office at the Georgia Department of Economic Development, the Business Chronicle reported.

Project Boss was “planning to potentially deploy two manufacturing facilities” that combined could employ about 1,500, according to a request for information dated June 5, 2008. The RFI also noted that the facilities could be located in the same region, or in separate locations with international air access, available life science labor, and an ability to source and attract engineers and PhDs.

The company has since downsized those initial plans — and has also scouted the suburban Atlanta counties of Cobb, Douglas and Gwinnett, the newspaper reported.

“It would be an outstanding recruitment [tool for new business],” said Mike Cassidy, president of the Georgia Research Alliance.

It would also fill a longtime hole in Georgia's life sciences effort. The Peachtree State has won praise for its Georgia Research Alliance, formed to commercialize technologies developed by the University of Georgia, the Medical College of Georgia, Emory University, Clark Atlanta University, the Georgia Institute of Technology, and Georgia State University. Georgia is also home to laboratories of the US Centers for Disease Control and Prevention and the American Cancer Society.

But Georgia has faced tough competition from other states, especially North Carolina, for life-sci employers and their jobs. In 2006, Georgia waged an eleventh-hour campaign to attract a Novartis manufacturing plant now under construction in Holly Springs, NC, only to lose out when the company chose the Tar Heel State over Maryland.

And last December, the US Department of Homeland Security chose Kansas over Georgia, Texas, North Carolina, and Mississippi as the site of a planned National Bio and Agro-Defense Facility. Georgia's bid suffered after Athens FAQ, also known as “For Athens Quality-of-Life,” persuaded hundreds of local residents to attend public hearings where dozens spoke out against the project.

Hershey, PA Center for Applied Research Delays Second Building

The Hershey Center for Applied Research (HCAR) has put on hold plans for a second research building of 100,000 square feet that, like its current building, would have been built by owner/developer Wexford Science + Technology, the Central Penn Business Journal has reported.

Laura Butcher, HCAR's executive director, said HCAR's expansion plans have been snagged by tighter rules from lenders in the capital markets and fewer tenants to fill the existing 80,448-square-foot HCAR building. Opened in May 2007 the building is one of up to a dozen buildings totaling 1.2 million square feet envisioned for a 165-acre campus near Penn State University's Milton S. Hershey Medical Center and College of Medicine.

Butcher said HCAR and Wexford were seeking federal and state funds to help them construct the second building, projected to cost $40 million. HCAR has applied for a $1 million grant under the $787 billion American Recovery and Reinvestment Act, the economic stimulus measure enacted by President Obama in February.

Butcher told the Business Journal HCAR must reach three milestones before it can proceed with the second building. Because of the current economic upheaval, potential lenders want the second building to be at least 60 percent pre-leased to tenants, including at least two anchor tenants. In addition, would-be lenders want HCAR to lease more space in the existing building, from the current occupancy rate of 70 percent to at least 85 percent full.

To speed construction of the second building along, HCAR has hired Jack Atchason as its new director of business development. Atchason, who started May 18, has the task of marketing the new building to tenant prospects.

HCAR hopes to recruit as tenants several startups launched by executives recently laid off from pharma giants.

Life-Sci Company Miltenyi Biotec Buys 60K-Sq.-Ft. Auburn, CA, Building

German-owned Miltenyi Biotec has purchased a 60,000-square-foot building within the Auburn, CA Airport Business Park from the Abbey Co., a Long Beach, Calif.-based real estate company. The sale price was not disclosed.

Abbey paid $10 million when it bought the four-building, 256,000-square-foot business park in 2007. Among the buildings is 2303 Lindbergh Street, which was sold to Miltenyi. The company develops, manufactures, and sells more than 1,000 products focused on cell biology, immunology, regenerative medicine, and molecular biology.

Hamner Institutes, UNC Chapel Hill Launch Drug Safety Sciences Institute

The Hamner Institutes for Health Sciences and the University of North Carolina at Chapel Hill launched the Institute for Drug Safety Sciences, with the recent dedication of a 14,000-square-foot, state-of-the-art research laboratory located on the Hamner’s 56-acre campus in Research Triangle Park.

The Institute will be led by Paul Watkins, an expert in drug-induced liver injury who also serves as the Verne S. Caviness Distinguished Professor of Medicine at UNC-Chapel Hill. The institute said in a statement Watkins has assembled a core group of internal scientists and academic partners to develop new global drug safety initiatives, in collaboration with the bio/pharmaceutical industry, the National Institutes of Health, and the FDA. A major initial focus of the institute, it said, will be to develop new computational models and in vitro assays, starting first with evaluating liver toxicity, and expanding into cardiovascular and kidney drug side effects.

The Hamner and UNC committed to raising the $10 million needed for the new institute on June 11, more than a year after the Hamner and UNC in April 2008 signed a memorandum of understanding pledging to collaborate in developing the institute.

“The Institute for Drug Safety Sciences is positioned to make transformative advances in human predictive safety sciences that will accelerate the development of new and safer therapeutics,” said William Greenlee, President and CEO of the Hamner Institutes for Health Sciences.

PSS Expanding cGMP Storage Facility

Precision Stability Storage (PSS) is expanding its cGMP storage facility in Wilson, North Carolina, doubling its size and adding a room for bulk powder and liquid sampling and dispensing.

The expansion will add 8500 cubic feet of stability storage space and 2500 cubic feet of sample storage, which will be in compliance with current good manufacturing practices (cGMP).

PSS has undertaken the expansion to increase its temperature and humidity controlled storage capacity, logistical support and sample data management.

Azopharma Expands Cytotoxics Capacity

University of Buffalo Starts Construction of New Cleanroom

The University of Buffalo has begun construction on a $61 million engineering building. The building will include a cleanroom, cybertorium, and flexible research labs, classrooms, and meeting areas.

The construction is part of a $362 million construction project funded by New York State and private donors. The funding and construction has resulted in over 1,000 new construction jobs and will raise more than $2 billion in regional economic activity.

The 2006 grand opening of the University at Buffalo's New York State Center of Excellence in Bioinformatics and Life Sciences was hailed by local and university officials as a milestone in Buffalo's transformation from rust-belt city to a hub for groundbreaking life sciences research and industry. Just three years later, evidence of that transformation and how much UB and its Center of Excellence is a driver of the region's new economy was apparent at the 2009 Explore Buffalo Niagara Investor High-Tech Forum held June 25 in the Albright-Knox Art Gallery, 1285 Elmwood Ave. in Buffalo. The High-Tech Forum was a highlight of the Explore Buffalo Niagara 2009 program.

UB's Center of Excellence is part of UB's emerging Downtown Campus. New projects on the campus include renovation of the former M. Wile building into a Downtown Gateway Complex for community and economic resources, and construction of a 10-story global vascular treatment and research building with Kaleida Health. This new building also will be home to a UB Biotechnology Incubator for new companies spun off from UB medical discoveries.

With more than two dozen homegrown companies in the life sciences, energy, IT and advanced manufacturing sectors presenting, the High-Tech Forum is designed to facilitate and grow investor and entrepreneur involvement in the local high-tech economy.

The University at Buffalo is a premier research-intensive public university, a flagship institution in the State University of New York system and its largest and most comprehensive campus. UB's more than 28,000 students pursue their academic interests through more than 300 undergraduate, graduate and professional degree programs. Founded in 1846, the University at Buffalo is a member of the Association of American Universities.

TGen's Center for Proteomics Set to Open to Hasten Personalized Medicine

A proteomics center, the final piece of an initiative created two years ago to bring proteins to the forefront of personalized medicine, is scheduled to become operational by the end of the summer, according to officials.

In late May, the Translational Genomics Research Institute named Konstantinos Petritis the first head of the Center for Proteomics in anticipation of opening its doors in August and performing what many see as the next step in bringing proteomics to the mainstream — the validation of biomarkers.

In the meantime, construction of the center, located in Phoenix, Ariz., is being completed, staff is being hired, and officials are in the final stages of choosing instruments, including mass specs, for the 3,400-square-foot space.

Other instruments and tools in the lab will include liquid chromatographs, plate readers, immunoprecipitation instruments, and thermal mixers. Eventually the staff will number 12 to 15 full-timers and post-docs whose numbers will depend on the number of research projects underway at the center.

The center is the final component of an initiative called the Partnership for Personalized Medicine, started in 2007 to try to realize the potential of personalized medicine through the use of protein biomarkers. Along with TGen, the partnership includes the Fred Hutchinson Cancer Research Center and Arizona State University's Biodesign Institute.

Funding for PPM came from the Virginia G. Piper Charitable Trust, which contributed $35 million, and the Flinn Foundation, which provided $10 million.

While discussions about personalized medicine have often centered on the role of genomics, PPM was founded to try to capitalize on the potential of proteins to diagnose, predict, and cure diseases.

A fact sheet from the Piper trust says that proteins will be "more informative than DNA or RNA as a basis for diagnostic tests and can be applied to a broader spectrum of diseases" because of the changes in proteins that accompany changes in physiological conditions; the greater variation of proteins present in disease states; and the easy accessibility of blood, which contains the proteins from diseased tissue.

The goals of the partnership are twofold — to reduce healthcare costs, and to translate scientific discoveries into diagnostics and treatments.

By aligning high-throughput biology with healthcare economics, PPM can begin to address "whether we can actually take a biomarker for a given specific situation in a clinical context [and] reduce healthcare costs," said Jeffrey Trent, president and research director of TGen.

To answer that question, PPM officials decided they needed first to "think of single-payer nations, rather than try to figure out how to do this within the environment of the US healthcare system," with its jumble of private and public payers, Trent said. The first demonstration project PPM established was with Luxembourg, looking at lung cancer, which the TGen Center for Proteomics will continue working on as its initial project.

The center will focus on the discovery and validation of biomarkers for lung cancer.

TGen has two other projects with Luxembourg "to help turn that country into Europe's premier biomedical center," TGen said in a statement: the Integrated BioBank of Luxembourg to create a repository for tissue samples, and the Center for Systems Biology Luxembourg, which will track the genetic basis of disease and develop protein-based tests. The Institute for Systems Biology, which is not part of PPM, is the lead institute in the last project.

Patrizia Luchetta, deputy director for the Board of Economic Development for Luxembourg's Ministry of the Economy and Foreign Trade, said that the country had been searching for potential partners for projects aimed at jumpstarting Luxembourg's developing biotech industry.

As a small country, Luxembourg had to target an area of interest rather than take a broad, multi-pronged strategy, and "as the aim of personalized medicine gets closer and with all the technological advances that have happened in proteomics, molecular diagnostics seems to be one of the potential successful niches," Luchetta said. Because of the costs involved — Luxembourg is investing €140 million ($193 million) over five years into the three projects, including €13 million over three years for the lung cancer project — it was also important that the citizens of the country could reap any rewards resulting from the efforts, she added.

"Being able to work on a subject where you can say, 'Well, we can maybe hopefully, if not decrease, then at least contain healthcare costs and also offer better therapies to our citizens,' then that's a good way to go," she said.

The partners are currently estimating how much cost savings may result from the work with TGen and expect to publish a report on their findings in November, Luchetta said.

REST OF WORLD

Almac Diagnostics Craigavon HQ Open for Business

The new Northern Ireland HQ of Almac’s diagnostics unit was opened in a ceremony presided over by renowned cancer specialist Martin Murphy.

The diagnostics unit will provide research services for pharma and biotech industry customers developing personalized medicines. Key to this offering is Almac’s unique disease specific array (DSA) technology that can differentiate between various different types of cancer.

The unit’s operations will be split between the new Craigavon site and the $112m (€78.6m) facility that Almac is building in Durham, North Carolina. The US facility has been under construction since July last year and is due to be operations sometime in 2010.

Lonza Forms Custom Manufacturing Division

Lonza has combined its exclusive synthesis and biopharmaceutical businesses into a single unit to “enhance synergies in sales and marketing and on the operational side.”

The new division, known as Lonza custom manufacturing, consolidates the Swiss firm’s suite of R&D and production services for chemicals, intermediates, active pharmaceutical ingredients (API) and biotherapeutics.

Lonza will hope that the new group’s broad offering will be able to win contract manufacturing business from a diverse range of pharmaceutical players, particularly those seeking biomanufacturing and development solutions.

Stephen Kutzer and Uwe Boehlke, from Lonza’s biopharmaceutical and exclusive synthesis groups, will jointly lead the new unit.

Marchesini has Begun Work on a €6.5 Million (US$9.2 Million) Upgrade in Pianoro, Bologna

Italian production machine specialist Marchesini has begun work on a €6.5m ($9.2m) extension of its facility in Pianoro, Bologna.

The 3,500 sq.meters (37,660 sq. ft.) plant will house Marchesini’s logistics unit and is part of a wider strategy to consolidate operations.

The plant features a geothermal heating system designed by Bologna-based eco engineering specialist Airklima which, according to Marchesini, “will ensure a comfortable workplace [that is] warm in winter and cool in summer.” Group management and production director Marco Marchesini said that the extension will help boost operational efficiency and meet with the firm’s environmentally friendly objectives.

In related news, Marchesini unveiled plans for an open house at its new commercial services and after sales facility in the Parisian suburb of Saint Mesmes. The three day event, which will take place in September, is designed to showcase the 1,000 sqm (10,760 sq. ft.) unit’s range of services.

Again the facility is part of Marchesini’s consolidation program, in this case bringing together its French pharmaceutical and cosmetic packaging machine operations and technical support services.

Belgian Authorities Positive about NextPharma’s Sterile Unit

NextPharma Technologies’ development facility in Braine l’Alleud, Belgium has received positive early feedback following an inspection by the country’s drug watchdog, the AFMPS.

The facility, NextPharma’s sterile products development centre (SPDC), will supply pharma and biopharma industry customers with a broad spectrum of early-stage services, ranging from pre-formulation through to the manufacture of drugs for trials.

Although the AFMPS’ final verdict is not expected until next month, NextPharma's managing director of product development services Sean Marett is confident the new facility will “provide customers with a more efficient and faster option to develop and manufacture their products for clinical trials.”

He added that: “We are able to manufacture batch sizes for early phase clinical development of a few hundred to 6,000 rising to 110,000 vials of cytotoxic product for a Phase III clinical program.”

The facility is capable of producing high potency OEL4 products, biological injectables, as well as conventional small molecule medication, pharmaceutical emulsions and lyophilised formulations.

The plant’s suite of analytical laboratories will provide customers with molecular testing capacity, lyophilisation cycle development and validation services.

The UK contract manufacturing organization (CMO) also said that the unit will provide packaging and distribution services for a wide range of products, ranging from small molecule tablets and capsules to hormones and controlled release drugs.

The Belgian plant will work in concert with NextPharma’s worldwide network of manufacturing, storage and distribution centers, all of which comply with the requirements of key global drug regulatory agencies.

The location also fits with an agreement NextPharma signed with Aseptic Technologies in September last year. Under that deal, NextPharma added Aseptic’s “revolutionary” closed vial filling technology, which bypasses traditional washing and stoppering steps using gamma irradiation, to its roster of services.

The vial filling for NextPharma will occur at Aseptic’s facility near Brussels, Belgium. Aseptic believes that it has created a simpler way of complying with increasingly stringent good manufacturing practices (GMP).

Korea's Genomic Medicine Institute Adds Seven Illumina Genome Analyzers

Illumina said that the Genomic Medicine Institute at Seoul National University College of Medicine in Korea has purchased seven Genome Analyzer IIx sequencers.

The purchase expands the sequencing capacity of the center to 10 Illumina systems. As reported by GenomeWeb Daily News sister publication In Sequence, the center also has three Applied Biosystems SOLiD sequencers installed.

Researchers at the institute have already sequenced and analyzed the genome of a Korean individual, which they described in a study published in June.

GMI said in a statement that it is the second largest Genome Center in Asia, after the Beijing Genome Institute, "and the largest center that focuses exclusively on human genome analysis and its clinical application in Asia."

The institute is leading an effort called the Asian 100 Genome Project that aims to sequence 100 Asian individuals by 2012 and establish an Asian Genome Database with genome information that specifically targets Asian populations.

Nycomed to Expand Manufacturing Operations in Russia

Swiss drugmaker Nycomed will invest $84 million (€60million) in a pharmaceutical manufacturing plant in Russia, boosting its presence in the country.

According to new market analysis by Russia Profile, Nycomed’s Russian operations generated $243m (€171m) last year, almost ten per cent of its total revenues for 2008 and up from just $26m a decade ago.

The report suggests that the new plant will be used to make both finished drug formulations and, uniquely for a foreign drugmaker in Russia, active pharmaceutical ingredients (API).

It goes on to reveal that Nycomed has been looking at potential sites for the new facility for the past two years and is expected to make a final decision sometime in Q4 this year.

The authors cite predications that Russia’s drug market will be worth $20bn a year by 2013 as part of the attraction for Nycomed. This idea was reiterated by Jostein Davidsen, Nycomed’s general manager in the country.

He said that: “If we look at the current plans for Nycomed Group, the Russia-CIS region will represent 38 per cent of the total growth of Nycomed in 2013, on sales reaching €900m.”

Davidsen also believes that access to the market will be vital for success in Russia given the Ministry of Industry and Trade’s 2008 pledge to only purchase drugs from overseas if they are provided at a 15 per cent discount to locally made products.

In other Nycomed news, Reuters reports that the firm is in a bidding war with an unnamed Japanese group to acquire the pharma unit of Belgian drug and chemicals firm Solvay.

Although details are still unclear at this stage, analysts suggest that the business could be worth as much as $7bn. The report goes on to suggest that Nycomed may achieve significant cost saving and synergies through an acquisition.

Solvay has declined to comment on any potential deal.

UK Cancer Institute Taps Thermo Fisher to Outfit Proteomics Lab

The UK’s Institute of Cancer Research will use Thermo Fisher Scientific’s proteomics technologies in an integrative network biology initiative, the company said.

ICR will use Thermo’s TSQ Vantage triple quadrupole system, the Kingfisher Flex sample prep system, two LTQ Orbitrap Velos mass spectrometers, and other technologies. The agreement includes lab equipment, protein reagents, mass spectrometry, RNA silencing, and related services.

The ICR team is assessing how networks of cancer cells interact with each other and surrounding tissues to metastasize throughout the body.

Chris Marshall, a professor of cell and molecular biology at ICR, said in a statement that integrating mass spectrometry data with other data, including RNAi screens, "will allow us to generate detailed models of processes such as invasion and metastasis.”

Financial terms of the agreement were not released.

Center for Immunodeficiencies Opens at the Federal University in Sao Paulo, Brazil

The Jeffrey Modell Foundation (JMF) together with Baxter International Inc. celebrated the opening of the Jeffrey Modell Diagnostic Center for Primary Immunodeficiencies at the Federal University of Sao Paulo, located in Sao Paulo, Brazil. The announcement coincides with the 5th World Day of Immunology (WDI), a day acknowledging how the immune system works to better help people avoid illness and infections. WDI was established through the European Federation of Immunological Societies (EFIS) to strengthen the public awareness of immunology as a basis for individual health and well-being. Baxter WDI awareness activities span from Brazil to the United States and Germany.

“We are thrilled to support this important work at the Federal University of Sao Paulo, in collaboration with Baxter,” said Fred Modell, co-founder of the JMF. “Today, 19 countries have expressed support for WDI and the need for more awareness. We have seen a large, undiagnosed population that continues to suffer from these diseases, which keep them from enjoying a full life. They often miss 30 or 40 days of school or work every year. Their illness interrupts their activities, detours their plans and shatters their dreams.”

The JMF diagnostic center in Sao Paulo is one of only 51 of its kind in the world and is expected to be the first in a growing network of centers in Latin America focusing on the diagnosis, care and treatment of people suffering with primary immunodeficiency disease (PID). The center is part of the Federal University of Sao Paulo, which focuses on the interrelated activities of teaching and research for national and international leadership in health sciences. PID encompasses more than 150 different forms of disease caused by an immune system that does not function properly.

Stem-Cell Lab to be Removed at Hospital in Dublin

A new high-tech stem cell lab at Our Lady’s Children’s Hospital Crumlin will have to be removed from the hospital in seven years under an order from Dublin City Council (DCC).

The single-storey, 89 sq.meters (958 sq. ft.) prefabricated Haematopoietic Stem Cell Transplant (HSCT) processing laboratory has been granted permission by the Council, provided that the structure be removed from the site on or before November 30, 2016, unless a further grant of permission is obtained prior to that date. The DCC issued the compliance order in the interests of the ‘proper planning and development of the area’.

Crumlin is the national centre for the treatment of childhood cancer. Currently, bone marrow and peripheral blood stem cell therapeutic processing and storage takes place in a small dedicated unit adjacent to the hematology lab.

A new facility is required to comply with stringent conditions contained in an EU Directive on human tissue and cells. The Irish Medicines Board is also insisting that a new facility be built.

The HSCT lab will involve the building of a cleanroom consisting of a series of graded air-quality rooms — separated by interlocking doors — and liquid nitrogen facilities for storage and processing. Products to be processed will include bone marrow (allogenic and autologous); peripheral blood stem cells (allogenic and autologous); and liquid nitrogen preserved samples.

Full planning permission for the facility was received from DCC in November 2006. Following a competitive tender exercise in June 2008, a contractor was selected to construct the building. The construction program is of 20 weeks’ duration.

The agent on the build is Ardmac Ltd, which has worked on projects for St Vincent’s Hospital and Beacon Medical.

The new national pediatric hospital at the Mater site, into which the three existing children’s hospitals in Dublin are due to be merged, is expected to be completed by 2014.

PPD’s Central Lab Operations in Beijing Has Earned Accreditation

PPD, Inc. announced its global central lab operations in Beijing has earned accreditation by the College of American Pathologists (CAP), making it the company's third central lab to meet the highest standard of excellence in enhancing patient safety and speeding drug development.

The CAP Laboratory Accreditation Program is an internationally recognized program using rigorous accreditation standards to help laboratories advance the quality of laboratory services to improve patient care. The program uses multidisciplinary teams of practicing lab professionals as inspectors who assess management and operations of laboratories, extending beyond regulatory requirements.

PPD's Beijing lab also earned certification by the National Glycohemoglobin Standardization Program (NGSP), a standard requirement for hemoglobin A1c testing key to diabetes clinical research.

PPD expanded its global central lab services into China last year through an exclusive agreement with Peking Union Lawke Biomedical Development Limited and immediately began providing biopharmaceutical clients its full range of highly customized central lab services.

In addition to Beijing, PPD operates central labs in Highland Heights, Ky., and Brussels, Belgium. The company is opening a global central lab facility in Singapore this year based on growing client demand in Southeast Asia.

PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 38 countries and approximately 10,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients. For more information, visit our Web site at http:/PPD, Inc. (Nasdaq: PPDI) announced its global central lab operations in Beijing has earned accreditation by the College of American Pathologists (CAP), making it the company's third central lab to meet the highest standard of excellence in enhancing patient safety and speeding drug development.

"Earning CAP accreditation at our Beijing partner lab validates our commitment to deliver high-quality, reliable data to our clients in a high-growth region for global clinical research," said Steve Lobel, Ph.D., vice president of PPD's global central laboratory operations. "This accreditation demonstrates our dedication to excellence in providing a broad range of laboratory testing capabilities and the expertise of our global team."

PPD's Beijing lab also earned certification by the National Glycohemoglobin Standardization Program (NGSP), a standard requirement for hemoglobin A1c testing key to diabetes clinical research.

GW Pharmaceuticals’ Plant for MS and Cancer Pain Drug Gets U.K. GMP Clearance

GW Pharmaceuticals’ manufacturing facility for its cannabinoid-based multiple sclerosis (MS) and cancer pain therapy, Sativex®, passed a GMP inspection by U.K. regulatory authorities. The company can now take over full commercial manufacture of the drug in advance of expected European approval.

Although GW Pharm was previously licensed to manufacture the product for clinical trials and named-patient supply, the final stage in bulk GMP manufacture of Sativex has until now been carried out by a CMO. GW Pharm says that the new facility will initially be able to generate enough Sativex to treat 25,000 patients a year, but plans are also in place for expansion as required.

The company recently pointed out that the lead indication for Sativex differs across different regions of the world. In Europe, the primary indication for approval is MS spasticity and in the U.S., cancer pain. Although Sativex has still not been approved outside Canada, the drug can be prescribed as an unlicensed medicine on a named-patient basis. It has now reportedly been exported from the U.K. to 21 countries either for named-patient prescription use or for use in clinical trials.

GW Pharm recently reported that total sales of Sativex were up 15% to £1.3 million, or about $2.13 million. Named-patient sales grew by 47% to £0.9 million, or $1.48 million. Bayer HealthCare, which markets Sativex in Canada, says sales in that country were running at an annual rate of around C$3 million, or $2.69 million.

In May 2009 GW Pharm filed applications with U.K. and Spanish regulatory authorities via the European decentralized procedure for approval of Sativex as a treatment for MS-related spasticity. Regulatory decisions are expected during late 2009 or early 2010. If approved in Europe, the oral spray will be marketed in the U.K. by Bayer HealthCare and in the rest of the EU by Almirall. Marketing approval authorizations in other European countries will be sought after sanction in the U.K. and Spain.

In February 2007 GW and Otsuka signed a long-term strategic cannabinoid alliance, initially based on the development and commercialization of Sativex in the U.S. A Sativex Phase IIb/III cancer pain trial, funded by Otsuka as part of the U.S. development program, is due to end during the second half of this year.

The Canadian authorities approved Sativex for the symptomatic relief of neuropathic pain in MS in April 2005. In August 2007 Health Canada also green-lighted the drug as an adjunctive analgesic for patients with advanced cancer who experience moderate-to-severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.

ACRO Hopes to Boost Research in Africa

South-Africa based ACRO is aiming at building partnerships across its home continent, according to its MD who told Outsourcing-Pharma of its ambition to have more local people performing research.

Mary-Ann Richardson, managing director of ACRO, explained how the company is establishing partnerships with investigative sites in Africa and offering training services for people across the continent.

ACRO offers training from its HQ in South Africa but will also visit investigative sites in Africa to offer assistance based on the needs of a particular facility. This includes ACRO staff visiting Malawi every 45 days.

These efforts to boost research across Africa, which also include an ambition to increase the quantity of publications coming out of the continent, are in keeping with the ethos behind ACRO’s formation.

ACRO, which stands for African Clinical Research Organization, was established two years ago as a partnership between public body LIFElab and private biotech Batswadi Pharmaceuticals.

The contract research organization (CRO) was setup as a black economically empowered company. Part of ACRO’s purpose is to offer an alternative to multinational CROs for local biotechs seeking to conduct research.

This includes research into HIV, tuberculosis and malaria but also diabetes and other diseases. Richardson explained that by avoiding being a niche CRO the company’s client base extends beyond non-governmental organizations (NGO).

Consequently, ACRO has sought international clients and building this area of the business was part of its goals for 2009. Richardson explained that ACRO’s deal with New Jersey-based EDC Pharma will assist this process.

By offering clients training and services, including data management and regulatory services, ACRO has grown quickly. In its first year it secured 21 contracts and from March 2008 to November the same year its staff grew from five people to 25.

Richardson added that the economic downturn had created an opportunity for ACRO because as a smaller CRO it is well equipped to offer more flexible arrangements that are being sought by clients.

Richardson explained that in the coming 12 months ACRO is hoping to perform full service studies, adding that the company currently has proposals out for this work.

ACRO also aims to support at least one donor funded proposal. Richardson believes that as an Africa-based CRO capable of providing local expertise and training it can add value to procedures.

In addition, in the coming months ACRO is seeking to raise awareness of itself and of what Africa can offer as a location for clinical trials.

Icon Buys Veeda’s UK Biomarker Lab

The Oxford, UK, biomarker laboratory facilities of India’s Veeda CR have been taken over by Icon Development Solutions, in a deal which both consolidates existing customer relationships for the buyer and opens up new product areas to focus on.

The Veeda deal adds biomarker analysis and development capacity to Icon’s offering which, the firm hopes, will help it attract development work from sponsors keen to make no/go development decisions at the earliest possible stage.

John Chapel, who headed Veeda Laboratories’ Oxford facility, told Outsourcing-pharma, that the timing for the move was straightforward: “Veeda wanted to sell and Icon wanted to buy,” he said.

Veeda Labs provides specialist laboratory services to many of the global pharmaceutical and biotechnology drugmakers. Icon already has a UK research centre at Manchester, and the firm acquired Prevalere Life Sciences, a USA-based bioanalytical and immunoassay laboratory, in November 2008.

Thomas Frey, President, Icon Development Solutions, highlighted Veeda’s “very strong reputation for biomarker development” and “well-established relationships with top-tier pharmaceutical and biotechnology companies.”

He went on to say that the new unit’s research team will “greatly enhance Icon’s existing team of biomarker experts.”

A call to the Oxford site confirmed that the deal has been completed, although some details of how the new site will fit into Icon’s management structure have not been announced.

Use of biomarker analysis by drug developers has increased considerably in recent years. The technique provides a way of assessing the impact of a particular drug or candidate on a disease state via analysis of pre-characterized markers.

This approach allows no/go development decisions to be taken at an early stage, helping researchers identify promising projects and, perhaps more crucially, halt the development of ineffectual drugs at the earliest possible stage.

LFB Picks Lonza for CMO Deal

French biopharmaceutical group LFB has contracted Lonza’s biopharmaceuticals division to make trial supplies of its candidated monoclonal anti-RhD antibody.

The antibody is used in cases of rhesus incompatibility between a mother and her fetus. RhD-negative women who carry an RhD-positive fetus may produce antibodies to fetal RhD antigens, triggering an immune response that can result in miscarriage.

Although plasma-derived therapies are available for rhesus incompatibility, LFB hope that the relative ease of making its antibody on an industrial scale will help it compete in the already well established market.

Lonza will make supplies of the compound for Phase II trials, which are expected to start later this year, as well as for any Phase III trials that are carried out.

Edward Balbirnie, director of bioproduction at LFB, told Outsourcing-pharma that because the French firm's lead product was reaching a significant development stage, it made sense to partner with a CMO with Lonza's mix of experience and production scale.

He said: "LFB would have looked at several potential partners in the European market" and "Lonza being one of the biggest serving CMO firms in the sector in Europe, it had the appropriate scale of equipment for us."

Balbirnie also highlighted Lonza's experience of working towards FDA approval in the US as well as with European regulators.

“We are very pleased to enter this new collaboration with LFB, a successful French biopharmaceutical company and major player in plasma-derived medicinal products. Supporting LFB in the development of proteins using innovative technologies is exciting and will be the basis for a long-term relationship,” said Stephan Kutzer, head of Lonza Biopharmaceuticals.

Financial details of the agreement are not being disclosed, both firms said.

Waterloo Building Advanced Research Center

Cooper Construction has begun the design of a 68,000 sq.ft. Research Advancement Center in the Univ. of Waterloo Business Park. The Phase II building will closely resemble the Phase I building completed by Cooper in January 2008. Phase II will incorporate three floors of laboratory and office space. The building will feature hydroponic heating and cooling with central computerized BMS system.

With Phase One of the project successfully completed, we're very pleased to be commencing Phase Two," said William Cooper, President and CEO. "This is an interesting project that will serve the Canadian research community for many years to come.

Three floors of combined office and laboratory space will locate offices on the building's perimeter, with multi-use laboratory space on three floors in the building's core, including one 2000 sq. ft., two-story lab. The lab space is designed for separation into up to 14 labs with independent HVAC and lighting. A central service area links all lab space to the penthouse mechanical space, with provision for easy installation of dedicated HVAC and ventilation equipment for special purposes.

The HVAC is designed to accommodate fume hoods to the labs, with hydroponic heating and cooling to offices and labs and a central computerized BMS system.

The building will have a steel frame structure, with pre-cast concrete floor slabs, architectural pre-cast, distinctive three color curtainwall glazing, one drive-in door with loading dock and two grade-level dock doors. A screened patio will provide secluded breakout space adjacent to the property's extensive landscaped reserve.

Bernhard-Nocht BSL-4 Opens in Germany

The Hamburg Bernhard-Nocht Institute for Tropical Medicine (BNI) has opened a $42 million expansion of its lab containing a Level 4 Biosafety Lab (BSL-4). The new Bernhard Nocht facility is only the second lab in the country to receive the highest security clearance for such research. A lab in Marburg in Hesse is the only other BSL-4 facility in Germany.

The new lab will be used to explore extremely dangerous pathogens, according to Germany's Federal Health Minister Ulla Schmidt. "The trends in the globalized world bring new dangers that include the rapid spread of dangerous pathogens. Tropical diseases are the face of climate change, even in our temperate latitudes a growing challenge."

Prof. Bernhard Fleischer from the Foundation Board of BNI first announced a trial operation for the stainless steel produced in laboratories. The overall adds 5000 m2 next to the 1914 Institute, with the expansion adding about 3,000 m2 of extra space to the facility. It is part of an EU-funded project for training of scientists in dealing with highly infectious pathogens.

The BNI now has the ability to compete against other secured facilities," said Schmidt. Schmidt said it was an important signal: "Even in difficult times, investment in science and research is what we need." The Minister praised the research institutes in Germany. "We have a very high international reputation." The federal government supports the BNI with an annual six million Euros.

Hamburg Mayor Ole von Beust spoke of money well spent - despite all the difficulties in the construction, whose cost at the end was a half times higher than planned. "This was not an easy building to make."

The BNI already investigates dangerous diseases such as malaria, hemorrhagic fever, and tissue worm infections. The BSL-4 labs will allow the BNI to investigate highly infectious and deadly pathogens such as Lassa and Ebola viruses as well.

Sanofi-aventis Plans France Consolidations, Eyes Shifts Elsewhere, in R&D Restructuring

Two Life-Sci Expansions in Ireland's County Cork: New Pfizer Lab, New Gilead Financial Center

Two life sciences giants announced plans to expand their presences in Ireland's County Cork.

Pfizer will spend €11m ($15.3 million) to develop a new kilo technology R&D laboratory at its active pharmaceutical ingredient, or API, manufacturing facility in Ringaskiddy, County Cork, the Industrial Development Agency Ireland announced.

The lab will be housed in the site’s existing process development center, and will be designed to research, develop and create new manufacturing technology for more efficient production processes for Pfizer’s facilities around the world, IDA Ireland said.

Pfizer — which is celebrating its 40th anniversary in Ireland this year — employs more than 550 people at the Ringaskiddy site. The facility consists of four API bulk pharmaceutical plants producing a range of material for many of Pfizer’s major products. All of the Lipitor active API, and 70 percent of all Lipitor tablets, are produced in Cork by Pfizer, which has eight different operations in Ireland employing a total of 2,000 people.

"The decision to invest in the Cork PDC was based on demonstrated technical competence with similar projects and the successful completion of a number of R&D programs," Paul Duffy, vice president of Pfizer Manufacturing for Ireland and Singapore, said in IDA Ireland's statement.

Gilead said it will create a new financial center for its European businesses in Carrigtwohill, an expansion the company said will lead to the creation of 30 new jobs.

The new European Financial Shared Services Centre will process financial activities for Gilead's operations. Gilead currently employs 125 people at its facility in Carrigtwohill.

Gilead expanded into Carrigtwohill when it bought the Cork manufacturing facilities of Nycomed in 2007, and employs 125 people there at present. Gilead uses those facilities now to manufacture HIV medication at reduced costs for countries in the developing world.

'The decision to choose to locate in Cork was based on our track record of success here, the experience in the region, the availability of skills and the presence of several global international companies,' said Julie O'Neill, Gilead Sciences' general manager in Ireland, in a statement.

The Hamner Institutes for Health Sciences Signed Agreement with China Medical City

In Consolidation Move, AMRI Opens 32K Sq. Ft. Research Facility in Budapest

Albany Molecular Research, or AMRI, said it has finished the construction of a new chemistry R&D facility in Budapest, Hungary, with the goal of consolidating equipment previously at multiple locations, and thus containing costs.

The facility, which consists of into 32,300 square feet of laboratory and administrative space, will provide space for the anticipated expansion of the company's synthetic chemistry services, which AMRI projects will double over the next five years. Those services will include parallel synthesis and medicinal chemistry, as well as the establishment of fragment-based drug discovery. The facility also includes a scale-up laboratory for non GMP synthesis for batch sizes up to 25 liters.

AMRI specializes in the manufacturing of active ingredients and pharmaceutical intermediates.

FABA Signs DuBiotech as 18th Member; Announces MOU with Biopark Near Torino, Italy

The Federation of Asian Biotech Associations announced it has signed the Dubai Biotechnology and Research Park, known as DuBiotech, as its 18th country member, allowing for the launch of a new FABA chapter in the UAE.

FABA, based in Hyderabad, India, also announced it signed a memorandum of understanding with Bioindustry Park Canavese, near Torino, Italy, to encourage and promote cooperation in the fields of clustering, support to internationalization of companies, incubation and technology development, and services to new emerging biotechnology companies. FABA said it is also in talks with officials from Canada to involve it as a member country, and increase opportunities for business cooperation.

“This will not only help in development of new business initiatives, but we will also see an increase in the number of foreign companies coming to India to set up their base here. Within the next year, I believe we will see a lot more joint ventures and tie-ups between Indian and these foreign companies,” FABA Secretary General BS Bajaj said in a statement.

UK's University of York Opens Mass Spectrometry Center of Excellence

The UK's University of York has opened a new £1.6 million ($2.8 million) Centre of Excellence in Mass Spectrometry, a facility intended to benefit the pharmaceutical, chemical, and healthcare industries, as well as support regional academic research — including the identification and characterization of proteins of interest to researchers trying to identify new drug targets and biopharmaceuticals.

The new facility — a joint initiative between the University’s Biology and Chemistry departments — was established through funding from Science City York, supported by Yorkshire Forward, with funds from the Northern Way Initiative.

NXP and Siemens Collaborate on Pharmaceutical RFID Innovation

NXP’s unique application and system center provides high frequency Gen2 standard-ready RFID System know-how.

NXP, the independent semiconductor company founded by Philips, announced a collaboration with Siemens on an RFID-based supply chain pharmaceutical project designed to improve efficiency from manufacture to retail. Using NXP’s Application and System Center (ASC, formerly known as RFID Reference Design Center), a facility that provides real-life conditions for evaluating and optimizing RFID applications, the Siemens IT Solutions & Services team created a customized RFID system to ensure a high read accuracy throughout the supply chain.

The project focuses on creating a system based on NXP’s ICODE high frequency (HF) RFID technology incorporated into the labels of pharmaceutical products. The whole system is configured to already comply with the latest edition of the HF Gen2 standard, which is currently under final review by EPCglobal. The aim of the installation is to accurately bulk read several hundreds of labeled packages quickly, allowing the manufacturer to keep a thorough stock inventory at all points along the supply chain. The ASC enabled the Siemens IT Solutions and Services team to achieve industry benchmark HF read accuracy results. This was accomplished through the use of an advanced high speed anti-collision concept and the optimization of the entire system.

"We selected NXP as the chip supplier for our innovative RFID pharmaceutical project. During project planning, NXP offered us the services of its highly sophisticated ASC,” said Matthias Bruckschen, Principal Consultant SCM / RFID, Siemens IT Solutions and Services. “The facility supported our engineers, enabling them to evaluate and tune the design of the HF RFID labels. By simulating the interactions between the readers and samples, we were able to obtain first qualitative results and calibrate the solution accordingly. The support provided by NXP's ASC saved us a lot of development time and we look forward to a renewed cooperation between NXP and Siemens IT Solutions and Services in future."

Based near Graz, Austria, the ASC was created with the aim of driving the adoption of RFID technology. NXP’s team of engineers based at the ASC can help systems engineers tackle common problems and support the development of RFID projects. In addition, the facility can be used to build and test full scale supply-chain scenarios to evaluate the robustness of an RFID-based system – enabling the development of a business-ready solution and reducing development time.

“NXP’s aim in founding the ASC was to create an environment which would spur the advancement of RFID and industry-wide research through methodological analysis, test and validation of all elements of an RFID system,” said Dirk Morgenroth, Director Marketing, RFID, NXP Semiconductors. “We are pleased to support Siemens IT Solutions and Services in the optimization of their implementation for pharmaceutical supply chain management, by delivering a future proof RFID system set-up prepared for HF Gen2-specified solutions.”

End customers integrating RFID solutions in their businesses are demanding a fully integrated, turnkey solution which provides them with a high-level of business intelligence. NXP’s systems level approach and leadership in RFID technology enables systems integrators to design and build business ready solutions and reduce the complexities of the technology.

BASF Expanding China JV

BASF and Sinopec are to invest $1.4bn (€1bn) in expanding their Chinese specialty chemical joint venture, adding 10 plants and increasing capacity at three existing sites.

The companies can now push ahead with their expansion plans, which will boost capacity and broaden product portfolio, having had them approved by the Chinese central government.

Joint venture BASF-YPC (BYC) was established in 2000 with a $2.9bn investment and has been economically successful for both parties, according to Martin Brudermüller, member of the Board of Executive Directors of BASF SE responsible for Asia Pacific.

He added: “The expansion of BYC underscores our strong belief in the growth opportunities of the Chinese market and is another milestone in cooperative development.

“At the same time, it demonstrates BASF’s long-term commitment to China and will further expand our competitive advantage.”

The expansion is also good news for China, according to Wang Tianpu, president of Sinopec, who said the move is part of the country’s “revitalization plan for the petrochemical industry”.

BYC started commercial operations in 2005 and had one steam cracker for production of ethylene, a chemical used in the production of pharma excipient polyethylene glycol, and nine downstream plants.

The steam cracker is now being expanded and will produce 740,000 metric tons of ethylene per year when fully operational. BYC’s expansion of ethylene production is in contrast to Dow Chemical’s recent decision to shutter three facilities.

Dow is cutting back its ethylene production capacity as it moves away from basic chemicals that have small profit margins and are affected by crude oil fluctuations. BYC however appears to have found a way of making production viable.

In addition to the steam cracker expansion BYC’s ethylene oxide (EO) plant is being expanded. This will be supplemented by a new EO purification unit and construction of EO derivatives plants.

Startup of the new operations will take place in a staggered approach and are predicted to be online from 2011 onwards.

India & China Differences in Outsourcing

India and China share many similarities as outsourcing locations but there are also significant differences that are important to understand before making a commitment, according to a report.

Both countries have large populations and low wages but the report by JZMed highlights the cultural and industrial differences, an understanding of which is beneficial to pharmas and biotechs looking to outsource activities.

For instance, Chinese contract research organizations (CRO) tend to have stronger preclinical offerings whereas their Indian counterparts specialize in clinical trials.

The report states that both countries have similar discovery services but in the field of target identification and validation, as well as related areas in genomics and proteomics, China has a superior offering.

In contrast, India has stronger capabilities in small molecule R&D. The differences between the countries expertise with small molecules and biologics runs throughout the report, with China’s superiority in biotech being noted in both R&D and manufacturing.

However, the report acknowledges that India is stronger in the formulation, manufacture and marketing of generic drugs. Given this expertise in generics the imminent growth in follow-on biologics could be the shift that causes India’s biotech sector to improve.

The report also notes that process R&D and scale-up synthesis capabilities are similar in both countries.

Given the strengths and weaknesses of each market, deals such as the alliance between India-based GVK Biosciences and China-based Excel may be a good way to take advantage of each countries’ specializations.

Although the report believes China has better industrial infrastructure than India there are cultural issues that put it at a disadvantage.

Indian companies share a business operation style and philosophy with Western firms, according to the report, and also have a better understanding of regulations in established markets than their Chinese counterparts.

This may have played a role in the differing approaches Western businesses have taken to their Indian and Chinese operations. The report notes that in India major pharmas tend to form joint ventures, sharing risks to co-develop drug candidates.

However, very few of them have established a large, permanent R&D or manufacturing facilities, according to the report. In contrast, hundreds of millions of dollars have been pumped into China by western pharmas to build large, wholly-owned facilities for in-house research.

Who will be the biggest?

The report values India’s pharma outsourcing sector at $1.77bn (€1.27bn), putting it slightly ahead of China that currently stands at $1.42bn. Each country has about a 2 per cent share of the global market.

Despite India’s current advantage the report predicts that China is very likely to overtake India after 2010. This assertion is based upon China having fewer growth resistors.

Novasep Acquires Henogen to Increase Processing and Manufacturing Capabilities

Novasep has bolstered its upstream processing capabilities by acquiring Henogen, a Belgium-based CMO that has biotech development and cGMP manufacturing expertise.

The acquisition allows Novasep, a producer of active pharmaceutical ingredients (API) and purification systems, to offer “manufacturing solutions covering almost every type of biopharmaceutical”.

Novasep views the acquisition as a confirmation of its “determination to become a major player in the world biomanufacturing market”, according to Roger-Marc Nicoud, the company’s CEO.

The complementary nature of Henogen’s capabilities led to it being selected as an acquisition target. In addition the companies have collaborated on several biomanufacturing projects.

Henogen has expertise in upstream processing and experience using an array of expression tools including viral vectors, Escherichia coli, yeast, Lactococcus lactis and insect and mammalian cells.

Novasep hopes to marry these capabilities to its downstream processing capacity, allowing it to offer clients a comprehensive antibody-drug conjugates manufacturing services.

Antibody-drug conjugates have been identified by Novasep as a growth area and through the acquisition it believes it will be one of the leading businesses in the field, with services spanning from early development to commercial manufacture.

Lonza Has Invested in Capacity for Manufacturing in Visp, Switzerland

Lonza has also invested in capacity for manufacturing antibody-drug conjugates. The Swiss-based contract manufacturing organization (CMO) finished building a facility in Visp, Switzerland in 2008 and has also identified the sector as a growth opportunity.

Stephen Borgas, CEO at Lonza, explained the company’s decision to enter the market at a meeting of the European Fine Chemicals Group (EFCG) last year.

He commented: “We are going back from antibodies, to antibody fragments, proteins and finally to small molecules, in other words full circle from biology back to chemistry.”

Cambrex has also shown an interest in the sector, producing and packaging its first antibody-drug conjugate for CuraGen in 2006.

PerkinElmer to Open New India Facility

PerkinElmer said that it will open a new Bio-pharma Center of Excellence in Hyderabad, India, later this year.

The center, which is scheduled to open in October, will provide PerkinElmer's clients with screening and profiling technologies, access to drug discovery tools and services and quality control applications, training facilities, and expertise.

The center will enable the company to focus on the drug discovery market in India, and it is part of PerkinElmer's plan to "substantially broaden" its presence in India in certain markets, and to expand "links with government and private research institutes," the company said.

PerkinElmer India's President, Fedja Bobanovic, said in a statement that the company is expanding in the country because it "presents compelling growth opportunities in environmental monitoring, neonatal and maternal screening, and pharmaceutical research."

In 2008 the company opened a Technology and Innovations Facility in Mumbai that focuses on environmental health sciences.

UAE Predicted to Be Clinical Trial Hub

The number of CROs operating in the United Arab Emirates (UAE) is set to rise, according to an expert on the region, as companies are attracted by the cost effectiveness and presence of big pharma.

Currently there are few contract research organizations (CROs) with offices in the UAE but Faiz Kermani, author of A quick guide to healthcare and biotechnology in the Middle East, believes this will change in coming years.

Speaking to Outsourcing-Pharma, Kermani predicted that the UAE’s incentives to attract pharmas to the region, which have seen Pfizer, Amgen and AstraZeneca establish offices, will result in CROs following them.

In particular Kermani believes CROs will be attracted to Dubai. Kermani explained that the emirate has used “massive amounts of money and huge incentives” to attract pharmas to its DuBiotech and Dubai Healthcare City developments and predicted that CROs will follow.

Some CROs have already established offices in these developments. Ergomed became the first CRO to have an office in DuBiotech in October 2007 and in May the following year ClinTec moved into Dubai Healthcare City.

ClinTec’s decision to set up in Dubai was partly because of the presence of top 10 pharma companies, according to Rani Abraham, the CROs regional manager for the Middle East & North Africa.

Abraham explained to Outsourcing-Pharma that the UAE has “opened up immensely for research” and that this, coupled to the concentration of big pharmas in the region, could lead to it becoming a hub for clinical trials.

In addition Abraham believes that operating in the UAE could quicken regulatory approval for a drug because it allows data to be generated from a different ethnic population.

Operating in the UAE

Studies conducted in the UAE comply with International Council on Harmonisation good clinical practice (ICH GCP) guidelines, according to Abraham, meaning the data should be accepted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMEA).

In correspondence with Outsourcing-Pharma both regulatory bodies explained that the actual country where the study is carried out is not an issue, as long as the study is done appropriately.

There are currently 11 trials recruiting patients in the UAE, according to the World Health Organization’s (WHO) clinical trial database, and with this number predicted to increase ClinTec believes its services will be in demand.

From its base in Dubai the CRO offers project management, data management, training and regulatory affairs services. To execute these tasks the company employs local experts, a move which Abraham believes offers numerous advantages.

She explained that employing locals helps deliver faster services because they have a better understanding of regional regulations. In addition tasks such as translating informed consent forms require staff to know Arabic.

WuXi only CRO to Make China’s List of Top Ten Outsourcers

Shanghai based CRO WuXi PharmaTech has been named as one of China’s top ten outsourcing enterprises in 2008 by the country’s Ministry of Commerce.

The list, which was announced at the Second Annual China International Service Outsourcing Cooperation Conference in Nanjing late last month, features the top ten revenue generators of last year.

WuXi, which posted revenue of $256m (€183.7m) in 2008 thanks largely to gains made by the integration of AppTec into its laboratory analysis business, was the only contract research organization (CRO) to make the top ten.

The Chinese government, which has been actively encouraging the growth of the outsourcing sector for a few years, estimated that it was worth some $1.5bn in 2008, up around 34 per cent on the previous year.

Evolvence Plans More Indian Pharma Investment

Dubai-based investment group Evolvence Capital plans to invest in more India drugmakers, according to a report in the Emirates Business newspaper.

Evolvence, which recently paid Dh19.2 m (€3.7m) for a stake in Chennai-based epilepsy specialist Anjan Drugs, said it plans to invest $100m (€72m) in Indian pharma firms over the next few years.

Evolvence CEO Khaled Al Muhairy told the paper that: "We are investing with a long-term perspective. India will attract a lot of pharmaceutical research as costs are significantly lower when compared to the West “

In 2008, Evolvence invested $30m in Hyderabad drug delivery specialist Grand Pharma and a further $5m in Bangalore-based cancer research network Health Care Global.

MJ Biopharm GMP Breach Prompts Recalls

Novartis and Jubilant Organosys are among several companies forced to recall generic drugs after manufacturing operations at their shared CMO, India’s MJ Biopharm, were found to be in breach of GMP guidelines.

A UK Medicines and Healthcare products Regulatory Agency (MHRA) inspection at MJ’s facility in Mumbai last month revealed several “serious” deficiencies from good manufacturing practice (GMP) standards.

While the MHRA said that it has discovered a number of inaccuracies in batch manufacture and testing records, but stress that, at present, no drug safety issues have emerged.

While MJ has yet to issue a response to the inspection its contract manufacturing clients have been quick to address the problem with several, including Stranhaven, LPC Medical, Karib Kemi Pharm, Milipharm and Greystone, initiating recalls.

Sandoz, the generics unit of Swiss drug major Novartis, is one of the highest profile companies affected. MJ produced the firm’s version of the antidepressant floxetine and the muscle agent baclofen and the diabetes drug metformin.

Company spokesman Chris Lewis told the Wall Street Journal that the recalled drugs “were not major products,” adding that the firm had already discontinued marketing the medications in question some time ago.

Jubilant Organosys was the other high profile casualty and was forced to withdraw 5mg and 10mg non-branded formulations of the anti-hypertension treatment amlodipine from UK shelves.

The recall, which was enacted by the firm’s Belgian Jubilant Pharmaceutical unit, also impacted Wockhardt, which was responsible for distribution of the drug in the UK.

Jubilant told Reuters that: “This recall pertains to the supplies made from ... MJBP in 2008,” and added that: “The value of the products recalled is insignificant to the overall turnover of Jubilant.”

ISO 9001 Accreditation a “huge step” for Prosonix

Ultrasonic particle engineering specialist Prosonix has been accredited under the ISO 9001:2008 quality scheme, after an inspection by the UK unit of independent auditing group SGS.

Prosonix’ business is based on a suite of ultrasonic particle engineering and process chemistry technologies that are used by drug and chemicals firms, including giants like Pfizer and UCB, to exert greater control of crystallization and processing operations.

The new certification covers the management systems that govern Prosonix’ ultrasonic crystallization and formulation operations as well as those used during its technology licensing activities.

Prosonix’ CEO, David Hipkiss, told in-PharmaTechnologist that: “This is a huge step forward,” adding that it enables the firm to manage all aspects of its business in the most cost and time efficient manner.

He explained that the audit, which took six months to complete and involved a significant amount of new training for the whole Prosonix team, has delivered several business improvements.

Key among these improvements is the new quality policy and objectives the firm developed particularly, as Hipkiss explained, because they were created organically by the whole team “and not simply dictated from senior management.”

He went on to say that: “Customers should take confidence in [the fact that] we are making strategic investments into the business as it grows to enable our continued success in the long term.

German developer Aeropharm, which licensed Prosonix’ sonocrystallisation technology late last year, is likely to be one of the first to benefit from the new ISO 9001:2008 accreditation.

The Rudolstadt-headquartered company uses the technology to make uniform active pharmaceutical ingredient (API) particles for inhalable generics, bypassing the milling and micronization steps required by traditional crystallization methods.

Hipkiss also spoke about Prosonix' performance in the global economic downturn, explaining that its turnover for the year ended March 31 was more than double that recorded in the previous fiscal year.

He predicted that: “While we expect to have another strong year, it is fair to say that with continued Big Pharma consolidation that some projects were put on hold pending company integration.

On the other hand Hipkiss said that: “Other mergers have actually accelerated some projects which we had not expected to progress so fast.”

“What is certain is that our pharma customers are increasingly focused on understanding the full cost of production, and failure, from API synthesis to drug product in packaging.”

Pfizer Plans Irish Process Lab, Shelves SF Unit and Sells Skin Drugs to Graceway

Pfizer will invest €11 million ($15.3 million) in a new kilo technology R&D laboratory at its API manufacturing facility in Ringaskiddy, Ireland.

The lab, which will be housed in the site’s existing process development centre, will develop manufacturing technologies and protocols for application at other Pfizer production sites around the world.

Pfizer Ireland spokesperson Tara Delany told in-PharmaTechnologist that the “[investment] demonstrates a clear commitment by Pfizer to growing the R&D capability at the Centre as an integral part of our corporate R&D strategy.”

She explained that the unit, which will be operational before the end of the year, will focus on the development of “less costly and more efficient second generation processes [for] existing products.”

The investment, which is supported by the Irish Development Agency (IDA), will provide some reassurance of Pfizer’s commitment to Ireland’s manufacturing sector after the sale of its active pharmaceutical ingredient (API) to Hovione in April.

It will also help ease specific concerns about the Ringaskiddy site’s future given that, at present, its primary role is to make the API for its cholesterol drug Lipitor, which is due to lose patent protection over the next few years.

In a press statement Paul Duffy, VP of Pfizer’s manufacturing operations in Ireland, told RTE that investment is based on the sites’ track-record of industrial research and technical competence.

Vetter Expands Secondary Packaging Capacity

German aseptic filling specialist Vetter has boosted packaging operations at its new facility in Ravensburg to meet growing demand for cost-effective secondary packaging services

The firm installed six new fully automatic production lines at the plant, doubling capacity for everything from aseptic-filling, pen assemblies and auto-injectors to labeling and blister packaging.

Company managing director Thomas Otto explained the rationale for the new unit, suggesting that increasing economic and regulatory pressures had made secondary packaging a critical issue for the firm’s customers.

Aseptic filling is one of the areas that has seen the most growth in the pharmaceutical outsourcing sector in recent years as drugmakers keen to enter the lucrative markets have sought ways to reduce the cost of such operations.

The Ravensburg plant, known as Vetter Secondary Packaging (VSP), has been in development since 2006, with construction being completed late last year. Since then Vetter has been working to install and validate the new packaging lines.

“What makes VSP particularly advanced is the complete automation of all steps on the finishing lines, including labeling, plunger installation, blistering, packing and transport from one station to the next.”

Otto added that: “Compared to conventional procedures, VSP allows twice the number of systems to be assembled in half the time.”

Vetter also claims that the facility’s hygienic manufacturing area, which complies with good manufacturing practice (GMP) specifications, provides optimal conditions for pharmaceutical finishing.

The plant is part of Vetter’s recent efforts to expand its pharmaceutical industry offering. In March the firm set up a new subsidiary, Vetter Pharma International (VPI) to take charge of sales, marketing and customer services.

Spain to Build its First Vaccine Plant

The Spanish Ministry of Health is leading a €60m ($84.9m) program that will build the country’s first vaccine production facility and use Novavax’s recombinant virus-like-particle (VLP) technology.

By establishing the program Spain believes it will be able to provide vaccines for the entire population and is developing pandemic and seasonal variants.

ROVI Pharmaceuticals is collaborating with the health ministry on the project and has exclusive license to use Novavax’s VLP technology in commercializing vaccines in Spain and Portugal. It also has a non-exclusive license for the rest of Europe.

The establishment of a relationship Novavax, which has become increasingly prominent during the H1N1 outbreak, suggests that Spain is keen to equip itself against a pandemic.

Novavax has a research agreement with the US National Institutes of Health (NIH) to evaluate its H1N1 but Rahul Singhvi, CEO of Novavax, believes VLP offer numerous benefits in treating seasonal influenza.

Singhvi explained: “This influenza vaccine supply solution consisting of our VLP technology and portable manufacturing avoids the use of chicken eggs, creates vaccines for emerging strains faster, and promises less expensive, in-border manufacturing capacity.”

This technology will be used at the €20m vaccine plant that ROVI, with support from the state of Andalucía, will build in Granada, Spain. The plant is predicted to be operational in 2012.

By that time ROVI hopes that it will have gained European marketing authorization for its vaccine. A non-profit foundation, jointly sponsored by ROVI and the Spanish government, is being established to support Phase III development of the vaccine.

The Spanish authorities are putting forward a €25m credit line to fund the foundation and support development of the vaccine.

As part of the deal ROVI is making a $3m equity investment in Novavax. The investment and earnings from the deal will be a welcome boost for Novavax, which posted a loss of $8.3m in Q1 and had cash reserves of $25.6m.

Novavax’s share price spiked by 30 per cent when the deal was announced, with the cash injection and broadening of the company’s geographical reach being welcomed by investors.

The deal is Novavax’s first move into Europe and follows the joint venture with Cadila Pharmaceuticals in India.

Cardiff Univ. Uses $6.6 Million for Neuro-Genetics and Genomics Center

Cardiff University in Wales has established a new center to study the genetic underpinnings of mental illnesses, and said that it will be funded with over £4 million ($6.6 million) from sources within the UK and from its own coffers.

The Centre for Neuropsychiatric Genetics and Genomics will conduct studies seeking risk genes for brain diseases and finding ways to use those genes, and will develop collaborations, fund bioinformatics, and establish a new PhD program.

The center, which opened on April 1 but is celebrating its official launch today, will receive £2 million over five years from the UK's Medical Research Council, £1 million each from Cardiff University's School of Medicine and from its strategic fund, and £277,000 from the Wales Office of Research and Development for Health and Social Care (WORD).

"Over the next five years, we want to use technological advances to identify new genes which put people at risk of brain disorders," Mike Owen, a professor at the School of Medicine and the center's director, said in a statement. "We then want to work out exactly how these genes affect the operation of the brain and, ultimately, start building treatments which can tackle some of these terrible diseases.

"We see the public engagement work as central to our mission. Our research projects need a large amount of data from a large number of volunteers and public support is vital," Owen added.

MRC Director of Research and Training Declan Mulkeen said in a statement that the center "will provide exciting new opportunities for future translational research based upon world class expertise in neuropsychiatric genetics."

The center will conduct studies of mental illnesses such as schizophrenia and bipolar disorder, degenerative diseases like Alzheimer's and Parkinson's, and developmental disorders like dyslexia and childhood depression.

It will develop collaborations to research risk genes for brain diseases, establish a four-year program with two new postgraduate studentships each year, conduct public engagement and communications, and establish a senior post in bioinformatics for handling data used in the research.

Mylan and Biocon Enter the Global Generic Biologics Market

Mylan Inc. announced that it has executed a definitive agreement with Biocon Limited, a publicly traded company on the Indian stock exchanges, for an exclusive collaboration on the development, manufacturing, supply and commercialization of multiple, high value generic biologic compounds for the global marketplace. Through this partnership, Mylan and Biocon bring together highly complementary capabilities that will significantly advance their efforts to secure a leading position in the emerging generic biologics industry. As part of this collaboration, Mylan and Biocon will share development, capital and certain other costs to bring products to market. Mylan will have exclusive commercialization rights in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries through a profit sharing arrangement with Biocon. Mylan will have co-exclusive commercialization rights with Biocon in all other markets around the world. All other financial terms and product details remain confidential.

UK Group Chiltern International has Opened an Office in Budapest Hungary

The new office, which will manage Chiltern’s local early development and Phase I to IV clinical trial activities, is one of a number set up by trials firms hoping to tap central and Eastern Europe’s (CEE) large treatment naïve patient population.

In the last few months for example US firm Synteract and Sweden’s Trial Form Support International (TFS) both announced plans to set up offices in the region of the first time.

In addition contract research organizations with an established presence in the region like Icon, PRA International, Quintiles, Covance and PPD have all expanded their operations.

Lewis Cameron, Chiltern’s executive vice president for Europe, confirmed this trend explaining that: “Central and Eastern Europe continues to be a key focus for our clinical trials and Hungary is an important component of this region.”

Attila Lorinczi, who will manage Chiltern’s new Hungarian unit, said that: “Hungary and the CEE region continue to provide excellent quality data and good patient recruitment rates,” both of which are critical factors for clinical development.

Silliker Buys French Firm for More Healthy Food Research

Silliker is building clout in the provision of food clinical studies with the acquisition of French CRO Biofortis, as the healthy eating drive and claims legislation demand top notch research.

Silliker, part of the Mérieux-Alliance group, already has a reputation for providing research, testing, training, consulting and auditing services throughout the food industry, especially on practical controls and risk.

However it has been looking to increase the research services it can offer to food manufacturers and ingredients supplier, especially in the healthy foods arena.

“One major area of innovation and development for these companies is related to their ability to provide healthier foods with proven health benefits,” said Silliker. “At the same time, regulations are tightening and consumers are becoming more demanding.”

In particular, the new health claims regulation requires a storehouse of research behind any ingredient or food’s application.

According to Silliker, companies need additional, outside expertise – not only to prove the effectiveness of their products, but also to speed up development and commercialization of new market entrants.

Biofortis, which was founded in 2002, is especially interesting for its Central Lab which specializes in metabolism disorders. This means that Biofortis can integrate the most recent biomarkers into the clinical trials it conducts.

The contract research organization (CRO) also has close ties with the human health services of Nantes.

Philip Sans, CEO of Silliker, said: “Biofortis will complete and reinforce Silliker capabilities on a worldwide basis to support ingredients and food manufacturers throughout the product development process.”

Financial details of the acquisition have not been released.

In April Silliker announced the acquisition of two Chinese laboratories - Shanghai Allsuccess Commodity Inspection Co., Ltd (ACIC) and Beijing Inspection JR Laboratories Inc (BJJR) in order to extend the analytical services it can offer to primary food producers, industry and international agencies.

Such acquisitions, subject to PRC regulatory approval, are timely given the high attention paid to food safety standards in China – especially in the wake of the melamine milk contamination crisis, which had far reaching implications throughout the food and ingredients sector.

Silliker is one of a small number of foreign analytical agencies in China.

In 2008 Silliker made no less than three acquisitions, of Brazilian analytical firm BioAgri; Portuguese food testing and consulting lab EGI; and Pioneer Dairy Laboratories in the US.

GlaxoSmithKline Opens Singapore Biologics Vaccine Plant, Creates Endowment Fund

GlaxoSmithKline this week opened a S$600 million ($414 million) vaccine plant in Singapore's Tuas Business Park, in the Asian country's western section. The plant will begin production of GSK's pneumococcal conjugate vaccine, designed to combat meningitis, pneumonia, and blood poisoning, in 2011 following audits from the US Food and Drug Administration and the World Health Organization.

The new 85,000-square-meter (914,932-square-foot) plant will employ about 200 people, and grow GSK's Singapore workforce, which now totals 1,000 employees. Company vice president Emmanuel Amory told In-Pharmatechnologist.com that Singapore had been chosen as the site for GSK’s first vaccine plant in Asia due to what he called its highly skilled local workforce, following a decade-long plan by the government to boost expertise in biologics.

Another possible factor is the country’s lower labor costs for manufacturing than the US, Canada, or Europe. Data issued April 1 by the US Bureau of Labor Statistics concluded that as of 2007, the hourly compensation for manufacturing employees in Singapore was half that of their American counterparts.

GSK also announced that it was setting up a S$30 million endowment fund for graduate studies in sustainable manufacturing processes, green chemistry, and health policies. The prime minister said Singapore would chip in another $20 million to the fund, which he termed a symbol of cooperation between GSK and Singapore.

Icon Collaborates with the Central Manchester University Hospitals Foundation (CMFT)

Icon has entered into a collaboration with the Central Manchester University Hospitals Foundation (CMFT) to establish a purpose built translational medicine facility in the UK.

When the project is completed in 2012 Icon will have a hospital-based setting for translational medicine, which it believes will help it accommodate clients that want to conduct first-in-human studies in this environment.

The collaboration is intended to establish Manchester, UK as an international centre of excellence in translational medicine, with the nation’s pharma industry excited to see collaboration between different sectors.

Allison Jeynes-Ellis, Medical and Innovation Director at the Association of the British Pharmaceutical Industry (ABPI), explained: "This is an example of the type of collaboration between industry, academia and the NHS (National Health Service) that the ABPI is seeking to encourage and which we believe will help drive forward translational medicine, building on the strength of the pharmaceutical, science and clinical base in the UK.”

Icon will gain access to the facilities used by other NHS members and the University of Manchester, as well as share expertise and contribute to education and training of clinical academics.

The investment is part of the development of Manchester Royal Infirmary (MRI). Prior to the completion of Icon’s translational medicine site the company will house its current clinical pharmacology services in dedicated research facilities at MRI.

When completed the facility will increase Icon’s ability to conduct translational research, which has grown in prominence in recent years and become a priority for the US National Institutes of Health (NIH).

Translational research is an attempt to help knowledge move between laboratories, clinical trials and population studies. In Phase I translational medicine aims to take laboratory based research and apply it to human illnesses, a concept known as “bench to bedside”.

The NIH launched the Clinical and Translational Science Awards (CTSA) Consortium in 2006 to further research and the number of health centers participating recently expanded to 39. By 2012 it is predicted that 60 institutions will be in the CTSA.

Genome Sequencing Center Opens in Dublin

Trinity College Dublin's Institute of Molecular Medicine has opened a Genome Sequencing Laboratory, the university recently announced.

The new lab, which opened within the past couple of weeks, will enable research into psychiatric disorders, cancers, infectious diseases, and immune system disorders being conducted at the Institute of Molecular Medicine. Funding for the sequencing lab was provided by Science Foundation Ireland through a grant of €557,724 ($773,680).

The university had claimed that the new lab was Ireland's first genome sequencing lab and also housed Ireland's first next-generation sequencing platform — an Illumina Genome Analyzer II. However, University College Dublin has refuted that claim, saying it was already using an Illumina GA II in its own sequencing lab.

"This new DNA sequencing technology will greatly accelerate the search for risk genes for schizophrenia by enabling Trinity's Neuropsychiatric Genetics Research Group to sequence many genes in many patient samples to identify the subtle changes to the DNA code that results in a gene not functioning properly and thus contributing to the development of the illness," said Professor Michael Gill, head of the Neuropsychiatric Genetic Research Group in Trinity's School of Medicine.

OctoPlus Opens GMP Site in The Netherlands

OctoPlus N.V. has started pharmaceutical production in its new GMP manufacturing facility in Leiden, The Netherlands. The facility has received a license from the Dutch authorities to manufacture pharmaceutical products according to international GMPs and the first production has taken place successfully.

The expansion of OctoPlus' headquarters started in November 2006. The new building includes offices, laboratories and a GMP manufacturing plant that produces final drug product for OctoPlus' clients. Expansion of the manufacturing capacity was necessary to facilitate the growing client demand. With the expansion, OctoPlus' manufacturing capacity more than doubled and the company can now produce clinical scale Phase I, II, III and small-scale commercial supplies of injectable pharmaceutical products and other complex formulations.

Simon Sturge, chief executive officer of OctoPlus, commented, "We are very proud to report that the expansion of the production facility in our headquarters in Leiden has obtained official approval from the Dutch authorities and we have now started producing pharmaceutical products as a fully licensed facility."

Syntagon Renews GMP Accreditation

Syntagon has successfully renewed its GMP certification for the manufacture of clinical APIs following an audit by the Swedish Medical Products Agency. The two-day audit scrutinized Syntagon’s facilities, documentation, QA and QC departments.

The Swedish agency, known as Läkemedelsverket, carries out GMP audits every three years. Syntagon first gained accreditation from the Agency in 2003. The certification allows Syntagon to continue to make clinical APIs for clinical trials throughout Europe and North America.

“We are delighted to be successfully re-audited by the [Swedish Medical Products] Agency. It demonstrates our continued commitment to quality and our full compliance with GMP,” said Paul Alhadeff, Syntagon's QA officer.

With operations in Sweden, Latvia, and China, Syntagon specializes in synthetic preparation of small molecules under GMP manufacture.

Helsinn Plans for HPAPI Manufacture

Swiss drugmaker Helsinn has unveiled plans to add high-potency API R&D and manufacturing capacity to its facility in Biasca in the south of the country.

The plan will see Helsinn expand development and manufacturing services in a bid to capture a share of the growing market demand for potent active pharmaceutical ingredients (APIs).

Company CEO Riccardo Braglia explained that: "The new organization of our R&D and production facilities in both Switzerland and Ireland represents one of our corporate strategic goals and is of significant benefit for the further growth of our international business."

The move follows just weeks after the Biasca facility gained ISO 14001, OHSAS 18001 certifications for the development and manufacture of APIs for the drug industry following a May inspection by accreditation group SGS International.

At the time, Paolo Guainazzi described the certifications as an important step for the firm and a vindication of its decision to invest around €5m ($7m) to raise quality, safety and manufacturing standards at the plant.

Helsinn Ireland Sold to Medinco

Helsinn also confirmed that, as part of ongoing reorganization efforts, it has signed an agreement to sell its Irish manufacturing plant in Mulhuddart, Dublin to Italian pharmaceutical chemicals supplier Medinco for an undisclosed sum.

The year so far has been a busy one for Helsinn’s executive team. In January, the firm set up a base in US pharmaceutical hub New Jersey with the acquisition of Sapphire Therapeutics.

Speaking at the time Braglia explained the Sapphire purchase would “allow [the firm] to expand our current pipeline of products in existing, focused therapeutic areas in particular in cancer supportive care.”

He went on to say that the unit would act as both an R&D and commercial operations centre for the firm’s burgeoning North American business.

This was followed in March by Helsinn’s investment of €13m ($18m) to set up an R&D centre of excellence for oral solid-dose drugs at a second facility in the Irish capital Dublin, creating 10 new high-tech jobs.

DeltaDot-QSTP JV to Create Qatar's First Proteomics Facility

The 5,382-square-feet center is expected to open by the end of the year and will concentrate initially on biomarker discovery and validation with a focus on diseases that are of special concern to the Qatari people, such as cancer and diabetes.

McIlvaine Company,

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