march 09 update

The Cleveland Foundation has given a large grant to expand a proteomics research facility at Case Western Reserve University as part of a $10 million community investment program.

The $1.5 million grant will be used to expand Case Western Reserve's Center for Proteomic Medicine, which focuses on using proteomics studies for disease research. The grant is part of the foundation's efforts to address the ongoing economic downturn.

The foundation initially gave the proteomics center a $1.5 million grant in 2005.

Meissner Purchases 172,077 sq. ft. Manufacturing Facility

Meissner Filtration Products, Inc. announced recently that it closed escrow on a 172,077 square foot facility in Camarillo, CA, which is ideally suited for use as its corporate headquarters. The building will be leased back to its current occupant for the next 2 ½ years, at which point Meissner will consolidate two locations into the new facility.

"By making the acquisition at this time, we are assured that we can sustain growth without experiencing space limitations," stated Christopher Meissner, CEO. "With land becoming scarce for large industrial facilities in Ventura County, there is an extremely limited inventory of facilities capable of meeting our needs. With this acquisition, we have solved our need not only for additional manufacturing space, but also for laboratory space. Furthermore, with 68,000 square feet of office space, the new facility is well suited to meet our requirements for R&D, engineering, quality and training."

Meissner's ability to secure financing in the current uncertain financial environment is a testament to the strength of the company's balance sheet, cash fl ows and growth prospects. Bank of America financed the transaction.

Catalent Pharma Solutions Closing NJ Packaging Facility

Catalent Pharma Solutions, one of the leading providers of advanced technologies and outsourced services to the global pharmaceutical, biotechnology and consumer health industries, announces the intended August 2009 closing of its folding carton printing facility in Pennsauken, NJ, and the parallel expansion of its capabilities at its Moorestown, NJ facility. Both sites are part of the Printed Components business, in Catalent’s Packaging Services segment.

To meet the ongoing needs of its folding carton customers, Catalent is upgrading its carton printing capabilities at its Moorestown printing facility and over the next six months relocating key equipment from Pennsauken to Moorestown. At the same time, Catalent will be investing in additional new equipment and technology to be based at its newer Moorestown plant.

Some of the expected new and upgraded equipment will include UV coating, vision systems, additional printing technologies and the establishment of a new design and pre-press center. We also expect to introduce our recent printing innovation, e-Magineering™. Catalent’s e-Magineering Web-based solution will automate the development, management and delivery of printed labels, inserts, cartons, and other printed components, from the design phase to supply replenishment. It will also track document work flow, order history and billing.

“We believe housing our continental US Printed Components business in a single location will bring important benefits for our customers, including more efficient distribution, a consolidated invoice, and the ability to pack or ‘kit’ all products, including labels, inserts and cartons, together,” said Victor Dixon, Catalent’s Vice President and General Manager, Printed Components. He continued, “Closing our Pennsauken plant was a difficult but necessary step in the evolution of the business, and we are dedicated to supporting efforts to help the employees that will be affected by the closing. We believe that both of these changes will bring about a stronger Printed Components business.”

J-Pac Adds Contract Thin-Film Cutting and Sealing

Contract manufacturing and packaging firm J-PAC’s addition of thin film converting and sealing capacity to its roster of services completes its offering according to CEO Richard Eagling.

J-Pac said that the new machine, the Doyen thin-film converting and platen sealing system, has particular application in the creating of orally-dissolving sub-lingual strips that are already popular in the over-the-counter (OTC) drug sector.

The system operates in an environmentally controlled cleanroom that J-PAC claims allows it to efficiently process delicate, brittle films and materials, maximizing material utilization to 85 per cent or better, thereby offering significant cost savings for its customers.

The new machine is being provided by J-PAC’s sister organization Doyen Medipharm that has previously supplied the company with four rotary side seal units for products like wound care dressing and diagnostic strips and two industrial thermoforming units.

Eagling said that: “With the ability to offer both contract manufacturing and medical manufacturing machinery we can provide a complete service to medical, diagnostic and pharmaceutical companies in delivering their products to market.”

He added that the new machine means that J-PAC can offer drug industry customers a complete in-house service from product design and development through the production of both clinical trial samples and commercial-scale manufacture.

Other contract services offered by J-PAC include medical device assembly, implantable textile concerting and packaging, RF sealing & welding, ultrasonic welding, heat sealing, custom tray design and plastic fabrication.

As Big Pharma continues to seek outsourcing options for non-core processes the demand for packing services looks set to continue increasing. As a result more and more contract packaging firms are trying to act as one-stop shops for drug industry clients as competition for the lucrative market heats up.

Schott Developing U.S. Syringe Production

Schott's Pharmaceutical Packaging business plans to expand both its product line and production capacity in the U.S., adding the full line of Schott ready-to-fill syringe products to its portfolio of vials and cartridges manufactured at its existing Pharmaceutical Packaging facility in Lebanon, PA.

The company expects to add 125 new jobs to its Lebanon facility and will begin hiring this year. The expansion into the syringe market represents a $46 million investment in the facility.

The expansions are intended to meet the accelerating demand for syringes in the North American market. Market analysis shows global demand for prefilled syringes will grow at a rate of 8-10% annually for the next several years.

"Demand for syringes in the U.S. has grown steadily in recent years and will continue with the increased incidence and detection of chronic diseases," said Gary Waller, director North American Sales & Marketing for Schott Pharmaceutical Packaging."Schott is well positioned to leverage its high-quality global production capabilities for the U.S. market."

Regis Opens QC Lab

Regis has opened its new 15,000-sq.-ft. Analytical Development and Quality Control laboratories. The expansion at the existing site adds 8,000 sq. ft. of new lab space and includes a 400 MHz Bruker NMR. The expanded QC lab allows the company to provide GMP custom manufacturing and separations of API and nutraceuticals.

The addition was completed in September 2008 in preparation for future expansion to a 30,000-sq.-ft. manufacturing facility that is scheduled to begin this year.

Shire’s MA Facility Uses Honeywell Systems

Industrial manufacturing specialist Honeywell has been contracted to manage and control production processes at the newly constructed US operations of UK biotechnology company Shire.

Honeywell said that it will help expand R&D capabilities at Shire’s Human Genetic Therapies (SHGT) subsidiary in Lexington, Massachusetts, using its Experion Process Knowledge system and batch management technology.

Honeywell said that the Experion system, which will be the primary means of production control, will provide Shire with a complete overview of operations through the integration of all subsystems being used at the plant.

The firm went on to highlight the system’s C300 controller unit as a key advantage for Shire, claiming that its processing capacity reduces the amount of hardware required to automate manufacture and therefore cuts operating costs.

The Phoenix-based firm will also use its OneWireless network platform and Uniformance Process Historian database software to control manufacturing operations at the $250m (€183m) facility.

The plant, which is scheduled to become operational in 2010, is part of Shire’s efforts to spearhead the use of disposable production vessels in the US biotechnology sector in a bid to cut cleaning costs and delays associated with equipment verification.

Don Wuchterl, director of manufacturing at SHGT, explained that: “Technology that simplifies scale-up from R&D to commercialised production is critical for biotech facilities to produce as efficiently and reliable as possible.”

Wuchterl went on to praise the streamlining benefits of Honeywell’s technologies which he said will “provide the flexibility required for a multi-purpose facility.”

Honeywell spokesman Jake Saylor told the Phoenix Business Journal that: “While some of the technology used in the project was developed in Phoenix, implementation will be handled primarily by Honeywell teams in Fort Washington and Atlanta.”

Pfizer Markets for Sale La Jolla, CA, Incubator Building, With Three Tenant Companies Inside

Pfizer has put its La Jolla, Calif., incubator building up for sale, in one of several moves to restructure its real estate portfolio and cut costs in light of its planned $68 billion acquisition of Wyeth.

The 26,600-square-foot building, known as CB-7, is listed without an asking price, and has been up for sale since late last year, said Cushman & Wakefield broker Steve Rosetta.

The incubator building is one of eight at Pfizer's 33.5-acre La Jolla campus, and houses three early-stage biotech companies: Fabrus, Wintherix and RGo Bioscience.

The 30 employees of the three companies test products and ideas using equipment and supplies provided by Pfizer under an equity-share arrangement. Life sciences startups chosen for the incubator receive $2 million a year and access to equipment, lab space, and administrative support in exchange for Pfizer's right to purchase the businesses or their technologies. Beginning in 2007, Pfizer agreed to invest $10 million in the program over five years.

As part of the building's sale, Pfizer said it was seeking a lease-back arrangement to allow the three companies to remain in place. Those three may be joined by two additional fledgling companies with which the incubator is in talks, said Mark Benedyk, who heads the facility. He declined to name the prospective tenants.

Chromocell to Open New 15,000 Square-Foot Research Facility in NJ

Chromocell is set on March 25 to celebrate the opening of a new 15,000 square-foot research and development facility at the New Jersey Economic Development Authority's Biotechnology Development Center, on the campus of the Technology Centre of New Jersey in North Brunswick, NJ.

New Jersey Gov. Jon Corzine is expected to lead dignitaries in marking completion of the new R&D facility, set to employ 80 researchers and support staffers. Founded in 2003, Chromocell focuses on drug discovery programs in pain relief, anxiety and respiratory disorders.

Chromocell also maintains an internship program designed to give students from Rutgers, the State University of New Jersey, and other academic institutions an opportunity to gain lab experience in an industry setting.

The company has grown from a three-person operation located in a single, 800 square-foot laboratory at the Commercialization Center for Innovative Technologies, on the campus of the Technology Centre of New Jersey.

Mack-Cali Completes Leases with New Jersey, New York Biopharma Companies

Two suburban New York biopharma businesses have completed lease deals for spaces at properties owned by Mack-Cali Realty, a publicly-traded real estate investment trust.

In Parsippany, NJ, Wockhardt USA — a subsidiary of India-based pharmaceutical and biotechnology company Wockhardt — has relocated to 12,000 square feet at Mack-Cali's 13-acre Waterview Corporate Center.

And in Hawthorne, NY, Acorda Therapeutics has signed a three-year renewal of its lease for 46,000 square feet at 15 Skyline Drive, within Mack-Cali's Mid-Westchester Executive Park. The building is fully leased.

Kodak Moments: Biotechs Eye Pieces of Imaging Giant's Rochester, NY, Industrial Campus

Four separate biotechnology companies have toured lab space available for lease within the 900-acre Eastman Business Park industrial campus being marketed by imaging giant Eastman Kodak.

Kodak has buildings totaling more than 1.7 million square feet available for sale or lease, including a site on St. Paul Street that is about 50 percent occupied by ITT's space systems division, as well as Building 642 along Lee Road in neighboring Greece, NY, which is partially occupied by the Ortho-Clinical Diagnostics division of Johnson & Johnson. The company also is looking for parties interested in nearly 4.5 million square feet of office, manufacturing, and warehousing space available in other buildings. And it is marketing nine separate parcels of empty land as ready for construction, according to the Democrat and Chronicle.

Kodak is marketing available sites at Eastman Business Park, formerly Kodak Park, through commercial real estate brokerage CB Richard Ellis, as well as with help of a few tools — namely a 3-D virtual simulation created by the Rochester engineering and planning firm Bergmann Associates, and a Website that went live about a month ago, said David Stoklosa, Eastman Kodak's director of Rochester business development and facilities.

"I have more leads of people investigating getting into the park since I started a year and a half ago," including representatives from industries as varied as food production and information technology, Stoklosa said.

Michigan OKs $10.9 Million in Incentives for Biodefense Firm's Lansing Expansion

The board of the Michigan Economic Growth Authority approved a $10.9 million tax break for Emergent Biodefense Operations, the producer of BioThrax — the only vaccine approved by the US Food and Drug Administration for the prevention of anthrax infection.

Emergent's $10.9 million in tax incentives is tied to an expansion of the company's operations in Lansing. That expansion would create 93 direct jobs, part of the 302 overall jobs MEGA has projected for the project.

Lansing is competing with sites in California and Maryland, and the company has yet to announce where it will proceed with its expansion.

Emergent focuses on the development, manufacture and commercialization of vaccines and immune-related therapeutics

26-Acre Portland (ME) Technology Park, Including Biotech Sites, 'Poised for Takeoff'

Portland, Me., officials are finalizing plans for a 26-acre business park specializing in biotechnology, hoping to diversify the city's economic base and provide a campus-like environment to attract new companies to the area, according to the Portland Press Herald.

The site, known as the Portland Technology Park and located just off Exit 47 on Rand Road, will have nine building sites available. The nine can accommodate buildings from 6,000 to 20,000 square feet. Interested businesses would buy lots condominium-style, owning their lots but paying fees toward upkeep in common areas owned by the city.

The city tentatively plans to sell the lots for between $20 and $30 per square foot, Hanig said. There is a total of 120,000 square feet available, and the business park is expected to create 400 jobs. If successful, Portland Technology Park would mark the city's first time owning and managing a business park.

The city hopes to compete for new companies seeking proximity to, and a lower cost of business than, Boston. No tenants have been selected, though the city is coordinating a region-wide marketing campaign to attract new biotech companies to the area, touting the new technology park and other regional advantages. Representatives from Portland, South Portland, Westbrook and Scarborough will attend the Biotechnology Industry Organization's 2009 BIO International Convention set for Atlanta from May 18-21.

"We want to get Maine's name out there," Nelle Hanig, a business development representative for Portland, said "When people think of Maine, they think of blueberries and lobster, but we want them to realize we have world-class institutes, we're near Boston and we have this (biotech) cluster here."

The business park sits on part of a 40-acre lot purchased in 1999 for $1.7 million from the Snyder and Barris families. Because the remainder of the lot is designated as resource protection land, the city plans to develop trails and public access to the property, as well as linking it to an adjacent 200-acre protected area.

Mitchell said the city expects to hear within a few weeks whether Portland and the city of Westbrook, Me., will get a $1.4 million federal grant from the US Economic Development Administration, to be matched by the city, toward the cost of roads and utilities leading to the project site.

Hanig said they hoped to put the project out to bid by December or next January.

University of Rochester (NY) Medical Center Freezes Action on Research Expansion

The University of Rochester Medical Center has put on hold its plans to complete a 150,000-square-foot research building until state funding for the project comes through.

Construction on the $76.4 million Clinical and Translational Science Building, slated for completion next summer, will wait until after the state has formally signed off on its $50 million commitment to the project — something expected in the next two to three months.

The medical center has had "repeated assurances that support for (the research building) project is on its way," UR President Joel Seligman said.

In October, medical center and state officials participated in a ceremonial groundbreaking for the building. "With the volatility that exists at the New York state budget level, our biggest concern is (what will happen) despite the commitments that have been made," the medical center's Chief Financial Officer Michael Goonan told a newspaper. "We won't begin construction until we know the funds are ready to draw down."

The research building, to be built on Crittenden Boulevard and connected to the School of Nursing's Helen Wood Hall, will house more than 600 scientists, physicians, nurses, statisticians and other workers from across the university campus, as well as be a hub of the Upstate New York Translational Research Network, which includes 10 biomedical study programs.

Also up in the air: A $262 million, six-story hospital expansion that was expected to alleviate overcrowding in the area's emergency rooms. Due to the economic upheaval, Seligman said, the university would no longer be able to borrow the $250 million needed for construction of the Pediatric Replacement and Imaging Sciences Modernization, or PRISM, and instead would seek a loan of $80 million to $90 million this year. The project is still in the university's long-term plans, he added.

The ongoing financial market turmoil also explains why since November, medical center officials have cut $39.8 million from its $1.9 billion annual budget and laid off 36 of its 13,000 employees, though some were reassigned to new positions. Officials also eliminated all overtime not required for patient care, placed a moratorium on giving staff new job titles that come with raises, and implemented a stringent review process for approving new positions and filling vacant jobs.

Forma Therapeutics, Experimental Therapeutics Centre of Singapore Unite to Develop New Drugs

Forma Therapeutics, a Cambridge, MA, cancer therapy developer, and the Experimental

Therapeutics Centre of Singapore have announced a collaboration agreement intended to use FORMA's platform to discover compounds for further development by ETC. Financial terms were not disclosed.

ETC is funded by Singapore's Agency for Science, Technology & Research, or A*STAR.

"We share a commitment to advancing early-stage science and translating those discoveries into practical clinical applications. This collaboration is therefore mutually beneficial, potentially bolstering Singapore's biomedical pipeline of the future, while also further validating the productivity and efficiency of Forma's proprietary drug discovery technologies in identifying new, promising compounds," Forma CEO Steven Tregay said in a statement.

UK Visualization/Bioinformatics Startup Chooses San Diego Suburb for Expansion

Bioinformatics company Dotmatics, a UK-based scientific visualization and bioinformatics software developer, has opened an office in the San Diego suburb of Del Mar, Calif., as part of an expansion that targets the US life sciences market.

"Now with an expanding team we were finally at a point where we needed a US office," said Dotmatics CEO and co-founder Stephen Gallagher told Xconomy San Diego. "We always had an eye on San Diego because it would help cover a wider territory and because of the great history of biotechnology in the area. Another real attraction was the mix of small biotech, start-ups, major pharmaceuticals, research institutes and contract research companies, all of whom are our potential customers or partners."

Gallagher co-founded Dotmatics in 2005 as a spin-out from the pharmaceutical company Merck Sharp & Dohme. The company initially worked with small biotechs, but discovered that big pharma also sought its services.

RTP Foundation, Marking 50th Anniversary, Will Add Biofuel Shops as Tenants

Life-sciences companies will likely continue to command the largest share of tenants and building owners within North Carolina's Research Triangle Park well into the next half-century, just as they had leading up to the 50th anniversary of the foundation sharing the park's name, the man charged with managing the campus predicted last week to an audience of science writers in New York.

Rick Weddle, president and CEO of the Research Triangle Foundation of North Carolina, said that the research park's roster of more than 170 companies will be joined by shops focusing on energy efficiency and clean technology due to the prospect of new subsidy programs from the Obama administration.

Some of these concerns include biofuel makers, which could also be considered life sciences.

"We don't see either our life science or our IT presence declining. We see it stabilizing, and continuing to grow. But some of [those presences] will be supplanted by this [cleantech] growth," Weddle told BioRegion News during the March 18 meeting with members of Science Writers in New York, a regional affiliate of the National Association of Science Writers.

RTP houses 59 life-sciences employers all with a combined 10,607 employees. According to the state-funded North Carolina Biotechnology Center, which is also based at RTP but not counted as a life-sci employer, North Carolina is home to "more than 450" biotech companies employing 55,000 people headquartered or operating in the state.

RTP is also home to a research institution, the Hamner Institutes for Health Sciences; the Burroughs Wellcome Fund, which funds biomedical research and educational activities; and the GlaxoSmithKline Foundation, which funds programs that promote the sciences, health, and education.

At 29 percent, life-sci companies represent the largest plurality of RTP occupants, followed by information-technology companies, with 21 percent. The next-highest category is professional business services providers, at 15 percent, followed by materials sciences and engineering firms (13 percent) and scientific associations and institutes (11 percent).

If life-sci remains the largest category of RTP companies in the next 50 years, Weddle's foundation will have played no small role in that. Owners of property at RTP are required, before they sell any of their land, to first present the terms and conditions of their proposed sale to the foundation.

"The Research Triangle Foundation of North Carolina has the right of first refusal to purchase the property under the same terms and conditions as may be contained in such bona fide offer made to the [seller] company by any third party," according to the organization's Summary of Covenants, Zoning & Restrictions, last updated Feb. 10.

Weddle said his appearance was part of a series of talks with journalists aimed at promoting RTP, which is marking the 50th anniversary of the founding of the namesake nonprofit group that has grown into a $150 million foundation.

The RTP foundation played a key role in re-anchoring the Tar Heel State's economy away from the tobacco, textiles, and furniture industries by overseeing the development of some 7,000 acres — within the "triangle" formed by the cities of Raleigh, Durham, and Chapel Hill — into 25 million square feet of space for businesses and institutions employing more than 40,000 people.

Employers range from startups spun out of area universities, to a US Department of Agriculture's Forest Research Station, a US Environmental Protection Agency lab, and the only National Institute for Environmental Health Sciences lab outside of Bethesda, Md. Tenants also include life-sci giants such as Biogen Idec and the US headquarters of GlaxoSmithKline.

Roche Closes Manufacturing Site and Heads Out West

Roche is closing its manufacturing facility in Nutley, New Jersey and relocating its centre of commercial operations in the US to California following its $46.8bn (€36.3bn) takeover of Genentech.

The companies finally reached an agreement after eight months of wrangling, with Genentech accepting a lower offer than it had initially wanted because of the downturn in financial markets.

Roche will now operate in the US under the name Genentech, because of its strong brand in the country, and move some of its divisions to South San Francisco where the biotech is based.

Among the causalities of this consolidation will be the manufacturing operations in Nutley and its Palo Alto, California research facility. Nutley will retain its research staff and be supplemented by the inflammation group working at the Palo Alto site, with the California facility’s virology research team relocating to South San Francisco.

Consolidation of the companies’ late stage development and manufacturing operations is also planned, with the intention of “achieving substantial scale benefits”, but specific details of this are yet to be released.

Despite this alignment of operations Roche has been keen to stress that Genentech’s research and early development operations will remain independent, with the Swiss pharma saying it wants to retain the biotech’s talent.

This has been a major concern throughout the takeover negotiations, with some fearing that by losing its independence Genentech would struggle to retain the staff and corporate culture that have made it a success.

Part of this will involve retaining Genentech’s management, which many analysts and stockholders have said is unlikely to happen. However, Franz Humer, chairman of Roche, said: "I have a strong conviction that most if not all senior management will stay on."

Genentech Plans September Debut of New $240 Million Rx Fill/Finish Plant in Oregon

Genentech is months away from starting operations at a new $240 million pharmaceutical-fill/finish plant it recently built in Hillsboro, Ore., designed to accommodate its needs and those of its partner-turned-acquirer, Roche.

Genentech's Hillsboro Fill/Finish Facility, which the company calls HFF, is now carrying out validation testing for its packaging lines, required in order to obtain the US Food and Drug Administration approvals needed to start receiving bulk shipments of drugs the company produces in South San Francisco, Calif., then carrying out final processing and packaging of those drugs.

These drugs, which include the recombinant growth hormone Nutropin, non-Hodgkin's Lymphoma treatment Rituxan, and cancer drugs Avastin and Herceptin, are part of the product line Roche agreed to buy earlier this month when it acquired the South San Francisco, Calif., biotech pioneer for $46.8 billion.

"The goal for that is to get those [packaging lines] up and running by September of 2009," said Joe Miller, principal architect in Genentech's design-engineering group, addressing attendees last week at a session discussing the three-story, 296,000-square-foot facility.

"We do want to start shipping it out there [Hillsboro] for packaging, so inspection will go up there, as well as labeling and packaging," Genentech said. "By the end of this year, those components will be already validated and licensed and ready to start operations."

Miller said the plant's filling lines "are just really going through operational qualifications. They're still doing startup [tests]," while "we just finished air balancing in our fill and finish facility, so we know that's set.

"It's a little bit more complicated with the isolators, cause there's much more linkage now between the air balancing and the actual isolator operation, so they're fine tuning those," Miller said. "They are starting to do some initial test runs. I've seen they've been filling vials, and they're actually doing some test runs through the inspection."

Miller spoke March 18 during a discussion session on the project held as part of Interphex 2009, the pharmaceutical manufacturing conference held at the Jacob K. Javits Convention Center in New York. Miller and two architectural principals from project — Andrew Cunningham and Jim Gazvoda from Flad Architects of San Francisco — detailed the thinking behind the new HFF, as well as the effort to design and construct the facility.

The HFF consists of five buildings — the main administrative offices, the GMP-manufacturing building, a utility building, a GMP warehouse, and a distribution center, all occupying 12.5 acres of a 75-acre site about 13 miles west of Portland.

Inside the manufacturing building, Genentech has built out two freeze dryers, with room for two additional freeze dryers should production needs warrant them; as well as two filling and packaging lines — one liquid, one either liquid or "lab like" products — and shell space for a third filling line that "we anticipate may be a syringe fill line."

HFF expects to reach its full staff capacity of 300 employees by 2015 for the just-in-time facility, which is designed to produce 20 million vials of drugs annually at sizes ranging from 3cc to 100cc; as well as cut manufacturing costs by minimizing on-site inventory space.

Formal planning for the project began in 2006, nearly three years before Genentech agreed to sell its remaining 44-percent share to Roche, creating the nation's seventh-largest pharmaceutical company with combined revenues of about $17 billion, and a combined workforce of about 17,500 people.

Because Roche has had a stake in Genentech for almost two decades, the companies have worked closely on a number of ventures. A supply agreement between the companies, for example, committed Genentech to producing 25 percent of the Avastin, Rituxan, and Herceptin sold by Roche worldwide.

Roche was also interested in seeing a new facility emerge that could take the place of a similar plant it designed at the same time in Basel, Switzerland, in the event it were to be shut down for repairs or maintenance.

To satisfy the agreement with Roche, the plant has 25-percent additional capacity designed into it.

"This facility can serve as a backup to the Roche facility, and the Roche facility [can serve] as a backup for the Genentech facility," Miller said. "Both companies were looking at technologies that were compatible with each other's" — though not costlier custom technologies.

Miller added that Genentech also had its own interests in mind in developing the HFF — namely a need to build production capacity projected to be needed in 2015, and a desire to do that by spreading out a manufacturing operation mostly focused till now within its South San Francisco headquarters campus.

"Operations were developed and spread out through the site, so you don't really have operational efficiencies when you have to do a lot of transportation of raw materials, finished product, and you're doing multiple handling steps," Miller said. "You certainly need work-in-progress staging at these handoff points.

"The major driver was really risk mitigation," Miller recalled. "We're in a very active seismic zone. We have a lot of older facilities, and to strengthen the business continuity of our supply chain … there was a conscious effort to look at our current operations and say, 'How do we diversify, and spread out our risk, and not be so California-based anymore?'"

After a search, Genentech found the location it wanted in Hillsboro then worked out a series of tax breaks with the state and Washington County. The state agreed to spend $4.8 million, including $2 million from the Governor's Strategic Reserve Fund, toward infrastructure repairs and worker training.

"This is a great company with a history of strong growth, and it will be a jewel in the crown of Oregon manufacturing," Gov. Ted Kulongoski declared in 2006 when he announced the project.

The Washington County deal was even sweeter: Genentech qualified for the county's Rural Strategic Investment Program because its site lay outside Hillsboro's urban growth boundary. Under "rural SIP," Genentech agreed to pay property taxes assessed on the first $25 million of its project costs, while the county agreed to raise its property tax exemption threshold by 3 percent every year thereafter, in return for Genentech paying a $500,000 "community service" fee. The biotech giant also received property-tax incentives on its specialized equipment that extend 15 years after the end of construction.

Genentech worked with an engineering firm to define the project's elements and to arrive at a fixed budget, then brought in a construction team to execute detailed design and construct the building shells. The biotech then worked with a process-engineering team to design the elements of Hillboro's utilities and equipment building.

While the HFF's five buildings were originally planned to be built sequentially, late in the design process Genentech added a distribution center that it insisted should be built first, and within 16 months, changing the sequence of construction from counterclockwise to clockwise.

Because the all-important, three-story manufacturing building was in the middle of both sequences, Miller said, "it allowed us the time to really spend doing the detailed engineering for the process equipment and the utility system."

Genentech wanted that building built within 24 months; it was completed just over two months ahead of schedule with more than 520 construction workers on site during the peak of the work, Cunningham said. The 21.7-month timeframe reflects an overlap between the 7.9 months it took to perfect the design, followed by 19 months of construction.

Key to that success, Cunningham said, was the decision by Genentech and its design and construction teams to hold 17 standing weekly meetings and "multiple meetings beyond that."

Gazvoda said Genentech had assigned a leader to oversee every functional and technical area of the HFF.

"Important right up front, through preliminary engineering and preliminary design, we worked collaboratively as a team. Everybody got and met together regularly. We all understood how each discipline affected the other's discipline," Gazvoda said.

He said the meetings served to help the group, which got as large as 250 consultants and team members, by prioritizing issues and pinpointing which ones needed immediate answers. Once it got to final engineering, then we broke into silos. We needed focus. And when you push and you drive a process as hard as we did, you have to have energy in those areas where it counted most."

The design and construction professionals, he said, capitalized on their vendors, who in turn drew upon the know-how of their equipment vendors. "They provided ideas right up front to all of us, so that we could coordinate the building plans, the organization, and the utilities and services that were being planned," Cunningham said.

He added that architects from Flad strove to improve a conceptual plan sketched out by Genentech and another consultant, fleshing out a facility design based on the flows of the processes to be carried out at the plant. At the manufacturing building, formulations will be made on the top floor, followed by filling and inspection on the second floor, and packaging on the ground floor, with space designed within for some additional storage if Genentech needs it someday, though not months of inventory.

Those plans, in turn, were reviewed for quality control and cost; as part of those reviews, "we had to cut out thousands of square feet to bring this building back into a target area where it would fit with Genentech's budget," Cunningham said.

After years of producing its drugs within several buildings scattered through its headquarters campus — a inefficient byproduct of Genentech expanding gradually there, adding space over time as its needs grew — the biotech giant wanted its new facility to be as compact as possible: "We were given the purview to try to consolidate this area into as tight an area of the site as we possibly could," Cunningham said.

"By the end of the day, it became quite self-evident that the solution we ended up with was really probably the most effective and most sufficient layout that was going to give Genentech a consistent flow around the project site, but also satisfy its just-in-time delivery requirement, but not having flows go backwards and forwards across the building, potentially having cross-contamination," he added.

Genentech's desire for compactness, he said, was also evident in the main administrative building, which also houses not only the quality control labs, but the employee training center, and an employee cafeteria whose amenities include a fireplace.

"It was important for Genentech. As a company, they have a culture of really taking care of their employees, [hence] having facilities on the site where they'll be working long hours, and where they could actually have areas of refuge from the manufacturing area, where they could go and relax, Cunningham said. "They were really looking to try to break the paradigm of, what's a manufacturing building all about? How do you build community? How do you build team within that building? We were looking for those public spaces to help bring people together."

Adding to the uses of the administrative building, he said, offered another benefit: reducing the cost of the manufacturing building, which because of its functions and equipment was already the costliest building within Genentech's Hillsboro campus.

The cleaning and storage area for tanks undergoing maintenance was also moved outside of the manufacturing building, to the warehouse building "where we had more room to clean and then store the empty tanks ready for shipping" back to the manufacturing facility.

Cunningham said the skill of the various teams involved in construction reflected a shared sense of the facility's purpose — a purpose Genentech sought to convey by having the director of its Hillsboro operations, Barry Starkman, discuss the project with the teams.

"He got up and explained what the mission of Genentech was, what this facility was going to do, the fact that they were producing drugs to cure people from cancer. I think that was probably one of the big 'Aha!' moments in pulling this team together. There was a single goal about what we were trying to do here," Cunningham said. "It wasn't about just building a building. It was about something much bigger than that."

AECOM Environment Collaborates with UC Santa Barbara on Nanotechnology

AECOM Environment and the University of California at Santa Barbara (UCSB) are collaborating on the new Sustainable Nanotechnology Initiative (SNI) at UCSB’s Bren School of Environmental Science and Management. AECOM Environment is the global environmental practice of AECOM, and a leader in environmental health and safety solutions.

Nanotechnology involves engineering at atomic-scale levels to create new materials, devices, and systems with unique properties and capabilities – the ability to manipulate matter roughly 1/100,000 the width of a human hair. While new nanotechnology-related products are brought to market daily and are impacting global industry and society, the environmental and human health risks are largely unknown. The goal of the SNI is to begin to understand the environmental risks associated with engineered nanomaterials.

AECOM’s Environmental Toxicology Lab and risk assessment group will collaborate with UCSB to study nanomaterial fate and transport, assist in exposure assessment and risk quantification and modeling, develop outreach programs and related training materials for use by industry involved in handling nanomaterials, and conduct “real world" testing of methods and instrumentation for the detection and characterization of nanomaterials.

“New nanotechnology-related products are already impacting global industry and society, and the Bren School’s SNI is critical to helping industry and the public understand the health and environmental implications of nanomaterials,” said Robert Weber, AECOM Environment Group Chief Executive. “Our collaboration provides another platform to share expertise, and positions us to better assist our clients in addressing issues associated with some nanomaterials.”

AECOM Environment is also working on nanotechnology projects for other public- and private-sector clients, including aquatic toxicity studies for a major commercial producer of carbon nanotubes which will help determine how wastewater discharge from the production of these materials affects aquatic species.

GorePharmBIO Expands Manufacturing in Elkton, MD

Gore PharmBIO Products, a business initiative of W.L. Gore & Associates, announced that it has doubled its manufacturing capacity by opening a new production facility in Elkton, MD. The new facility will handle production of several lines of Gore PharmBIO's products and was needed in order to boost output and efficiencies to meet growing customer demand.

One key feature of the new facility is a state-of-the-art-cleanroom. The cleanroom is ISO Class 7 (Class 10,000) as built and ISO Class 6 (Class 1,000) at rest. The cleanroom process is designed to be more efficient and to improve process flow and segregation. The facility also features different pressure control zones and physical barriers minimizing product cross-contamination.

The cleanroom incorporates the latest in technology in high-efficiency, low power consumption fan filter units as well as air handling equipment utilizing high efficiency motors, drives and control system features. The new facility has also begun shipping products in a newly designed, fully recyclable secondary packaging. The lower energy consumption and environment impact give customers a competitive edge in the marketplace.

"The new facility is another strategic component of Gore PharmBIO's initiative to align with its customers and meet their global requirements," says Jacques Rene, business leader. "We see this category as a great growth opportunity for Gore and these latest developments represent our commitment to this industry and our customers."

Gore PharmBIO Plans for Continued Growth

From the company that invented expanded polytetrafluoroethylene (ePTFE) and introduced it in the marketplace, Gore PharmBIO Products continues the company's legacy of innovation and product leadership in the global pharmaceutical and bioprocess markets.

This announcement comes at the end of two years marked by significant growth for Gore PharmBIO Products. Following its successful acquisition and integration of Amesil in 2007, Gore PharmBIO Products has been at the forefront of successfully launching several innovative, high-value products including the GORE(TM) STA-PURE(TM) Fluid Sampling System and the GORE(TM) STA-PURE(SM) Bioprocess Configurator. The GORE(TM) STA-PURE(TM) Fluid Sampling System is just one of the many products available to customers for customized design. In addition, Gore PharmBIO has several new product launches planned for 2009.

Launching at Interphex 2009 is the GORE(TM) STA-PURE(TM) Gasket for Sanitary Fittings that seals critical bioprocesses and enables pure processing. Commercially available in the Summer of 2009, this new product is constructed of a 100% patent pending ePTFE, can withstand up to 500 SIP cycles, and is designed to meet the new ASME BPE equipment seal standards for sanitary gaskets. It features full supply chain and lot traceability and has a low stress-to-seal design, does not require re-torque and ensures minimal gasket intrusion. The GORE(TM) STA-PURE(TM) Gasket for Sanitary Fittings can be used universally and integrated into a variety of different systems which allows for standardized operations, reduced inventory and improved purchasing efficiency.

Also available commercially in the fall of 2009 will be The GORE(TM) STA-PURE(TM) Septa which is made of a unique, proprietary fluroelastomer material and is used in enclosures specifically designed for chromatography, diagnostics and chemical packaging applications. This product will utilize the only septa technology that ensures accuracy and enables optimized purity because it reseals after multiple punctures. The GORE(TM) STA-PURE(TM) Septa virtually eliminate solvent loss and significantly extends shelf life for even the most aggressive solvents. In addition, its unique construction will help to achieve low levels of leachable/extractable profiles that are necessary for many applications.

Second Lyophilizer Goes Online at Formatech in Andover

US CMO Formatech has brought a new Virtis Benchmark 3000 luophilizer into service at its manufacturing facility in Andover, Massachusetts, boosting capacity by 13,000 vials per production run.

Increasingly, drugs made in one part of the world are sold in another, making stability a key concern for pharmaceutical firms. While lyophilisation is not a new approach to the problem, its cost and complexity had meant that global capacity was limited.

In recent years however a number of contract manufacturing organisations (CMO), including Patheon, Recipharm, HollisterStier and Clairvest, have been investing in lyophilisation capacity in a bid to address the imbalance.

Formatech business director Jeffrey Bernard also believes activation of the good manufacturing practice (GMP) standard lyophilizer, the second to be installed at the plant, is a timely move.

He said that: “Given the cash burn rate of the typical emerging biotech or pharmaceutical company, a delay in production by even a week due to production capacity constraints may cost a client hundreds of thousands of dollars.

“By doubling our capacity for processing lyophilized products, we have reduced the bottleneck, can better meet our clients scheduling needs and most importantly get them to the clinic on time,” added Bernard.

Installation and validation work on the new lyophilizer was completed in December, as was the Food and Drug Administration (FDA) GMP inspection.

Formatech stressed that, aside from the capacity boost, Formatech the similarity of the new lyophilizer to its existing FTS system is another key benefit as it improves the efficiency of its technician training programme and will reduce errors.

The firm went on to explain that interchangability of parts between the two units, and the timeline flexibility that this allows, had also played a major role in selection of the unit.

$1 Billion Biotechnology Project for Elk Run

Residents of Pine Island can expect construction at the Elk Run biotechnology project to begin "very soon," the venture capitalist funding the project said.

"We're ready to start construction. We're ready to begin recruiting tenants," said G. Steven Burrill, founder and CEO of California-based Burrill & Company.

Burrill said that Burrill & Co. has $1 billion "in our pile today" to invest in Elk Run. But he expects to raise nearly that much from investors.

Plans for Elk Run, according to its Web site, include a new commercial district, a wellness community for retirees, residential neighborhoods and a biobusiness park.

"The cornerstone of that will be biobusiness," Burrill said. "It's the biobusiness park which will be the anchor for all of this. The money that will be raised will be used for infrastructure."

Burrill & Company always "syndicates" projects, meaning it solicits multiple investors for any project. The same will be true of Elk Run.

Burrill, who's done this type of investing for 40 years, said it won't be easy to raise $1 billion, but he already has that amount available to draw upon in the meantime, he said.

Minnesota politics might be the only hurdle remaining for Elk Run, according to Burrill, because a $40 million interchange along U.S. 52 is needed and the Minnesota Department of Transportation says it has no money available.

But state Rep. Steve Drazkowski, R-Wabasha, said this week that the state will come through. "I think that the political will to find a way is pretty strong," he said.

Researchers with marketable ideas will find it easier to get them into the development pipeline as Elk Run matures.

"Not every great idea deserves a company, and so the challenge for any organization like ours will be to sort through a lot of great ideas," Burrill said.

Burrill said Mayo Clinic is "extraordinarily rich with technology from within." But Mayo is "landlocked" in Rochester and needs room for expansion. The Elk Run research park will fill that need, Burrill said.

The growth will be gradual, he said, taking 15 to 20 years to complete.

"There's a lot of opportunity that's going to come out of this," Burrill said. "We just need to make it happen."

Mass General Hospital to Genetically Test All Cancer Patients within One Year

In an attempt to further validate genetic mutations linked to cancer, Massachusetts General Hospital Cancer Center plans to start off genetically testing lung cancer patients, and eventually test all patients that come to the hospital with a positive biopsy or a tumor.

"Genetic fingerprinting is currently being offered to our lung cancer group," said Darrell Borger, co-director of Mass General's new Translational Research Lab where the genetic profiling will be conducted.

"Our goal is to offer tumor screening to all patients that enter the MGH Cancer Center, regardless of tumor location, in approximately one year," he told Pharmacogenomics Reporter.

The center — claiming to be "the first and only cancer center" to attempt to molecularly profile all cancer patients that present to the facility — issued a statement announcing that it has so far identified 110 gene mutations linked to the growth of various malignant tumors.

"This new and improved classification of cancers that we are doing is intended to give our oncologists more information about a patient's cancer, so they can treat it in a very specific way, thereby significantly increasing the odds of successful treatment," said Leif Ellisen, co-director of the translational research laboratory, in a statement.

Furthermore the gene analysis will allow doctors to prescribe "smart drugs" designed to block certain gene mutations and pathways that cause cancer tumor cell growth.

"By targeting tumor gene mutations with these smart drugs, doctors may be able to eradicate malignant cells without using traditional treatments like chemotherapy and radiation, which have significant side effects," the researchers said in a statement. "The lab's new tumor genotyping initiative should also expedite the time it takes to find the right drug for the right patient."

Borger did not specify which "smart drugs" doctors will prescribe using genotyping. However, Ellisen noted in a statement that in the case of lung cancer, since that is the first group of cancer patients to be genotyped in the lab, researchers suspect that a colon cancer drug shown to be efficacious in a particular genetic subpopulation may also be useful in lung cancer patients with the same gene mutations.

While Ellison did not name the drug, data from recent studies have shown that patients with metastatic colorectal cancer whose tumors carry the wild-type version of the KRAS gene are much more likely than patients with the mutated form of the gene to benefit from the monoclonal antibodies such as Amgen's Vectibix and ImClone's Erbitux.

While neither drug is indicated for lung cancer, studies have show a marginal benefit in lung cancer patients when treated with Erbitux, and have not shown any benefit in lung cancer patients treated with Vectibix.

But targeting patients specifically with wild-type KRAS mutations, might experience better outcomes with these monoclonal antibodies, and this is exactly the kind of information Mass General's researchers are hoping to uncover at their new molecular pathology lab.

Mass General worked with Beckman Coulter subsidiary Agencourt to develop an automated method for extracting genetic material from diagnostic tumor samples, which will allow the lab to increase its sample processing capacity by 10-fold. The lab will use a multiplexed single-base extension method, which was developed to identify single nucleotide polymorphisms, to interrogate a number of somatic cancer gene mutations at once.

"We now have the capacity to process 100 diagnostic tumor samples per day," Borger said. "Additional robotics are currently being adapted by our laboratory to provide a similar increase in capacity at the level of our genotyping assays."

At the laboratory, it is expected that samples will be able to turnaround test results within two to three weeks. This is the turnaround time that is necessary, "in order for genotyping information to be useful to our clinicians in guiding initial therapeutic decisions with their cancer patients," Borger said.

Borger could not provide an estimate of how much it will cost to genotype all cancer patients at its laboratory, saying "the cost of the tumor screening is still being finalized." He added that the cost will be comparable to other routine clinical diagnostic tests.

Clinical diagnostic tests for cancer are not cheap, usually carrying a price tag of several thousands of dollars. It is unclear if health insurers in the state will cover the cost of testing. Mass General officials have made public comments suggesting that the hospital may absorb part of the cost and ask patients to foot the rest of the bill.

Despite the high cost and uncertain reimbursement environment, Borger focused on the long-term health benefits and cost savings genetic testing promises. "The potential for identifying the most effective treatment strategies from those that have little chance of success is expected to provide large cost benefits," he said.

While Mass General may be the first hospital to take on the challenge of genotyping all cancer patients, other cancer centers have similar projects on a smaller scale.

According to reports, Dana-Farber Cancer Institute genetically screens patients with certain melanomas to gauge whether they will be responsive to certain drugs. Memorial Sloan-Kettering Cancer Center is also said to be launching a program to genetically screen lung cancer patients in the coming weeks.

AMPAC Opens cGMP Kilo-Facility

American Pacific Corp.'s subsidiary, AMPAC Fine Chemicals (AFC), opened a new kilogram scale cGMP batch/continuous processing development facility. The new facility can accommodate batch reactors 20 to 50 liters or AFC's continuous zone reactor technology using as many as seven reactors from 0.25 to 1 liter in volume.

This new facility expands AFC's scale-up capabilities. According to the company, it will also be useful in demonstrating continuous reaction performance (throughput, yield and purity) using its zone-reactor concept at 0.25 to 1 liter reactors. The facility has two large walk-in hoods, a separate room for solid isolation using two dryers and two remote bays for handling energetic reactions.

Dr. Aslam Malik, president of AMPAC Fine Chemicals LLC, said, "We are excited by the opening of this new facility. Through our history of handling energetic chemistry and highly potent compounds, AFC has developed an extensive knowledge and expertise in continuous processing. Smaller reactor volumes, smaller quantities of reactants, better yield and cleaner impurity profiles make the process safer, more reliable, and more economical than the traditional batch process. In an industry that has been traditionally batch, implementing continuous processing is not easy. However, due to the recent push by the FDA for Quality by Design and use of Process Analytical Technology, continuous processing is achieving greater acceptance in the pharmaceutical industry."

New Bottling Plant Extends Aseptic Capabilities, claims Flavours Inc

A new aseptic polyethylene terephthalate (PET) and high density polyethylene (HDPE) bottling plant is one of the few co-packing facilities to offer three methods of aseptic processing, says a US based manufacturer.

Flavours Inc said its new 60,000 sq ft facility, located in southern California, will produce 200 million units annually using tubular, steam injection, and plate and frame aseptic processing.

The California headquartered company, which develops flavour, aseptic, and soft chew technologies for functional foods and nutraceutical products, said the target customer base for the new plant's output is health and wellness beverage companies.

Tara Foster, director of sales at the company, said that as a result of increased demand for aseptic packaging in plastic bottles the company required a new plant to double its capacity while also leaving room for expansion:

“The plant is kitted out with new equipment and also includes existing lines from our previous plant in Rancho Santa Margarita.”

She said the facility is customer driven due to the fact that it can provide flexibility in terms of processing as well as downstream packaging and customization: “Our R&D pilot capabilities and flavour development service is a key customer benefit and is unique in the beverage co-packing industry.”

The plant has bottling capabilities for both large scale commercial quantities or for clinical trials and market testing purposes: “We can do anything from 15 gallon pilot trials to 350 gallon plant trials to 40,000 plus gallon runs,” continued Foster.

She explained that the fundamental objective of the new aseptic bottling facility is to utilize key capabilities, such as aseptic flavour and ingredient dosing, high pressure homogenization, and tea brewing vacuum extraction to provide the best system for each type of beverage.

“Should a customer have a supplement that requires high pressure homogenization for stability, we would use that capability or should a customer have a product that has a sensitive ingredient to heat, then we would use our aseptic dosing technology.

“Our unique capabilities lend our plant to be useful to a broad range of beverages and supplements,” claims Foster.

Having Buoyed Healthcare Products and Services, MI Growth Group Eyes Med-Devices Incubator

Enjoying growth in the state's human healthcare-products, -services, -and technologies businesses, a Michigan economic-development group is casting its attention on medical device makers.

The regional Southwest Michigan First is working to launch later this year an incubator focused on startup medical-device makers. The move comes one week after it wrapped up the completion of a $3.5 million addition to its healthcare products, services, and technologies.center.

The med-device incubator would open “by the fall of ’09,” Ronald Kitchens, CEO of the private nonprofit Southwest Michigan First, told BioRegion News last week.

“It will be summer before we finalize the details. We’ve got a needs-analysis going on to figure out how many square feet, what the services that need to be offered [are], and what the best practices are around the country,” Kitchens said.

The med-device incubator would be located “probably either adjacent to [Western Michigan University]’s engineering school, or in close proximity to the healthcare-technology company Stryker Corp., based in Kalamazoo, and known for its hospital beds, gurneys, and surgical tables,” Kitchens said.

It would not be combined with the nearby Southwest Michigan Innovation Center, he added, since the med-device startups he envisions as incubator tenants “tend to need more access to engineering and manufacturing assistance, so it really makes sense to get them closer to where those synergies are.”

And while it would be nice to receive state funding for the med-device facility, Michigan officials, like many of their counterparts in other states facing a cash drought and tightening budgets, are scrambling to plug some $2.5 billion in revenue shortfalls through the 2010 fiscal year being blamed on the ongoing economic turmoil.

“We’re proceeding as if we’re on our own." Kitchens said. "We’d certainly love to have the partnerships. But our go or no-go [decision] won’t be determined by the state’s ability to participate."

Monitoring Two Incubators

The med-device incubator is one of two incubators in planning stages at SMF. The other is a commercialization accelerator for Israeli-based life-sciences startups hoping to establish headquarters and other operations in the US [BRN, Dec. 8, 2008].

Kitchens said the group is in the process of performing due-diligence reviews on prospective tenants, with “at least two and maybe three” giving presentations to a scientific advisory board in May.

“Assuming that goes well, we certainly should see at least an investment or two by mid-summer,” Kitchens said last week.

Kitchens spoke with BRN March 4, one day before joining other SMF executives and local dignitaries in cutting a ceremonial ribbon marking completion of an 11,000-square-foot addition to the Southwest Michigan Innovation Center, located at 4717 Campus Drive, within WMU’s Business Technology and Research Park.

The addition will give the center more office space, allowing the center to convert in the original building some makeshift offices and even the roughly 150-seat conference center into its intended use of lab space. Up to nine new labs will be created, and a new multipurpose room built as a result of the expansion, which is projected to accommodate 40 additional employees in a facility where more than 200 people already work.

“When we originally built the innovation center, we didn’t really know what our needs would be in terms of lab space versus office space, and what that mix would be," Kitchen said. "We ended up with a number of companies that were operating offices within spaces that were built out to be labs” at one-quarter the $200 per square foot cost of lab construction.

“We were at 100-percent occupancy, and were able to graduate a few companies, which gave us the flexibility to move some things around,” Kitchen added.

One such tenant is ProNAi, which uses DNA interference technology to develop new cancer therapies, Last week, Robert Forgey. ProNAi’s president and chief operating officer said his company has relocated offices that were previously housed within the innovation center’s lab space.

“Our offices will be used for the business- and clinical-development functions that are not lab-based,” Forgey told BRN via e-mail. “SMIC was the only functional business incubator in western Michigan with operational lab space appropriate for biotechnology lab work. As the number of companies has grown, and several have matured enough, alternative lab spaces have been developed. That said, SMIC is the only life-science incubator in Southwest Michigan.”

ProNAi last summer converted into series B preferred shares $3 million in funding from the Michigan Economic Development Corp., and more than $7 million in bridge funding raised between 2006 and 2008. Since then, ProNAi has raised another $500,000.

Forgey said the company is awaiting word from prospective investors on additional funding, proceeds of which will pay for clinical development of its lead drug candidate, PNT2258.

“We anticipate the close to be in 2Q ’09,” Forgey told BRN.

The office space addition has allowed contract research organization Proteos Inc. to grow into the innovation center’s first anchor tenant. Proteos, which provides custom peptides and proteins, grew to 10,000 square feet of lab space last November by converting former office space it no longer needed when the new space was built.

Proteos was founded in 2003 by Bob Heinrikson and Clark Smith, two of six former Pharmacia employees who left the company shortly after its acquisition by Pfizer. To get started, the founders used a $200,000 state loan, a $225,000 revenue-sharing package from WMU's Biosciences Research and Commercialization Center, and $200,000 from individual investors that included some ex-Pfizer employees.

Though the fledgling Proteos successfully donated inexpensive lab equipment to WMU by Pfizer, Smith and Heinrikson went without salaries during the company’s first 18 months; while their staffers went for six months.

Including the addition, the innovation center is now about 80 percent occupied. “We’ll also be able to add three, or four, or maybe five new companies to the facility over the course of the next six months,” Kitchens said.

SMF won’t disclose the names of those companies since they are in talks to lease space at the innovation center. The tenant prospects would join the roster of 13 startup companies overseen by the center’s new CEO, Rob DeWit, who came on board nearly two months ago.

The 13 companies account for most of the 20 that have been nurtured at the center since it opened in 2003. Graduate companies that have moved into their own locations include AureoGen Biosciences, a developer of genetic engineering technologies for the discovery and production of cyclic peptide-based drugs; PharmOptima, a provider of drug discovery consulting and laboratory services; and Kalexsyn, an expansion-minded contract research organization serving smaller pharmaceutical companies.

Many of the innovation center’s tenant companies rely on professionals and technologies from outside Michigan. One such company is Venomix, a developer of human-safe insecticides that use peptides from spiders, and are based on research from the University of Connecticut, whose Research & Development Corp. spun the company out. The first insecticides are set to reach the market in late 2011 or early 2012.

“The company has reached the point where we are preparing for our first season of field evaluations with our products,” and their effectiveness in keeping insects from destroying vegetable crops in California, the Northeast, and Florida, John McIntyre, president and CEO of Venomix, told BRN last week.

“We have scaled up our production processes. We have a formulation in hand. We are really focused on getting out into the field the year to reproduce the reality of what we’ve seen in the laboratory into the real world," McIntyre said.

McIntyre, who previously ran Lansing, Mich.-based Emerald BioAgriculture Corp. as president and CEO, said his company hopes to close “between $6 million and $10 million” in series B financing in the third or fourth quarter of this year, “and we want that to take us up to the timing of our product launch,” McIntyre said.

Venomix has reached milestones set in return for previous financing of undisclosed sums announced last year by Open Prairie Ventures II LP, and two years earlier by the $50 million Southwest Michigan First Life Science Fund.

The innovation center’s expansion, McIntyre said, “probably fortuitously helps us,” given the conversion of office space used by other tenants into lab space, including space Venomix now maintains next to its research lab. “If push came to shove, and some time they forced us to move out, they wouldn’t have to do any upgrade or changes to move right back in and have an operating lab.”

For McIntyre and other tenants, one key attraction of the innovation center is its below-market monthly rent. The group starts tenants out at $7 per square foot triple net, a rate that rises over six years to $30 per square foot. Rents account for two-third of the innovation center’s revenues; the remainder, subsidies from SMF.

The Michigan Economic Development Corp. has approved $500,000 in funding for the incubator addition that was matched by SMF. The project will also receive $350,000 from Kalamazoo County, $250,000 from the city of Kalamazoo, and a low-interest loan from the Kalamazoo Community Foundation, which assists nonprofit organization and was founded by pharma pioneer W.E. Upjohn.

West Tech Design designed and engineered the innovation center addition, for which Miller Davis served as general contractor.

The addition is SMF’s latest move toward building a life-sci cluster in and around Kalamazoo. Among out-of-town prospects the economic development group has recently attracted is Micronics, a Redmond, Wash., developers of point-of-care products for disease diagnosis, prognosis and treatment monitoring. Last year, Micronics won a combined $9 million that included series C financing from the SMF Life Science Fund as well as series B financing from undisclosed private investors.

“We’re building our production line in the Midwest, with the goal of ultimately building its warehousing, logistics, and centralized sales and marketing organization out of the Kalamazoo region,” Karen Hedine, Micronix’ president and CEO, told BRN. “Our building would be more of a manufacturing facility, so it’s unlikely it would be in the incubator per se.”

“First and foremost, however, we are focused on advancing our products, getting those out the door, and generating revenue from those,” Hedine added.

It will be up to other tenant companies, therefore, to drum up demand for space at the innovation center — a facility that Kitchens said SMF can expand again if that demand warrants it: “We could conceivably add about another 30,000 square feet, although certainly in the next few years, that’s not something we’re considering.”

North Carolina Nanobiotech Innovation Center Has New Director, Cash, and a Game Plan to Grow

With a new director and the promise of additional funding the summer, the new North Carolina Center of Innovation in Nanobiotechnology has some challenges ahead of it.

For now, the center is planning how to create a venue that would grow North Carolina's established biotech sector by capitalizing on the nanotech sector that has emerged in recent years in the state's Piedmont Triad region.

Brooks Adams, a Richmond, Va.-based professional who, according to organizers, has 14 years of life-sci industry experience, has been named executive director of the center, which is also known by its acronym COIN.

The center is in its initial planning phase, funded by a $100,000 first-phase planning grant from the state-funded North Carolina Biotechnology Center that is being administered by the Piedmont Triad Partnership, the group that promotes economic development in the 12-county region of in and around the cities of Greensboro, Winston-Salem, and High Point.

Over the next three to four months, Adams will lead COIN in creating a business plan for spending the $2.5 million the center is expected to receive from Tar Heel State toward a second planning phase. The second-stage cash will start flowing this summer and is supposed to stretch over four years.

During that time, Adams will write a formal business plan for COIN, which most likely will take the form of a nonprofit corporation. Future funding will be tied to milestones "to make progress in moving this technology into the marketplace," as well as "characterizing what the technology assets are in North Carolina, and also helping find new ways to bundle the technology for outlicensing," Gwyn Riddick, director of the biotech center's Piedmont Triad office, told BioRegion News last week.

"One of the big milestones will be making it self-sustaining," Riddick said." Certainly it needs to be done by the time our grant is complete, and preferably before that."

He acknowledged that securing more state funding would be hard at best given the state's budget shortfall, which newly elected Gov. Bev Perdue has projected could reach $2.2 billion through next fiscal year. Perdue, a Democrat, has ordered most state agencies to reduce their spending by 9 percent of their budgeted amounts for the current fiscal year, which ends June 30. In January, term-limited Gov. Mike Easley asked the agencies to slash 7 percent off all spending.

That is not expected to be held up by the Legislature, he added: "They recognize that even in tough times, you need to support your big job generators and your high-wage industries. This is certainly one of them."

Donald Kirkman, president and CEO of the Piedmont Triad Partnership, said the nanobio effort could begin operation with state support before moving toward independence: "There would ultimately be a third grant that will fund the initial operations for the first three years of operation, with the goal that this will then evolve into a self-sustaining, self-supporting center, that will be both industry- and private-sector demand driven, and funded."

COIN Designed to Commercialize New R&D in North Carolina

COIN is designed to commercialize new technologies developed by researchers through collaborations involving Wake Forest University, North Carolina Agricultural and Technical State University, and the University of North Carolina at Greensboro.

Two years ago, the three schools formed a consortium to develop the center and develop other avenues for advancing nanobiotech.

Last week, Kirkman told BRN the universities sought out his group to manage the grant because it could serve as an "intermediary that would be the central point of contract to be the fiscal agent and administrator of this grant" based on its own initiatives with a number of area higher education institutions, and its history in receiving a previous NC biotech center grant related to industrial biotechnology.

For the partnership, COIN is meant to boost one of three economic sector niches it is striving to grow in the region. In addition to nanobiotech, the regional group has targeted regenerative medicine, and medical technology and devices, according to its inventory of regional biotechnology assets.

NCA&T and UNCG have established a roughly $60 million, two-campus collaboration focusing on nanotechnology: the Joint School for Nanoscience and Nanoengineering. The school will offer both a masters and a doctoral program.

"We're still hopeful that we'll be able to admit the first students for the joint school for the fall," subject to approval from the UNC system's general administration, UNCG spokesman Dan Nonte told BRN last week.

Those students will attend classes in temporary space for the joint school within the recently-completed first building of the Gateway University Research Park, a $250 million, 850,000-square-foot expanse to consist of twin 75-acre campuses in Greensboro. The roughly $13 million, 65,000-square-foot first building at the South Campus — at 2901 East Lee St. off the interchange of Interstate 40 Business and East Lee Street — is anchored by a regional center for the US Department of Agriculture's Natural Resources Conservation Service that opened last October.

The more than 30,000-square-foot USDA regional center — one of four such centers nationwide — houses UDSA's East National Technology Support Center and East Remote Sensing Lab, drawing about 100 technical specialists to the Triad. Gateway is marketing some 25,000 square feet of space there.

Long-term, the joint school will build out its own building of 85,000 to 90,000 square feet within Gateway.

"We are in the schematic design phase, and we hope to begin construction mid- to late-summer of this year, and have that facility up and running by spring to mid summer of 2011," John Merrill, executive director of Gateway University Research Park, told BRN.

The school would occupy the second of three buildings planned for Gateway; the third will be a state-funded $10 million interdisciplinary research facility of 35,000 to 40,000 square feet, for which the research park hopes to hire a design firm "within the next 30 to 45 days."

"With those two facilities, we should be up in the neighborhood of 180,000 to 190,000 square feet of space at the park," Merrill said.

The joint school will build on the nanotechnology research activity established at nearby Wake Forest and at NCA&T. A decade-long leader in fusing nanotech and biotech, NC A&T last fall won an $18 million, five-year National Science Foundation grant to establish an Engineering Research Center for Revolutionizing Metallic Biomaterials. One research program of the ERC — the first to be led by an historically black college or university — is designed to aid children with birth defects and injured veterans through the development of implanted devices with magnesium alloys that can grow without refitting, then be absorbed into the body’s bloodstream with no side effects.

UNC Greensboro has established a Center for Research Excellence in Nanobiosciences, led by Yousef Haik. Last summer, the center spun out its first startup company into the North Carolina Nanotech Accelerator in High Point. Thermiacure hopes to reduce side effects associated with chemotherapy and radiation treatments, such as nausea and hair loss, by attaching nano-size particles to non-harmful bacteria that pursue cancerous tumor cells.

Wake Forest operates a Center for Nanotechnology and Molecular Materials that opened in 2004. Its director, David Carroll, has spun off two companies designed to commercialize technologies developed there: FiberCell, which is focused on plastic solar cells that convert 6 percent of light into electricity through nano-filaments; and PlexiLight, focused uses nanotechnology to develop lightweight, ultra-thin, energy-efficient lighting sources.

"We are at the early stages of developing research in the universities, and that's why this center of innovation is so important. Instead of creating it after an industry has already been started; it's much better to start a center of innovation at the beginning of the innovation process," Riddick said.

Another priority for the consortium, Riddick and Kirkman said, will be engaging companies in nanobiotech — both Triad-based companies such as Nanotech Labs and Quartek International, and other businesses looking to get into the field.

"Various industries will be enlisted as partners, and they will in some fashion pay for sponsored research that will leverage the university assets in support of their specific product requirements," Kirkman said.

Said Riddick: "The idea is to engage and characterize all of the companies we can fund that are working in this sector, and then really engage them in the process. There will be out of this center of innovation, a science advisory board. On that board will be researchers and academicians as well as industry folks to help chart the course of this."

Merrill said he and others involved with COIN hope that many of the spinouts grow to take space at Gateway: "We're really hopeful that through partnering, we'll be able to bring corporate partners into the facility that will want to be there because of the programs that we're offering, and because of the equipment that we'll have available. If we can attract a good group of corporate partners, that's one of those things that tends to snowball, and that's certainly what we're hoping for — that getting those kinds of folks in there will attract other folks who will want to come and work with us as well."

COIN is being housed temporarily at the Piedmont Triad Partnership's offices in Greensboro. A permanent home base has yet to be decided, though Kirkman said: "I anticipate this COIN initiative would be spun out from our offices and would operate independently or autonomously — we certainly would want to continue to interface with that, but I see our role diminishing once it is established and operating as an independent entity."

Most likely, Riddick said," the center itself is going to be pretty much virtual for a while. It's a facilitating organization that's going to be working with the technology transfer offices across the state in the different universities to move this technology into the marketplace. A physical location is not that important to us right now."

Once the center is up and running, "we would not anticipate more than a couple of folks. It's going to be a very lean. It's going to rely on collaboration, rather than a huge staff of people," Riddick said. "Collaborating and getting people to the table from all these different sectors of industry and research is going to be the real secret ingredient, so to speak."

The academic side of that collaboration, he added, will begin with the universities in the Piedmont region, "and then expanding across the state to all of the universities that are working in this sector."

COIN is one of four centers of innovation carrying out first-phase planning through grants from the NC Biotechnology Center. The other three are the Advanced Medical Technology Center of Innovation, the Marine Biotechnology Center of Innovation, and the Bent Creek Center of Innovation for Natural Biotechnology & Integrative Medicine. Links to all three are available here.

The four are among nine centers of innovation that the NC biotech center plans to create through 2012 by working with university researchers, technology transfer offices, industrial partners, non-profit stakeholders, regional and state-wide community leaders.

"Future Centers of Innovation will boost other industries that rely on biotechnology for new ideas, better solutions and great competitiveness," the biotech center has stated on its web site.

Biogen Idec Weighs New Building for 600 Administrative Employees at RTP, Among Options

Biogen Idec "has been talking with at least 10 real estate development companies in the area" about constructing a 180,000-square-foot office building that would accommodate more than 600 administrative employees on the company's Research Triangle Park campus – "one of several" options the biotechnology giant is considering, the Triangle Business Journal reported last week.

Biogen Idec, which is headquartered in Cambridge, Mass., would lease space within the building from the developer that would build it on the biotech company's 176-acre campus on Davis Drive, the newspaper reported, citing unnamed sources. The campus already has six Biogen Idec buildings that house 525 employees in drug manufacturing functions, and another 300 in patient services.

Biogen Idec spokesman Mike McBrierty said the build-to-suit building is among options the company is considering, but would not discuss the others. He told the News & Observer of Raleigh that the company has ongoing conversations with state economic development officials in Massachusetts, California, and North Carolina.

Biogen had sought for several years to build the administration office building, called Bio 26, on design plans at RTP. The company even built an 800-space parking garage in 2002 to accommodate the office expansion, but the garage is not being used.

The Business Journal quoted a Tri Properties executive as saying his firm has submitted a construction proposal, while another executive from Teer Associates, which has built Biogen's four RTP buildings since 1994, would not comment about the Biogen expansion project due to confidentiality agreements with the biotech company. Biogen also leases office space at the Imperial Center business park in Durham for its 300 customer call center employees – who would likely be relocated to the planned administration building, the newspaper reported.

Genzyme Tops Off 86K Sq. Ft. Expaqnsion of Allston Landing Manufacturing Plant

Genzyme has "topped out" its Allston Landing biomanufacturing facility, under construction along the Charles River in Boston, by placing the last piece of steel of an 86,000-square-foot addition to the company's main protein manufacturing facility.

The biotechnology giant has expanded production at the Allston facility from four to six bioreactors in the last several years by fitting out two cell culture halls. The current expansion, slated for completion this spring, will add space for manufacturing support functions.

The expansion also includes a new, 26,000 square foot underground cogeneration plant that will generate steam to run the plant's process operations and will also produce electricity. ARC/Architectural Resources Cambridge designed the expanded facility, while Turner Construction serves as general contractor.

AURP Honors Sandia Sci/Tech Park, USF, Wake Forest Institute for Regenerative Medicine

At its 2008 Annual Awards of Excellence, held at the Renaissance Vinoy Resort & Golf Club in St. Petersburg, Fla., during its annual conference, the Association of University Research Parks presented awards to three research campuses:

· Sandia Science & Technology Park in Albuquerque, NM, won AURP's 2008 Outstanding Research/Science Park award, designed to recognize well-established research parks that excel in bringing technology from the laboratory to economically viable business activities. Sandia was established in 1998 as a public/private partnership to help New Mexico's economy by creating high-paying technology-based jobs and provide a location for companies commercializing technology developed at the adjacent Sandia National Laboratories. The 200-acre park has grown to 28 organizations employing 2,284 people.

· University of South Florida Research Park of Tampa Bay received the 2008 Emerging Research/Science Park Award, intended to honor a park in operation for fewer than five years. The park is home to more than 20 early-stage companies working in life sciences, engineering and software industries, as well as the Tampa Bay Technology Incubator, whose companies have total annual revenues of more than $4.3 million and have received more than $7.7 million in funding

· Wake Forest Institute for Regenerative Medicine, located in the Piedmont Triad Research Park in Winston-Salem, NC, captured the Innovation Award for its work in applying principles of regenerative medicine to develop new clinical therapies to treat human diseases and disabilities

Missouri House Approves Bill to Create BEST Districts, Blue Springs Tech Park

Missouri's House of Representatives has passed a bill that will create a science and technology park in Blue Springs, Mo., as well as allow local governments to establish Business-Education-Science-Technology or "BEST" districts, the Kansas City Business Journal reported.

House Bill 191 would fund BEST districts through sales and state income tax revenue generated by businesses within the district. In Blue Springs, that would include the proposed Adams Dairy Landing, a 600,000-square-foot retail project that RED Development LLC is developing at the southeast corner of Adams Dairy Parkway and Interstate 70.

Biotech/Pharma, Medical Devices Among 'Feasible' Uses for Winston Farm in Saugerties, NY

A consultant studying future potential uses for the 850-acre Winston Farm property in upstate Saugerties, NY, has included biotechnology and pharmaceutical business, and medical imaging/devices, as among feasible uses for the site's 370 buildable acres.

CH2M Hill, which is studying the farm's development future, concluded that the farm could attract a pharma or biotech user based on its proximity to the General Electric campus in Schenectady, NY, and the pharma cluster in northern New Jersey. A medical imaging and devices user could also work because of the New Jersey pharma cluster, Roger Pearson, director of planning for CH2M Hill subsidiary IDC Architects, told some 125 attendees at a recent public forum held to discuss the future of Winston Farm, according to the blog Saugerties.

MEMS/nanotechnology could also work, the consultant said, because of the site's location near a growing nanotech cluster in the state capital of Albany; while solar/photovoltaics was also deemed feasible given the presence in Saugerties of the New York State Thruway.

The parcel, at Routes 212 and 32 just west of the village of Saugerties, was the site of the Woodstock '94 concert. Over the past two decades, residents successfully turned back plans to transform the site into a landfill, and a casino.

Pearson said CH2M Hill has posted online a survey asking residents which potential uses for the Winston Farm would they favor the town exploring. If the public says yes, then, Pearson promised, an open process will begin. "There will be workshops, there will be much opportunity for further comment."

Following the CH2M Hill presentation, the blog reported, several residents expressed skepticism about the potential for high-tech business in Saugerties: "I don't know how high-tech they are thinking, but I'm thinking low-tech. Low-tech is what's going to give us our farm-fresh vegetables and low-tech is what's going keep the water around from not being polluted," said Shelli Lipton, who with husband Nathan Koenig are founders of the Woodstock Museum in West Saugerties, NY.

Not so Michael Vallarella, a resident and businessman: "I would just urge all of the residents of Saugerties to have an open mind, and to understand that [future use of Winston Farm] needs to be economically viable. It still needs to make money, and it still needs to provide jobs for the people of Saugerties."

Boehringer Ingelheim Vetmedica Plans $150M St. Joseph, Mo., Expansion

Boehringer Ingelheim Vetmedica has announced plans for a $150 million, five-year expansion of its animal pharmaceutical operation in St. Joseph, Mo., projected to create at least 124 jobs. The project — to be built on the main campus at the North Belt Highway and Gene Field Road — will include expanded manufacturing, more research and development activities, a new central administration building, and new technology throughout the campus.

Boehringer has been in St. Joseph for 27 years and has more than 600 employees at facilities in the area. The new jobs will include skill levels from high-level scientists to technicians, said Dr. Gary Clapp, director of the Institute for Industrial and Applied Life Sciences. It also strengthens St. Joseph's position in the global animal health industry, he said.

Boehringer is in line to receive $735,000 from Buchanan County's economic development fund. Of the forgivable loans, $100,000 is tied to building the corporate headquarters. Another $135,000 will be given to the company to encourage employees to move to St. Joseph. In addition, Boehringer will be eligible for $100,000 if it chooses to buy the shell building in Mitchell Woods Business Park for a warehouse and distribution facility.

The St. Joseph City Council previously approved $160 million in Chapter 100 development bonds, which will provide tax incentives for the company. The bonds technically give the city ownership of the property and equipment built with the bonds. Because Boehringer will not own the property, the company will receive tax abatements totaling more than $13 million. The city will lease the project to Boehringer or a third party for 10 years, after which the company will take ownership.

In addition, Boehringer will receive $1.8 million under the Quality Jobs program — a fact cited by new Gov. Jay Nixon a week after the original announcement during a visit to the campus, at which he called for state lawmakers to pass a package of legislation aimed at increasing incentives for businesses [BRN, Feb.

"We have a long and successful history in St. Joseph and are committed to growing our business in this community," George Heidgerken, Boehringer Ingelheim's president, said in a statement. "I feel confident about our growth strategy and ability to compete globally as an animal health research and development and manufacturing facility."

Knowledge Park Unveils Expansion Plans; 14 More Buildings Totaling 650K Sq. Ft. Proposed

Officials of Knowledge Park in Fredericton, New Brunswick, Canada, have unveiled plans to develop 14 more buildings totaling 650,000 square feet of space, intended to address the growing need for space by businesses in biotechnology as well as information technology, forestry, health care, and advanced learning sectors, the Daily Gleaner reported.

Conceptual drawings call for the addition of the buildings on land between Knowledge Park Drive and the Hugh John Flemming Forestry Complex. The pace of development will depend on demand, though construction of the first of those buildings is expected to be announced in six to eight weeks, the newspaper reported, since the park's existing vacancy rate stands at 2 percent.

The park, which is owned by Enterprise Fredericton, consists of three buildings — one each opened in 1999, 2001 and 2003.

"The difficulty we face at the moment is that often people come and want space immediately, but we're always in a position where we need the people before we can build the building," Laura O'Blenis, general manager of Knowledge Park, told the Daily Gleaner.

She cited Q1 Labs, a spinoff company from the University of New Brunswick that is moving to nearby Bishop Drive because it needed more space than was available.

Mayor Brad Woodside told the newspaper the plans gibe with Fredericton's ongoing effort to diversify its local economy away from reliance on the civil service: "We're extremely motivated in what we're doing and we won't let up."

Ferring Pharmaceuticals, Research Institute Open R&D Facility in San Diego's Sorrento Valley

Ferring Pharmaceuticals and its affiliate Ferring Research Institute have opened in San Diego's Sorrento Valley a newly-expanded, 38,000-square-foot Sorrento Valley Boulevard facility to be dedicated to further development of peptide research and therapeutics. Swiss-owned Ferring has had its U.S. outpost in San Diego since 1996.

The new San Diego research facility now houses expanded research laboratories for peptide medicinal chemistry, bioanalytical and distribution, metabolism and pharmacokinetics, molecular and cell biology, cell culture, in vitro and in vivo pharmacology.

Ferring bases 70 of its 3,200 worldwide employees in San Diego at Ferring Research Institute, which handles most of the company's drug research. Until now, it had been renting space on the General Atomics campus.

Ferring also used the occasion to recognize the recent approval by the US Food and Drug Administration of degarelix, a new once-a month, injectable prostate cancer drug for the treatment of patients with advanced hormone-dependent prostate cancer. Degarelix is the first peptide new chemical entity to be developed globally by privately-held Ferring following its discovery at the San Diego research institute. Ferring is preparing to launch degarelix in the US later in the first quarter.

EntreMed Lease Extension Slashes Rockville, Md. Biotech Company's Space, Rent Cost

EntreMed, a biotechnology company in Rockville, Md., has come to terms on a 12-month lease extension through February 2010 with landlord Red Gate III LLC that will reduce the space it rents for its headquarters at 9460 Medical Center Drive from 46,267 square feet to 8,554 square feet.

EntreMed's monthly rent will fall to $16,288 from about $85,000, the company said in a filing with the US Securities and Exchange Commission.

The lease extension also lets EntreMed use other parts of the premises at no additional cost.

RXi Pharmaceuticals Extends Lease Following Fall Expansion at Gateway Park in Worcester, MA

RXi Pharmaceuticals, a biopharmaceutical company formed to develop and commercialize therapeutics based on RNA interference, has extended its lease for two years at the Gateway Park campus in Worcester, Mass. The extension covers RXi's original 6,000 square feet lease at the Worcester Polytechnic Institute's Life Sciences and Bioengineering Center at Gateway Park, which the company has occupied since December 2007, as well as more than 800 additional square feet of space it took last fall.

The two-year extension on RXi's lease, executed on Jan. 23, is effective through August 2011.

RXi — co-founded by Nobel Laureate Craig Mello— also retains an option to move into 15,000 square feet at the next life sciences building planned for Gateway Park. That building is expected to commence construction later this year.

A joint venture of WPI and the Worcester Business Development Corporation, Gateway Park is planned as an 11-acre, mixed-use destination for life sciences companies and the people who work for them, and when fully developed will include five buildings totaling 500,000 square feet of flexible, adaptable lab and office space designed to meet the needs of research organizations and growing companies; 241,000 square feet of market rate, loft condominiums; and several planned retail establishments.

McGuire AFB, Stevens Institute of Technology Join Forces to Build Biofuel Power Plant/Refinery

McGuire Air Force Base and Hoboken, NJ,-based Stevens Institute of Technology have announced plans to co-develop a power plant and refinery that would generate biofuel on the Trenton, NJ, base from household garbage, grass clippings and other organic materials.

US Reps. Rob Andrews (D-Haddon Heights) and John Adler (D-Cherry Hill) announced that the project could generate as many as 350 new jobs within a few years. Andrews joined Adler's predecessor, Jim Saxton of Mount Holly, in securing $3.2 million in defense funding for the power plant, which is expected to begin construction on the base this spring or summer — and which, the congressmen told the Burlington County Times, would require more funding to complete.

The facility would convert bio-waste materials such as garbage, grass clippings, and corn stalks into synthetic gas that would be generate energy to provide power to up to 40 homes. Water vapor would be the plant's only byproduct, the officials said. The plant fits into the US military's goal of generating at least 25 percent of its energy needs from renewable sources like biofuels, solar, and wind sources by the year 2025.

"What Capitol Hill is talking about doing in the future, we're already doing today in South Jersey, and we have a down payment on that," Andrews said in a statement.

Complete Genomics Doubles Mountain View, CA, Office/Lab Space for 'Genome Center'

Complete Genomics, a Mountain View, Calif., provider of data allowing researchers to sequence the human genome for as little as $5,000, has doubled its office and laboratory space by leasing an additional 32,000 square feet, according to BRN sister newsletter In Sequence [Feb. 10].

The extra space will be used as a pilot "genome center" that is part of the company's effort to commercialize its services by providing customers in the academic and biopharmaceutical industry sectors to use the company's genome data in their research.

Complete Genomics has increased its headcount by about 20 percent since last October, to 120 staffers, and expects a "big increase" in headcount when the genome center opens this summer.

URI Opens Institute for Immunology and Informatics on Providence Campus

The University of Rhode Island has opened at its Providence Biotechnology Center a research institute focused on development of vaccines against AIDS, malaria, tuberculosis, dengue fever and other diseases ravaging the developing world.

URI's new Institute for Immunology and Informatics will work on potential vaccines, and provide access to its technology to the global research community working on vaccine development for emerging infectious diseases. The institute will also pursue partnership opportunities at nearby hospitals, as well as Brown University and other life sciences companies in the city.

The institute is led by Annie De Groot, the CEO of EpiVax, a developer of computational immunology tools toward vaccine design; and a professor in URI's department of cell and molecular biology. She created the new institute with long-time associate Leonard Moise, director of vaccine research at EpiVax; URI professors Thomas Mather, a vector-borne disease researcher, and Marta Gomez-Chiarri, a fisheries researcher developing vaccines for fish; and De Groot's father Leslie DeGroot, an internationally recognized endocrinology researcher. The university said Greg Paquette, URI's director of biotechnology programs, will also help guide the institute.

The institute has defined its mission as improving human and animal health by applying the power of immunomics — defined as informatics, genomics and immunology — for the design of better vaccines, diagnostics, and therapeutics.

"The Institute for Immunology and Informatics represents a critically important opportunity for URI to have an essential science research presence in Providence," Jeff Seemann, dean of URI's College of the Environment and Life Sciences, said in a statement. "This is a positive step toward increasing the R&D capacity at the University, and it will serve to augment the life sciences activities taking place on our Kingston campus as well."

URI last month opened on its Kingston campus the $59 million, 140,000-square-foot Center for Biotechnology and Life Sciences, a five-level facility whose top floor will remain unfinished until URI can raise the $5 million needed to complete the administrative offices and research space planned there [BRN, Jan. 26].

Fargo, ND, Packager/Distributor Completing Facility Expansion, With West Coast Clients in Mind

Clinical Supplies Management, a Fargo, ND, provider of packaging, labeling and distribution services for biotechnology and pharmaceutical companies nationwide and overseas, is completing work on a 15,000-square-foot addition to the 20,000-square-foot facility it has occupied since October 2007 at 342 42nd St.

The new space is designed to persuade potential clients – most on the West Coast – that CSM has the ability to take on new and additional projects, Don Berg, the company's president, told the Forum of Fargo, adding: "It's really helping us grow."

Privately owned Clinical Supplies Management has 48 employees, up from 26 three years ago, and its revenue has doubled in the past three years, Berg told the newspaper. The company's clients are typically small companies involved in early-stage medical testing that often lack the resources to package, label and distribute the drugs they're testing.

CSM is part of the Fargo-Moorhead's tiny medical services industry, which includes two other companies: PRACs offers pre-clinical, clinical, bioanalytical and statistical research services to serve the pharmaceutical, biotechnology and skin care industries; while Aldevron offers products and services for DNA vaccine and gene therapy.

Fire Causes Minor Damage to GreenHunter Biofuels Refinery Near Houston

GreenHunter Biofuels has confirmed that its 105 million gallons per year biofuel refinery near Houston sustained minor damages due to a small fire earlier this month, Biodiesel Magazine reported.

The cause of the fire was attributed to a mechanical seal failure on a circulation pump, which caused excessive heat, generating the fire. Firefighters reached the scene within about 10 minutes, and were able to extinguish the fire using the company's fire water system and the fire department's foam materials and equipment, according to the magazine.

GreenHunter has estimated repair costs were less than $50,000 and the facility's downtime was about three days. No injuries were sustained by GreenHunter personnel or firefighters during the incident, according to the company.

This is the second time in the past year that GreenHunter's biodiesel facility has been damaged. In September, the facility was shut down for more than two months due to water damage caused by Hurricane Ike.

GreenHunter is a wholly-owned subsidiary of GreenHunter Energy of Grapevine, Tex.

LabCorp to Offer Roche HCV Test

Laboratory Corporation of America is offering Roche's new Cobas AmpliPrep/Cobas TaqMan HCV test, which the US Food and Drug Administration cleared for marketing in October 2008.

The test is fully automated and uses Roche's proprietary real-time PCR technology to quantify the amount of virus in an individual's blood. Physicians can use it to monitor viral load at baseline and during treatment to help determine the effectiveness of therapy.

LabCorp is the first national clinical lab to offer HCV PCR testing using the new assay, the Burlington, NC-based clinical lab firm says.

LabCorp already offers Roche's AmpliPrep/COBAS TaqMan HIV-1 test under an agreement signed in May 2007.

Charles River Cuts Workforce and Closes its Preclinical Facilities

Charles River Laboratories will reduce its workforce by 3 per cent, close its preclinical facility in Arkansas, US and sell off its Phase I trial site in Edinburgh, Scotland as part of a cost reduction program.

The firm added that it will reduce headcount at its plant in Shewsbury, Massachusetts, and said the decision to restructure its preclinical services (PCS) division “is reflective of [its] global client base and the current demand.”

Charles River explained that divestiture of the Edinburgh site, for which it may have already found a buyer according to the Boston Globe, is a response to the decision by many of its preclinical clients to shift their trial programs to India and China due to increased regulatory demands in Europe.

The latest announcement follows on from a poor set of Q4 results that saw revenue from its PCS business fall 8 per cent to $158.6m (€123m) on a decline in demand it linked to pharma industry “restructuring and pipeline reprioritization”.

For 2008 the PCS unit performed slightly better, with revenues climbing 4.6 per cent to $683.6m, although margins declined to 1.6 per cent on costs linked to new preclinical sites in Shanghai, China and Nevada.

Company CEO James Foster added that the firm’s annual results “reflect the impact of the global economic crisis and the challenges our pharmaceutical and biotechnology clients are facing, especially in the PCS segment.”

He added that while the firm considers the economic gloom is temporary, it is using the period of uncertainty as a window to streamline operations and reduce operating costs by 20 per cent this year.

Baxter Recognized Among Global 100 Most Sustainable Corporations

Baxter International Inc. was recently recognized among the Global 100 Most Sustainable Corporations in the World and released a new Code of Conduct, reinforcing the company's commitment to the highest standards of business ethics and integrity. Baxter was also featured in the new book Green Biz: 50 Green, Profitable Companies Reveal Their Strategies and Successes for its leadership in sustainability.

Several Baxter regions and locations recently received recognition for their efforts to advance diversity and environmental initiatives. In Asia Pacific, Baxter received the prestigious Catalyst Award for its diversity and inclusion initiatives. Baxter's Thousand Oaks, Calif. facility was honored with the "Flex Your Power Award," the Cleveland, Miss. facility was selected to participate in the state's enHance program, and the Round Lake, Ill. facility was recognized with a Pollution Prevention Award. Further information about Baxter's sustainability activities can be found on http://sustainability.baxter.com/.

Baxter Recognized Among the Global 100 Most Sustainable Corporations

For the fifth consecutive year, Baxter has been recognized as one of the Global 100 Most Sustainable Corporations in the World by Innovest Strategic Value Advisors, an internationally recognized investment research and advisory firm. Baxter is one of four healthcare companies globally, and the only U.S. healthcare company, to have been recognized in the Global 100 each year since the list was first published in 2005. The 2009 list includes 20 U.S. companies recognized for corporate sustainability performance, Baxter being one of two U.S.-based healthcare companies. The Global 100 was announced on January 28, 2009 during the World Economic Forum in Davos, Switzerland. The Global 100 is selected from a pool of 1,800 publicly-traded international companies to form a list of those that have the best developed abilities, relative to their peers, to manage the environmental, social and governance risks and opportunities that they face.

Genzyme Has 86,000-sq. ft. Addition at Allston Landing Bio. Facility in Boston

Biotechnology firm Genzyme has placed the last piece of steel of an 86,000-square-foot addition at its Allston Landing biomanufacturing facility along the Charles River in Boston.

Allston Landing is Genzyme’s main protein manufacturing facility and one of the world’s largest cell-culture manufacturing plants. Genzyme has expanded production at the Allston facility from four to six bioreactors in the last several years by fitting out two cell culture halls. The current expansion, slated for completion this spring, will add space for manufacturing support functions.

The expansion also includes a new, 26,000 square foot underground cogeneration plant that will generate steam to run the plant’s process operations and will also produce electricity.

ARC/Architectural Resources Cambridge designed the expanded facility. Turner Construction Co. is the general contractor.

Genzyme's Corporate Headquarters in Boston Wins Harleston Parker Medal

Genzyme Center, the biotech giant's 12-story, 350,000-square-foot global corporate headquarters in the Kendall Square section of Cambridge, Mass., has been awarded the 2008 Harleston Parker Medal, a design award presented by the Boston Society of Architects and the city of Boston to honor what they deem the most beautiful building or other structure built in the greater Boston area during the past decade.

A jury evaluated about 170 nominations for the award, which was established in 1921 by Boston architect J. Harleston Parker.

"In addition to the Genzyme headquarters building's striking physical aesthetic, the project has had a catalytic influence on the Boston area design and policy making community, representing the marriage of design and innovation and setting the stage for a new standard of sustainable design in the region," the award jury concluded in a report to the BSA.

"As a self-described 'symbol of progress', Genzyme Center has, in fact, already served as a kind of 'demonstration project', pointing the way to a future where collaboration and clear goals can yield results that work at the many different levels necessary to create a successful 21st-century workplace," the jury added.

Designed by the Stuttgart, Germany-, and Los Angeles-based architecture firm Behnisch, Behnisch & Partner, in collaboration with Boston-based Next Phase Studios Architects, Genzyme Center has received the highest rating issued by the US Green Building Council, a Platinum certification under the council's Leadership in Energy and Environmental Design rating system. Nearly 75 percent of the materials used in Genzyme Center contain recycled content, and over 90 percent of construction waste was recycled.

Since the building opened, more than 15,000 visitors have toured Genzyme Center, according to Genzyme.

Genzyme Buys $1.1M Framingham, Mass., Parcel, With Technology Park Expansion in Mind

Genzyme has purchased for $1.1 million a property straddling the communities of Marlborough, Mass., and Northborough, Mass., where the national school bus company First Student is completing a new $2.7 million, 24,000-square-foot terminal, a site into which the biotech giant contemplates expansion someday, the Worcester Business Journal reported.

The Hayes Memorial Drive property is within the Framingham (Mass.) Technology Park, where Genzyme opened a $125 million, 180,000-square-foot science center in September. First Student is moving to Marlborough from its current depot location, at 47 New York Ave. in Framingham in February, Michael Sullivan of First Student told the Business Journal. The newspaper could not reach Genzyme officials for comment.

Genzyme bought the land for the new bus depot on Jan. 7 from the Marlborough Northborough Land Realty Trust, according to the South Middlesex County Registry of Deeds, the newspaper reported, adding that the biotech company struck a deal with the trust for the purchase of the land in June.

Texas Announces $5.5M Investment to Create New Biomedical Institute at U of Houston

Texas Governor Rick Perry announced that the state will invest $5.5 million in the University of Houston to create an Institute of Biomedical Research in conjunction with the Methodist Hospital Research Institute.

The governor also urged the Texas legislature to appropriate funds for the Texas Emerging Technology Fund, a $200 million initiative created by the state legislature in 2005 and reauthorized in 2007 to fund research projects with commercial potential at Texas universities.

The new Institute for Biomedical Research will house the Texas International Center for Cell Signaling and Nuclear Receptors. Jan-Ake Gustafsson, formerly of Sweden's Karolinska Institute, will serve as director of the new institute.

Alexandria Wins South San Francisco, Calif., Approval for 292K Sq. Ft. Lab Building

The South San Francisco, Calif., City Council has approved plans for a nine-story, 292,000-square-foot research and development center by Alexandria Real Estate Equities that will replace a pair of 40-year-old buildings at 213 East Grand Ave.

"The project will go a long way to revitalize and underscore this high visible corridor of South San Francisco. The development will be a significant statement in redefining the neighborhood while fully complying with the city's area development guidelines.”

The center will be erected as soon as a tenant is identified, which is likely to happen soon, Michael Lappen, economic development coordinator for South San Francisco.

"Biotech is one of the few growth industries in California, and it will continue to grow," Lappen said. "We'll see a slowdown in the next four or five years, but we won't need to scramble to attract businesses to come here."

Approval for Alexandria's project came just weeks after Centrum Properties announced it will spend $23 million to renovate the 572,000-square foot SFO Logistics Center on San Mateo Avenue. Centrum will likely keep the center's current tenants, which include the US Postal Service and the US Drug Enforcement Agency.

Northeast Georgia Officials Briefed on State of the State's Life Sciences Industry

The Georgia Bio-science Joint Development Authority briefed some 50 officials from Gwinnett, Barrow, Oconee and Athens-Clarke counties and researchers from both ends of Georgia's Highway 316 corridor on Feb. 5 about the state of the Peachtree State's life sciences industry, and how to foster biotech in Northeast Georgia, the Athens Banner-Herald reported.

Georgia is home to about 300 life-sciences businesses that employ about 15,000 people, GeorgiaBio President Charles Craig told the officials. That number of employees doubles when people working in research labs at public universities and government research centers are counted, he added.

Rather than trying to attract one or two internationally known bioscience firms to the state, Georgia should seek to retain homegrown life-sci businesses within the state as they grow, Kerry Armstrong, a broker with Duke Realty in Atlanta, told the Banner-Herald.

"We have the research happening now. My worry is that when it becomes monetized, when it's a product ready to come out of the lab, that were going to lose them because they have no place to set up shop," Armstrong said.

Armstrong, a founding member of the authority, estimated that a bioscience research park would cost as much as $180 million, based on the expenses to develop a 170-acre, 20-building business park on Sugarloaf Parkway in Gwinnett County.

NC Research Campus Institutions Grapple with Likelihood of State Budget Cuts

The University of North Carolina System has asked the state's General Assembly for an additional $10 million for food/real estate magnate David Murdock's NC Research Campus, taking shape in Kannapolis, NC — a sum that would boost state funding for the biocampus to $29.5 million for the fiscal year that starts July 1, said Rob Nelson, the system's vice president for finance.

Roughly half of that increase — nearly $5 million — is for staffing. About $3.2 million would be for faculty positions, with the balance allocated for operating costs, equipment and supplies.

But the state's worsening fiscal condition may lead instead to budget cuts likely to slow the hiring of tenure-track faculty at the 350-acre life sciences hub, which focuses its research on health and nutrition. Just how deep those cuts will be is still to be determined. It also will require those on campus to tighten their belts, from trimming the purchase of supplies to scaling back on travel, Nelson said.

Several of the universities with a presence on the research campus say they are preparing for a 7 percent cut in the upcoming state budget — on a par with cuts recently imposed for several state agencies as North Carolina grapples with a $2 billion budget shortfall for the fiscal year that ends June 30.

Steve Zeisel, director of the UNC Nutrition Research Institute, told the Business Journal he had hoped to add 12 tenure-track faculty positions, increasing the institute's total to 18. He added that he was continuing with his recruitment efforts, noting it takes about eight months to bring a new faculty member on board.

"My hope is everybody will see this is one of the investments that helps us eventually climb out of this economic problem and that they will decide to give us the resources to continue with our growth," Zeisel said.

It will be at least early March before state officials have a clear idea of where the cuts will be needed in the new budget, Chrissy Pearson, a spokeswoman for new Gov. Bev Perdue, told the newspaper, adding: "Nothing's off the table completely, but she's trying to take care of certain issues she considers to be her seed-corn."

Gilead Adds to Foster City, CA, Presence with $137.5M Purchase of EFI HQ, 30-Acre Parcel

Gilead Sciences has completed its partial acquisition of the Electronics For Imaging headquarters along with a 30-acre parcel adjacent to its headquarters in Foster City, CA, for $137.5 million.

Gilead intends to occupy the five-story, 163,000-square-foot building, at 301 Velocity Way, and formulate a development plan for the parcel, which can accommodate 542,000 square feet of office space. The biopharmaceutical company owns the Vintage Park office campus that surrounds the EFI headquarters with 17 buildings.

John Milligan, president and COO of Gilead, called the deal "an efficient means for expanding our Foster City campus to create flexibility and to accommodate planned long-term growth."

Gilead's new building was completed in 2001 as the second within the EFI campus. EFI received approvals from the Foster City Council several years ago for 1 million square feet of offices, R&D and light warehousing. EFI will remain in its 295,000-square-foot headquarters at 303 Velocity Way. As part of the deal, Gilead obtained the right of first refusal to acquire the rest of EFI's adjacent real estate assets, including the neighboring 10-story, 300,000-square-foot office building 303 Velocity Way, according to an October filing with the US Securities and Exchange Commission.

EFI began marketing its 35-acre property in May as part of a downsizing effort. Per the option agreement, Gilead had until Dec. 12 to terminate the deal without losing a $5 million deposit, or commit to the deal by putting up an additional $5 million, according to GlobeSt.com. But on deadline day, Gilead and EFI agreed to extend Gilead's termination right to Jan. 13, according to a Dec. 18 filing with the SEC by EFI. The January deadline came and went without an announcement or SEC filing from either party, which have not discussed the transaction until they disclosed that the property had changed hands.

Max Planck Florida Institute Issues Requests for Proposal Seeking Construction Manager

The Max Planck Florida Institute has issued a request for proposals for a construction manager to build a 100,000-square-foot biomedical research facility at Florida Atlantic University's MacArthur Campus in Jupiter, Fla.

Interested firms must meet minimum qualifications that include experience in the construction of complex, major educational, institutional, industrial and research projects. Three of those projects should have been completed within the last 10 years, and each have a value of more than $50 million. Firms should also have demonstrated experience in managing and executing projects certified by the US Green Building Council's Leadership in Energy and Environmental Design, or LEED, ratings system, and include a commitment to maximizing local business and small business enterprise participation throughout the construction program.

Construction on the Max Planck Florida Institute is expected to begin in spring 2010, and completed by fall 2011. Proposals are due by Feb. 25.

Washington, D.C.-based Zimmer Gunsul Frasca Architects, LLP is the project architect, while Jones Lang LaSalle Americas serves as the program manager that will oversee development and construction.

Max Planck agreed to establish its Jupiter facility following approval by Florida Gov. Charlie Crist's Office of Tourism, Trade & Economic Development for $94 million from the now-defunct Innovation Incentive Fund, as well as $94 million from Palm Beach County, FAU, and the town of Jupiter. The county's contribution alone was $86.9 million.

In return for the subsidies, Max Planck Florida is expected to support the creation of more than 1,800 jobs --- both directly and indirectly --- over the next two decades, and generate more than $2 billion in economic activity.

Research at the Max Planck Florida Institute will focus on bioimaging, using the most advanced techniques to visualize microscopic molecular processes.

New Jersey Lauds Eli Lilly After Promise to Retain ImClone Operations in Branchburg

New Jersey Gov. Jon Corzine's Office of Economic Growth has showered praise on Eli Lilly and Co. for a recent pledge to keep newly acquired ImClone Systems' operations and employee base in New Jersey.

OEG Chief Jerold Zaro joined John Lechleiter, Eli Lilly's chairman, president, and CEO, and other company officials for a recent celebration of the deal closing and a tour of the Lilly-ImClone biotechnology manufacturing facility in Branchburg, NJ, where more than 900 employees now work, primarily in biotech clinical development and manufacturing jobs.

Lechleiter said the Branchburg facility, with its recent FDA approval to manufacture multiple biotech products, was poised for future growth as Lilly expands its biotechnology capabilities.

VWR International Inks 150K Sq. Ft. Lease for New HQ at Malvern, PA, Complex

Global laboratory supply and distribution company VWR International has signed a 150,000-square-foot, build-to-suit office lease to relocate its headquarters to Uptown Worthington, a 1.6 million-square-foot mixed-use community being developed in Malvern, Pa., by O'Neill Properties Group.

VWR's new space will be part of a 240,000-square-foot building that will also house a fitness center and several restaurants. The lease marks the end of a yearlong search for VWR, whose lease at its present headquarters in West Chester, Pa., expires in 2010.

President and CEO David Binswanger, as well as senior vice presidents Scott Gabrielsen and Scott Williams, handled negotiations for VWR and assisted in the search. Binswanger will also serve as project manager for the build-to-suit development, which is slated for completion in the third quarter of 2010.

Uptown Worthington, now under construction at the site of the former Worthington Steel factory, is planned for 185,000 square feet of office space, 745,000 square feet of retail space and 753 residences.

Gateway Park Looms as a Plan B for Insurance Provider Eager to Move within Worcester, MS

Gateway Park, the laboratory-residential-retail campus being developed as a joint venture of Worcester (Mass.) Polytechnic Institute and the Worcester Business Development Corp., is being considered as a possible location for new offices that disability insurance provider Unum Group wants to relocate within the city.

Unum wants to relocate offices and 700 employees now based at 18 Chestnut St. Unum is in talks with Berkeley Investments to become an anchor tenant for the CitySquare mixed-use development being planned for the site of a now-shuttered downtown mall. If those talks fail, Unum would consider Gateway Park, which till now has positioned itself as focused on life sciences development, with retail shops, residential units, and possibly graduate student housing having been discussed on the project's web site as potential uses.

Novavax’s Pilot Manufacturing Plant at Rockville, MD, HQ Ready for Operations

Novavax of Rockville, Md., has announced that all the equipment is installed and ready for operations at its new $5 million, 10,000-square-foot Good Manufacturing Practice pilot plant, within its Rockville, Md., headquarters. The pilot plant is designed to manufacture pandemic and seasonal influenza vaccine clinical supplies and commercial batches at a 1,000 liter scale.

The company uses virus-like particle technology in the plant, which has an expected capacity of 2 million to 3 million doses of monovalent pandemic flu vaccine per week. The plant must still obtain approvals from the US Food and Drug Administration before it can begin vaccine production.

Metro Orlando Economic Development Commission, Florida's Blood Centers Eye Biotech Incubator

The Metro Orlando (Fla.) Economic Development Commission and Florida's Blood Centers may create a biotechnology incubator in Orlando that would house up to a half-dozen start-up firms, the Orlando Business Journal has reported.

Creating the biotech incubator would involve using the 10,000 square feet of biology and chemistry labs in the Florida's Blood Centers offices now serving as a temporary home for the Burnham Institute for Medical Research. Burnham will vacate the space when it moves to its new $60 million headquarters in Lake Nona once its construction is completed in April.

Like other parts of Florida, the Orlando area as has sought to attract biotech businesses in recent years, since they are considered part of a non-polluting "clean" industry whose jobs pay more than $100,000 a year, compared to the average Central Florida annual wage of $38,000.

Citing Economy, India's Uttarakhand State Shelves Plans for Biotech/IT Park at Pantnagar

The Indian state of Uttarakhand has shelved plans announced five years ago for a 500-acre biotechnology and information technology park in a Special Economic Zone within the Pantnagar section of the Kumoan region. While the decision was blamed on the global economic slowdown, officials said the land has been allotted to other industries for expansion purposes, leaving no place for the project.

Ernst and Young served as marketing consultant for the project, whose cost had been pegged at between Rs 150 to Rs 300 crore ($30.8 million to $61.7 million). Hyderabad-based Ramky Infra Consulting Pvt Ltd had served as project designer.

The shelving of the IT-BT project is considered a setback to the Uttarakhand government's efforts to accord priority to the biotechnology sector, since the state had proposed to establish a state-of-the-art biotech park since releasing its first Biotechnology Policy in 2004.

Some 175 of the 500 species of medicinal plants found in the Indian system of medicine can be found in Uttarakhand, as can several research institutes, including Roorkee, Forest Research Institute, Herbal Research & Development, regional centers of the National Bureau of Plant & Genetic Resources, and the Central Institute of Medicinal & Aromatic Plants. The existing industrial cluster in Pantnagar is home to food and natural product corporations such as Dabur, Britannia and Nestle.

Memorandum of Understanding Links Barcelona's BioCat, Asian Biotech Federation

BioCat, the association that promotes life sciences activity in Barcelona, Spain, has signed a formal memorandum of understanding with the Federation of Asian Biotech Associations, representing the biotech parks in India's Genome Valley region, calling for collaborative activities between the two organizations. The accord was signed on the concluding day of the three-day Bio-Asia 2009 in Hyderabad, India, on Feb. 4.

The MoU aims for exchange of technologies, researchers and students between Hyderabad and Barcelona. It was signed by Manel Balcells, President of BioCat's executive committee; BS Bajaj, secretary-general of FABA; and BP Acharya, chairman of the Andhra Pradesh Industrial and Infrastructure Corp.

GE Healthcare, Wave Biotech Sell Somerset, NJ, Flex Building for $5.5M

A joint venture of GE Healthcare and Wave Biotech has sold Franklin Square 3, a two-story, 70,000-square-foot office/warehouse "flex" building in Somerset, NJ, to Everest Production Corp., a television and video production company focused on multimedia projects, for $5.5 million, or $79 per square-foot, according to CoStar News.

The building, located at 300 Franklin Square Drive, was built in 1988. Todd Stires of Lamington Properties represented Everest Production, while Huseyin Copur of Coldwell Banker represented the seller.

Proof-of-Concept Center QED Debuts in Philly to Help Fund Regional Life-Sci Innovators

A new multi-institutional proof-of-concept center in five months will begin soliciting the first of three rounds of formal proposals from researchers in the Philadelphia region seeking pre-seed funding to help commercialize their life-science technologies, a key organizer of the effort told reporter.

The proof-of-concept center will award up to $200,000 over 12 months that will be matched by the institutions contributing the technology, and this city's University City Science Center.

The center is part of a broader 18-month pilot program intended to strengthen the region's tech-commercialization effort — long a weakness in the region's quest to build a top-tier life-sci cluster.

The center will be named QED, the abbreviation for "quod erat demonstrandum," the Latin phrase appended to mathematical or philosophical proofs.

"We're taking projects that are still owned by university tech-transfer offices, and funding them to the point where they can be a viable venture," Stephen Tang, the Science Center's president and CEO, said in describing the effort during a presentation before a group of journalists, held at the campus. "We know that we won't pick all winners. So the idea here is to clear the pipeline of the losers quickly so that things don’t linger in our environment and lose credibility over time."

QED is one of several tech commercialization programs planned for launch over the next year and a half by a consortium of research institutions, life-sci businesses, and Science Center.

With 2 million square feet of space in 15 buildings spread over 17 acres, Science Center is the nation's oldest and largest urban science campus and is a key player in the tech-commercialization campaign.

The first request for proposals "will come to fruition in June or July. We're going to be in pre-solicitation over the next, probably, 30 to 60 days," Tang said.

Tang's remarks followed a presentation of the multiple programs that will comprise the broader tech-commercialization effort to the group of journalists, which was invited to visit Science Center as part of a four-day tour of life-sciences employers.

The 2nd International Life Sciences Press Tour was arranged by Select Greater Philadelphia, a regional economic-development group that promotes life-sci and other technology development within an 11-county region that straddles northeast Pennsylvania, southern New Jersey, and northern Delaware.

During his presentation, Tang detailed plans to solicit three rounds of RFPs for entrepreneurs interested in commercializing technologies developed by subsets of the two dozen universities and research institutions participating in QED.

The first subset, which will join with responding entrepreneurs, includes Children's Hospital, the University of Delaware, Drexel University, the Lankenau Institute for Medical Research, Rutgers-the State University of New Jersey, Temple University, Thomas Jefferson University, the University of Pennsylvania, the University of the Sciences, and the Wistar Institute, a nonprofit biomedical research institute in Philadelphia.

During the fourth quarter, QED will release its second RFP for work with technologies developed at Fox Chase Cancer Center, Monell Chemical Senses Center, Philadelphia University, Rowan University, Villanova University, and Widener University.

And during the second quarter of 2010, QED's third RFP will go to entrepreneurs wishing to form tech-commercialization partnerships with Delaware State University, East Stroudsburg University, Lafayette College, Lehigh University, Lincoln University, the Philadelphia College of Medicine, Salus University, and Swarthmore College.

Tang said he envisions funding three projects based on the first RFP, five projects detailed in the second RFP, and 10 projects from the third RFP.

"The ultimate goal here is to create a much larger fund, and have a much larger presence, and fund many more projects," he said. "Very simply, we see ourselves as an intermediary that catalyzes convergence of early-stage technology, funding, entrepreneurs, facilities, and business services, in the greater Philadelphia technology ecosystem.

"What we're trying to do is maximize the value of early-stage technology generated by researchers across the region, to accelerate technology commercialization," Tang added.

As a result, he said, Science Center hopes to reduce the risk for entrepreneurs and investors, match new technologies to successful entrepreneurs, and help the region draw top-flight faculty and students to metro Philadelphia.

QED hopes to support emerging companies in Philadelphia's life-sciences industry much as two such existing centers nationwide have done for engineering: The Deshpande Center at the MIT School of Engineering, and the von Liebig Center at the University of California-San Diego Jacobs School of Engineering.

QED will fund "some combination of therapeutics, whether pharmaceuticals or medical devices, in vivo and in vitro diagnostics, or some sort of other device or research tool," Tang said. "We're going to target the life science industry because we have such a high concentration of those companies here."

Not only startups, he said, but later-stage companies that could expand within University City, including overseas companies eligible to use the Science Center's 3-year-old Global Soft Landing program, funded in part by the US Commerce Department's Economic Development Administration.

Metro Philadelphia, he said, could learn from Cambridge, Mass., which has evolved into the East Coast's largest biocluster by nurturing life-sci startups and retaining them as they grew into multi-million-dollar corporations. He cited Novartis' growth in the city in part by converting a former factory of the New England Confectionary Co. into the 500,000-square-foot headquarters of the Novartis Institutes for BioMedical Research.

The Science Center also plans to turn 4,000 square feet of vacant space within its newest building, the 155,000-square-foot 3711 Market St., into a "clubhouse," or site for formal and informal meetings between researchers, venture capitalists, entrepreneurs, and other life-sci professionals.

The clubhouse will offer a boardroom with videoconferencing capability, "the ability to have something to eat, something to drink in a café style, with very soft seating areas, all of which will be wired in a Wi-Fi environment" and designed to look "a lot like a really nice airport lounge," Tang said.

The clubhouse will be intended to be a place "where people can gather and talk about ideas, talk about innovation, which will ultimately lead to higher-quality projects and higher-quality entrepreneurial ventures," said Tang.

In addition to life-sci entrepreneurs, the clubhouse hopes to draw IT, nanotechnology, marine and alternative energy, "and the businesses and financial services supporting these communities," he added.

That site, to be dubbed the Quorum, is one of three services planned under that name. In addition to building out the Physical Quorum, Science Center will support programs and events at numerous venues around the Philadelphia region as part of what it calls a Satellite Quorum. Philadelphia-area life-sci and tech community members will also be linked through an online community, or Virtual Quorum.

"The reason we picked 'Quorum' is because it means 'that which is required to transact business,'" Tang said.

Science Center has committed $1 million over "several" years to launch the tech-commercialization programs, Tang said, adding that the center has won support from Pennsylvania officials to match an as-yet undisclosed part of that investment. Science Center will seek a similar amount of funding from Delaware and New Jersey, said Tang.

The Quorum services, like the proof-of-concept center, are designed to accelerate tech commercialization in a region whose historically weak tech-transfer effort was faulted by a group of CEOs in a 2007 report.

CEO Council for Growth, a group of more than 70 business leaders in Philadelphia and 10 nearby counties, concluded in a recent report that the region’s tech-commercialization effort did not reflect the volume of commercial tech activity, including biotech startups, of its concentration of academic institutions and pharmaceutical companies.

The 36-page report, titled Accelerating Technology Growth in Greater Philadelphia, was commissioned by the Economy League of Greater Philadelphia, a nonprofit policy research group that champions regional economic growth.

Tang said the Science Center will position itself as an intermediary that can help bridge what he called the "culture clash" between the region's academic and business sectors. He said it will also strive to become a catalyst to promote tech commercialization in and around Philadelphia by uniting the two sectors with venture capitalists and public and private economic-development groups.

The Philadelphia region's key challenge, Tang said, is attracting venture capital comparable to the research dollars drawn by the region's universities and research institutions. While Philadelphia is third-highest among metropolitan areas in drawing National Institutes of Health research grant dollars — about $800 million in the federal fiscal year that ended Sept 30, 2007 — it fares worse in VC awards.

According to an annual report, just as the US economy and financial institutions were skidding into financial turmoil, the Philadelphia region racked up $45.5 million in seven venture capital deals during the fourth quarter of 2008, down almost 26 percent from $61.3 million in nine deals during the final three months of 2007.

Year to year, however, metro-Philadelphia finished 2008 with $278.7 million in venture capital, down nearly 19 percent from $343 million in Q4 '07, both years yielding 29 deals.

"That gap today is really an opportunity to accelerate technology commercialization," Tang said.

The current financial upheaval, he said, heightens the chances of startups being stranded by nervous investors pulling back from earlier commitments.

"We believe if we start this process right now, even under this rather severe economic climate we can begin to fill the pipeline of projects, so that when we do recover, that pipeline will be full," said Tang. "And by engaging the rest of the ecosystem, the rest of the community, we can gain support of some very early-stage technology that hasn’t been there before."

The tech-commercialization effort marks Science Center's effort to address priorities that Tang cited in an interview with BRN just over a year ago, when he was named to the Science Center helm over interim president Dean Lewis and other candidates.

“I think it’s a matter of defining the community, setting priorities, and finding a way to work together. Those are the challenges ahead,” said Tang. "Perhaps we needed a catalyst or a way to align interests better. That’s hopefully the basis of the leadership that I will bring to the SC and to the region.”

During the presentation, Tang and Curt Hess, the Science Center's senior vice president of real estate operations, told reporters that the campus has a new asset ready to use in its tech commercialization program: the 10,000-square-foot third incubator of lab and office space recently completed.

At deadline two companies had agreed to lease office space in the space: Avid Radiopharmaceuticals, a clinical-stage developer of molecular imaging agents; and ERYtech Pharma, a French biotechnology company specializing in encapsulating therapeutic molecules or enzymes into red blood cells.

Rents in the third incubator will range on average from about $1,300 per month for office space — with office amenities that will include Internet, use of a copier, and a fax machine — while lab rents will range from about $2,500 per month for a quarter of a lab suite, to about $10,000 per month for a full lab suite.

The new incubator joins two existing facilities at Science Center, one at 3701 Market St., the other at 3624 Market St.

Neopac Offers New Packaging to Increase Patient Compliance

Neopac has launched its Twist’n’Use single dose applicator, which it claims improves patient compliance, ensures administration of the correct dosage and prevents contamination.

The system has been developed for administering liquids, creams and gels using Neopac’s Polyfoil tubing that provides protection to sensitive, pharmaceutical grade formulations.

Polyfoil has been used in a range of Neopac’s products but the Twist’n’Use system introduces an activation system that releases a pin in the nozzle when the user twists the cap. This pierces the nozzle and results in the correct dose being dispensed onto the affected area.

In addition since the tube is sealed prior to twisting the cap, and cannot be resealed, the risk of contamination is reduced and any tampering is evident.

Richard Misdom, sales manager of Neopac, said: "Our new Twist'n'Use System enhances patient compliance and is the most secure and convenient single dose package on the market. We are happy to offer a product that meets the needs of pharmaceutical and biotech manufacturers and end-users alike."

The product is available 10mm and 13.5mm versions, with a different design available for the dispensing of low-viscosity gels and creams. This is only available in 10mm and comes with a shorter nozzle to improve the dispensing of low-viscosity therapeutics.

In addition Twist’n’Use offers the same benefits as other products using Polyfoil, such as preservation of sensitive products, with added compliance.

Compliance packaging is forecast to be a growth sector, with a 2008 report predicting it would be an important factor in the US drug packaging sales reaching $16bn by 2008.

NC Research Campus Ready for Jobs to Come

And few scientific institutes can create jobs as quickly as the N.C. Research Campus.

That's the message scientists at the campus are pushing as Congress debates an economic stimulus plan that could pump millions of dollars and hundreds of jobs into Kannapolis.

The Research Campus, with its three massive but mostly empty buildings outfitted with some of the world's best scientific equipment, could launch projects that would put people to work immediately, scientists say. They just need funding.

"Shovels are already in the ground," said Dr. Steven Zeisel, director for the UNC Nutrition Research Institute in Kannapolis. "Scientists here are ready right now."

The stimulus package could include up to $10 billion for the National Institutes of Health, a major source of biomedical and health research funding for the eight North Carolina universities with branches at the Research Campus.

"Every dollar that the federal government gives us for basic research will translate into jobs right here in this community," said Dr. Mary Ann Lila, director for N.C. State University's Plants for Human Health Institute in Kannapolis.

For every Ph.D.-trained scientist hired in Kannapolis, several jobs that don't require a doctorate are created as well.

Although campus founder David Murdock constructed the buildings, scientists must secure their own research funding, Lila said.

The $1.5 billion biotechnology complex, which focuses on health and nutrition, seems tailor-made to fit President Barack Obama's vision for the health research component of the stimulus package, scientists say.

The stimulus would provide money to create electronic medical records, identify biomarkers and prevent disease, all specialties of the Research Campus.

"No place is better poised to do this," said Dr. Andrew Conrad, chief scientific officer for the campus and co-founder of LabCorp's National Genetics Institute. "We could win the day."

Conrad described the stimulus package as a "call to arms" and said scientists, university administrators, political leaders and private industry connected to the campus should work together to secure funding.

The campus will compete with "every science environment worth its salt, trying to get this money," said Victoria Christian, chief operating officer for Duke University's long-term medical research study based in Kannapolis.

The Research Campus has several selling points, including 350 acres of land and facilities ready to house scientists and their staffs. This public-private biotech partnership features the kind of collaboration that Obama wants to encourage, Conrad said.

If the campus wins funding for a project, "instead of having lawyers draft documents for the first six months, we start now," he said.

Zeisel has instructed scientists at the UNC Nutrition Research Institute to apply for as many grants as possible by this summer. If they make the June deadline, they will know by November if they can start hiring, he said.

"Every dollar we bring in research funding, we spend immediately on people and supplies that come from this area and live in this area," Zeisel said.

The Massachusetts Life Sciences Collaborative has estimated that each grant from the National Institutes of Health creates an average of seven jobs, and that every dollar invested in the NIH generates twice as much in economic output.

The Research Campus can "deliver incredibly," Conrad said. "Lots of jobs."

For example, converting written medical records into electronic form for thousands of people enrolled in Duke's medical research study would require information and technology experts, typists, computer programmers, even survey takers.

Duke Wants to Create a Business Incubator in Kannapolis Called the Biomarker Factory

Duke wants to create a business incubator in Kannapolis called the Biomarker Factory, which would house the long-term medical research study. Both projects could be candidates for federal funding, as well as new collaborative efforts between Duke and the UNC system.

Scientists at the Duke Translational Medicine Institute are "poring over" the stimulus package to find grant opportunities "and ways of using them that will ripple into the North Carolina Research Campus and Kannapolis," Christian said.

Making the Research Campus' five-story centerpiece Core Laboratory available nationwide could result in start-up companies, global collaboratives and networks "all directly flowing into the Kannapolis area.”

Duke and all the universities at the Research Campus are working to find ways to prevent disease. Obama's stimulus package includes funding for these efforts.

"Prevention of disease is going to be a major part of his administration," said Dr. David Nieman, director of the ASU Human Performance Lab in Kannapolis and Boone. "That's what I am very excited about. Instead of pouring money into the treatment of disease, put it into prevention."

If Obama's administration can make exercise science and health and nutrition research new priorities in the federal government, it will create more awareness around the country, Nieman said.

The Research Campus could serve as a model.

REST OF WORLD

Foundation Inaugurates Qatar Science and Technology Park

Qatar Science & Technology Park, the Qatar Foundation's research accelerator, was formally opened in an inauguration ceremony attended by 1,200 leaders of science, business and government from in and outside Qatar. Presiding were the Emir of Qatar Sheikh Hamad bin Khalifa Al-Thani, and Sheikha Mozah Bint Nasser Al Missned, chairperson of the Qatar Foundation.

"As we have planned for our national vision by the year 2030, we are confident that QSTP as a component of [the] Qatar Foundation for Education, Science and Community Development, will be a tributary for human development, an incubator of creativity and innovation, a safe haven for free scientific research, a magnet for national and international expertise, and a space where cultures and ethnicities integrate," the emir said.

QSTP's 21 partner companies have committed a combined $225 million of R&D investment at QSTP, while Qatar Foundation itself has invested $600 million building the science park.

Borealis Manufacturing Film Stays Clear Even Post-Sterilisation

Borealis, Germany, is launching a new cast film that it claims offers best-in-class transparency, high purity and can be tailored to a client’s needs, making it ideal for packaging manufacturers needing clear coverings.

High-transparency is retained during and after sterilisation, which Borealis believes will make its film, called Bormed RE806CF, highly desirable to manufacturers of pharmaceutical, medical device and diagnostic packaging.

Borealis claims the film’s high-transparency, coupled with its very high gloss, low haze, 143ºC melting point and good sealability, put it at the forefront of existing copolymer offerings.

Nina Ackermans, application marketing manager, Borealis Film and Fibre Business Unit, said: “Bormed RE806CF is an excellent example of Borealis’ commitment to investing in new technologies.

“We understand the high value that our customers in the medical film industry place on product consistency, reliability of supply and easy processing, in addition to responding to the aesthetic and performance criteria required by the demanding healthcare market. Bormed RE806CF has been tailored to help cast film converters meet these challenges.”

The film is based upon Borealis’ Borstar-Sirius catalyst technology, which is the company’s proprietary manufacturing technique for tailoring the molecular structure of polyolefins to meet a client’s needs.

Borealis claims use of this technology allows it to produce polymers with high environmental stress-cracking resistance, low shrinkage and a tailored balance between stiffness and impact.

The film will be manufactured at Borealis’ new PP facility in Burghausen, Germany, which operates under conditions designed to ensure consistent, high quality and compliance with international standards.

Scotland's Impact Laboratories to Set Up $43 Million Polymers Research Center in Saudi Arabia

Impact Laboratories (Grangemouth, Scotland), a research and technical support services provider to the plastic and polymer industries and a BP- (NYSE:BP) (London) associated company, has secured a contract to develop a $43 million polymers research and technical center at the Al Jubail industrial city in eastern Saudi Arabia. The research and technical center will come up as part of the $1 billion petrochemical complex being developed at Al Jubail by National Industrialization Company (SAU:2060) (Riyadh, Saudi Arabia), also known as Tasnee Petrochemicals. Although the value of the contract has not yet been disclosed, the deal is reportedly the largest secured to date by Impact in Saudi Arabia.

Under the contract, Impact will function as the technical advisor to Tasnee and design the research center, select processing and lab equipment to be installed in the facility, ensure knowledge management, set up information technology infrastructure, and train the workforce. The research and technical center is scheduled for commissioning later this year and will employ about 35 personnel.

Tasnee, Saudi Arabia's second-largest petrochemical and industrial group, has developed a petrochemical complex comprising an ethylene cracker with a capacity of 1 million tons per year, a polypropylene plant with a capacity of 750,000 tons per year, a 400,000-ton-per-year high-density polyethylene unit and a 400,000-ton-per-year low-density polyethylene unit.

The research and technical center will consist of nine laboratories that will undertake product development activities, provide assistance to manufacturing units, support downstream activities, provide technical support for customers and train in-house staff and customers. The laboratories will facilitate analytical and physical testing, thermal and rheological analysis, failure analysis, study of molecular structure and crystal morphology, microscopy studies, polymer identification, and film, container, environmental and pipe testing. Research work will be conducted on polypropylene, polyethylene and ethylene.

A processing machine hall, fitted with advanced compounding and pipe extrusion lines, will be developed on 3,000 square meters of land area and will be equipped to process small laboratory-sized quantities and semi-commercial quantities of products. Products will be tested for adherence to industry standards as outlined by the American Society for Testing and Materials and International Organization for Standardization.

Impact hopes to capitalize on this deal to further penetrate the Middle East and is reportedly in talks with the government of Saudi Arabia to develop additional downstream plastics facilities. The firm is also likely to set up a regional office in the Gulf and is scouting for expansion opportunities in Eastern Europe and Russia.

AstraZeneca and BioDuro Expand Discovery Contract

The Chinese unit of US contract drug discovery firm BioDuro says that AstraZeneca has expand its relationship with the firm to include the optimization of discovery research operations focused on drugs for respiratory and inflammatory disease.

Under the updated contract, financial terms of which were not made public, BioDuro will provide integrated research services in the areas of chemistry, biology, ADME, and DMPK to help enhance AstraZeneca’s discovery program and shorten timelines.

Lena Martensson, AstraZeneca’s director of strategic planning and business development explained that the new deal is based on the firm's previous success and excellent working relationship with BioDuro.

Martensson said that: "After a successful collaboration involving discovery chemistry, ADMET, and DMPK, AstraZeneca has expanded its collaboration with BioDuro to leverage the strengths of its team to help develop new therapeutics."

This positive opinion was echoed by BioDuro CEO John Oyler who said that the firm "is pleased to build upon this existing collaboration and work closely with the experienced team at AstraZeneca to develop new clinical compounds.”

BioDuro has a team of 580 researches and technicians at its facility in the Chinese capital Beijing. It currently has a roster of 40 pharma and biotech clients that it claims include 10 of the top 12 worldwide.

With Big Pharma increasingly cutting R&D budgets and in-house expertise being scaled-back there is considerable scope for contract research organisations (CRO) to expand their businesses.

BioDuro appears to have positioned itself well to take advantage of the burgeoning contract research market, with Frost & Sullivan predicting Asian CROs will be doing $2bn worth of business a year before 2010.

SGS Opens a New Microbiology Lab

SGS has opened a new microbiology lab offering full cGMP-compliant testing in its Shanghai, China facility. The facility provides services for method development and validation, testing of raw materials, APIs and finished products, as well as testing of traditional Chinese medicines.

The new microbiology lab was established under full cGMP compliance, enhancing quality standards of service offerings in China. The company can now provide microbiology limit test, sterility test, challenge test, and endotoxin testing services. The Shanghai operation covers 700 m2, (7,532 sq. ft.) employs 27 full time staff, and is the 10th life science services lab to operate under GMP.

The 700 square metre (7,532 sq. ft.) laboratory, which employs 27 full time analytical staff, will offer local drug developers current good manufacturing (cGMP) practice standard microbiology, stability and endotoxin assessment services for active pharmaceutical ingredients (API), finished products and traditional Chinese medicines.

The quality of APIs and drugs from China has become an increasing concern for patients and importers worldwide following a series of high profile contamination problems that emerged in recent year.

While standards in China are beginning to improve as a result of efforts by both the Chinese Food and Drug Administration (SFDA) and other regulators, analytical testing capacity has not grown at the same rate as the manufacturing sector, creating demand for contract offerings like SGS’.

Ulrich Markens, vice president and regional manager of SGS’ Chinese operations, explained that the firm had “received an increasing number of requests from several multinational companies for microbiology testing in a fully cGMP-compliant environment.”

Markens added that: “Integrating microbiological testing broadens our service portfolio…in compliance with the increased scrutiny of pharmaceutical manufacturing in China by the US Food and Drug Administration (FDA).”

The laboratory, which began offering contract analytical services in January 2006, is part of SGS’ integrated network of 14 cGMP-compliant testing facilities worldwide that the firm believes enhances the quality control operations of both its local and multinational pharmaceutical industry clients.

SGS also said that the laboratory, which already holds a Chinese National Accreditation Board for Laboratories’ ISO 17025 certification, further expands its range of offerings in the country.

The firm offers consultancy in regulatory affairs and the registration of medical products in both Hong Kong and China, third party facility inspection and auditing services and advises producers of import and export requirements.

“This development is significant because throughout 2008, SGS received increasing requests from several multinational companies for microbiology testing in a fully cGMP-compliant environment – and based on this requirement we have a solution,” said Ulrich Markens, vice president and regional business manager, Asia Pacific. “The construction of the microbiology lab is part of the strategy for our Life Science Services operations in China. Integrating microbiological testing broadens our service portfolio while implementing a dedicated cGMP-compliant Quality Management System for the entire laboratory. This ensures a quality improvement level which is demanded by our multinational customers and in compliance with the increased scrutiny of pharmaceutical manufacturing in China by US FDA.”

Merck Ramps Up Biologics Spending in Ireland

Merck & Co is investing an additional €20m ($27m) in its biologics plant in Carlow, Ireland just weeks after it unveiled plans to create a “powerful biologics presence” through its $41bn move for fellow US drug giant Schering-Plough.

According to reports in the Irish media, the extra funds bring Merck’s total investment in the facility to €220m and create an additional 160 construction jobs.

In October last year when construction at the Carlow began, Merck announced that the plant be used for the formulation and filling of biologic drugs and vaccine products and employ a staff of 170 when fully operational in 2011.

ACM Buys Pivotal Bringing it into the Central Laboratory Group

US contract research organisation ACM Global Central Laboratory has bought its longstanding business partner Pivotal Laboratories of the UK in a bid to boost its international reach.

Pivotal provides central laboratory testing services to customers across Europe, as well as in Israel and South Africa, and has been pushing into central and eastern European markets of late.

While Pivotal has worked closely with ACM for four years, the US-based company said it wanted to bring it fully in-house, in keeping with the prevailing trend among CROs to position themselves as global, integrated providers. This approach, it is held, makes it easier to win high-level, strategic contracts with customers.

In a statement, ACM said the Pivotal acquisition will enable it to “centralise certain functional areas where cost savings are possible.” Neither company provided details about the terms of the acquisition agreement.

“Establishing ownership in Europe strengthens our presence in this very important region,” said Elena Logan, vice president, clinical trials, at ACM Global Central Lab.

The UK firm is also one of only eight labs in the UK with College of American Pathologists (CAP) accreditation, which involves a rigorous on-site inspection of records and quality control procedures including staff qualifications, equipment, health and safety and the overall site management.

“The complete integration of the two companies places us in a stronger position, as we anticipate continued growth in the global clinical trials market,” said Art Glenz, president and CEO, ACM Medical Laboratory.

The acquisition will increase ACM’s employee base in both the US and the UK.

Central laboratory services, which span numerous medical disciplines, including safety, pathology, microbiology, flow cytometry and pharmacogenomics, is a fast-growing sector, driven both by the increasing size and complexity of clinical trials and the fact that no drugmakers has this capability in-house.

Other large-scale suppliers of central laboratory services include Covance, Quintiles, PPD, MDS Pharma Services, PRA and Eurofins.

Penn Pharma Redevelopment Increases Manufacturing & Efficiency

At a time when many companies are downsizing, UK-based contract manufacturer Penn Pharmaceuticals has just announced a £12m (€13.5m) redevelopment project that could see the creation of 133 new jobs.

Penn already employs nearly 250 people at the site in Tafarnaubach Industrial Estate in Tredegar, Wales, where the expansion programme will take place. The redevelopment is designed to both increase manufacturing capacity and also improve efficiencies at the plant.

The company said the investment – which comes with the backing of the Welsh Assembly Governments Single Investment Fund - will also safeguard 100 existing jobs at the Tafarnaubach site.

Penn focuses on the production of small volumes of medicine – particularly for clinical trials - and also provides drug development services such as formulation and analytical development.

The company has seen impressive growth in recent years: last September it announced fiscal year revenues of £23m, up 34 per cent year-on-year, and it has a strategic objective to increases sales by 20 per cent a year going forward.

This is the second expansion programme to take place in Wales in a year.

Last May, the firm expanded its clinical trial supplies distribution capabilities seven-fold with the opening of a 75,000 sq. ft. temperature controlled storage and distribution facility. It also recently extended and refurbished its laboratories. In the short term, Penn said it will move existing stores to the new site to allow the new expansion programme to take place.

And in April 2008, Penn opened a new facility that will allow it to manufacture highly-potent compounds in a contained environment. At the time the firm said the facility would help it to expand further across Europe.

SkyePharma Mulls 30 Percent Cuts at Lyon Geomatrix Plant

UK drugmaker SkyePharma may reduce the workforce at its production plant in Lyon, France by a third after “long-running” underutilisation of its manufacturing capacity.

The firm, which initiated a consultation process with the facility’s 129 employees late last week, hopes that the proposed move will improve competitiveness and save it around approximately €1.8m ($2.3m) a year in operating costs.

SkyPharma CFO Peter Grant told in-PharmaTechnologist that: “The factory has been owned by SkyePharma for many years primarily as a means of providing customers with a supplier for tablets designed using our Geomatrix technology.

“Whilst this technology has been a success and has resulted in 10 approved products on the market today, we have found that Big Pharma tends to prefer to manufacture the products themselves, which means that our Lyon factory is dealing with smaller customers who tend to take longer to achieve substantial market penetration,” explained Grant.

He stressed that the current difficult global climate had not played any part in the proposed cutbacks and could not say how long the employee consultation period will take to complete.

SkyePharma’s controlled-release Geomatrix technology uses multilayered tablets composed of hydrophilic polymers like hydroxypropyl methylcellulose (HPMC) and a surface barrier layer.

Geomatrix has already been used in a number of products such as Sciele’s Sular, Critical Therapeutics’ Zyflo CR, Roche’s Madopar DR and, most recently, Nitec’s rheumatoid arthritis treatment Lodotra.

In a press statement, company CEO Ken Cunningham commented that: "We regret the need to propose this potential reduction in the workforce at our French manufacturing operations and, following consultation, intend to implement an appropriate social plan to assist any employees affected.

“However, changes are essential to ensure that we have the correct staffing for the forecast levels of demand. We will continue to constrain cash utilisation to ensure that we meet our goal of retaining cash resources that are sufficient to enable SkyePharma to reach its target of sustainable profitability," he added.

India's Kerala State to Develop Incubator, Tech Development Center

India's Kerala State Industrial Development Corp. will develop a Rs. 300 billion ($60.5 million) life sciences park within 260 acres at Veiloor Village near Thonnakkal, in Thiruvananthapuram.

The park will consist of an incubation center for startups and a technology development center for later-stage companies in biotechnology and nanotechnology, as well as research institutions and sci-tech academia. Facilities would include dry and wet Labs, a technology transfer center, computational biology labs, an IT center, a digital imaging center, a central instrumentation center, a virtual reality center, a business center, a bio-IT software and database library, an administrative center, and an intellectual property center.

KSIDC also envisions developing the park through a public-private Trivandrum Life Sciences Park Company, with equity contributions from the government of Kerala and private investors.

The planned tech park is designed to capitalize on proximity to other tech campuses, including Technopark and the Rajiv Gandhi Centre for Biotechnology.

Bayer Schering Pharma to Build €100 million Global R&D Center in Beijing

Bayer Schering Pharma, the pharmaceutical division of Bayer HealthCare, said it will build a global R&D center in Beijing, at a cost of €100 million ($125.7 million) over the next five years.

China is the Bayer group's third largest market worldwide, and will become the third country after Germany and the US to host a Global R&D Center for Bayer Schering Pharma, which focuses on women's healthcare, cardiology, oncology and diagnostic imaging.

"Our aim is to systematically include Asian patients earlier in global drug development, breaking the tradition of 'US and EU first'," Kemal Malik, member of the board of management of Bayer Schering Pharma, head of global development and chief medical officer, said in a statement.

In addition, Bayer Schering Pharma will also launch a Global Drug Discovery Innovation Center in Beijing where company scientists will collaborate with Chinese partners. The pharma giant also announced that it is in advanced discussions with Tsinghua University on entering into a strategic partnership "to pursue research collaborations for the discovery of new disease-related targets in the core areas of Bayer's pharmaceutical research."

ISO 15378:2006 Awarded to French Alcan Plants

Three plants owned by contract packaging maker Alcan have been cleared to produce containers for pharmaceutical products under the International Organization for Standardization’s ISO 15378:2006 guidelines.

The units, which include two glass vial plants in Authon and Lucenay and a flexibles facility in Montreuil Bellay, were all judged to have “consistently met customer regulatory requirements and International Standards applicable to primary drug packaging materials”.

Mike Schmitt, president of Alcan’s pharmaceutical packaging unit, explained the facilities “join several of our other plants in reaching this advanced level of certification and demonstrate our continued commitment to providing world-class packaging for the healthcare industry”.

In 2007, Alcan’s facility in Kreuzlingen, Switzerland became the first flexible packaging unit in the world to achieve ISO 15378:2006, which was originally designed for glass products before being extended to include all types of drug packaging. Christian Durand, vice president of glass tubing operations, said that the ISO 15378:2006 standard is a competitive advantage as it ensures customers' sensitive pharmaceutical products are packaged safely and effectively.

The accreditation will undoubtedly be welcomed by Alcan’s owner Rio Tinto. The mining giant has been looking to off-load the packaging unit since acquiring its parent company for $38bn (€30bn) in 2007.

Despite speculation about a number of potential suitors over the past year only one, Australia’s Amcor, has confirmed that it has any interest in Alcan’s packaging operations so far.

The latest accreditation, coupled with Alcan’s recent expansion in key pharmaceutical packaging markets like India, only serves to make the company a more attractive proposition for companies like Amcor that wish to strengthen their standing in traditional and emerging regions.

Additionally, Rio is likely to welcome any news will allow it to focus on its core strengths at the moment given Chinese aluminium firm’s Chinalco repeated efforts to invest an additional $19.5bn in the global mining group.

Elan Cuts Jobs, Shelves Biofacility

Faced with a tougher operating environment, Irish drugmaker Elan has decided to slash staff numbers by 230 – or around 14 per cent of its total workforce – shelve the construction of a new biologics manufacturing facility and shutter fill-and-finish capacity in Ireland.

The aim is to save more than $30m this year and $50m in subsequent years. Elan is facing maturation of debt to the tune of more than $1bn in 2011, a situation made worse by the credit crunch, and has been furiously cutting costs to prepare.

In late 2008, Elan closed its New York and Tokyo offices and consolidated all its commercial and R&D operations in San Francisco. This was followed in early 2009 with a strategic redesign and realignment of Elan’s R&D organisation.

December 31, 2008, Elan employed 601 people in manufacturing and supply activities, out of a total headcount of 1,687 employees. Over half of the manufacturing staff are located at the firm’s plant in Athlone, Ireland.

The news came shortly after the firm published its 2008 annual results. Once again, contract manufacturing made another useful addition to Elan’s revenues last year, helping the firm pull in total net sales of $1.01bn, up 30 per cent year-on-year.

The bulk ($760m) of that total – and sales growth - came from sales of Elan’s biopharmaceutical products, including multiple sclerosis treatment Tysabri (natalizumab).

Manufacturing revenue and royalties advanced 4 per cent to $282m, with non-manufacturing contract revenue – mainly research fees - adding $20m to the company’s tally, around 50 per cent lower than in 2007.

Elan Drug Technologies, Elan’s drug delivery unit which was up for sale for a time last year, generated $302m in revenue and an operating profit of $86m in 2008. CEO Kelly Martin told shareholders in a letter that EDT is an important pillar of the Elan group.

“EDT provides Elan Corporation with a diversified source of revenue that further mitigates risk by spreading out business across multiple molecules, therapeutic areas and partners,” he noted.

The division generates revenue from royalties from sales of products which make use of its drug delivery technologies – such as its NanoCrystal formulation for poorly-soluble actives - as well as manufacturing fees for the production of licensed products, and contract revenues relating to R&D services, license fees and milestones.

UCB Plans New Bio Pilot Plant

UCB plans to build a biologics pilot plant at its site Braine-l'Alleud in Belgium, as part of the company's efforts to focus on central nervous system (CNS) and immunology. The biologics pilot plant will help the company to further optimize the biomanufacturing processes for its biological compounds under development, with the goal of enhancing competencies in this field.

“The intent to build a new pilot plant within UCB's Braine-l'Alleud site is in line with UCB's decision to focus on its core skills and adapt its competencies for the future,” said Roch Doliveux, chief executive officer of UCB.

The company's plan to invest $82 million is supported by the Walloon Government. The biologics pilot plant is expected to be operational in early 2012 and 100 new job opportunities should be created in the medium-term. Advanced feasibility studies are currently ongoing.

Michigan's Wayne County, Tech Town Plan Stem Cell Commercialization Center

Wayne County Executive Robert Ficano used his annual State of the County address to announce that his county would team up with Tech Town, the Wayne State University research and technology park in Detroit, to create a Wayne County Stem Cell Commercialization Center.

Ficano cited the recent approval by Michigan voters of Proposal 2, which amends Michigan's state constitution by ending restrictions on human embryonic stem cell research, declaring that "any research permitted under federal law on human embryos may be conducted in Michigan," subject to federal law and four stipulations.

"Our Stem Cell Center will be the first of its kind in Michigan. We are creating a new biotechnology industry that will attract new companies, new jobs and alliances with researchers around the world," Ficano said during his address.

The center, Wayne County Deputy Executive Azzam Elder told Crain's Detroit Business after the speech, could attract between $60 million and $80 million in private investment, and should make TechTown the largest incubator in the country.

Elder told the Detroit Free Press the county could spend up to $10 million toward the business initiative: "What we're doing in Wayne County is trying to apply the glue to connect the dots for companies."

Synexus Opens New Bulgarian Site for Secondary Care Trials

Synexus' new trial site in Bulgaria, which is part of the firm’s clinical research centre strategy, will help sponsors cut development times and significantly reduce costs, according to CEO Michael Fort.

The Sophia centre, which will be run by leading clinician Borislav Borissov, expands Synexus’ Bulgarian network and enables the firm to add secondary care trials to its existing primary care offering.

While Synexus is not the only trials firm to be operating in Eastern Europe, both PPD and Covance have recently bolstered their local presences in recent months, the UK firm believes it has adopted a unique strategic approach to making the best of the advantages offered by the region.

Fort said that while trials in Eastern Europe provide cost savings compared with Western Europe, they are less significant than those provided by having a single research centre capable of handling hundreds of patients rather than many trial sites managing few .

“For example a major pharma shared with us some figures involving a major trial that are revealing,” said Fort explaining that the company in question had spent $17m on setting up investigator sites, 60 per cent of which recruited one patient or less.

“We have verified these figures with several other pharmas and CROs who found them in line with their own experience. So with one contract for hundreds, and increasingly thousands, of patients Synexus offers huge savings.”

He also said that eastern Europe offers a much large pool of treatment naive patients than Western Europe and added that Synexus plans to “substantially increase” its number of trial sites in the region.

In terms of the Synexus’ global trials presence, Fort explained that: “We are already in India and are presently looking at a number of further opportunities. We have not yet entered China and while we have no immediate plans we are l[examining] a couple of possibilities.”

“However we have a lot on our plate as we are already aggressively expanding in Europe, India and Africa with several announcements scheduled in the next six months.”

Penn Pharma Expands in Wales

Penn already employs nearly 250 people at the site in Tafarnaubach Industrial Estate in Tredegar, Wales, where the expansion programs will take place. The redevelopment is designed to both increase manufacturing capacity and also improve efficiencies at the plant.

The company said the investment – which comes with the backing of the Welsh Assembly Governments Single Investment Fund - will also safeguard 100 existing jobs at the Tafarnaubach site.

Penn focuses on the production of small volumes of medicine – particularly for clinical trials - and also provides drug development services such as formulation and analytical development.

This is the second expansion program to take place in Wales in a year.

Belgium Opens Antarctic Station

Belgium has opened a new 20 million euro ($26 million) "zero emissions" polar science station in Antarctica, returning to the continent to study climate change 42 years after closing its first base there.

The Princess Elisabeth research hub is totally energy self-sufficient and also aims not to emit any carbon dioxide emissions, according to the Belgian-based International Polar Foundation that runs the base. The octagonal, spaceship-like base sits on stilts on a ridge a few miles (kilometers) north of the Soer Rondane Mountains. It will focus on analyzing nearby deep ice shelves.

The station's roof is covered by solar panels, designed to provide the bulk of energy needed to run the isolated post. Other energy sources will come from large wind turbines. The base is expected to have a lifespan of 25 years and will conduct research in climatology, glaciology and microbiology. Teams of scientists, including glaciologists, are already at work there from Belgium, Japan, France, Britain and the U.S.

The station was inaugurated by Belgian Defense Minister Pieter De Crem and other government officials. "It is really important that as a small country we can show our participation in large international efforts here in Antarctica," De Crem told VRT television from Antarctica.

Maaike Van Cauwenbergh, from the Belgian Science Policy Office, said the base is in an isolated area "where there has been little research done." She said it cost euro20 million to build and is located in a vast 600-mile (1,000-kilometer) zone between the Russian and Japanese research stations. The Belgian government partially funds the public-private project.

The IPF said the new station "raises new standards" in research on the inhospitable polar continent. "The Princess Elisabeth station attests that there is growing public interest in projects carrying a message of sustainable development, especially in terms of energy management," the polar group said in a statement.

"The conception of a 'zero emission' building capable of standing up to the extreme conditions in the Antarctic goes to show that similar techniques can also be deployed in more temperate areas of the world," it added. The prefabricated station took two years to move from Belgium to the South Pole, where it was rebuilt. Belgium closed its first science station in Antarctica in 1967.

Russia’s Clinical Market Rising

Russia approved 615 clinical trials last year, a 9 per cent increase over 2007, lending weight to the notion that the country is becoming a global hub for clinical testing.

A just-published analysis of the Russian clinical sector from local contract research organisation Synergy Research Group (SynRG) has painted a picture of a market with a high proportion of late-stage trials in chronic indications such as cancer and cardiovascular disease, with foreign companies still the driving force.

The number of Phase II trials actually declined over the prior year, but this was offset by a small increase in the number of Phase I trials – up by six to 38 – and a hefty rise in Phase III studies which rose 20 per cent to 282.

Cancer and cardiovascular disease made up the largest proportion of studies with 14 per cent of the total apiece, followed by respiratory indications with around 10 per cent.

According to the data from Russia’s Federal Service on Surveillance in Healthcare and Social Development (RZN), as of the 12 November 2008 there were 946 hospitals licensed to conduct clinical trials in Russia. 92 new sites were approved by the RZN during the course of the year.

Roughly a third of trials were sponsored by Russian groups, with US sponsors accounting for around a quarter of the total, with German, UK and Swiss sponsors rounding out the top 5, all with under 10 per cent.

“The lion’s share of clinical trials in Russia is still being sponsored by foreign companies,” said SynRG. ”Whilst their share slightly decreased from 72 per cent to 67 per cent, their number is up from 407 in 2007 to 414 new studies in 2008, since the number of local studies grew faster during the period.”

Novartis topped the table of multinational sponsors with 22 studies, shadowed by Sanofi-Aventis with 21 and GlaxoSmithKline with 20. Pfizer and Merck & Co make up the top 5 with 18 apiece.

Among domestic sponsors, ZAO Valenta Pharmaceutica backed 14 new trials, with more than 1,000 patients enrolled, followed by ZAO Biocad with 11 trials involving 630 patients. The runners up were OAO Sintez and OAO Nizhpharm with nine trials apiece, followed by FGUP NIOPIK with eight.

According to data from the US Food and Drug Administration (FDA), as of 7 January 2009, 13 FDA inspections had been conducted at Russian investigative sites during 2008, - the maximum annual number since 1995 when the first FDA inspection was conducted in Russia.

No objectionable conditions or practices were found during seven of the inspections, and while some issues were uncovered during the other six these did not require any regulatory action.

PPD’ buys AbCRO to Expand Presence in Booming Central Eastern Europe

PPD has reached an agreement to buy AbCRO, which it hopes will strengthen its position in the thriving Central and Eastern European (CEE) clinical trials scene.

Through the acquisition PPD will gain a presence in Romania, Bulgaria, Serbia and Croatia and the infrastructure and expertise that AbCRO has in these markets.

In addition the purchase will enhance PPD’s operations in Poland, Ukraine and Russia, which are increasingly being recognised as key markets for conducting clinical trials.

Fred Eshelman, CEO of PPD, said: "This acquisition will strengthen our foothold in Central and Eastern Europe and enhance our ability to conduct global trials for our clients.

“We see many synergies with AbCRO and anticipate a relatively seamless integration, with many of the AbCRO employees already well-versed on basic PPD procedures and systems."

PPD initially moved into clinical trials in CEE through the acquisition of InnoPharm and since then has enhanced its presence. The acquisition of AbCRO will further cement its position in the region but the level of interest in CEE is making it an increasingly competitive market place.

For instance, Covance has recently expanded its presence in the market through the opening of offices in Ukraine, Slovakia and Israel. The majority of these markets offer a large pool of treatment naïve Caucasian patients which makes recruiting for trials far quicker.

In addition a recent RNCOS stated that: “with a sizeable population still unable to afford costly medications, the number of potential patients participating in clinical trials is expected to be large.”

Charles River Laboratories Implements Cost Reduction with Layoffs and Closures

Charles River explained that divestiture of the Edinburgh site, for which it may have already found a buyer according to the Boston Globe, is a response to the decision by many of its preclinical clients to shift their trial programmes to India and China due to increased regulatory demands in Europe.

He added that while the firm considers the economic gloom is temporary, it is using the period of uncertainty as a window to streamline operations and reduce operating costs by 20 per cent this year.

University of Melbourne Spinout, Fibrotech, Nabs $3M in Series A Financing

Fibrotech Therapeutics, a spinout of the University of Melbourne, has secured a $3 million Series A financing to advance development of its lead fibrosis drug FT011 through Phase Ib clinical trials.

The company was formed by Darren Kelly, an associate professor of medicine at the University of Melbourne and St. Vincent's Hospital, with the support of Melbourne Ventures, the technology transfer company for the university.

Fibrotech's lead fibrosis drug has been shown to be orally bioavailable and significantly inhibit the progression of renal fibrosis in a rat model of diabetic nephropathy, Fibrotech said. The company expects to begin testing its first human patients within 18 to 24 months.

Syngenta Will Collaborate with China's Anhui Academy of Agricultural Sciences

Syngenta will collaborate with China's Anhui Academy of Agricultural Sciences to conduct field tests of how novel gene functions relate to drought tolerance and nitrogen use in crops such as corn and soybean.

Under the eight-year collaboration, Syngenta's biotech and technology center in Beijing will work with the academy's Anhui Rice Research Institute.

The base crop for the collaboration will be rice, which the company said is suited for genetics research because it is well characterized regarding genetic, molecular, and agronomic information, and because it is related to corn and other corps. Rice's short growing cycle also makes it good for research because it allows for more testing in a shorter time frame.

The company explained that the agreement also is part of an effort to work closely with Chinese academics. In 2007, the company entered into a collaboration with the Institute of Genetics and Developmental Biology in Beijing to focus on development of new agronomic traits for corn, soybean, sugar cane, and other crops.

Biogen Expands Denmark Facility

Biogen Idec Inc. was formed in 2003 upon the acquisition of Biogen, Inc. by IDEC Pharmaceuticals Corporation in a merger transaction, or the Merger. The company states, “We are a global biotechnology company that creates new standards of care in therapeutic areas of high unmet medical needs. We have two licensed biological bulk-manufacturing facilities, including our large-scale manufacturing plant in Research Triangle Park, NC, which is one of the world's largest cell culture facilities. An additional large-scale manufacturing plant is under construction in Hillerød, Denmark. We conduct research in San Diego, CA and Cambridge, MA. In 2008, we entered into an agreement with a real estate developer for the construction and leasing of a corporate headquarters in Weston, MA. We anticipate occupancy in 2010. We have additional offices in Canada, Brazil, Argentina, Australia, New Zealand, Japan, China, India and throughout Europe, including our international headquarters in Zug, Switzerland and operate a global distribution network, which covers over 70 countries. We currently employ approximately 4,700 people worldwide.”

Quintiles and India’s Apollo Plan Phase I Clinical Trials

Contract research organization (CRO) Quintiles has announced a deal with India’s Apollo Hospitals Group that will see the two firms collaborate in opening a Phase I clinical trials unit.

The move will allow Quintiles to bolster its presence in the fast-growing Indian clinical research market, which is expected to more than double in size by 2012, according to research published earlier this month by research firm RNCOS.

The new unit is due to open in early 2010 on Apollo’s hospital campus in Hyderabad, and will start with a capacity of approximately 50 beds, which will increase to 100 beds if demand develops as predicted.

Apollo is the largest private hospital chain in India, while Quintiles is the biggest CRO globally with 14 per cent of the world market. Their new unit, which will evaluate compounds developed both within and outside of India, will be Quintiles’ fifth location in India, but the first offering Phase I services. Quintiles’ other Phase I units are located in England, Kansas in the US and Sweden (Lulea and Uppsala).

India is increasingly attractive as a hub for clinical research thanks to a huge patient pool representing both chronic and infectious diseases, as well as easy recruitment of patients. RNCOS also estimates that cost savings afforded by locating trials in India can be 50 to 75 per cent.

“This new Phase I unit will draw on the existing experience of Quintiles staff in India, including our established cardiology group,” commented Eddie Caffrey , Quintiles’ senior vice president, global Phase I. Quintiles and Apollo anticipate their combined investment for the new unit will be around $6m.

Keata Pharma / PharmEng Gets $3-Million for Research

Canadian contract manufacturing organisation PharmEng International, which has been hit by dwindling cash reserves in recent months, got a boost when its subsidiary Keata Pharma was awarded a C$3m research grant.

The three-year award, from the Atlantic Canada Opportunities Agency, has been given for research and eventual commercialization of galanthamine, a daffodil-derived extract for the treatment of Alzheimer's disease.

PharmEng opened the C$15m Keata Pharma facility, based in Sydney, Nova Scotia, in 2007, with C$6m in backing from the federal government. Since then the expected volume of contract work has not been achieved and Keata has been forced to cut back staffing to reduce its cash burn.

Earlier this month it laid off another nine workers to pare its headcount back to 26 employees; having predicted that the unit would eventually require 165 employees when running at capacity. 20 staff were let go in August 2008. The latest funding comes at an opportune time for the firm, which has been trying to raise funds through private investors.

The Alzheimer’s project involves formulation development, extraction of the active pharmaceutical ingredient (galantamine), purification and final dosage finishing. Access to Government funding is expected as the project meets certain deliverables over the 3 year period.

Johnson & Johnson sells a version of the compound as Razadyne/Reminyl (galantamine hydrobromide) which had sales of $138m in the fourth quarter of 2008.

J&J’s Ortho-McNeil subsidiary lost patent protection for the immediate-release formulation of galantamine in December, opening the door to generic competition. It also saw patent protection for an extended-release form of the drug overturned by a US court in September 2008, but has said it will appeal that decision.

Keata said it will provide commercial manufacturing of the ingredient for the North American market “once research has been successfully completed and all the necessary regulatory approvals have been obtained, a process that could take three to five years.”

Alan Kwong, CEO of PharmEng International, was upbeat about the impact of the project on Keata.

"The potential for this product as a natural and cost effective treatment for Alzheimer's disease will provide the Sydney facility with manufacturing volumes that will push the limits of the plant capacity given the anticipated demand,” he said.

PRA Has Collaboration with Contract Research Organizations (CROs) in Southeast Asia / Mediscience Planning (MPI) and LSK Global

U.S. company PRA International has entered into a strategic collaboration with two contract research organizations (CROs) in Southeast Asia in order to tap the fast-growing clinical research market in the region.

Via its Taiwanese subsidiary, PRA Taiwan, the CRO has formed alliances with South Korean company LSK Global Pharma Services and Mediscience Planning (MPI) in Japan.

The aim is to “meet the growing demand for pan-Asian clinical trials,” according to Edward Ian, senior director of clinical operations for PRA-Asia Pacific.

The terms of the collaborations include the joint management of multinational clinical trials in Asia as well as related services such as study monitoring and data management, according to PRA.

“The addition of regulatory intelligence and investigator sites in Japan through Mediscience, and in South Korea through LSK, bolsters PRA’s ability to serve clients in Asia,” it added.

A number of CROs have expanded their presence in Asia to serve both a growing customer base of Asian companies, as well as multinationals that are moving their clinical activities overseas to seek cost advantages and new pools of clinical trial subjects.

Clinical research in the Asia-Pacific region grew more than 50 per cent from 2005 to 2006. The region's population of 3.9 billion includes a lot of treatment-naïve patients and sophisticated healthcare systems which make recruitment of patients and carrying out trials easier.

In addition to its Taiwanese subsidiary, PRA already has offices in Australia, China and India and has said it plans to open a South Korean unit by the end of March.

Covance Opens Offices in Ukraine, Slovakia and Israel

Covance has expanded its presence in central and Eastern Europe and Middle East with the opening of offices in Ukraine, Slovakia and Israel.

The three new clinical development offices are intended to speed clinical trials and develop strategic relationships in these emerging markets, said the company in a statement.

"We will continue moving forward with our strategy to expand into geographies that align our therapeutic focus with investigators that consistently demonstrate high-quality results, regulatory compliance, and enrolment performance,” said Dr. Robert Davie, Covance’s vice president and general manager, clinical development services Europe.

Eastern Europe is increasingly drawing the attention of foreign clinical research investments by virtue of the regions high growth potential. Ukraine, for example, has a population of around 46 million largely treatment naïve patients and has become a popular destination for trial sponsors and contract research organisations (CROs). The country represents the second largest patient pool (after Russia) in Eastern Europe, according to a just-published market research report from RNCOS.

RNCOS notes that in Ukraine both primary and specialist healthcare is structured around big hospitals with a centralised structure and vertical referral system, which allows principal investigators to recruit patients from a regional population without internal competition.

Moreover, “with a sizeable population still unable to afford costly medications, the number of potential patients participating in clinical trials is expected to be large,” according to RNCOS.

The Israel office meanwhile will provide a hub for Covance’s activities for the Middle East, including Turkey – another fast-growing clinical research market – and Greece.

While Israel’s own population is small, the country also boasts an effective national health and reimbursement system, with 80 per cent of the population covered by the same health maintenance organisation (HMO). That makes patient recruitment and the conduct of trials much easier.

Covance has been providing clinical research services in CEE since 1994 and in Israel since 1995. The new offices are located in Kiev, Bratislava and Tel Aviv.

Almac Pharmaceutical Services has won the contract to produce packaging for physician samples of Middlebrook Pharmaceuticals antibiotic Moxatag (amoxicillin)

The 775mg version of the drug has been developed with an extended release formulation and is a lower dose, once-daily alternative to currently approved penicillin and amoxicillin regimens for the treatment of tonsillitis and or pharyngitis.

MiddleBrook CEO John Thievon said: "Moxatag samples will be a key element of our nationwide launch to health care professional in March." Almac Pharma Services’ vice president of commercial operations, David Downey, added that the firm is happy to be working on the project.

Biological E’s New Vaccine Campus Inaugurated

Dr Rajashekar Reddy, chief minister of Andhra Pradesh, India presided over the inauguration ceremony for Biological E’s new INR3bn ($61m) vaccine and biopharmaceuticals manufacturing campus.

The 75 acre site, which is located just outside Hyderabad, is being developed in partnership with the Indian government to make products for both the domestic and international markets, including Europe and the US.

Hyderabased-headquartered vaccine maker Biological E, which will run the facility to produce a range of vaccines and biologics for diseases including tetanus, Hepatitis B (HBV), Haemophilus influenza Type B (Hib), and a diphtheria-tetanus-pertussis combination vaccine.

The firm said that it plans to invest a further INR2.5bn in the site over the next few years to “[expand] capacities and [create] infrastructure for the future pipeline products of the company”.

The most advanced product in Biological E’s pipeline is a novel vaccine for Japanese encephalitis, which the firm says it may also produce in Hyderabad if it is approved by the country’s drug regulators.

This is good vaccine news for India’s beleaguered government.

India’s government plans to re-open three state owned vaccine markers that it closed in 2007 to cope with a shortfall in its immunization programme were heavily criticised.

The firms in question, BCG Lab, the Pasteur Institute of India (PII) and the Central Research Institute (CRI) were shut down after they failed to meet good manufacturing practice (GMP) standards for vaccine production.

At the time the government said it planned to convert the businesses to testing facilities and replace the lost manufacturing capacity with that from Hydreabad and a similar public-private co-funded campus being constructed in Chennai.

For the past year however, the government has sought to compensate by increasing the amount of vaccines it buys from private suppliers both in India and overseas. Despite these efforts, there have been problems sourcing sufficient doses for state vaccination programs.

Last month Union Health and Family Welfare Minister Anbumani Ramadoss told the Indian parliament that a shortage of vaccines affected the Universal Immunisation Programme “in some states.”

Lab-In-A-Cartridge Licensed from Singapore’s Institute of Bioengineering and Nanotechnology to Dyamed

DYAMED Biotech Pte Ltd has licensed an all-in-one automated diagnostic system called MicroKit from Singapore's Institute of Bioengineering and Nanotechnology. Dyamed will set up a spin-off company to develop and produce a range of new diagnostic products as part of its agreement with Exploit Technologies Pte Ltd (ETPL), the commercialization arm of Singapore's A*STAR (Agency for Science, Technology and Research). IBN is one of the research institutes under A*STAR.

Dyamed will spin off SG Molecular Diagnostics to develop a range of diagnostic devices based on the MicroKit. The company expects to roll out a molecular diagnostic real-time PCR platform called "MicroKit AIO" as its first product for the global market by 2010.

Theodore Tan, Dyamed's Managing Director, said, "We are deeply privileged to license this exciting technology which has the potential to make the mass diagnosis of a whole host of diseases faster, better and cheaper. With the MicroKit platform, we hope to make the diagnosis of infectious diseases and cancer more timely and widespread, thus giving patients a much higher chance of combating their afflictions."

Cancer patients are among those who stand to benefit from the MicroKit's sensitive and accurate diagnostic capabilities, which enable early-stage disease detection from raw biological samples. IBN Executive Director Jackie Ying, who led the scientific team that developed the MicroKit, added, "Early detection of diseases such as cancer or avian flu is critical to enhancing a patient's chances of survival. The treatment of diseases at the early stages is usually more effective and has a greater potential for improving the long-term health of the patient.

The portable and automated MicroKit is easy to operate and can be used by non-clinical personnel for mass health screenings at strategic locations, such as airports, to contain epidemics of infectious diseases like H5N1 avian flu, according to Ying.

IBN's device is able to handle a wide variety of samples, including tissues and body fluids, and can perform automated gene extraction in just six minutes and gene detection within an hour, enabling substantial cost and timesavings. Disease detection with IBN's MicroKit is much faster than conventional laboratory testing that requires 1 to 24 hours to complete.

Another key feature of IBN's MicroKit is that all the molecular diagnostics processes are carried out in a self-contained, compact cartridge that is preloaded with reagents, instead of complex, time-consuming and labor-intensive laboratory processes.

Prosecutions Loom for 110 Drugmakers in India

Regulators in India’s Maharashtra state have compiled a hit list of 110 drugmakers that they intend to prosecute for sub-standard manufacturing practices, according to media reports.

The move follows the Maharashtra Food and Drug Administration’s announcement that around 500 of the 6,000 drugs it reviewed last year did not meet standards laid out by the office of the Drugs Controller General (DCGI).

While the full list has not yet been published, an agency spokesperson confirmed the action, commenting that: “sub-standard drugs have been detected and defaulting companies have been ordered to withdraw the drugs from the market.”

The spokesman explained that: ''After issuing prosecution orders, a charge sheet will be filed against the pharma companies and action will be taken accordingly,''

Government medical education and drugs secretary Bhushan Gagrani also confirmed the move. He told the Times of India that pharmaceutical firms, with manufacturing operations both inside and outside the state, were selling substandard medicines in Maharashtra.

"It's a matter of concern. We have taken it up with FDA commissioners of the respective states. We hope the competent authorities in these states will initiate action against the erring companies,'' added Gagran.i

News website webindia123.com reported that companies like Dr Reddy’s Laboratories and Ranbaxy as well as the local operations of international players such as GlaxoSmithKline (GSK) and Pfizer are included on the list, although none of the firms were prepared to comment.

Other media reports suggest that Viagra (sildenafil citrate), the antibiotic moxclav, Ferogen syrup (ferrous fumarate) and the generic anti-emetic ondansetron are among the 500 drugs found to be substandard.

Haupt Receives Italian Opportunities with Pfizer Site

Haupt Pharma has acquired Pfizer’s production facility in Latina, Italy, which moves the contract manufacturer into antibiotics and allows it to provide additional services to clients.

The acquisition of the facility brings the number of sites owned by Haupt up to 11 and allows it to expand its operations in Italy, which the company has identified as a growth area for generics.

In addition to the extended geographic reach the site offers Haupt the capacity to produce hormones, cytotoxics and beta-lactams, which allows it to offer penicillin and cephalosporin manufacturing services to clients.

Hans-Christian Semmler, chairman of Haupt Pharma, said: “Through the acquisition of the Latina plant with its state-of-the-art facilities and highly qualified staff, we are well positioned to significantly expand our international market position.

“In Italy, we are expecting a considerable increase in demand for generic medicaments within the next ten years. Moreover, our new beta-lactams competence centre in Latina enables us to complete our product portfolio and to improve our competitive advantages.”

Pfizer employed 450 people at the site and Haupt has indicated its desire to retain all staff. In addition Haupt will continue to manufacture products for Pfizer on a contract basis.

The Italian generics market has traditionally made up a smaller proportion of the nation’s total pharmaceutical sales than other European nations, owing to the extended national patent supplementary certificates in place.

This restricted the sale of generics in Italy for a long time after the product had come off patent in other European countries.

Consequently the market was valued at $809m in 2007, which is less than in Portugal despite total pharmaceutical sales in Italy being six times as much.

However, the market is predicted to grow to $1.8bn by 2012 as big products come off patent and efforts to revise the laws covering generics gain pace.

Facility of the Year Category Winners Showcased During INTERPHEX2009

Six pharmaceutical manufacturing facilities constructed by companies located in Belgium, India, Ireland, Germany, and Switzerland have been selected as Category Winners in the fifth annual Facility of the Year Awards program sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine. The companies and respective award categories include:

Aseptic Technologies, located in Gembloux, Belgium, winner of the Facility of the Year Award for Equipment Innovation
Centocor Biologics Ireland, located in Ringaskiddy, Cork, Ireland, winner of the Facility of the Year Award for Sustainability
Centocor R&D Schaffhausen, located in Schaffhausen, Switzerland, winner of the Facility of the Year Award for Facility Integration
Hameln Pharma, located in Hameln, Germany, winner of the Facility of the Year Award for Operational Excellence
Orchid Chemicals & Pharmaceuticals, located in Aurangabad, India, winner of the Facility of the Year Award for Regional Excellence
Roche Pharma Biotech Production Basel, located in Basel, Switzerland, winner of the Facility of the Year Award for Project Execution
In addition, GlaxoSmithKline Manufacturing was awarded an Honorable Mention for the company's project in Verona, Italy.

The Facility of the Year Awards (FOYA) program recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing high-quality medicines. Now in its fifth year, the awards program effectively spotlights the accomplishments, shared commitment, and dedication of individuals in companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of all global consumers.

“We were truly impressed with the quality of this year's submissions, as well as the depth and breadth of each organization's innovative solutions for pharmaceutical manufacturing challenges,” said Robert P. Best, ISPE President and CEO. “It seems that each year the best and brightest minds in the industry raise the bar for quality, creativity, and ingenuity…which will ultimately benefit people worldwide,” said Best.

The Facility of the Year Awards program is truly global, as submissions over the past five years have been received from more than 20 different countries and territories. Each of the submissions was reviewed by an independent, blue-ribbon judging panel of global representatives from the pharmaceutical design, construction, and manufacturing sectors.

2009 Facility of the Year Events

There will be several opportunities to meet the 2009 Facility of the Year Award Winners and learn first-hand about the facilities being honored as “best in their class.” These events include:

· INTERPHEX2009- Meet the Category Award Winners at the Facility of the Year Awards Display Area at booth number 1059, Level 3 of the Jacob K. Javits Convention Center. This is your opportunity to meet personally with representatives from companies of the Category Winners to discuss the success stories associated with these pharmaceutical manufacturing facilities. To register, or for more information, visit www.interphex.com.

· ISPE 2009 Annual Meeting - Learn first-hand who the Overall Winner of the coveted 2009 Facility of the Year Award is during ISPE's 2009 Annual Meeting, 8-11 November in San Diego, California, USA. For more information, visit www.ISPE.org.

At each event, a Facility of the Year Awards display will feature the 2009 Category Award Winners. Additionally, comprehensive coverage and publicity will be conducted by ISPE and Pharmaceutical Engineering magazine, INTERPHEX, and Pharmaceutical Processing magazine. Visit www.facilityoftheyear.org for more information about the awards program and detailed information about each Category Winner's project participants.

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