Eli Lilly and Co. is not considering moving its headquarters out of Indianapolis, despite announcing plans to reduce its workforce there and at other company facilities by a total 5,500 workers, CEO and president John Lechleiter told the Indianapolis Star.

Lechleiter acknowledged that Indianapolis could see a large portion of job cuts occurring here, because this is where the highest concentration of jobs is located. But he declined to tell the Star how many jobs might be lost in Indianapolis, the company's headquarters city since its founding 133 years ago.

Lilly employs 40,500 people, of which about 13,500 work in the Indianapolis corporate headquarters, laboratories and manufacturing plants. According to the newspaper, Lechleiter would not say whether the job cuts would hit one job group or department more heavily than another, adding that those decisions have not yet been made: "There are no sacred cows. We are studying everything."

The job cuts are part of a company-wide effort to cut $1 billion in costs over the next two years, and are expected to exceed those carried out in 2001, following the loss of patent protection for the anti-depressant drug Prozac, cutting company revenues by about one-third.

The current job cuts stem from Lilly losing, starting in 2011, patent protection on several drugs accounting for a combined roughly 70 percent of sales. The pharma giant also faces growing pressure from private insurers and the federal government to contain soaring drug prices as a means of reducing healthcare costs. In addition to the layoffs, Lilly said it will restructure itself by establishing a Development Center of Excellence designed to speed up development of new drugs.

Bayer Sets $100 Million Retooling of Berkeley, CA, Manufacturing Site, Eyed for Next-Generation Hemophilia Drug

After hinting it may move out of Berkeley, Calif., Bayer HealthCare announced it will stay in the California city and spend more than $100 million to retool its manufacturing facility there to allow for producing future versions of its hemophilia drug Kogenate, in return for the promise of $13.6 million in tax credits over 10 years.

The project marks the largest investment ever made by Bayer at the 43-acre Berkeley site, which employs 1,300 people, Joerg Heidrich, head of Bayer HealthCare's product supply biotech organization, told the Contra Costa Times.

The plan hinges on an expansion of the lower-tax state Enterprise Zone where the facility is located. The Berkeley City Council and the state of California are expected to approve the expansion of the zone, which straddles Berkeley and Oakland. The city council is due to take up the enterprise zone issue on Sept. 22, the newspaper reported.

Bayer had considered the expansion as one of several options for producing Kogenate; other options included farming out the work to contract manufacturers, which would likely have resulted in Bayer dismantling the Berkeley facility, the San Francisco Business Times reported last month.

After Bayer approached Berkeley earlier this year to inform the city it was considering a move, Berkeley responded by accelerating efforts to join an enterprise zone originally within Oakland. In less than two weeks, Oakland drafted a resolution to add Berkeley and nearby Emeryville, Calif., to its enterprise zone, urging the Oakland City Council to approve the extension at its July 28 meeting — which the council did, unanimously.

Genzyme Plans $68 Million Renovation for Northborough, MA, Set to Consolidate Framingham, Allston Operations

Genzyme plans to spend about $68 million to renovate an existing 210,000-square-foot facility in Northborough, Mass., which the biotech giant will turn into a center for its warehouse and distribution operations, quality control group, finished goods, labeling and packaging group, and its clinical pharmacy research group. Those operations are all being consolidated at Northborough from cramped facilities in nearby Framingham, Mass., and Allston, Mass.

About 165 of Genzyme's current employees will work in the Northborough complex, at 11 Forbes Road, upon completion next year, with the company also planning to hire another 30 to 50 new employees. Between 150 and 200 construction workers will be needed for the renovation.

A significant part of the money being spent on the site will be used to install heating and air conditioning systems intended to help the new facility earn the second-highest or "gold" rating under the US Green Building Council's Leadership in Energy and Environmental Design certification program.

Inside the building, workers have already stripped floors down to concrete and ripped out walls, exposing pillars, wires and beams. Ceilings in the warehouse are 34 feet tall, enough for Genzyme to install stacks of pallets and refrigeration units. Loading docks line two sides of the warehouse.

Maryland Biotechnology Center Opens Two Offices

Maryland officials and biotechnology leaders celebrated the opening of two offices for the Maryland Biotechnology Center, a state agency launched earlier this year as a "one-stop stop" for life-sci employers seeking to relocate to Maryland or expand there.

The center's eight staffers work from central offices at the World Trade Center building at 401 East Pratt St. in Baltimore, and an office at 9700 Great Seneca Highway in the Shady Grove life-sci campus in Rockville, Md., within biotech-rich, suburban Montgomery County.

Lawrence Mahan, the center’s executive director, told the Maryland Daily Record that the center was launched with $5.5 million in state funds — $1.2 million from the fiscal year 2009 budget, $4.3 million from the budget of the current fiscal year, which began July 1.

He said getting entrepreneurs started will be among the goals of the new office, as will giving them access to information about Maryland’s grant-funding programs, opportunities to collaborate with scientists at local universities and help with developing their businesses, the newspaper reported.

The biotech center was the first recommendation of BioMaryland 2020: A Strategic Plan for the Life Sciences in Maryland, a 17-point program to boost the state's life-sci industry hammered out by the Maryland Life Science Advisory Board, a 15-member panel created by Gov. Martin O'Malley. The biotech center was also included in O'Malley's BioMaryland 2020 initiative, a $1.3 billion package of programs intended to catapult the state to the top strata of life-sci leadership.

Karen Olson, a member of the state’s Life Sciences Advisory Board and CEO of Baltimore-based BioMarker Strategies, told the Daily Record the board was able to push for a biotechnology center after O’Malley visited a similar center in North Carolina, one of the state’s biggest competitors in the field: “We entrepreneurs were calling for it and then he was able to see how effective that was in North Carolina."

Regeneron Pharmaceuticals Reaches the 1,000-Employees

Regeneron Pharmaceuticals in Tarrytown, NY, has hired its 1,000th employee, and plans to hire another 50 staffers by year's end after increasing staff by 35 percent in 2008.

News of the hirings comes as Regeneron moves into two new three-story buildings totaling 229,000 square feet bamboo-floored, naturally lighted space within the Landmark at Eastview, the life-sci campus owned by BioMed Realty Trust of San Diego. A third building was also constructed, but remains available for lease.

With the expansion, Regeneron now occupies 390,000 square feet of lab and office space at Landmark at Eastview.

The company's workforce includes about 300 workers at its manufacturing facility in upstate Rensselaer, NY, a former drug company plant acquired in 1993, as well as staffers at a satellite office for clinical development in Bridgewater, NJ, opened last year in order to attract experienced employees from the Garden State's downsizing pharmaceutical companies, according to the Business Journal.

Almac Building New HQ in PA

Almac Group of Northern Ireland is building a new 240,000-square-foot North American headquarters building on a 40-acre site in Souderton, Pa. — the first phase of a planned $100 million, 1 million-square-foot expansion for the international pharma and biotech services firm.

Almac chose Pennsylvania over sites in New Jersey, North Carolina, and Montana after Keystone State officials offered the company state grants and a loan totaling just over $12 million. The subsidies include $1.25 million from the state infrastructure development program, and $400,000 from the opportunity grant program — two programs targeted for elimination by Republicans in the state House of Representatives and state Senate. Rendell has proposed $17.5 million for infrastructure development and $18.3 million for opportunity grants.

One-third of the state incentive package for Almac, $4.5 million, was offered as a grant under the state Infrastructure and Facilities Improvement Program, which legislative Republicans would reduce in FY ’10 to $25.5 million from the $30 million proposed.

GOP lawmakers eliminated those programs as part of their proposed $27.14 billion state budget, which would reduce state spending 6.4 percent from the fiscal year than ended June 30. Rendell has proposed a $29 billion budget that would add 0.5 percent to the state’s current 3.07 percent income tax.

Rendell and lawmakers are at odds over how to eliminate a $3.2 billion budget shortfall stemming from lower revenues that officials blame on the economic slump. The stalemate has delayed the adoption of a state budget by more than two months from the July 1 start of the state fiscal year — leaving Pennsylvania as the nation’s only state with no budget currently in place.

Almac’s package of state incentives also includes $3 million from the Redevelopment Capital Assistance or RCAP program, a $2 million loan from the Pennsylvania Industrial Development Authority; $786,000 in state Job Creation Tax Credits, and $100,000 under the state Customized Job Training Funds program.

Construction of Almac's new headquarters in Montgomery County began last year. Upon completion of the first phase, expected in 2010, Almac will combine separate divisions now operating in Audubon, Pa., and Yardley, Pa., with a combined 510 jobs. Within three years, Almac has projected adding 262 jobs, with another 550 set to be created by 2016.

North Carolina Biotechnology Center Industry Drives Need for New Programs and Space

The state-funded North Carolina Biotechnology Center plans to start construction in October on a $10.4 million, 20,000-square-foot addition to its Research Triangle Park headquarters, within a four-story building set to be completed in the fall of 2010.

The addition will house offices for several biotech center initiatives in biotechnology leadership, entrepreneurship, K-12 education, workforce training, business development and university research programs. The new space will expand a 47,000-square-foot facility that was built to house 50 employees but now accommodates 65 staffers and attracts an estimated 35,000 visitors annually, according to the biotech center.

Perkins + Will, which designed the original building, created the plans for the addition, construction of which is being managed by general contractor Skanska, which, according to the biotech center, expects to employ as many as 200 people in the project. The expansion will be designed to the "silver" rating of the Leadership in Energy and Environmental Design standards developed by the US Green Building Council.

The expansion won some key funding this week, when the Biogen Idec Foundation announced Wednesday that it had made a $1 million gift through its Transformational Grants in Science Education initiative. "The Biotech center aligns very well with our foundation’s mission charter, which is to improve life and science literacy and to encourage young people to pursue science careers,” Esther Alegria, Biogen’s vice president of manufacturing and a key executive in its grant awarding process, told Local Tech Wire.

The center will receive the $1 million over the next five years, she added.

The project has also won funding from the Duke Energy Foundation, PPD, and the Triangle University Center for Advanced Studies. TUCAS owns the land in Research Triangle Park that is home to the biotech center's headquarters as well as other institutes that strive to promote Triangle university collaboration.

"Leadership by the Center created a thriving industry with broader needs, and we are pleased to move forward with building the infrastructure to allow the Center to extend that leadership," Robert Ingram, vice chairman of pharmaceuticals for GlaxoSmithKline, and chairman of the biotech center's building committee, said in a statement.

According to the biotech center, North Carolina is home to more than 520 biotechnology companies and almost 60,000 jobs with an average salary of more than $69,000, and a projected annual economic impact of $45.8 billion. That number of jobs could more than double, with 65,000 to 70,000 new jobs possible by 2020, E. Norris Tolson, the biotech center's president and chief executive officer, said in a statement announcing the expansion project.

University of Colorado Boulder Breaks Ground on Up-to-$145 Million First Phase of New Biotech Facility

The University of Colorado broke ground on the 257,000-square-foot first phase of the Jennie Smoly Caruthers Biotechnology Building, set to rise on the CU-Boulder East Campus, slated for completion in fall 2011. A 54,000-square-foot addition has also been planned for construction at a later date.

The cost of the first-phase construction is projected at between $120 million and $145 million. According to CU, more than half of that cost has already has been committed, including more than $60 million from the university; $20 million in gifts from CU Distinguished Professor Marvin Caruthers; $2 million from Jeannie Thompson, chair of the University of Colorado Foundation board of directors, and her husband, Jack; and other private gifts. CU said it is seeking additional public and private support for the project.

The building will house 60 senior faculty researchers and more than 500 research and support staffers working on diagnoses and therapies for cardiovascular disease, cancer, and infectious diseases, as well as in regenerative medicine. The building also will house the university's Colorado Initiative in Molecular Biotechnology, the department of chemical and biological engineering, and the biochemistry division faculty of the department of chemistry and biochemistry.

CIMB's research team of scientists and engineers spanning eight CU departments will be housed in one location for the first time since its formation. The team received a boost this year when Tom Cech, 1989 winner of the Nobel Prize in chemistry, rejoined CU's faculty as a distinguished professor in spring 2009 to head up the initiative.

Activities within the Caruthers building also will include a center for hosting workshops for K-12 teachers and students, as well as CU-Boulder undergraduates working to establish careers in biomedical research.

The building's design concept consists of "research neighborhoods" consisting of research labs, with support spaces and collaboration spaces, all connected via a corridor or "main street." HDR Architects, in association with Robert A. M. Stern Architects, designed the building.

Hawaii CDA Approves 29-Acre Kakaako Plan, Including 400K Sq.-Ft. Research Center

The Hawaii Community Development Authority has approved the master plan of Kamehameha Schools for a 29-acre mixed-use community that would include a 400,000-square-foot Asia Pacific Research Center designed to house biotech companies and labs, the Honolulu Star-Bulletin reported.

The project, officially called "Kaiaulu 'O Kakaako," will also include up to 2,750 residences in high-rises, townhomes and lofts; a Safeway supermarket set to open in the former CompUSA space along Ala Moana Boulevard; and a 25,000-square-foot plaza along Auahi Street.

Kamehameha Schools said it will issue a request for proposals from developers for one piece of the housing component, a residential tower at the corner of Halekauwila and South streets geared toward below-market "workforce" housing. Hawaii requires developers to set aside at least 20 percent of their units in multi-family projects as below-market "reserved" housing, though Kamehameha Schools has also offered to set aside an additional 2 percent for lower-income residents, the newspaper reported.

Before starting construction, Kamehameha still will need to apply for a city building permit, as well as a development permit from the authority, according to the Star-Bulletin.

Fox Chase Cancer Center Wins $8M NIH Grant for Expanded Laboratory

The Fox Chase Cancer Center in Philadelphia has received an $8 million grant — made available through the $787 billion American Recovery and Reinvestment Act, the economic stimulus measure enacted in February by President Obama — toward expanding its laboratory animal research facility from the National Center for Research Resources of the National Institutes of Health.

The new four-story, 25,290 square-foot facility will be designed to support advanced research into cancer, opening the way for the development of new treatments. Construction of the facility, which will house mouse models for cancer research, should begin within a year, the cancer center said in a statement.

The space will be built alongside and serve as an expansion to the existing animal facility on the Fox Chase campus. Plans entail using the top two floors, roughly 12,910 square feet, for new animal research space, reserving the remaining two floors for support areas and future expansion. The new facility will include high efficiency particulate air or HEPA ventilation systems, and improved support for animal care equipment.

"While the current facilities are entirely adequate for the care and feeding of the animal models they house, they are simply not large enough or sophisticated enough to meet the needs of Fox Chase's expanding research faculty," Harry Rozmiarek, director of Fox Chase's laboratory animal medicine program, said in a statement.

inVentiv Health Moves Into New Franklin Township, NJ, Headquarters

New Jersey officials joined more than 500 inVentiv Health employees in celebrating the company's opening of its new four-story, 154,000-square-foot headquarters at 500 Atrium Drive in Somerset, NJ, which the company built after agreeing to consolidate there several offices scattered throughout the region, in return for economic development incentives from the New Jersey Economic Development Authority.

The provider of commercialization services to the global pharmaceutical and health care industries agreed to retain 400 jobs in New Jersey by moving to the new HQ employees based elsewhere in Somerset, and Somerville; shift 50 employees to the headquarters from Newtown, Pa. before year's end; and create 150 new full-time jobs at the new HQ.

In return, inVentiv received a 10-year grant under the state's Business Employment Incentive Program for the maximum 80 percent of the total amount of employees' state income taxes withheld by the company during the calendar year from the new employees hired, awarded for up to 10 years, as well as other incentives under the Business Relocation and Retention Assistance Grant Program.

"The estimated value of the BRRAG benefit for this project is $621,000, based on 414 retained New Jersey employees times $1,500 per employee," Lauren Moore, director of the New Jersey EDA's business retention and attraction unit, told the board of directors of the state Commerce Commission, according to minutes of the commission's May 21, 2008, meeting.

inVentiv now employs 550 people in New Jersey, including 100 temporary workers, part of a global 7,000-person workforce.

BMS Outsources Manufacturing to Sigma

Bristol-Myers Squibb has outsourced the manufacturing of some products to Australia-based Sigma Pharmaceuticals, which has also spent A$60 million ($51.7 million) to acquire a Victoria, Australia, facility from the pharma giant.

The Victoria facility and the five-year manufacturing deal were part of a transaction that included BMS transferring to Sigma the rights to make and distribute 15 of its products, including Lipostat (pravastatin), in Australia and New Zealand.

Sigma will raise A$297 million from shareholders to fund the acquisition and help cut its debt, which is currently A$227 million. To achieve this Sigma has halted trading and is offering shareholders one new share at a 16 percent discount for every three that they own.

Sigma said it anticipates generating revenues of A$17 million from the B-MS contract and. Sigma intends to retain all 140 staff employed at the Victoria facility.

Lonza Group Breaks Ground on Singapore Cell Therapy Facility near Mammalian Manufacturing Facility

Swiss-owned Lonza Group broke ground on a CHF 30 million ($28.9 million) cell therapy facility within Singapore's Tuas Biomedical Park, adjacent to Lonza’s large-scale mammalian manufacturing facility.

Site work began in May, and construction is expected to begin in earnest next year, with the first two suites expected to begin manufacturing therapies by mid-2011, and another two suites set to be completed in 2013.

The new facility "is a next step in fulfilling our strategy to expand our capacity globally and our presence in Asia," Lonza CEO Stefan Borgas said at the Sept. 8 groundbreaking ceremony.

During the ceremony, S. Iswaran, Singapore's senior minister of state for trade & industry and education, hailed the plant as a key milestone in Singapore developing within its borders a cluster of biologics facilities projected to employ more than 1,000 people, according to a text of his remarks released by the Singapore Economic Development Board.

Brooklyn, NY, Partners Win $3M US EDA Grant for Addition to SUNY Downstate's Advanced Biotechnology Incubator

The US Economic Development Administration has approved a $3 million grant to the Health Science Center at Brooklyn Foundation and the Downstate Technology Center toward a three-story, 24,000-square-foot addition to the Advanced Biotechnology Incubator operated by SUNY Downstate Medical Center, part of the State University of New York.

The expansion project is expected to create 90 jobs and generate $20 million in private investment, the grantees have told EDA.

The incubator, at 450 Clarkson Ave., houses eight tenant companies and is connected with a space for larger life-sci companies operated by SUNY Downstate five miles south, at the Brooklyn Army Terminal in the borough's Sunset Park section. Over the past five years, the incubator has generated between 100 and 150 mainly research jobs, Eva Cramer, SUNY Downstate’s vice president for biotechnology and scientific affairs, told the New York Post.

Cramer, a professor of anatomy and cell biology at SUNY Downstate, told the newspaper that supporters have raised $25 million for the incubator, as well as another $42 million from New York state and $12 million from the New York City Economic Development Corp. for the Brooklyn Army Terminal space.

One of the incubator's most prominent tenants is the International AIDS Vaccine Initiative, a nonprofit research institute that occupies 1,000 square feet there as well as a $17 million, 36,000-square-foot AIDS Vaccine Development Laboratory that opened late last year at the Brooklyn Army Terminal.

IAVI recently joined the Scripps Research Institute, and biotechnology companies Theraclone Sciences and Monogram Biosciences in publishing in Science the results of research showing that two new antibodies to HIV revealed potential targets for a future AIDS vaccine.

Wisconsin Molder EuroPlast Boosts Medical Business

With the completion of a Class 100,000 modular cleanroom, plastics injection molder EuroPlast Ltd. expects to be able to further expand its medical business, which has grown from a minimal amount of sales to 20 percent of its business in the last four years.

The company received ISO 13485 certification for medical device manufacturing in June for the clean room that was completed earlier this year.

“That opens a lot of doors with OEMs [original equipment manufacturers],” said Dave Kirkendall, sales manager for the Endeavor, Wis., company. “We are aggressively seeking new business in this medical component sector.”

The company has 17 injection molding machines ranging from 50-680 tons, and is currently using a 50-ton all-electric injection molding machine with a robot in its cleanroom, with plans for further expansion of its medical business.

“In the past four years, we have grown dramatically in health care,” Kirkendall said. “It is an area we intend to aggressively pursue.”

The company’s products for the medical business include housings for temperature controls used for warming blankets, enclosures for defibrillators, medical appliances and non-UL listed hardware, molded roll carts, housings for electrical equipment used in hospitals, devices that allow surgeons to more accurately inflate air into angioplasty devices, and spikes for blood bags.

EuroPlast has been ISO 9001 certified since the year 2000, and was recertified last year to ISO 9001:2008.

“Our strength has always been and continues to be in part/mold design engineering and precision mold making,” Kirkendall said. The rest of the company’s products and sales are in the housing and construction, consumer durables and commercial electronics markets.

EuroPlast and tool and die maker Apex Mold & Die Corp. are owned and operated by the same management team. Apex, founded in 1982, formed EuroPlast three years to mold parts at the request of one of its key customers.

Vireo Opens Biomedical Plant in Nebraska

Tennessee-based Vireo Resources opened its new biomedical plant in Plattsmouth on April 22. The company processes and packages human nutritional products and animal health-care products developed at the University of Nebraska Medical Center (UNMC).

The high-end, 2,000-sq.-ft. (186-sq.-m.) cleanroom facility will be used to prepare products that are "natural alternatives to traditional pain management medications," says Mark Faulkner, owner and president of Vireo. "We are working with UNMC to develop products that have very defensible and provable efficacy behind them. Most popular pain relievers have toxic side effects that can cause problems with the liver, kidney and stomach. We have designed a line of pain management compounds that actually work without any of those side effects. And we have good science that proves they work."

Deal-closers in favor of Nebraska, he says, were the ongoing research partnership with UNMC, the fact that "Nebraska has been able to offer attractive incentives," the highly motivated work force in the local area, "very attractive leasing rates" and the "tenacious and persistent efforts of the state Department of Economic Development."

Faulkner says the deal would not have happened without the leadership of Darrell Ullman of the state DED. "Darrell was absolutely critical in putting together all of the key players and putting me in touch with them," says Faulkner. "Gov. Heineman's Diplomat Program really helped. The ambassadorship of companies in Nebraska played a big role in convincing me to locate this operation in Plattsmouth."

Richard Baier, director of the DED, notes that Vireo is one of many growing life-science firms in Nebraska. "We have strength in a couple of areas – animal health and bio-manufacturing," he says. "Companies like Schering Plough and Pfizer develop products for animal health here, and firms like Novartis and Becton Dickinson do bio-manufacturing in Nebraska. We stepped up our public and private support for research at the University of Nebraska Medical Center."

Faulkner says the work in Plattsmouth is progressing so well that "the Nebraska facility will probably be growing faster and larger in the near future. I can see us going from one shift to three shifts a day and doubling our space soon," he adds. "Managing from afar in Tennessee, I have to have a lot of confidence in the managers and employees that I have on site in Nebraska. I was confident that I could find a good work force with that great Midwestern work ethic, and it has turned out to be the truth."

Companies in wind energy have discovered the same. Katana Summit LLC, a joint venture of Sumitomo Corp. of Tokyo and Katana Industries of Ephrata, Wash., recently opened a wind tower assembly plant in Columbus, Neb. The 75-acre (30-hectare) complex employs 204 workers in 250,000 sq. ft. (23,225 sq. m.) of manufacturing space. The plant's goal is to produce 600 windmill towers per year.

"We bought a small plant and added to it," says Darrell Lehmann, president and CEO of Katana Summit. "The price of the property was good. The business climate and work force in the area were very good, and the economic development group was very aggressive in helping us locate here."

Lehmann says he wasn't sure what to expect at first. "Relocating from Washington, I wasn't sure what I would find in the Midwest, but I have to admit that this town is phenomenal," he says. "There are a lot of skilled craftsmen here."

Incentives from the Nebraska Advantage program expedited the deal. "I have never seen a greenfield project happen this quickly," adds Lehmann. "We broke ground in June 2007 and started making towers in May 2008."

According to the Nebraska Public Power District, Nebraska has the sixth highest potential for wind energy generation in the country. An estimated 868 billion kilowatt-hours could be produced from wind in the state, NPPD states.

Aushon Expands Facility to Meet Biomarker Service Demand

Aushon BioSystems has added laboratory and manufacturing capacity to its corporate headquarters to meet rising demand from clinical trials for some of its protein biomarker services.

The company reports that there has been strong demand for its multiplex immunoassays products and services, which it claims can detect low quantities of proteins, adding that it maintains its belief in the potential of the protein biomarker business.

Consequently a focus of the expansion of the Billerica, Massachusetts, US facility has been doubling multiplex immunoassay manufacturing capacity. The new operations are increasingly automated to improve throughput and reduce variability of a number of production processes.

Furthermore, the expansion and renovation of the headquarters has allowed Aushon to consolidate the operations of the recently acquired Searchlight at the facility.

Peter Honkanen, CEO of Aushon, believes this “allows [the company] to work more efficiently, encourages collaboration and innovation, and takes advantage of the inherent synergies that inspired Aushon to acquire the SearchLight business and technology assets”.

From the expanded facility, which houses a BL-2 level laboratory and clean and cold rooms, Aushon will offer a range of products and services for biomarker discovery, development and analysis.

These include a protein biomarker sample testing service that allows researchers to submit samples for quantitative analysis in Searchlight Biomarker arrays. In addition Aushon offers custom microarray printing that it claims offers “unmatched versatility and flexibility”.

This allows Aushon to print virtually any sample on to any substrate, “with unequalled reproducibility, accuracy and rapid turnaround”, according to the company.

Aushon also manufactures a range of products for use by researchers. These include chemiluminescent and Infrared Assay Kits and a microarray printer.

Biotechnology OSI Pharmaceuticals will Move HQ to a Facility in Greenburgh, New York.

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

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

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

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

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

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

FDA Renews Lease in Piedmont-Owned Shady Grove V in Rockville, Md.

The US Food & Drug Administration has renewed for a five-year term its lease for 108,518 square feet within Shady Grove V, at 9200 Corporate Blvd in Rockville, Md. The four-story building, within the Shady Grove Executive Center, is home to the FDA's Center for Devices and Radiological Health's Office of Device Evaluation.

Shady Grove V owner Piedmont Office Realty Trust, which announced the lease renewal, was represented by Ken Mulrane, Vice President, as well as Keith Foery of Transwestern. The FDA was represented by the US General Services Administration.

Genentech Inks New South San Francisco, Calif., Lease for 75K Sq. Ft.

Genentech has signed a lease for 75,000 square feet on four floors at 601 Gateway Blvd., a South San Francisco, Calif., building known as Gateway Commons and owned by Boston Properties, CoStar Group reported. The lease will commence in the first quarter of next year.

Gateway Commons is a 12-story, 215,767-square-foot, Class A office property built in 1984 on 7.24 acres. Tom Hayes of NAI BT Commercial represented Genentech, while Gregg Walker, Scott Miller and Sharon Chen of Jones Lang LaSalle represented Boston Properties.

Allegheny Bradford Expands Machinery Production with New Facility

Allegheny Bradford of Lewis Run, Pa., has opened an $8 million, 50,000-square-foot manufacturing facility designed to double the company's capacity for production of pharmaceutical and biotech machinery, especially with tanks and modular process systems, or "skids" used in the production of drugs. Before building the roughly $8 million facility, the company produced the machinery at a smaller scale at a smaller plant which is being retained.

Allegheny Bradford moved into the new facility last December, but needed until February to receive its equipment for the facility. "We've been truly on line and in production for four or five months," Dan McCune, president and chief executive officer of Allegheny Bradford, told the Bradford (Pa.) Era. "It's our intention to add in the neighborhood of 100 jobs over the next couple years."

"We were limited in the tank market and modular process systems market because of a lack of space. Here we can better take advantage of those markets," McCune told the newspaper.

McCune told the Era Allegheny Bradford started planning for the warehouse facility in 2007 due to growing demand from customers: "This has been a couple-year process."

The new facility, he added, allows manufacturers to test equipment on-site before shipping, which is important because international customers make up roughly 50 percent of sales, McCune said.

North Carolina Regulators Approve $700 Million Duke Hospital Tower, $250 Million Cancer Center

Duke University Health System CEO Victor Dzau has the green light to build a billion dollars worth of new facilities at Duke Hospital.

View Larger State regulators have approved a new cancer center and patient tower at Duke Hospital, and the medical center plans to begin construction soon on the projects, which carry a total price tag of almost $1 billion.

Duke University Health System, which owns Duke Hospital, plans to open its new $250 million cancer center in 2012 and its nearly $700 million patient tower in 2013. The two facilities will add about 850,000 square feet to the sprawling medical center in Durham.

"The primary factor in our decision to move forward with these projects is our sense of responsibility and conviction to ensure that we meet the current and projected demands for the high quality healthcare services that patients have come to expect from Duke," said Victor J. Dzau, Duke University chancellor for health affairs and CEO of DUHS. "This project is all about our patients, faculty and staff, and our missions of clinical care, teaching and pursuing breakthrough research."

Duke will consolidate outpatient cancer services and clinical research in the seven story, 267,000-square-foot cancer center. That building will include 140 examination rooms, 75 infusion stations, a pharmacy and an outdoor terrace for chemotherapy patients receiving treatment.

The eight-story patient tower will have 16 operating suites, 96 critical care beds and 64 intermediate care beds.

It is estimated that construction of the two structures will bring 1,500 jobs to the area, while full-time staffing needs after completion are expected to result in the addition of 1,000 permanent jobs.

An exact starting date for construction was not available.

State law requires health systems to win approval for large capital projects under the Certificate of Need system, which is designed to keep health-care spending and costs in check.

Duke, rated as one of the top health systems in the world, also owns Duke Raleigh Hospital and operates Durham Regional Hospital in addition to its flagship hospital in Durham.

Economy Delay Construction of CIRM Projects at UC Santa Cruz, Buck Institute

California's budget squeeze and the ongoing economic slump have delayed two of the 12 facility projects for which the state's stem-cell agency approved a total $271 million in grants last year — at the University of California, Santa Cruz, and the Buck Institute for Age Research — though one of the projects has raised enough money to have just started pre-construction work, and the other hopes to break ground next year.

The updates were disclosed in a status report on projects funded by the California Institute for Regenerative Medicine's Major Facilities Grants program. The status report was submitted to CIRM's governing board, the Independent Citizens Oversight Committee, in advance of its meeting Aug. 19-20.

At Santa Cruz, site-preparation work has begun for its $12.9 million CIRM Institute for Biology of Stem Cells, following a delay in work wrought by the Golden State's financial mess, said Tim Stephens, a spokesman for UCSC.

The institute, which has won about $7.2 million in CIRM grant funding, would occupy the fourth floor of a five-story, 92,000-square-foot Biomedical Sciences & Engineering Facility. The remainder of funding for the institute is expected to come from the state.

But when the California Department of Finance imposed a freeze on capital funding in December 2008 due to the state's widening revenue shortfall, the action delayed construction of the project for months.

The state solicited bids, but did not award its construction contract until earlier this month, when UC bought $199.9 million in general obligation bonds, at 3.183 percent interest, from the state in a "private placement" transaction, in which the bonds were offered only to UC.

Proceeds from the bond sale will be used toward expanding telemedicine services and building facilities at eight UC campuses — including UC Santa Cruz, where about $64.4 million of the proceeds have been set aside for constructing the biomedical building.

As a result of the delay, the estimated completion date for the building has been pushed back to October 2011. Previously, occupancy had been projected for December 2010, then April 2011.

More than 100 miles north in Novato, Calif., the Buck Institute for Age Research has yet to break ground on its planned $41.4 million new laboratory and support building. While the institute received a $20.5 million CIRM grant toward construction of the 65,708-square-foot facility, it will not know for several weeks how much of the remainder it will need to raise through a fundraising campaign.

That answer will come after the Buck Institute learns whether it will receive all or part of the $15 million it is seeking for the project through a facilities grant program within the $787 billion American Recovery and Reinvestment Act, the economic stimulus measure enacted in February by President Obama.

"We hope to hear something later in the year,” said Kris Rebillot, a spokeswoman for the Buck Institute. “Depending what happens with that will [determine] how much other money we'll need to raise to finish the building off."

The institute originally envisioned breaking ground in September 2008 for the lab/support building, designed as an addition to Buck’s existing 185,000-square-foot research facility. But as the financial markets soured last fall, Buck, as with many institutions planning facility projects, found it harder to raise the funds it needed for a groundbreaking, and began talking with partners about alternatives.

Rhode Island Hospital Gets $11M NIH Grant for Cancer Core

The National Center for Research Resources has granted Rhode Island Hospital $11 million to renew the hospital's status as a Center of Biomedical Research Excellence (COBRE) Center for Cancer Research and Development, the hospital said today.

The five-year grant will continue the COBRE CCRD programs at Rhode Island Hospital, which uses it to offer cancer researchers access and use of a proteomics core and a molecular pathology core. The proteomics core provides mass spectrometry and analysis tools and services, and the molecular pathology core provides a tissue bank for storing and cataloging human and animal tissues and a range of services.

The aim is to support researchers who seek biomarkers for use in developing early detection and diagnostic tools for cancer.

The hospital also this year received a $500,000 economic stimulus funding grant to purchase an imaging mass spectrometer for the proteomics core, Douglas Hixson, a Brown University professor who directs the hospital's Molecular Carcinogenesis Laboratory, said in a statement. The center purchased a Bruker Daltonics Ultraflex MALDI TOF/TOF with the funds.

"By allowing investigators to identify proteins differentially expressed in malignant and normal cells by directly scanning tissue sections, this exciting new technology will accelerate the identification of biomarkers by directly linking the fields of proteomics and molecular pathology," said Hixson. The new mass spectrometer is expected to "become a catalyst for collaborative interactions aimed at developing novel clinical and basic research applications," he added.

Since the hospital opened the CCRD facility in 2003 it has been involved in a range of cancer-related discoveries, Hixson said. "We've identified a new mode of transmitting signals regulating the growth and spread of cancer, a new gene that determines sensitivity to anti cancer drugs, another gene elevated by acid reflux that increases the risk of esophageal cancer and two novel tumor suppressor genes whose loss elevates the risk of stomach cancer."

Skanska to Build Hospital in Tennessee for US$75 Million, about SEK 460 Million

Skanska has been awarded the construction management assignment for a new hospital in Johnson City, Tennessee. The contract amount is USD 75 M, about SEK 460 M, which is included in order bookings for the third quarter. The customer is Franklin Woods Community Hospital.

The project comprises 23,200 square meters (249,632 sq. ft.) and will among other things include 80 beds, a 22-bay emergency department, five operating rooms and radiology services.

Ambitions are high for environmental and energy performance and the project team has a goal of getting the hospital a Silver LEED [R] (Leadership in Energy and Environmental Design) certification.

Construction work has commenced, with completion scheduled for June 2010.

Skanska is a leader in the US healthcare sector. The total contract amount of the company's ongoing hospital projects exceeds USD 5 billion. So far this year new hospital contracts have also been received in Virginia, California, Ohio and in Memphis, Tennessee.

Skanska USA Building is a leading U.S. provider of construction, general contracting, design and design-build services. The company also provides pharmaceutical validation services to clients. Customers represent a broad spectrum of American industries, including the pharmaceutical, healthcare, educational, electronics, infrastructure, sports and entertainment industries. The company is based in Parsippany, New Jersey and has approximately 4,000 employees. Revenues totaled approximately SEK 27 billion in 2007.

Skanska to Build Hospital in Michigan for US$56 Million, SEK 340 Million

Skanska (STO:SKAB) has been awarded the construction management and design-build contract for the William Beaumont Hospital project in Troy, Michigan. The contract amount for Skanska is USD 56 M, SEK 340 M,

The multi-phased project comprises 51,800 square meters ( 557,360 sq. ft.), including a 20,700 square meter (222,732 sq. ft.) emergency center and critical care tower. It also includes a three-story ambulatory care center, a vertical expansion of the West Tower, loading dock and powerhouse expansion, a 500 square meter (5,380 sq. ft.) addition, and a connector bridge linking the existing main campus to the new ambulatory center on the hospital's east campus.

Sanofi-Aventis Shutting Down Kansas City, MO, Manufacturing Site

Sanofi-aventis US said it will close by mid-2012 a Kansas City, Mo., manufacturing site that mainly makes solid dose forms of oral medications, based on declining demand for the products in North America.

The company said in a statement it will close down the plant in phases stretching about two-and-a-half years, with additional details on the timetable and process to be disclosed by the end of November.

The shutdown will idle all 370 workers at the 33-year-old plant, originally operated by Ewing Kauffman's Marion Laboratories, and run since 2000 by Sanofi-Aventis and predecessor company Aventis.

Workers will be offered a transition bonus and offered career transition assistance, Sanofi-Aventis spokesman Jack Cox told the Kansas City Star.

Cox told the newspaper that Sanofi-Aventis had been seeking a buyer for the plant, at 10236 Marion Park Drive, since early 2008 and actually received some offers: “We did consider other buyers to sell the facility to, but determined their proposals weren’t sufficient to sustain the facility."

Sanofi-Aventis did not consider renovating the plant to manufacture other pharmaceutical products because the facility was designed to produce solid-dose medications involving chemicals, not biologic products such as injectable vaccines, Cox told the Star.

REST OF WORLD

Africa is the Next Drug Development Frontier for Quintiles

Quintiles has targeted Africa as the next non-traditional area to develop new medicines and the opening of its office in Ghana, which is now fully operational, is a major step in this process, said Gillian Corken, head of Quintiles in Africa.

The Accra, Ghana office was established in June and Corken believes it “offers huge potential” to reach the estimated 760m patients in Sub-Saharan Africa. Quintiles’ office is now fully operational and has initiated a large malaria vaccine trial.

Corken explained that the vaccine trial demonstrates how Quintiles staff are able to “anticipate needs and roll up our sleeves and deliver”, adding that the Ghana office represents “the beginning of an exciting journey” for the company.

The office is based in the grounds of the University of Ghana at the Noguchi Memorial Institute for Medical Research. Alex Nyarko is director of the institute and will continue to work with Quintiles, as will David Ofori-Adjei who has entered into a partner-site agreement with the company.

Neels Barnard is heading clinical operations at the Ghana site and is living and working in the country. Assisting him are five clinical research associates (CRA) and one clinical trial administrator (CTA).

The CRAs and CTA will follow a comprehensive global training plan for their job description. Training takes the form of self study, audio distance, webinars and teaching in classrooms, all of which is intended to give staff the technical capabilities and soft skills needed to conduct trials.

Investigators at the institute will also receive training covering good clinical practices (GCP), protocols, regulations and ethics committees. This forms part of Quintiles agreement with the institute.

Since the establishment of the Ghana office Quintiles has stressed that it will “strictly adhere to ethical principles articulated by international guidelines such as ICH, the Declaration of Helsinki, CIOMS and the Belmont Report”.

Modernization of Richter-Helm BioLogics Production Facility in Hannover

Richter-Helm BioLogics GmbH & Co. KG completed the modernization of its GMP-production facility in Hannover in September 2009. Hence GMP-production capacity in a scale of 300L fermentation volume and corresponding down-stream capacity for the production of recombinant proteins, plasmid DNA and vaccines deriving from microbial fermentation is now available at the Hannover location.

Richter-Helm’s service portfolio for GMP compliant manufacturing of biopharmaceuticals roots in the Hannover facility. For more than 20 years, recombinant proteins, plasmid DNA and vaccines have been produced, which have met the extremely high quality standards for biopharmaceuticals. After successfully modernizing the cleanroom area for purification in 2008, the up-stream processing area, i.e. the area for fermentation and primary recovery of microbial cultures, of this facility is now state of the art. The construction work was completed in September and the new facility is presently undergoing qualification operations. After repeatedly improving its facility Richter-Helm has now cleanrooms of class D up to class A in B available at the Hannover location, which were designed and constructed strictly following a GMP room concept. Planned for production of biopharmaceutical test samples for all clinical phases, the facility is also suitable for market supply. Two bacterial vaccines which are approved and available at the market are already produced at this site.

Having invested into state of the art equipment and facilities once again Richter-Helm underlines the constant readiness for innovation and improvement which makes it one of the leading providers of services for biopharmaceuticals development and manufacturing.

The new facility now closes the gap between Richter-Helm’s research facility and the large scale production in Bovenau near Kiel. Richter-Helm has now all common fermentation scales up to 1500L available for GMP production at three different locations, to serve the customers’ needs for consistent quality from pre-clinical development up to market approval and beyond

GenScript to Provide Assay R&D for Roche China Unit

U.S. contract research organization (CRO) GenScript will provide assay development services for Roche’s drug R&D unit in China.

GenScript vice president Sally Wang said the firm will create assays for drug targets selected by the Swiss drug major, and predicted that “the work will involve multiple functions from both sides considering the nature of drug discovery and development process.

“The project GenScript is undertaking will contribute to Roche’s drug discovery portfolio and preclinical programs by providing unique assay for novel drug targets.”

The Roche unit, known as Roche R&D Center China (RRDCC), was established in 2004 at the Zhangjiang Hi-Tech Park in Shanghai.

Prior to the GenScript partnership that site and its 40 strong staff of scientists had focused on medicinal chemistry research for lead optimization, which Roche’s CSO Li Chen explained, provided a firm base to add biology R&D.

Dr Li said: “After the success of medicinal chemistry outsourcing, biology CRO is becoming a new trend in drug discovery. We expect a fruitful collaboration with GenScript in assay development.”

Li went on to say that while previously it was difficult to find a provider capable of the development of assays, in the last few years an increasing number of CROs have begun offering this type of service and the market is becoming more competitive.

Despite this growth GenScript believes that scope of its assay offering makes its stand out from the crowd, as Wang explained.

“There are not many CRO companies except GenScript which can provide one-stop bio-reagent services ranging from custom gene synthesis and molecular biology, custom protein expression and purification, to custom peptide synthesis, antibody production, and custom cell line development.”

And, GenScript looks set to further expand its offering. In June the firm secured some $15m (€10m) in venture capital funding for infrastructure development.

Wang said: “The investment fund will be strategically used for recruiting more industry veterans and talented scientists and for investing in state-of-art instrumentation and capacity expansion.

“This strategic investment will benefit our customers for them to receive assay services with quality and timely delivery in broader therapeutic areas which are offered by experienced staff.”

U.S. Packaging Company Poised for China Growth

A new state-of-the-art packaging facility in Hainan Island, off the coast of southern China, will lead the expansion of U.S. company Shiner International in the country, according to its presentation at a business conference in New York.

The plant, which is expected to open later this year will double the company’s production of food safe packaging to 30,000 tons/year within two years, delegates heard at the Rodman & Renshaw Annual Global Investment Conference Asia Track.

It expects food safe packaging capacity to reach 50,000 tons/year by 2013.

Although China’s melamine milk crisis last year hit sales of all packaged food sold in supermarkets, it brought opportunities too. “This crisis gave us a big impact at first but now it turns out to be an opportunity also, since people are concerned more about the food quality and the government implemented the food safety law to control food quality.”

The company’s business has also been affected by global recession but the food business is now slowly recovering, she added.

Shiner's chairman, Yuet Ying told the conference: “With the increasing urbanization and rising consumer incomes in China, Shiner is positioned to continue its expansion and strengthen its placement as the leading supplier in China's domestic market. And it will increase its presence in international markets by increasing marketing through direct sales, produce superior product quality and technical content, while proving a cost efficient product for our customers."

At the conference, the company reported 2009 sales revenue at $34m; gross profit of $4.8m; gross profit margin of 14.1% and net income of $0.1m.

Food packaging sales during the first half of this year reached $5.4m which accounts for 36% of total sales. Shiner’s products are used to package a range of foods including biscuits, cookies, cakes, candies, nuts, meat, drinks and instant noodles.

Shiner predicted that for 2013 that sales revenue would grow to $180m, a 50% increase versus 2012 and gross profit would reach $37.2m. It forecast a gross profit margin of 20.7% and net income of $20.5m, a 71% increase on projections for 2012.

Rising consumer incomes are increasing demand for Shiner’s coating of BOPP film, said the spokesperson. “Food packaged in coated film has a much longer shelf life and a much better quality protection than packaged in bare BOPP film,” she said. “In the European and US market, about 20% of all the BOPP films are coated, However, in China, currently only around 0.5%. As more and more Chinese people move to the cities….the need for coated film will explode.”

About 60 per cent of Shiner's customers are located in China, with the remainder in Southeast Asia, Europe, the Middle East and North America.

Teva Further Streamlines Ops with Czech Plant Closure

Israeli generics giant Teva Pharmaceutical Industries will close one of its manufacturing plants in the Czech Republic by the end of the year, resulting in the loss of around 400 jobs.

Teva has not yet issued a statement on the move, although the firm did tell Reuters that it plans to invest $58m (€39m) in its Czech manufacturing operations next year to boost production.

Regardless of the motivation for the latest cuts, Teva’s business development strategy over the last years seems to be to streamline and refocus its global manufacturing operations to improve efficiency.

In February, Teva said that its Croatian subsidiary Pliva would reduce its workforce by 790 employees as part of an efficiency drive designed to boost local active pharmaceutical ingredient (API) production.

And, earlier this month, the firm announced plans to close one of its plants in Ireland and relocate 315 jobs to operations in a number of countries in Eastern Europe, including the Czech Republic, where costs are lower.

In other news, Teva has invested $3.5m in US specialty cancer drug developer Rexahn Pharmaceuticals as part of a licensing deal for the latter’s candidate oncology medication RX-3117.

In a press statement company VP of innovative ventures Aharon Schwartz said: "Our agreement with Rexahn underscores Teva's commitment to bolstering its innovative pipeline through licensing of promising compounds.

The investment fits with both the recent expansion of Teva’s specialty pharmaceutical portfolio, including the addition of Barr’s women’s health division and comments made by the firm at its Q2 results presentation in July.

At the time, Bill Marth, president of North American operations, said: “we believe that the same type of capabilities that we have developed in the generic market, we can also apply to specialty or some other area that we might go after.

Dalton Adds Formulation Service to Manufacturing Offering

Dalton Pharma Services has rolled out a new formulation development service that completes the firm’s contract drug manufacturing offering according to CEO Peter Pekos.

The new unit will provide formulation development for liquid, solid, semi-solid and lyophilized versions of small-molecules, proteins, monoclonal antibodies and potent active pharmaceutical ingredients (APIs).

Pekos said that the Canadian contract manufacturing organization (CMO) has “also expanded our Analytical Services to serve our formulation development experts and as a result now offer dissolution testing and particle size distribution testing.”

Gerresheimer Invests in Plastics with Two New Plants

Gerresheimer is increasing its presence in the pharmaceutical plastics business, which it believes is increasingly important, by opening an R&D centre in the US and a production facility in Spain.

The pharmaceutical plastics sector has become Gerresheimer’s fastest growing business sector and the company has made strategic investments to ensure it has the capacity to meet rising demand.

Gerresheimer has achieved this by opening a production facility in Masalaves, Spain that it believes is the largest of its kind in Southern Europe. The plant will serve the Southern and Central European markets and is regarded by Gerresheimer as “a significant strategic base”.

From the facility Gerresheimer will produce pharmaceutical bottles and multifunctional dosage and closure systems, for delivery forms such as eye drops, nose sprays and tablets.

Gerresheimer has also invested to bolster its R&D capabilities, opening a technological centre in Peachtree City, Georgia, US. The site previously only housed a manufacturing facility but has now been upgraded with the addition of R&D capabilities.

Prior to the expansion Gerresheimer lacked a US site that could handle customized serial production of entire product and process development, with only its European sites having this capability.

Following the expansion the US site will work on highly developed inhalation systems for respiratory diseases, as well as insulin pens, skin-prick aids and lancets for the diabetes sector.

Gerresheimer has experienced steady growth in these sectors and the expansion gives it the capacity to continue strengthening its market position. Following completion of the recent expansions Gerresheimer has 15 sites operating in the plastics sector.

This capacity has been created through acquisitions and targeting investments, which, coupled to organic growth, have helped accelerate the division’s growth over the past five years. The division now accounts for a third of group sales.

Ireland Awards $21.6 Million for Systems Biology Center

Ireland has granted €14.8 million ($21.6 million) to establish a center focused on systems biology. The five years of funding from Science Foundation Ireland (SFI) will start the Systems Biology Ireland (SBIR) center, which will be led by University College Dublin.

Several corporate partners are joining SBI in supporting the center, including Agilent Technologies, Siemens Ireland, Protagen, Ark Therapeutics, Hewlett Packard, and Servier.

QPS’ Taiwan Lab is First to get GLP Certification

QPS’ bioanalytical laboratory in Taiwan is the first in the country to be certified as compliant with good laboratory practice (GLP) standards by the Department of Health (DoH), according to unit president Vincent Yen.

The US based contract research organization (CRO) said that certification enables its Taiwan unit to begin offering analytical support services for both preclinical research and clinical development.

Yen said that the DoH based its decision on the firm’s track record, infrastructure and library of standard operating procedures (SOPs) that are employed at all of the firm’s research labs worldwide.

He explained that the lab, which is located in Taiwan’s Nan Kang Biotech Park, houses API 4000 triple quadrupole mass spectrometers, Shimadzu VP-series LCs, Tomtec Quadra, managing those using Rees Monitors and a Watson LIMS system.

QPS’ CEO, Ben Chien, said: “We view this as an additional assurance to our sponsors that the QPS state-of-the-art, Asian bioanalytical LC/MS/MS facility has the same high quality and operational standards as our FDA-audited QPS US facility.”

Taiwanese Biotech

In the 1980s the Taiwanese government began to invest in biotechnology R&D, spending around 30 per cent of its annual science budget on the sector which was, at the time, still relatively small.

This investment resulted in the development of three science bases: Hsinchu; the Central Taiwan Science Park and the Southern Taiwan Science Park, which generated revenues of $60.8bn in 2008 according to the National Science Council (NSC).

This infrastructure has proved irresistible to industry players like Applied Biosystems, Invitrogen, Dionex and Novartis which, in addition to German drugmaker Merck KGaA, all have an established presence in the country.

Despite Taiwan’s success in attracting the pharmaceutical industry, the country’s contract research sector, has until recently, remained relatively small according to center for drug evaluation (CDR) executive director Herng-Der Chern.

In an interview with BioSpecturm in March last year Chern said: “There is shortage of supply of skilled workforce in the segment because of the booming demand even though many CROs have set up intensive training course to nurture their staff.”

In response, the Taiwanese government instituted a “promotion plan” designed to attract contractors to the country.

The plan grants rights to CROs to submit investigational new drug (IND) applications and provides pharmaceutical sponsors with a number tax incentives relating to their outsourcing spend.

PPD Opens Global Central Lab in Singapore

PPD, Inc. has opened its global central lab facility in Singapore to provide customized lab services in Southeast Asia. PPD also has an office in Singapore that provides clinical development services, including clinical trial management and monitoring, patient recruitment, site identification and regulatory affairs.

"Expanding our global central lab services into Singapore demonstrates our commitment to deliver high quality specimens and laboratory results for our clients in a growing biopharmaceutical market," said Steve Lobel, vice president, global laboratory operations, PPD. "We can expedite delivery of lab data through reduced transportation and shipping time at better logistics costs for our clients."

Preclinical CRO Porsolt Expands in France, US

Porsolt, a French contract research organization (CRO) specializing in preclinical pharmacology services, has said it plans to open a new facility in Europe as well as boost its presence on the other side of the Atlantic.

The CRO has started construction of a new laboratory on a 10-hectare development in Laval, France. The first phase of the operation will see a 60,000 square foot facility completed in early 2010.

The new site will offer increased capacity for Porsolt's expanding cross-therapeutic area models and Good Laboratory Practices safety pharmacology expertise, according to the firm.

Porsolt’s chief executive, Mark Duxon, said the decision follows a period of good growth in 2008, and a growing awareness of the firm’s “cross-therapeutic area expertise,” which he believes has set the firm up for “sustained growth in the next five to 10 years.”

Porsolt has remained very focused on its core expertise – preclinical pharmacology – at a time when many CROs have pursued a strategy of broadening their service range in the hope of winning lucrative ‘preferred provider’ contracts.

The French CRO believes that concentrating on two core services - assessing novel substances for therapeutic activity and safety using animal models – is a more reliable model. The company has long argued that the best strategy is not to strive to become the biggest CRO, but to remain the best in selected areas of competence.

While the company is happy to remain a specialist service provider, it is keen to expand its geographic presence and has implemented a project to spearhead an expansion in the US.

Porsolt has hired two experienced PhD biologists from Big Pharma who will be permanently based in the USA to conduct business development support in that country.

The headcount in the US business development group will be further increased - in line with expansion of the company - in 2009 and 2010, the CRO noted. Porsolt already has a team of five business development staff located in Paris, France.

Martine Lemaire, senior director and head of business development, commented: "as our laboratory services grow and as we implement a new expansion strategy, we feel it is essential to have experienced personnel based in the US to offer direct face-to-face client interaction. “

Lab Research Lands New Preclinical R&D Contracts

New multi-million dollar R&D contracts with top three pharma and biotech players go some way to “alleviating” the negative impact of downturn, according to Lab Research CEO Luc Mainville.

The firm, which also signed an R&D deal with a European agrochemicals major, will undertake preclinical research on behalf the as yet unidentified drug industry majors at its testing facility in Laval in Quebec, Canada.

Over the last three years Lab Research has spent C$65m (€41.8) expanding the lab as well as two other testing facilities in Denmark and Hungary adding capacity which, Mainville said, had played a part in winning the new R&D contracts. He told Outsourcing-pharma that: “It is clear that adding scale and broadening our services to include bioanalytical, drug metabolism, reproductive toxicology and more inhalation have been key factors.

“But I think that it is a combination of our capabilities and high quality and flexibility as a mid-size lab that has contributed to each of these agreements.”

Mainville also highlighted Lab Research’s expertise and track record in safety pharmacology, infusion and primate modeling as being the key technical capabilities that had landed the new contracts.

He concluded that: “Clearly our ability to expand our client audience to include larger and sophisticated recurrent spenders has alleviated somewhat the negative impact of the recession.”

In a press release accompanying the announcement Lab Research said that the contracts are likely to lead to more deals later this year, adding that discussions are already ongoing for work to be conducted over the next two years.

The non-clinical contract research organization (CRO) predicted that the latest deals and subsequent agreements will contribute between five and 10 per cent of its total revenue for the current year.

Bangladesh a “Huge Opportunity” for Growth

Bangladesh represents a “huge opportunity” to pharma, according to the CEO of Amreteck Pharma who believes that CMOs will be attracted by the low costs, which undercut China, and help the industry grow to $10bn (€6.9m) in 10 years.

Speaking to Outsourcing-Pharma M Chowdhury, founder and CEO of Amreteck, explained that Bangladesh’s educated pharma workforce and costs that undercut India and China will attract multinationals and contract manufacturing organizations (CMO).

Companies including Roche and Sanofi-Aventis already have operations in Bangladesh, which is also home to 260 local pharma businesses. These local companies are growing at 20 per cent a year, according to Chowdhury, but there are concerns over the quality of medicines produced.

There is a lack of pharma production expertise in the country and good manufacturing practice (GMP) consultancy firms are expensive. To fill this void Chowdhury, who is from Bangladesh but is western educated and has worked at numerous pharmas, established Amreteck.

Chowdhury explained that Amreteck offers multiple services, at affordable prices, to help Bangladeshi companies improve understanding of the manufacturing process and reduce human error.

This covers the establishment of quality systems for all aspects of production, from raw materials through to final packaging. Amreteck then validates the operations.

Chowdhury intends to establish an office in Bangladesh next year. In addition to running the Bangladeshi operations the office will also support Armtek’s activities in India and China.

Bangladesh’s status as a less economically developed country (LDC) allows it to manufacture therapeutics covered by active patents. This has enabled companies to export patent protected products to countries in Africa.

Chowdhury explained that the top five Bangladeshi pharma companies account for most of the exports, and also have better quality controls, but there are opportunities for growth.

The exemption from patent protection is due to expire in 2016. In preparation some companies have begun to invest in R&D but, Chowdhury explained, they lack an understanding of international protocols and regulations, for instance investigational new drug (IND) applications.

Consequently, Amreteck will also provide services to help Bangladeshi companies with regulatory processes.

Asia Wins Amdipharm Manufacturing Contract

UK API maker and contract manufacturing organization (CMO) Aesica Pharmaceutical has landed a multi-year deal to produce and package drugs on behalf of Amdipharm.

Under the deal Aesica is providing production and packaging services for several key products including Erythrocin (erythromycin), Hytrin (terazosin) and Loftly (buflomedil) at its secondary manufacturing facility in Queenborough in the UK.

The plant houses both solid and liquid dose manufacturing capabilities for, among other things, anesthetics and controlled drugs. It also provides blister packaging, sachet production and bottling capabilities as part of Aesica’s supply chain services offering.

However, as Aesica spokesperson Maria Koustareva explained, the collaboration, which is likely to be extended to other drug products, also covers wider aspects of Amdipharm's manufacturing and distribution operations.

These services will include the 2D-matrix technology that Aesica is preparing to introduce “on all cartons to keep up with the latest legislation worldwide and to prevent [the] distribution of counterfeit medicines.”

Koustareva was also upbeat about the general state of the pharmaceutical contract manufacturing market suggesting that, in Aesica’s experience, demand has continued “to grow despite the economic downturn.”

“Over the last 12 months Aesica has seen an increased amount of enquiries and business opportunities for contract manufacturing finished dosage forms and providing packaging services to its customers around the world.”

In a press statement that accompanied news of the deal Amdipharm’s managing director, Mick Cullen praised his firm’s new contractor, commenting that: “We have been very pleased with our growing relationship with Aesica based on their reliability, flexibility and responsiveness.”

Tate & Lyle Cuts Ribbon at Australia Food Systems Site

Tate & Lyle is giving a boost to its Australian food systems business with the opening of a new R&D and manufacturing centre in Queensland.

The company, called Tate & Lyle Food Systems, has had a presence in South East Queensland for 19 years. It supplies stabilizer systems to food firms in Australia, New Zealand, Japan, Korea, South East Asia and the Middle East.

The new centre, which has cost AU$7m (around €4.1m at today’s exchange rates), will function as the headquarters for Asia Pacific, and will be used to help customers in their quest to develop healthier foods.

In Asia Pacific, just as in Europe and the US, consumers are seeking good tasting products that also have less macronutrients that are understood to have an impact on their health, such as saturated fat or sugar. There is also interest in boosting fiber intake, with foods that have fiber added.

Consumers are also watching their pennies closely, especially in the current economic climate, and foods that have a longer shelf-life – another attribute with which systems can help – are attractive as it helps reduce wastage.

However the new site will not just benefit the region in which it is located. Tate & Lyle has an global network of R&D centers and it draws on knowledge from all of these in the solutions it offers.

In 2007 the company acquired a 70 per cent share of GC Hahn, a German company specializing in stabilizer systems, which boosted its global competencies in this area.

Brian Walker, regional sales director of Tate & Lyle Food Systems, said: “Our facility in Queensland incorporates the latest in innovative design and technology in food hygiene and allergen control. Everything has been designed to have minimal impact on the environment with extensive waste management regimes in place and the best in occupational health and safety for our staff.”

The kinds of products into which stabilizer systems make their way include yoghurts, salads, ready meals and desserts.

Apotex Working to Get FDA Import Alert against Two Toronto Plants Lifted

Apotex Inc., the largest Canadian-owned pharmaceutical company, says it is working with U.S. regulators to correct problems at two of its plants in Toronto.

The U.S. Food and Drug Administration has issued an import alert banning products from Apotex plants in North York and Etobicoke.

Issued Aug. 28, the alert calls for "the detention without physical examination of all finished form drug products imported to the U.S. from these facilities," according to an FDA email in response to questions from The Canadian Press.

Apotex said that the alert relates to "observations made following routine audits for products destined to the U.S. only."

"We are actively working with the FDA to resolve the identified concerns as quickly as possible, and are optimistic that there will be a prompt resolution," Jack Kay, Apotex president and chief operating officer, said in statement.

Apotex, founded in 1974, employs over 6,500 people in research, development, manufacturing and distribution facilities worldwide.

Some 5,800 of the employees work at the Canadian operations in Ontario, Quebec, Manitoba, Alberta and British Columbia.

CRO Covance Sets Up Offices in Latin America

Covance says its new clinical development offices in Brazil and Mexico will increase access to treatment-naïve patients and, ultimately, save pharmaceutical sponsors money.

The new clinical offices, in Sao Paulo and Mexico City, will provide support for Covance’s Phase I to III clinical trial business in both countries and across the region as a whole.

Wayne Langlois, head of Covance’s local clinical development services unit, said the: “new offices increase our access to patients who are currently not receiving medical therapies and will enable us to shorten clinical trial cycle times.”

And, while such claims are usually made whenever CROs open new offices anywhere, on this occasion Langlois contention is supported by market analysis.

Last month, Business Insight’s published its “Emerging Clinical Trial Locations” report, which suggested that studies in Latin America are on average 50 per cent cheaper per patient than those conducted in the US.

The report also revealed that the number of trials being carried out in Mexico, Argentina and Brazil have increased dramatically over the last eight years, which lends further support to Langlois’ view.

While Covance has operated in the region for over a decade, opening its first office in the Argentinean capital Buenos Aires in 1997, the last 12 months have seen it accelerate its growth in the region.

Earlier this year for example, the contract research organization (CRO) set up new units in Chile and Peru again citing the improved access to patients as the primary motivation for the expansion.

And, from a wider industry perspective, Covance’s move fits with the current drive to improve access to patients that has seen most of the major CRO players expand their operations in Latin America over the last 12 months.

In April, Chiltern set up in Brazil through the acquisition of Vigiun shortly followed by AAIPharma, which bought the Instituto de Pesquisa Clinica in Sao Paulo, and PRA which opened a unit in June.

Prior to that, Swiss CRO PFC Pharma Focus entered the Latin American market through a partnership with Argentinean company Blanchard y Asociados.

Clearly the benefits of the Latin American market prove hard for a CRO to resist and are likely to continue to do so for the foreseeable future as the demand for trial participants continues to grow.

Schering-Plough Opens Dutch Injectables Facility

Schering-Plough has opened a new pharmaceutical manufacturing facility in Oss, the Netherlands, to help meet demand for the drugmakers' injectable drugs and hormonal products and boost its capacity to make biologics.

The addition of the new site makes Oss the largest pharmaceutical manufacturing centre in the Netherlands, said the company at the unveiling event earlier attended by Dutch Economic Affairs Minister Maria van der Hoeven.

The new 16,500 sq.m. (177,540 sq. ft.) factory has three separate production lines and was built on ground adjacent to the main production facilities of Organon, which was acquired by Schering-Plough for 11 billion Euros in November 2007. It cost 75 million Euros to construct and will employ between 80 and 100 staff.

The new Oss plant will initially be used to manufacture injectable drugs such as muscle relaxants Esmeron/Zemuron (rocuronium bromide) and Norcuron (vecuronium bromide) and their reversal agent Bridion (sugammadex).

It also has a dedicated production line for NuvaRing (etonogestrel/ethinyl estradiol), Schering-Plough's fast-growing contraceptive device which brought in sales of $115 million in the first quarter of this year, as well as other hormone-based treatments

The high-tech plant is designed very much in keeping with the current trends in pharmaceutical manufacturing - lean, flexible facilities that can be used to make a range of products with minimal risk of cross-contamination between production lines and from operators.

It makes extensive use of automation in cleanroom areas and the freeze-drying suite, and boasts closed systems for air and water supply and purification, as well as its own dedicated water treatment plant.

Around 25% of the plant's manufacturing capacity has been earmarked for use by BioConnection, an innovative company designed to help smaller biotechnology companies make batches of their pipeline products for use in trials, as well as large-scale commercial production and other activities such as formulation development.

BioConnection was set up in 2005 as a collaborative venture between the Dutch government and Organon's former parent Akzo Nobel.

Lonza to Set Up Singapore Cell Therapy Plant

Swiss biomedical science firm Lonza is investing CHF30m (€19.7m) in a new cell therapy facility in Singapore, continuing its global expansion effort.

The plant, which will produce novel therapeutics on a contractual basis, will be located next to the firm’s existing mammalian manufacturing unit at the Tuas Biomedical Park in the West of the country.

Company CEO Stefan Borgas said the unit is the next step in Lonza’s efforts to expand in Asia explaining that: “Cell therapy is expected to be one of the most important innovation drivers of modern medicine.

"The facility will operate with cutting-edge technologies and a skilled labor force, allowing it to readily meet the needs of a broad range of customers and address the growing global demand.”

Beh Swan Gin, managing director of the Singapore Economic Development Board (SEDB), said the new unit “extends the highly successful Lonza-Singapore partnership from chemicals to biologics manufacturing and now, the production of cellular therapeutics.”

Construction is expected to begin early next year with the aim it becoming fully operation sometime in mid-2011.

Lonza has a network of 12 good manufacturing practice (cGMP) accredited cell therapy plants worldwide, including a facility in Walkersvillie, Maryland, US in which it invested $26m to boost cell production capacity in January.

The firm also works with Novartis and Genentech on the manufacture and development of biologics.

Efforts to boost scientific development has seen Singapore emerge as a hub for high-tech drug manufacture, with global pharmaceutical firms investing more than $500m in the country last year alone, according to the SEDB.

Before Lonza announced its latest move, Bayer, Schering-Plough and Takeda all expanded operations in the country both by adding manufacturing capacity and forging closer links with academia.

Lonza is also working with Baxter, Genentech, GSK, Novartis and Millipore to set up a $2m biopharmaceutical manufacturing training facility in the country.

Speaking at the recent BIO 2009 event in Atlanta, Yeoh Keat Chuan, executive director of the SEDB’s biomedical sciences unit said that: "Singapore is aggressively positioning itself as a home for business, innovation and talent in Asia to be future- ready.”

Piramal Moves UK API Operations

Piramal Healthcare is switching its UK API making operations to Morpeth, Nothumberland after a downturn in the Indian CMO’s international business cut capacity utilization at its former base in Huddersfield to just 35 per cent.

The firm gained control of the Huddersfield plant in 2005 through its £10m (€11m) acquisition of Avecia Pharmaceuticals in December 2005. Pirmal plans to shut down the facility, which contributed £19m to its earnings last year, but has not yet said whether it is seeking a buyer.

The move, which will result in the loss of 93 jobs and cost Piramal around £10m, will split the Huddersfield plant’s roster of manufacturing contracts between the Morpeth plant and facilities in Ennore and Ahmedabad in India.

Piramal said that the move will improve margins in its Pharma Solutions Business (PBS) by between 6 to 8 per cent over the next two years, according to a report in India’s Business Standard.

CEO Ajay Piramal told the paper that Piramal’s international business will shrink by around 5 per cent this year but predicted that this will be more than offset by a 15 per cent expansion of its Indian operations.

He added that although the global downturn has cut spending by its smaller customers, a greater number of contracts from a Big Pharma sector keen to reduce manufacturing costs would drive growth of the firm’s business in India.

The Morpeth facility, which houses active pharmaceutical ingredient (API) and finished dosage manufacturing capacity as well as clinical packaging and distribution units, was purchased from global drug giant Pfizer in June 2006.

The plant is approved by both the US Food and Drug Administration (FDA) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA), employs a staff of 450 and already has a $350m (€260m) supply contract with Pfizer.

Approval Granted for Expansion of the Institute of Life Science at Swansea University

Approval has just been granted to expand the Institute of Life Science at the University of Wales Swansea in Swansea, United Kingdom. The project has been in the planning process since early 2008 and will involve the construction of a multi-storey bioscience laboratory complex adjacent to, and similar to, the existing ILS building. This £30 million ($49 million) initiative, known as 'ILS phase 2,' will incorporate cleanrooms and bespoke incubator facilities for biotechnology and nanotechnology research. Completion is slated for the third quarter 2011.

The scope of work involves construction of a multi-story building and plant room as well as laboratory construction including HVAC, cleanrooms, containment systems, benches and furniture, fume cupboards, bio-filtration, a reverse osmosis water system, an industrial gases area, laboratory furniture, bench-top instrumentation, autoclaves, and specialized flooring.

The Institute of Life Science (ILS) is a collaboration between Swansea University, the Welsh Assembly and IBM. Situated on Swansea University's campus, the ILS building is the research arm of the University's School of Medicine and contains state-of-the-art laboratory space for biomedical research.

Cobra’s Keele Bio-Facility Passes Inspection

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has completed a successful audit of Cobra Biomanufacturing’s facility in Keele. The authorization followed a three-day inspection and evaluation of the company’s manufacturing, analytical and quality management systems, which demonstrated that the facilities meet cGMP standards.

Simon Saxby, chief executive officer of Cobra Biomanufacturing, said, “This is excellent news and ongoing confirmation of the commitment of the company to meet the needs of worldwide Regulatory agencies. The renewal of our Manufacturers and Importers Authorization for Investigational Medicinal Products MIA (IMP) license acknowledges almost 10 years of cGMP compliance at Cobra and provision of a reliable and responsive biomanufacturing service to over 75 clients worldwide.”

Roche Acquires Lonza's Singapore Manufacturing Facility

Genentech Singapore, a wholly owned member of the Roche Group, has exercised an option to purchase from Lonza its cell culture biologic manufacturing facility in Singapore for $290 million plus additional milestone payments of $70 million, the companies have announced.

The facility, which is mechanically complete, will be merged with Genentech Singapore's existing biologic manufacturing facility. As part of Roche's integration of Genentech's technical operations following the former's $47 billion acquisition of the latter, biotechnology production facilities in Singapore operating under the Genentech name will later this year be renamed Roche Singapore Technical Operations.

About 230 Lonza employees will join Genentech Singapore Technical Operations, for a total site headcount of approximately 325. Lonza continues to employ over 80 people working at its own mammalian manufacturing plant, set to come on-stream in 2011, and plans to ramp up this number to over 300 employees in the next 12 months and beyond.

The Singapore manufacturing facility is expected to produce Avastin (bevacizumab), has 80,000 liters of fermentation capacity, and is located on approximately 10 acres at the Tuas Biomedical Park, with an option for up to 20 additional acres. Genentech Singapore’s existing 1,000-liter Ecoli manufacturing facility is expected to receive FDA licensure for bulk drug production of Lucentis (ranibizumab) injection in 2010.

Basel-headquartered Roche has paid fellow Swiss firm Lonza $290m (€203m) for its Singapore biologics plant in a bid to secure long-term manufacturing capacity for biotech cancer drugs.

The acquisition is a result of an option provided to Roche’s subsidiary Genentech under a 2006 deal that would have seen Lonza manufacture the Avastin active pharmaceutical ingredient (API) on a contractual basis.

And, while US Food and Drug Administration (FDA) clearance to produce Avastin is not expected until next year, Roche’s decision to exercise its option ahead of the 2012 deadline suggests it is keen to secure biologics capacity, particularly since acquiring Genentech.

Jim Miller, VP of Genentech Singapore, which will run the plant for the time being, stressed the importance of the country as a manufacturing destination, suggesting that “Singapore will play an important role in bringing important medicines to patients who need them.”

The facility, which is on a 10 acre site at the Tuas Biomedical Park, houses 80,000 liters of fermentation capacity. Roche said the plant and 230 of its workforce will be integrated into its other local manufacturing operations.

Roche’s interests in Singapore include an Escherichia coli (E.coli) production facility at which it plans to make components for its drug Lucentis when manufacturing operations are cleared by the FDA.

Sinovac Wins Flu Vaccine Contract in China

The Associated Press reports that Sinovac Biotech Ltd. has won a contract through the Beijing Public Health Bureau to supply the seasonal flu vaccine Anflu in Beijing. China-based Sinovac is one of four companies that won supplier contracts for seasonal flu vaccines. Terms of the contract were not disclosed. Earlier, the company said it completed clinical testing of a swine flu vaccine, and the product was successful at creating an immune system response to the virus. Sinovac is still evaluating the safety and effectiveness of the vaccine, and will apply for a production license for the China State Food and Drug Administration after the evaluation is complete.

Boron Molecular Completes Australian Cleanroom

Boron Molecular is a Melbourne-based fine chemical company which has its business based on an exclusive right to globally exploit unique organo-boron technology assigned from CSIRO. Many of Boron Molecular's customers are leading international pharmaceutical and

biotechnology companies which purchase the company's compounds to enhance their drug-development programs.

Boron Molecular has completed construction of its new ISO-8 cleanroom manufacturing facility which consists of a fully automated glass-lined 630 liter reactor together with a 50 liter pilot plant system to support process development manufacturing.

Commissioning and validation of the new facility is underway with first production expected in the 2ndquarter financial year 09/2010. The new facility has been fully financed out of cash flow.

The new facility has been installed as part of a change in the business model from a company that was positioned to deliver novel boronic acids to the drug discovery market, to one which can now support this industry during their critical scale-up phase and even early commercialization.

Boron Molecular continued to expand its product library now with over 800 compounds/products.

Mantecorp Installs Tech to Cut Energy Use

Mantecorp is using the Control and Communication Link (CC-Link) open fieldbus network to improve the environmental credentials of its facility in Rio de Janeiro, Brazil.

Concerns about energy costs and environmental sustainability have created new pressures for all industries, including pharma, and Mantecorp has responded by installing the CC-Link system.

The technology, which is being used in conjunction with Mitsubishi Electric controls, is serving as the supervisory control and data acquisition system for the 3.3m. sq. ft. facility.

Using the technology enables communication and control of the site’s major systems. These include the air conditioning, refrigeration, energy management, filtration and water handling, steam and air sterilization.

By linking sensors in these systems, drives, valves, actuators and other devices to an automated control system conditions can be monitored and automatically adjusted to ensure an optimal operating environment.

By using this technology Charles Lukasik, director of the CC-Link Partner Association, believes the facility achieves “a new level of economic and environmental sustainability through the optimum utilization of air, water, heat, and power”.

Pharma’s Green Initiatives

Numerous companies in the pharma industry are attempting to adjust operations to reduce their environmental impact. These measures include making more efficient use of energy and altering manufacturing processes to make them more sustainable.

For instance, Millipore has set a five-year goal of reducing its greenhouse gas emissions by 20 per cent. To achieve this Millipore has launched a program to improve efficiency, install and purchase renewable energy and ensure employees are aware of their role.

In addition research is being conducted into green solvents, catalysts and desiccants that will not cause harm if they enter the wider environment.

Big pharma’s position towards the top of the recent Climate Counts’ survey suggests that these measures appear to be having some effect.

Pfizer Inaugurates New $214 Million Swedish Biotech Plant

Pfizer’s new $214.8 million (€150m) biotechnology facility in Strangnas, Sweden was inaugurated, securing the country’s future in the company’s manufacturing network according to global manufacturing president Natale Ricciardi.

The new 6,000 sq.meter (64,560 sq. ft.) plant will be used to make active pharmaceutical ingredients (API) for Pfizer’s human growth hormone (HGH) drugs Somavert (pegvisomant) and Genotropin (somatropin [rDNA origin]) when fully operational in 2011.

A key focus of the plant will be growth of the bacteria Escherichia coli (E.coli) and yeast for the production of recombinant proteins, installing capacity that the US drug giant believes will accelerate the introduction of new drugs in the future.

However, Pfizer also stressed that the facility, which has been under construction since 2007 , was designed with flexibility in mind, explaining that the production of multiple biotechnology drugs is an option.

Genotropin, one of the best selling HGH drugs, was bought by Pfizer in 2003 through its acquisition of Pharmacia in a deal that included the Swedish biotech group’s existing Strangnas manufacturing unit.

That facility, which makes the anticlotting drug Fragmin (heparin), will be “connected” to the new plant in an approach the Pfizer said: “gives advantages in terms of materials and personnel flows.”

Ricciardi explained the decision to invest in Strangnas was based on the existing expertise and experience available in the country, and added that “Sweden will have a continued role in Pfizer’s global manufacturing network.”

Her comments will be reassuring for the local biotech manufacturing sector, which employs over 500 people, given the recent rapid growth of the industry in Asia in hubs like China, Singapore and India.

Pfizer Pays Venezuela $17m; US Pharmacies Try to Block Wyeth Deal

According to a number of reports, Pfizer has paid the $17m in back taxes to the Venezuelan tax authorities, after government threats to take control of the company’s manufacturing plants in the country.

Company spokesperson told the e-Taiwan News that the payment had been made, explaining that it follows a standard review of Pfizer's acquisition of pharmaceutical companies, including the 2003 purchase of Pharmacia.

Also, seven Californian pharmacies have sued to block Pfizer’s planned $68m acquisition of Wyeth on the basis that it will drive up drug prices, according to Bloomberg.

A company spokesperson told the newswire that Pfizer has not yet been served with the lawsuit and believes that it is without merit.

GEA Lyophil Supplies Freeze Dryers to Chinese Zheiiang Hisun Pharmaceuticals

GEA Lyophil has won a contract to supply €15m ($21.5m) worth of pharmaceutical freeze dryers with automatic load and unload systems (ALUS) to a Chinese manufacturer.

The order, which consists of seven freeze dryers and five ALUS systems, will be supplied to Zheiiang Hisun Pharmaceutical for use in its facility in Fuyang in eastern China.

Hisun is planning to invest more than €100m in its Fuyang facility to make it one of the biggest pharma production sites in China. Once the expansion is complete Hisun will have capacity to produce anti-tumor, anti-infectives and biologics for the domestic and international markets.

CRL and Quotient Form New European Lab

U.S. analysis group CRL will set up a new laboratory at Quotient Bioresearch’s facility in Cambridge in the UK, in a collaboration designed to expand the US company’s business on the global stage and extend Quotient's offering.

Kansas’ Clinical Reference Laboratory (CRL) plans to offer clinical analysis and testing services for trials conducted in the region, using the laboratory as its base of operations in Europe.

In return, Quotient said it will gain additional capability for services such as biomarker analysis and microbiology testing, for which pharmaceutical industry demand has grown significantly in recent years.

CRL Global Services has chosen to construct its own laboratory in Cambridgeshire, UK, embedded within the existing world-class facilities of Quotient Bioresearch. It will provide a further full service laboratory arm to CRL Global Services' existing global structure. The contract also provides for an immediate close collaboration between the companies on the development and delivery of new services, particularly in the areas of bioanalysis, biomarkers and microbiology.

Cambridge should be an ideal location for the collaboration given that it is part of the UK’s “golden triangle” where many of the world's leading pharmaceutical companies are based.

Additionally, while there are a number of laboratory testing companies operating in the region, including Azopharma which set up there last year, Quotient’s existing presence and local knowledge should help CRL win customers.

Although a Quotient spokesperson was not available for comment, a press statement issued by CEO Paul Cowan set out some of the other potential benefits of the accord with CRL.

He suggested that: “The collaboration brings exciting new opportunities,” adding that “working in tandem with CRL offers access to a well established, standardized global laboratory infrastructure.”

Quotient’s business development director, David Griffiths, reiterated the strategic sense of the partnership explaining that: “The established capabilities of the two companies are entirely comple

Griffiths also suggested that the synergies provided by the collaboration with CRL will “deliver a joint offering significantly broader than available from each party working alone.”

CRL CEO Tim Sotos also stressed the deal’s synergies, highlighting Quotient’s track record in early phase drug development as something that could provide “significant added value” to his firm’s laboratory operations.

Proteomics International Gains ISO Certification

Proteomics International has received International Organization for Standardization accreditation from an Australian accreditation agency for its proteomics service lab, the company said.

The Perth, Australia-based company offers contract research services such as high-throughput mass spectrometry for protein identification, as well as biomarker discovery and other lead molecule services. The accreditation is for compliance with ISO/IEC 17025 lab standards, which covers single protein analysis, biomarker detection, systems mapping and comparison, and peptide sequencing of unknown proteins.

The ISO accreditation was granted by the National Association of Testing Authorities, Australia.

Warner Chilcott Moves Operations to Ireland

Drug developer Warner Chilcott said it completed its move to Ireland from Bermuda.

The company is now Warner Chilcott PLC rather than Warner Chilcott Ltd. Its directors approved the move in May, pointing to advantages such as a stable long-term legal and regulatory environment, tax treaties, and history of international investment. Shareholders later approved as well.

Earlier, Warner Chilcott, which focuses on women's healthcare and dermatology, reported that its second-quarter profit rose 67 percent on higher sales of birth control, hormone therapy and dermatology products.

McIlvaine Company,

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