SGS Life Science Services (LSS) is expanding its R&D / QC operations in North America by doubling its facilities in Chicago and tripling those in Toronto. The moves are in response to 10-15% annual growth in the market for pharmaceutical contract testing.

SGS has been operating its LSS division in Canada since 1984, and has been in its existing facility located in the Toronto suburbs of Mississauga since 1987. The new facility, also located in Mississauga, will triple the space from 15,000 sq. ft. to 46,000 sq. ft. The company anticipates doubling its technical resources to handle new business opportunities.

Concurrent with the move to the new Mississauga facility, the R&D / QC group will expand its capabilities in Canada by offering testing services for the analysis and characterization of biopharmaceuticals. The move is currently underway in phases and is expected to be completed by September.

In the U.S., SGS LSS’ sites include a 35,000-sq.-ft. facility in northern NJ, in close proximity to top pharmaceutical companies. In 2006, SGS expanded its U.S. market presence by acquiring Northview Laboratories, adding an existing facility in the Chicago suburb of Northbrook, IL. SGS LSS will move from the Northbrook facility to a new site in Lincolnshire, IL, doubling the facility size from 21,500 sq. ft. to almost 40,000 sq. ft.

As part of the move, SGS will increase its offerings in Stability Studies and Stability Program Management. SGS LSS plans to double its technical staffing by the end of 1Q10,. Modifications to the building are currently in progress, with move-in by the end of 2009.

“For SGS’ Life Science Services, the expansion at these two sites demonstrates our continued commitment to delivering excellent quality and service.” said Sohil Mana, Sr., vice president and regional business manager, North America. “The move also involves the implementation of Lean Projects to increase efficiencies in our laboratories. These projects will strengthen our performance by developing innovative solutions to lead the industry in on-time delivery. Given that outsourcing is a continuing trend within the pharmaceutical market, these recent expansions will contribute to positioning SGS Life Science Services as the preferred partner to the pharmaceutical and biotechnology industries.”

SGS Life Science Services' R&D / QC division performs method development and quality control testing for the pharmaceutical, biopharmaceutical, medical device, chemicals and cosmetics markets.

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Millipore has acquired BioAnaLab, a European-based services provider that specializes in the analysis of biologic drugs and vaccines. The transaction enables Millipore to expand its biopharma services business into Europe

"Our acquisition of BioAnaLab will allow us to build on our reputation as a trusted outsource partner in North America by establishing a presence in the fast-growing European biotech market," said Jonathan DiVincenzo, president of Millipore's Bioscience Division. "BioAnaLab will add cGMP support testing capabilities to our portfolio, a solid customer base, and a team of highly talented services professionals with expertise in emerging scientific disciplines."

Based in Oxford, UK, BioAnaLab was spun out of the University of Oxford in 2002 to meet the unique requirements of the biopharmaceutical industry by helping its customers better understand the safety and efficacy of biologic drugs and vaccines, using "a broad range of services to assist with evaluating and advancing these therapeutics from the drug development pipeline to the market," according to a Millipore statement. BioAnaLab's services include assay transfer/development, validation and sample analysis, pharmacokinetics/toxicokinetics, immunogenicity, biological potency, and vaccine services.

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Nycomed and Forest Laboratories have entered into a collaboration and distribution agreement for Daxas in the U.S. Daxas is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that has been developed by Nycomed for the treatment of COPD (chronic obstructive pulmonary disease) and for which Nycomed submitted an NDA with the FDA in July.

Forest will make an upfront payment to Nycomed of $100 million and will pay undisclosed milestone payments. In addition, Nycomed will receive royalties based on Daxas sales. Forest will assume responsibility for the U.S. regulatory approval and commercialization of Daxas in the U.S. and the companies will collaborate on future development programs.

Hakan Bjorklund, chief executive officer of Nycomed, said: "We have received considerable interest in the marketing rights to Daxas and we believe Forest Laboratories is the best possible partner for Nycomed in the US. Forest Laboratories has a significant US sales force, an increasing focus on respiratory products and an unrivalled track record of partnering with European companies to build hugely successful franchises. We believe their absolute commitment to Daxas will help to bring this innovative new therapy to as many patients in the United Sates as possible who suffer from COPD, a disease which is predicted to become the third-leading cause of death worldwide by 2030."

Howard Solomon, chairman and chief executive officer of Forest, said, "Daxas represents the first in a new class of agents to treat COPD and would be the first oral agent to be approved for this debilitating disease. If approved, Daxas will give physicians and patients a much needed new treatment option in a unique oral dosage form that can augment the existing armamentarium of inhaled therapies."

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Patheon's solid dose manufacturing facility in Manati, Puerto Rico received regulatory approval from the EMEA following the completion of a successful inspection in May by the Medical Products Agency of Sweden. The inspection of the facility marks 19 successful regulatory inspections at nine manufacturing sites for the company in 2009, including eight FDA inspections and two European inspections.

"Patheon's track record of regulatory compliance underscores our commitment to quality and reliability for our customers," said Terry Novak, President, Patheon North America. "The approval of our Manati facility allows us to ship solid dosage product into Europe from Puerto Rico, which provides additional benefit and flexibility for our clients."

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