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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-06-22-2007, Volume 3, Issue 6

A roundup of manufacturing and service expansions.

(Basel, June 12, 2007) is planning to build a new, large-scale manufacturing site in Visp, Switzerland for highly potent active pharmaceutical ingredients (APIs). This large scale capacity expansion will complement Lonza's existing smaller scale facilities for highly potent APIs.

Lonza will invest more than CHF 80 million ($64 million) in the construction of API capacity and expects to hire approximately 40 new employees by 2009.

Cambridge, MA (June 11)– plans to build a new biomanufacturing plant in Lyon, France, for the production of "Thymoglobulin"(anti-thymocyte globulin [rabbit]), a treatment used in transplantation. The project represents one of several investments Genzyme is making in its global manufacturing infrastructure.

The new 140,000-ft2 facility in Lyon will replace Genzyme's smaller plant in nearby Marcy l'Etoile and will provide more than twice the manufacturing capacity. Approximately 165 people are employed at the existing Thymoglobulin plant, and Genzyme expects that approximately 50 new jobs will be created when the new facility operates at full capacity. The total cost of the project is expected to be EUR 105 million ($140 million).


Construction is expected to begin later this year, and regulatory approvals are expected starting in 2010. Routine manufacturing at the site is expected to commence in 2011.

In addition to the Lyon project, Genzyme is completing the development of a new plant in Belgium for the production of monoclonal antibodies and proteins and is expanding other facilities, including its Allston Landing protein manufacturing plant in Boston. Genzyme also recently received regulatory approvals for a new filling and packaging facility at its manufacturing site in Ireland, which has become the company's major European center for the final production and distribution of a range of products, including Thymoglobulin. Genzyme operates 15 GMP (good manufacturing practices) manufacturing plants around the world, seven of them in Europe.

In the United States, Genzyme is currently completing the construction of a new science center.

Paris (June 1) is investing EUR 55 million to strengthen its manufacturing facility and pharmaceutical development center in Dreux, France. The investment will focus on formulation, analytical development, and manufacturing batches for preclinical and clinical research. The company intends to construct two new buildings by 2009 and will renovate an existing building. The investment also is expected to create 85 new jobs

Seattle, WA (June 2) introduced the "RapidResponse" DNA vaccine platform, which is designed to quickly produce large quantities of vaccine. The platform uses a cell-free manufacturing process and single-step vaccine purification, which can be easily scaled up by employing larger manufacturing equipment. The process involves the production of a small segment of DNA that includes only those DNA sequences essential for the specific vaccine.

Toronto, ON, Canada (May 30) discovered a process that could boost influenza-vaccine production. The process increases the virus yield from eggs by retrieving virus from debris in the egg that usually is discarded. Independent testing at the Queen Elizabeth II Health Sciences Center in Halifax, Nova Scotia confirmed that this process doubles the amount of virus recovered.

Mumbai, India (May 25)— sterile manufacturing site in Bangalore received approval from the . The facility manufactures injectables in freeze-dried and liquid vials, prefilled syringes, and dry-powder sterile forms of nonpenicillin and noncephalosporin therapeutic formats.

Mississauga, ON, Canada (May 24)— manufacturing facility for nimotuzumab was successfully scaled up to a 500-L-capacity continuous-perfusion fermentation process. Also, Health Canada and a regulatory authority in the European Union inspected and certified the manufacturing process for nimotuzumab and the newly enlarged facility. Nimotuzumab is a humanized monoclonal antibody for the treatment of cancer.

Liverpool, UK (May 21) awarded a license to manufacture investigational medicinal products at the Eden-operated National Biomanufacturing Center in Liverpool. Eden now has the authority to manufacture biopharmaceutical drug substances for clients to use in EU clinical trials.