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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-07-13-2007, Volume 3, Issue 7

A roundup of manufacturing and service expansions.

Basel, Switzerland (July 3) plans to produce approximately 40 million doses of its "Fluvirin" vaccine for distribution in the United States during the upcoming 2007–2008 influenza season, a 30% increase in supply over last year.

Based on accelerated production plans, approximately half of these doses are planned for delivery by the end of September, with all doses expected to be delivered by the end of October. The exact timing of deliveries will depend on the release of doses by the (Rockville, MD).

Fluvirin contains the three influenza virus strains identified in the annual public health expert assessment for the 2007–2008 season in the United States: A/Solomon Islands/3/2006 (H1N1)-like virus, A/Wisconsin/67/2005 (H3N2)-like virus, and B/Malaysia/2506/2004-like virus.

Durham, NC (July 2), a biotechnology company advancing a pipeline of clinical-stage regenerative therapies, established a Class 10,000 cleanroom for good manufacturing practice certified manufacture of its cellular products. The manufacturing facility is approximately 1000 ft 2 and is fully validated and supported by environmental monitoring and quality control activities. Aldagen's proprietary stem-cell isolation technology is incorporated into the manufacturing process, and the products produced at this facility will be used for three ongoing clinical studies.


Oxford, UK (June 27)completed the construction of its good manufacturing practices (GMP) facility located at its subsidiary company, Dextra Laboratories, which specializes in carbohydrate chemistry. The GMP facility will allow VasTox to produce material in sufficient quantities for use in human clinical trials up to the Phase II stage of clinical development. To ensure the facility is fully GMP-compliant, VasTox will perform a test run to produce material for one of its own drug-discovery programs with the facility receiving its first fee-paying client by the end of July 2007.

Camarillo, CA(June 25)(formerly known as Integrity Biosolution), opened its good manufacturing practices fill–and–finish facility for the contract manufacturing of infusion- or injection-based products that are preclinical or entering Phase I and Phase II clinical trials.The facility has the capacity to accommodate the manufacturing of up to 10,000 liquid formulation vials or 3000 of lyophilized formulation vials per lot.

Clayton, NC (June 25) opened its newly expanded manufacturing facility in Clayton, North Carolina. The $100-million, 200,000-ft2 facility will produce Novo's prefilled insulin pen. This is the second time in three years the facility has been expanded.

Cheshire, CT (June 22) inaugurated its first manufacturing plant in Smithfield, Rhode Island. Alexion acquired the plant from (Midland, MI) and invested $47 million. To staff the new facility, the company expanded its workforce by more than 100 employees.

Newton, MA (June 21) unveiled its new Microfluidics Technology Center at its headquarters in Newton. The center houses technology to help customers prepare physical samples, documentation, microscopic digital images, and particle-size analysis of improved processes. In addition, customers can receive assistance in reformulating existing products using Microfluidics's proprietary high-shear "Microfluidizer" materials processors.

Skokie, IL (June 20)(MBR) is moving to a new facility in response to increased demand for its drug-disposition and toxicology services. The new 16,000-ft2 facility is located at the Illinois Science and Technology Park in Skokie. Illinois.

St. Louis, MO (June 19) launched "ChemDose," a compound-handling technology that enables easy delivery of reagents and catalysts in tablet form. ChemDose, which was codeveloped with (Manchester, UK), involves the absorption of reagents into an inert tablet matrix. When it is exposed to solvents, the reagents dissolve, leaving behind an insoluble tablet.

Brussels, Belgium (June 13)is expanding production capacity for ultrapure soda ash at its site in Dombasle, France. The plant's capacity will be expanded to 5 kt per year in the third quarter of 2007 to meet growing worldwide pharmaceutical demand. Soda ash is used as an excipient to make effervescent tablets.