Pharmaceutical manufacturing: news in brief
pharmafile | June 22, 2009 | News story | Manufacturing and Production | Genzyme
Pharmafocus presents a round-up of developments in manufacturing, including facility updates from Genzyme, Norwich Pharma and Kemwell/Boehringer Ingelheim, progress with Vical's rapid production technology and optimistic forecasts for the contract manufacturing market.
Genzyme has shut down production at one of the six bioreactors operating at its manufacturing facility in Allston Landing, after detecting a virus contaminant that was impairing cell growth. The company said it has decided to "temporarily interrupt bulk production at the plant to sanitise the facility", and anticipates production will restart by the end of July. In the meantime it expects some interruption in the supply of its Cerezyme (imiglucerase) for Gaucher disease and Fabrazyme (agalsidase beta) for Fabry disease.
Kemwell, an Indian contract research and manufacturing services (CRAMS) company, is collaborating with Boehringer Ingelheim on a biopharmaceutical manufacturing plant in Bangalore. The venture takes Kemwell into the area of large-scale manufacturing to complement its clinical supply services, while Boehringer gains a low-cost biologics unit in Asia. The total investment in the 15,000 sq. m. unit will be around $50 million.
Contract manufacturer Norwich Pharmaceuticals has expanded its service portfolio with the addition of a new production suite that will make high potency compounds at pilot scale for use in clinical trials. The $3 million facility can handle a range of solid-dose formats, including fast-dissolve and controlled-release tablets, said the firm.
The demand for biopharmaceutical contract manufacturing services will grow at a rate of 16% a year over the next five years from a 2009 level of around $2.6 billion, as industry business models shift toward more outsourcing of production, according to a study by HighTech Business Decisions. Capacity utilisation is a little down on 2006 levels, however, because of previous investment in capacity, improved expression yields, and a slowdown in biotechnology investments because of the credit crunch.
Vical is taking a project to develop a rapid manufacturing technology for DNA vaccines into its third year, after meeting the second-year milestones laid out in a $6 million grant award from the US National Institutes of Health. The RapidResponse system has the potential to make several million vaccine doses "in a matter of days", according to a company statement.
Human Genome Sciences is looking for a biopharmaceutical company to sublet a 175,000 sq. ft. manufacturing unit formerly operated by flu vaccine company MedImmune, according to a Washington Business Journal report. MedImmune decided to vacate the manufacturing space after losing a contract with the Department of Health and Human Services for a cell culture-based influenza vaccine.
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