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Genzyme Corp. has detected a virus that impairs cell growth in one of six bioreactors at its Allston Landing manufacturing facility.
June 16, 2009
By: Tim Wright
Editor-in-Chief, Contract Pharma
Genzyme Corp. has detected a virus that impairs cell growth in one of six bioreactors at its Allston Landing manufacturing facility. The company has temporarily interrupted bulk production to sanitize the facility and is collaborating with regulatory agencies to resume production. The company expects the plant to be fully operational by the end of July. The virus strain, vesivirus 2117, has not been shown to cause human infection but interferes with the growth of CHO cells used to produce biologic drugs. It was likely introduced through a nutrient used in the manufacturing process. According to the company, this virus caused declines in cell productivity at its Allston and Geel facilities in two previous instances in 2008, which were subsequently addressed. The company declared that its current inventories for Cerezyme and Fabrazyme are not sufficient to meet projected global demand. The timing and extent of the Cerezyme supply constraint is being clarified and will be communicated as soon as possible. The company expects Fabrazyme supply constraints to occur for a limited period beginning in September. The company will work with physicians, patients and regulators to help minimize the impact on patients. “The patients who need these therapies are our priority,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer. “We are confident in the quality of the products produced in Allston and in our ability to resolve the issue affecting the plant. The impact will be temporary.”
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