Genzyme Survives Virus Infection at Allston Manufacturing Plant and Resumes Drug Production

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Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas)--In a move befitting an industry laden with irony, a virus infection forced the Genzyme Corporation (NASDAQ:GENZ) to shut down the company's biopharmaceutical plant in Allston Landing, Massachusetts. The virus strain Vesivirus 2117, which was found in the site's six bioreactors, interferes with the growth of CHO cells, a component in biologic drug production.

With the faint symptoms of a problem surfacing in February this year, Genzyme definitively identified the virus in June. It then submitted the findings to the Food and Drug Administration (FDA) and the European Medicines Agency. Forced to halt production in Allston, the presence of the virus forced Genzyme to perform a full decontamination of the facility, including preventative maintenance and sanitization of the bioreactors. Typically introduced through a nutrient used in the manufacturing process, there is no evidence that the virus can cause infection in humans.

With the plant again operational, Genzyme is anxious for a re-inspection by the FDA to verify that it has performed all corrective and preventative actions as directed by the agency, including remediation efforts related to the identification of the virus. The company expects the first shipments of Cerezyme to be ready in November and December. Due to the later restart of the two bioreactors dedicated to Fabrazyme production, the product will not be ready to ship until mid-December. The company expects to meet the anticipated full patient demand for both products during the first quarter of 2010.

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