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Chitra Sethi, Managing Editor, BioPharm International
The biopharmaceutical company Genzyme Corporation (Cambridge, MA), which suffered from a series of manufacturing problems including viral contamination at its Allston Landing plant in June 2009, has announced that it will phase out its fill-finish operations from the plant gradually.
The biopharmaceutical company Genzyme Corporation (Cambridge, MA), which suffered from a series of manufacturing problems including viral contamination at its Allston Landing plant in June 2009, has announced that it will phase out its fill-finish operations from the plant gradually. The first product to be moved will be Thyrogen, which is expected to be transferred in the third quarter of this year.
The announcement was made at an investors conference held on March 31, where three newly appointed Genzyme officials including David Meeker, the chief operating officer, Ron Branning, senior vice president of global product quality, and Scott Canute, president of global manufacturing and corporate operations, gave an update on the company's manufacturing operations.
The new executives said the company is taking steps to resolve its manufacturing problems, which include strengthening risk management practices at the plant, testing new techniques to reduce the risk of viral contamination, and tightening in-process controls. They also said that Genzyme already has hired the Quantic Group as the third party to remediate its quality systems.
The meeting followed a recent notification by the FDA that it intends to take enforcement action to ensure that products manufactured at the Genzyme's Allston plant are made in compliance with GMP regulations. The FDA enforcement action will likely result in a consent decree, under which a third party would inspect and review the plant's operation and certify compliance with FDA regulations.
When asked during the meeting about the next steps involved in negotiating the consent decree, the executives said that so far they had received only one phone call from the FDA and they expect to get further clarity from the agency in the coming weeks.
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