Genzyme Is Ready For FDA: Geoff McDonough Explains What The Firm Is Doing To Overcome Its Problems
As summer turns to fall, Genzyme is trying to place the viral contamination problems at its Allston Landing, Mass., plant in the rear-view mirror. Both Cerezyme and Fabrazyme are back in production after a July shutdown that caused shortages of the two drugs. Cerezyme is the only approved therapy for Gaucher disease, while Fabrazyme is the only U.S.-approved drug for Fabry disease.
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Troubled by viral contamination problems at its enzyme-replacement therapy manufacturing site, Genzyme maintains full-scale production will resume by first-quarter 2010.
Letter specifying need for re-inspection cites equipment maintenance concerns, review of viral contamination remediation.
Genzyme's Allston Landing, Mass., plant - currently the only facility that produces its Cerezyme and Fabrazyme drugs - resumed working at full capacity on Aug. 28. But it seems the big biotech's manu-facturing woes are far from over: a mid-August visit by the European Medicines Agency found deficiencies, and a critical FDA inspection is still to come