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EMEA Inspection Findings Portend Further Manufacturing Problems For Genzyme

This article was originally published in The Pink Sheet Daily

Executive Summary

Market analysts note growing concerns about biotech's ability to handle manufacturing difficulties at Allston Landing, Mass., plant.

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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.

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.

FDA Inspection Items For Genzyme's Allston Plant Appear Minor

Letter specifying need for re-inspection cites equipment maintenance concerns, review of viral contamination remediation.

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