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Genzyme’s Manufacture of Myozyme Delayed

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has informed Genzyme that Myozyme (alglucosidase alfa) produced at the 160L bioreactor scale and Myozyme produced at the 2000L scale should be classified as two different products because of differences in the carbohydrate structures of the molecules. Genzyme currently has U.S. approval to sell Myozyme manufactured at the 160L scale and has been seeking FDA clearance for the 2000L scale. Production at this larger scale has been approved in more than 40 countries.     Based on the glob...

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