This article provides a link to the pdf version of Genzyme’s press release regarding Myozyme manufacturing.
CAMBRIDGE, MA – Genzyme Corporation (NASDAQ: GENZ) announced today that the FDA has informed the company of its opinion 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. Currently, Genzyme has U.S. approval to sell Myozyme manufactured at the 160L scale, and the company has been seeking clearance from the FDA for Myozyme produced at the 2000L scale. Production at this larger scale has already been approved in more than 40 countries…
Download the press release (PDF, 23 kB)