Undisclosed quality problems are behind Genzyme's recent disposal of batches of genetic-disorder treatments Cerezyme and Fabrazyme. Also affected and discarded are batches of thyroid medicine Thyrogen and cholesterol treatment Cholestagel, according to Reuters.
A Genzyme spokesman says the current manufacturing quality problems are unrelated to its water-supply problems of earlier this year. Those problems were preceded by an FDA warning for GMP violations and a stubborn viral contamination last summer at the company's Boston-area plant. Those issues ultimately yielded an FDA consent decree, under which the drugmaker now operates.
It's unclear whether the current batch problems are the result of the earlier manufacturing issues--i.e., the GMP violations or virus--or a new problem. A call to Genzyme Wednesday has not been returned.
The company now estimates, in a financial statement, a three- to four-year time frame for the manufacturing remediation required by consent decree; that's a year longer than its last projection, as reported. It's still developing the plan, which it aims to submit to the FDA by year's end.
Meanwhile, process validation runs for Fabrazyme and Thyrogen are underway at Hospira, and the company says it's on track to meet its late November 2010 deadline to complete the fill/finish transition.