Genzyme gains FDA and EMA approval for Irish production plant

US biotech firm Genzyme, a subsidiary of French drug major Sanofi (Euronext: SAN) said yesterday that the US Food and Drug Administration and the European Medicines Agency have approved a second suite for filling and finishing product at its Waterford, Ireland manufacturing plant.

With this approval, Genzyme has nearly doubled its ability to fill and finish Myozyme and Lumizyme (alglucosidase alfa) produced at the 4,000 liter bioreactor scale. Genzyme says it will also begin the process to secure FDA and EMA approvals to fill and finish additional products in the second suite, with the long-term goal to use the Waterford site as a filling and finishing platform across its portfolio of products.

“The approval of the second filling and finishing suite in Waterford is another important milestone on our journey to build a robust manufacturing network capable of ensuring reliable and consistent supply of our products to patients,” said Genzyme’s head of global manufacturing operations, Bill Aitchison.