The FDA and EMA have approved a second suite for filling and finishing product at Genzyme‘s Waterford, Ireland manufacturing plant. With this approval, Genzyme has nearly doubled its ability to fill and finish Myozyme and Lumizyme produced at the 4000 liter bioreactor scale. Genzyme 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.

Genzyme’s Waterford facility has been in operation for more than 10 years, and a $150 million expansion was completed earlier this year. The Waterford manufacturing site employs over 500 people and is considered Genzyme’s center of excellence for aseptic manufacturing.