Genzyme - Expanded Waterford Manufacturing Plant

Wednesday, 9th May 2012

Genzyme Announces Regulatory Approvals of Expanded Waterford Manufacturing Plant

Genzyme, a Sanofi company has announced that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) 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 4000 litre 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.

Pat O’Sullivan, General Manager, Genzyme Waterford, stated: "These approvals are a tremendous achievement for the Waterford site. This additional state of the art capacity reinforces Waterford’s strategic importance within the Genzyme manufacturing network. For me, the team who worked on the project was the single biggest contributor to making this happen. I want to acknowledge and thank everyone who worked on this important project."

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