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.
Letters to the Editor
- Editorialread more »
Google AlertWhen a company which has it's European Headquarters here in Ireland is called 'evil' and 'immoral' by M.P.s in The House of Commons you tend to sit up and take notice. The particular company that was being referred to was Google and the reason it had enraged M.P.s in London was because even though it has a big operation there and conducts a lot of business there it pays no corporate tax. It does this by having all of its financial transactions finished here in Ireland. And the company here is …
We're delighted to announce the launch of the new-look Waterford Today website. Tell us what you think of the new site design?
Total votes: 44 Refresh results