Genzyme’s Irish plant approved

Both the US FDA and the EMA have approved a second suite for filling and finishing products at Genzyme’s manufacturing plant in Waterford, Ireland.

The approval means Genzyme will almost double its ability to fill and finish Pompe disease treatments Myozyme and Lumizyme (alglucosidase alfa).

Bill Aitchison, Genzyme’s Head of Global Manufacturing Operations, said the approval is an “important milestone” for Genzyme as it aims to build a “robust manufacturing network”.

The manufacturing site employs more than 500 people and has been in operation for more than a decade. It is considered to be Genzyme’s centre of excellence for aseptic manufacturing and recently underwent a $150 million expansion earlier this year.

Genzyme now hopes to begin the process of securing further approval from the American and European health regulators to fill and finish additional products in the suite. The Sanofi company has the long-term aim to use the Irish plant as a filling and finishing platform across its portfolio of products.