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.

Genzyme is to build a new plant to meet the demand of Myozyme and Lumizyme, the only approved treatments approved for Pompe disease.

The €250 million plant in Geel, Belgium, will include 8,000 litres of production capacity and provide room for additional capacity expansions.

Scott Canute, Genzyme’s President, Global Manufacturing and Corporate Operations, says the new facility is a “critical element” of the company’s manufacturing strategy.

An adjacent plant on the site is also set to expand its production capacity to 12,000 litres, with the additional of a third bioreactor planned towards the end of 2011.

As part of the expansion, Genzyme expects approximately 150 new jobs to be created, bringing the total workforce at the site to nearly 600 people.

“We are committed to delivering a reliable supply of high quality medicines to our patients,” said Mr Canute.

“This investment ensures continued supply to our patients in the Pompe community for the long term.”

Myozyme is indicated for infants, children and adults with Pompe disease in Europe.