Genzyme Gets FDA, EMA Approvals for Production Plant in Waterford, Ireland

FDA and EMA cleared Genzyme’s second suite for filling and finishing products at its Waterford, Ireland, manufacturing plant. With this approval the company says that it has nearly doubled its ability to fill and finish Pompe disease therapies Myozyme® and Lumizyme® produced at the 4,000 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. Its long-term goal is 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,” says Genzyme’s head of global manufacturing operations, Bill Aitchison.

Genzyme’s Waterford facility has been in operation for over 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.

In January 2011, Genzyme said that it would build a €250 million manufacturing plant in Geel, Belgium, for Myozyme and Lumizyme. The new plant, sited next to its existing manufacturing site for these two drugs, will have a capacity of 8,000 liters, with room for expansion. Genzyme said it expects commercial approvals will start during late 2014. Meanwhile, production capacity at its current plant at Geel is also being increased to 12,000 liters. Genzyme separately operates a 160 L production plant in the U.S. for patients with infantile-onset Pompe disease.

Bioreactor contamination issues starting in 2009 led to shortages of Myozyme and other Genzyme drugs, followed by significant financial and regulatory problems. Having to shut down one of its production plants meant that for a prolonged period Genzyme was forced to reserve the Myozyme it could keep manufacturing for the treatment of infants and children with Pompe disease in the U.S.

Myozyme and Lumizyme are alglucosidase alfa enzyme-replacement therapies. Genzyme suggests that the Pompe disease drugs could match its Gaucher disease therapy Cerezyme in terms of commercial potential. Myozyme is currently available for all Pompe disease patients, and Lumizyme was cleared by FDA in May 2010 specifically for the treatment of patients aged eight years and older with late-onset (noninfantile) Pompe disease who do not have evidence of cardiac hypertrophy. In Europe the drug is indicated for infants, children, and adults with the neuromuscular disease.