Genzyme is also currently conducting approval-qualifying manufacturing runs of Cerezyme and Myozyme at the facility.
Myozyme, which is currently manufactured in the US, was approved this year in Europe and the US for the treatment of Pompe disease. The company expects to scale up bulk production of Myozyme at its new protein manufacturing facility in Geel, Belgium, and then fill and package the product in Waterford to ensure that it is able to meet the anticipated demand for Myozyme throughout the world.
Genzyme currently produces Cerezyme at its flagship manufacturing facility in Allston, Massachusetts. The company plans to use the Waterford facility for additional capacity and security for Cerezyme’s fill/finish.
When Genzyme completed a major expansion at Waterford last year, it added high-quality biological filling and packaging capabilities to support the growth of protein products such as Myozyme and Cerezyme, along with products like Thymoglobulin that are manufactured at other Genzyme facilities. The facility uses a state-of-the-art isolator system that provides the reliability of a sterile environment and the assurance of producing quality products.
Waterford is already the primary tableting and bottling center for Renagel. In 2005, the plant produced approximately three million bottles of Renagel for patients with chronic kidney disease who are on dialysis.
“We are very pleased with this approval, as it continues the development of our supply strategy with Waterford serving as our major European production and distribution center for large volume runs of a broad range of products,” stated Mark Bamforth, Genzyme’s senior vice president for corporate operations and pharmaceuticals. “We look forward to also receiving similar fill/finish approvals for two of our enzyme replacement therapies at Waterford in the coming months.”