Genzyme Receives Approval for Additional Manufacturing at Ireland Plant
Thymoglobulin Fill/Finishing to Begin Immediately
Genzyme Corporation announced that the U.S. food and Drug Administration has approved the fill/finishing, packaging and labeling of Thymoglobulin® (anti-thymocyte globulin, rabbit) at its state-of-the-art Waterford, Ireland facility. The approval allows Genzyme to begin manufacturing and distribution of Thymoglobulin, a product for the treatment of acute rejection in patients with a kidney transplant, from this single location and further enhances Genzyme's manufacturing efficiencies.
Genzyme is currently conducting approval-qualifying manufacturing runs of Cerezyme® (imiglucerase for injection) and Myozyme® (alglucosidase alfa) at the facility. Myozyme was approved this year in Europe and the U.S. for treatment of Pompe disease - a debilitating, progressive and often fatal disorder affecting fewer than 10,000 people worldwide. Genzyme currently manufactures Myozyme in the United States. The company expects to also 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, MA. 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.
Genzyme has a total of seven manufacturing sites in Europe, including a small molecule production site in Liestal, Switzerland, a polyclonal bio-manufacturing site in Lyon, France, and diagnostic manufacturing facilities in Kent, UK and Rüsselsheim, Germany.
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