Genzyme gets FDA nod for Thymoglobulin production in Ireland
Genzyme Corporation has had approval from the US FDA for the filling, finishing, packaging and labelling of Thymoglobulin at its Waterford, Ireland facility.
Genzyme Corporation has had approval from the US FDA for the filling, finishing, packaging and labelling of Thymoglobulin at its Waterford, Ireland facility.
The approval enables the biotech company to begin manufacturing and distribution of Thymoglobulin, a product for treatment of acute rejection in patients with a kidney transplant, from this single location. The move will increase manufacturing efficiencies, says the company.
"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 centre for large volume runs of a broad range of products," said 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."
The company 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 US for treatment of Pompe disease - a debilitating, progressive and often fatal disorder affecting fewer than 10,000 people worldwide.
Genzyme manufactures Myozyme in the US. 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 manufacturing facility in Allston, Massachusetts. The company plans to use the Waterford facility for additional capacity and security for Cerezyme's fill/finish.
When the company 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 facilities. The facility uses a state-of-the-art isolator system that provides the reliability of a sterile environment and product assurance.
Waterford is already the primary tableting and bottling centre for Renagel (sevelamer hydrochloride).