The approval allows Genzyme to immediately begin the manufacturing, fill/finishing, packaging and labelling of Thymoglobulin (anti-thymocyte globulin, rabbit) - a drug for the treatment of acute rejection in patients with a kidney transplant.
The company's Waterford facility has recently undergone a major expansion to add additional biological filling and packaging capabilities to be able to make Thymoglobulin from a single location - and in the process making major cost savings - as well as support the anticipated growth of both new and existing protein products that are manufactured at other Genzyme facilities.
"In the coming months we expect to receive similar fill/finish approvals at the plant for two of our enzyme replacement therapies (ERT), Myozyme and Cerezyme," said company spokesperson, Mark Bamforth.
"We are currently conducting approval-qualifying manufacturing runs at the facility for the two products."
Myozyme (alglucosidase alfa) - a newly-approved ERT for Pompe disease - is already manufactured at Genzyme's flagship facility in Allston, Massachusettes, and the company expects to soon receive the go-ahead 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 meet anticipated global demand."
Genzyme said it also plans to use the Waterford facility for additional capacity and security for the fill/finish of Cerezyme (imiglucerase for injection) - an ERT for Gaucher disease - also currently manufactured at its Allston plant.
Although Genzyme has a total of seven manufacturing sites in Europe, its Waterford plant serves as its major European production and distribution centre for large volume runs of range of its products.
Waterford is already the primary tabletting and bottling centre for Renagel (sevelamer hydrochloride) - a drug used in patients with chronic kidney disease (CKD) - and the plant produced 3m bottles in 2005.