FDA Approves Additional Manufacturing at Genzyme's Ireland Plant

Genzyme Corporation (Cambridge, MA, www.genzyme.com) reports the US Food and Drug Administration (Rockville, MD, www.fda.gov) has approved the fill–finishing, packaging, and labeling of "Thymoglobulin" (antithymocyte globulin, rabbit) at its Waterford, Ireland facility. The approval allows Genzyme to begin the manufacturing and distribution of Thymoglobulin from this facility.

Genzyme also is conducting approval-qualifying manufacturing runs of "Cerezyme" (imiglucerase for injection) and "Myozyme" (alglucosidase alfa) at the Waterford facility. The company hopes to receive similar fill–finish approvals for these enzyme replacement therapies at Waterford in the coming months.

Myozyme was approved in Europe and the United States earlier this year. Genzyme currently manufactures Myozyme in the United States. The company also 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. Genzyme 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.

Genzyme completed a major expansion at Waterford last year, adding biological filling and packaging capabilities to support the growth of protein products such as Myozyme and Cerezyme, along with products such as Thymoglobulin that are manufactured at other Genzyme facilities. Waterford also is the primary tableting and bottling center for Genzyme's "Renagel" (sevelamer hydrochloride). In 2005, the plant produced roughly 3 million bottles of Renagel.

The Wateford expansion was part of an overall expansion program for manufacturing and product development through four major recent expansion projects in Belgium, Ireland, and the United Kingdom. In addition to Waterford and Geel, Genzyme also expanded a manufacturing center in Haverhill, UK and created an antibody discovery research facility in Cambridge, UK.

Genzyme has a total of seven manufacturing sites in Europe, including a small-molecule production site in Liestal, Switzerland, a polyclonal biomanufacturing site in Lyon, France, and diagnostic manufacturing facilities in Kent, UK and Rüsselsheim, Germany.