Fill Finish Manufacturing
Construction commenced in 2002 of a three storey (6868sq.m) state of the art Sterile Fill Finish facility and associated Central Utility Building and Warehouse at the Waterford site. This first phase was designed as a multi product facility capable of filling vials from 2ml to 65ml at a speed from 100-400 vials per minute.
Commercial production of Thymoglobulin, an immunosuppressive polyclonal antibody, commenced in 2006. Two additional products, Cerezyme, for the treatment of Type 1 Gaucher disease and, Myozyme, the first treatment ever approved for Pompe disease subsequently transferred during 2007. Products filled at Waterford are packaged and distributed to patients world wide.
Manufacturing processes include formulation, sterile liquid vial filling, lyophilisation (freeze drying), capping, product 100% inspection and packaging. Product is protected during the filling process using isolator technology and an automated load/unload system is used for the lyophiliser
Work has commenced on the next phase of the facility expansion which will result in a tripling of the facility capacity which includes an additional filling line and lyophiliser and associated unit operations. The plan is to have this additional capacity available for commercial product by 2011.
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