BERKELEY, Calif.--(BUSINESS WIRE)--The European Medicines Agency (EMEA) has granted license approval to Bayer HealthCare LLC (Bayer) for its new sterile filling facility (SFF) on its Berkeley, Calif. campus. The approval closely follows authorization already given by the U.S. Food and Drug Administration in August 2008. Together, these licenses from the regulatory bodies ensure this state-of-the-art facility is ready to support the supply of Bayer’s Kogenate® FS/ KOGENATE® Bayer (Antihemophilic Factor [Recombinant]) line of products in its largest markets (U.S. and EU). The forward-looking technology and design of the new SFF represent a key investment by Bayer, already one of the top-10 biotech companies in the world, in further strengthening its bio-manufacturing operations on the West Coast of the United States. The facility will be utilized in the late-stage production processes of filling and lyophilization (freeze-drying) for Bayer’s Kogenate® FS/ KOGENATE® Bayer line of products, a leading treatment for hemophilia A.
