Bayer's New Sterile Fill Facility Receives EMEA, FDA Licenses

The European Medicines Agency (EMEA) has granted license approval to Bayer HealthCare LLC (Bayer, Berkeley, CA) for its new sterile filling facility on its Berkeley, CA, campus. The approval follows authorization already given by the US Food and Drug Administration (FDA) in August 2008. The facility will be used in the late-stage production processes of filling and lyophilization for Bayer’s Kogenate FS/Kogenate Bayer line of products, for the treatment of hemophilia A.

The 44,000 square foot sterile facility will support larger lot sizes and will allow Bayer to significantly increase product output. This capacity increase will support the Kogenate product line’s growth in several emerging markets. The high level of automation in the facility minimizes the risk of external contamination and provides high levels of quality assurance because it requires fewer personnel to operate than more manual setups.

The increased capacity of the new facility comes as Bayer continues to expand its hemophilia portfolio with new development candidates in clinical trials. Kogenate formulated with liposomes is currently in Phase 2 clinical development and may eventually allow once-weekly infusions in prophylaxis for hemophilia patients. Bayer is preparing Phase 1 clinical trials with its recombinant Factor VIIa for treating patients who develop inhibitors to FVIII and FIX treatment.

Bayer is continuing licensure activities for the facility to ensure it can supply product for all markets of the world. Regulatory agencies from Canada and other countries are in the final stages of inspections and application reviews. Pending these additional approvals, Kogenate products will continue to be manufactured at the existing approved filling and freeze-drying facility on the Berkeley campus.