Berkeley
Biomanufacturing Expertise at Berkeley
With more than $3 billion in protein drug sales and two decades of experience in producing complex protein therapies, the Berkeley site functions as the headquarters for Bayer’s biotechnology product supply organization as well as the global manufacturing center for Kogenate®*, a recombinant factor VIII treatment for hemophilia A. The biomanufacturing facilities in Berkeley are licensed by many of the major health regulatory agencies around the world, including the US Food and Drug Administration. As the company expands into new global markets, additional regulatory approvals are sought.
Compared to the manufacture of traditional, small-molecule pharmaceuticals, biomanufacturing of therapeutic proteins is a remarkably complex and exacting process, taking weeks or months compared to hours or days for traditional pharmaceuticals. For example, it takes more than 1000 people approximately 250 days to manufacture one lot of Kogenate® FS, representing approximately 200 grams of product (about the size of a handful).
Recently, Bayer invested more than $25 million to further upgrade state-of-the-art quality systems that ensure the highest possible quality control and quality assurance procedures.
New Sterile Fill/Finishing Facility
Recently added to the Berkeley campus and licensed in 2009 is a new, $100 million state-of-the-art sterile fill and finish facility. The 45,000 square foot facility houses our cGMP sterile filling operations, the final stage in the manufacture of Kogenate®*, our leading recombinant Factor VIII product for the treatment of hemophilia A. The facility features class 100,000, 10,000 and 100 cleanrooms, which are designed to keep environmental pollutants out of the product. The facility is just one example of the many steps Bayer takes to ensure that our product remains completely free of contamination by the time it reaches the final stage of production.
* Kogenate® FS Antihemophilic Factor (Recombinant) Prescribing Information.
