Berkeley
Biomanufacturing Expertise at Berkeley
With more than $3 billion in protein drug sales and two decades of experience in producing complex protein therapies, Bayer is the sixth largest biotechnology company in the world. 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.
A New Clinical Manufacturing Facility
To completely dedicate its existing manufacturing facilities for marketed products, Bayer built a $50 million clinical manufacturing facility on the Berkeley campus for producing clinical-grade proteins for use in human studies. In August 2006, Bayer opened this 37,000 sq. ft., state-of-the-art, multi-level clinical manufacturing facility (CMF), strengthening product development capabilities for Bayer HealthCare Pharmaceuticals. The CMF allows the campus to provide materials for clinical trials and generate master cell banks for continuing biotech R&D operations company-wide.
The building is segregated into four environmentally-controlled zones; it is able to produce new product pipeline materials for clinical testing as well as allow development, testing and validation of advanced technologies to support product registration. Designed with flexibility in mind, the infrastructure includes process cooling, process gasses and clean utilities, along with provisions to allow easier removal and installation of equipment.
The facility is designed to allow for a mirror-image expansion as needed. Bayer is now working to license this facility from all of the major regulatory bodies around the world.
Sterile Fill/Finishing Undergoing Licensure For Global Use
Recently added to the Berkeley campus 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.
Every Step of the Way: Kogenate® Manufacturing Video
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* Kogenate® FS Antihemophilic Factor (Recombinant), is a recombinant Factor VIII treatment indicated for the treatment of hemophilia A. The most frequently reported adverse events were local injection site reactions, dizziness and rash. Known intolerance or allergic reactions to constituents of the preparation is a contraindication to the use of Kogenate® FS. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Kogenate® FS. For important safety and use information, please see the full prescribing information.
* Product information is intended for U.S. Audiences Only
