Global Biologics Development
Located in one of the most active biotechnology corridors in the world, Bayer's Bay Area sites focus entirely on biologics and make up one of Bayer HealthCare Pharmaceutical's three Research & Development centers of excellence. R&D work at these sites encompasses a wide range of activities including translational and experimental biology, protein engineering, technology evaluation and development, and biomanufacturing process development.
Compared to the manufacture of traditional, small-molecule pharmaceuticals, manufacturing of therapeutic proteins is a remarkably complex and exacting process. For a protein therapy, manufacturing process development often starts when a molecule is in the pre-clinical stages. The Global Biologics Development team is responsible for the development of cost effective, environmentally safe, and state-of-the-art manufacturing processes for new protein products in the Bayer pipeline. The group has strong interfaces with both the research as well as the manufacturing organizations.
A 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.