Bayer, Clinical Manufacturing Facility

The new 38,000 square foot Building 66 Clinical Manufacturing Facility on Bayer’s main campus in Berkeley, California consists of four environmentally controlled zones for inoculum preparation, fermentation/isolation, and two purification suites.

The FDA-validated manufacturing facility is designed to produce clinical-grade proteins, generate master working cell banks, and support process development, optimization, and validation.

Each zone has dedicated air handlers and waste drains as well as multiple systems to allow equipment to be cleaned in place. Segregation enhances flexibility by enabling one zone to produce GMP material while the other operates in development mode.

The building creates an operational bridge between Bayer’s research and clinical initiatives by serving as a scale-up and clinical material manufacturing facility.

The two-story building with interstitial spaces includes separate functional areas ensuring separation and segregation of materials, personnel, and process flow. The first floor contains personnel gowning rooms, material pass-throughs, classified space for purification with transit zones, buffer prep and equipment wash areas, the cell bank storage room, and unclassified space for mechanical/process and electrical distribution. The second floor provides classified space for inoculum preparation and cell banking, fermentation, isolation, media preparation, equipment wash areas, office space, and unclassified space for the control room.

Bayer built flexibility into the 37,000 square foot facility to accommodate either pilot-scale development or clinical manufacturing, through such essentials as process cooling, process gasses, and clean utilities, and by designing in easier removal and installation of equipment. Building 66 is designed to allow for a mirror-image expansion to the east, as needed.