Grifols received approval from the FDA to relocate existing immunodiagnostic manufacturing operations to a new Consolidated Manufacturing Facility in Emeryville, California. This first submission enables commercial good manufacturing practices Fermentation, Purification, and Bulk Fill operations in the facility and the production of one recombinant HCV antigen. Additional submissions to the FDA are planned to relocate the production of other licensed recombinant protein products. The transition is targeted for completion in mid-2019, pending the FDA approvals for the licensed antigens. The company designed, built, and validated the $80M, state-of-the-art, biological manufacturing facility in the San Francisco Bay Area. The facility will use disposable technology and is expected to be complete in late 2019.
