Grifols has received approval from the U.S. Food & Drug Administration (FDA) to relocate existing immunodiagnostic manufacturing operations to a new Consolidated Manufacturing Facility (CMF) in Emeryville, California.
Grifols Consolidated Manufacturing Facility, Emeryville, California
This first submission enables commercial good manufacturing practices (GMP) 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. Once the transition is complete, Grifols will have transferred 21 products to CMF.
"The FDA approval is a major milestone for this multi-year project," said Ramon Biosca, vice president and general manager of Grifols Diagnostic Solutions. "The new facility is a significant investment in our manufacturing organization and will ensure reliable, long-term production of current and future products."
The new facility has 25,000 square feet of GMP manufacturing space, including two fermentation suites for E. coli and yeast processes, three purification suites, and a bulk fill area. Automation systems provide control of manufacturing processes and a central data historian monitors and stores all data generated in the facility, including the warehouse and utility systems.
Additionally, Grifols has recently begun an engineering project to convert the 9,000 square foot expansion space within CMF into cell culture and purification suites for production of recombinant proteins expressed in mammalian cells. The facility will use disposable technology and is expected to be complete in late 2019.