Grifols Achieves Key Milestone with FDA Approval of the New Consolidated Manufacturing Facility (CMF) for Production of Recombinant Proteins


03.08.2018
  • The new facility, equipment, and automation systems ensure reliable production of antigens for blood supply safety and patient health.
  • Grifols' investment opens growth opportunities in contract development and manufacturing services to current and future customers.

Emeryville, CA, August 03, 2018 - Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a global healthcare company with a history of more than 75 years of improving people's health and well-being and a leader in the development of innovative diagnostic solutions, recently received approval from the U.S. Food & Drug Administration to relocate existing immunodiagnostic manufacturing operations to a new Consolidated Manufacturing Facility (CMF) in 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."
 
As part of Grifols' investment for future growth, the company designed, built, and validated the $80 million, state-of-the-art, biological manufacturing facility in the San Francisco Bay Area. 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.
 
In addition, 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. 
 
The new Consolidated Manufacturing Facility, along with the development capabilities in the laboratories and pilot plant, provides a range of process scale and flexibility for the current portfolio of products and the R&D pipeline, as well as supports development and manufacturing services to third parties for recombinant protein production.
 
"The Emeryville campus has a long history of recombinant protein production, beginning with Chiron in the 1980s," said Biosca. "With this tradition of technical expertise and the new facility, Grifols is well equipped to provide contract development and manufacturing services to our current and future customers."