FDA approves Grifols facility for recombinant proteins 23rd August 2018
Grifols has received approval from the US FDA to relocate existing immunodiagnostic manufacturing operations to a new consolidated manufacturing facility (CMF) in Emeryville, CA.
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 the new facility.
“The FDA approval is a major milestone for this multi-year project,” said Ramon Biosca, vice president and general manager, 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 Mr. 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.”