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FDA Approves Grifols’ Facility for Production of Recombinant Proteins

New facility, equipment, and automation systems ensure reliable production of antigens for blood supply safety

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Grifols recently received approval from the U.S. 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 pro...

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