The Gates Biomanufacturing Facility (GBF) has completed the manufacturing and release of a protein-based biologic under Good Manufacturing Practice for Phase 1 Investigational Drugs for first-in-human clinical trials.

Manufacturing of this investigational, protein product demonstrates the GBF’s capacity to support both academic endeavors from Colorado’s university research centers and commercial partners from the burgeoning biotech and biologic industries throughout the West. Microbial-based recombinant proteins are important biologics (e.g., hormones, cytokines, and antibody fragments) and are used as therapies, vaccines, and cell-therapy reagents. The GBF, located on the University of Colorado Anschutz Medical Campus in Aurora, is one of the few Good Manufacturing Practice (GMP) facilities located on a major academic research and clinical campus in the western United States with the capacity to manufacture both protein- and cell-based therapies.

“We’re proud to see the Gates Biomanufacturing Facility join an elite academic group of clean, safe and technically innovative manufacturing facilities that can bring both bench research and commercial entrepreneurship together for the good of patients,” said GBF Executive Director Matthew Seefeldt. “Adding protein production to our capabilities in CAR-T cell and other cell therapy production for early phase clinical trials is a major milestone.”

Find out more in the press release.