Officials at the Aurora, CO-based Gates Biomanufacturing Facility (GBF) say they have completed the manufacturing and release of a protein-based biologic under GMP for Phase I Investigational Drugs for first-in-human clinical trials.

Congresswoman Diana DeGette (D-CO), who recently visited the Gates Biomanufacturing Facility, observes the facility’s bioreactor unit along with a facility staffer and University of Colorado School of Medicine Dean John Reilly, Jr., MD (on the left).[Gates Biomanufacturing Facility]

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 biotech and biologic industries throughout the West, notes Matthew Seefeldt, executive director.

“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,” he adds. “Adding protein production to our capabilities in CAR-T cell and other cell therapy production for early phase clinical trials is a major milestone.”

The facility, which develops and manufactures investigational cell therapy and biologic products to support FDA-approved early phase clinical trials, features 20,000 square feet of GMP-grade cleanrooms, laboratories, material and cryogenic storage which are located across the street from the Anschutz Medical Campus research laboratories  in the Fitzsimmons Innovation Zone.