Gates Biomanufacturing Facility reaches protein biologic manufacturing milestone
Aurora, Colo. (February 23, 2021) – 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.
A diverse group with expertise in tech Transfer, Process Development, and Manufacturing according to good laboratory principles (GLP) and current Good Manufacturing Principles (cGMP) for Phase 1 human clinical trials. The group specializes in E. Coli based recombinant protein therapies with special emphasis on refolding of inclusion bodies, nanoparticle conjugates and mRNA production. The group is always looking to increase novel biomolecules development capabilities and, in the pipeline, including nucleic acid and antibody 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.”
The full array of demonstrated GMP capabilities at the GBF, from protein manufacturing to generation of gene modified and other cell therapies allows the Gates Center team to help researchers translate university developed innovations into clinical trials of new treatments. The GBF provides laboratories and technical expertise to bring a potential clinical product through initial process development and subsequent translation of promising, new therapies into Phase 1 human studies testing their safety and effectiveness.
“The GBF is uniquely positioned to champion both the nonprofit academic world as well as for-profit entrepreneurship, advancing the world class bench research taking place throughout the Anschutz Medical Campus and delivering real-world results,” said CU Anschutz Chancellor Don Elliman Jr.
About the Gates Biomanufacturing Facility
The Charles C. Gates Center for Regenerative Medicine, in partnership with the University of Colorado School of Medicine, UCHealth University of Colorado Hospital, Children’s Hospital Colorado, the Gates Frontiers Fund and the private sector have established a state-of-the-art Good Manufacturing Practices (GMP) facility, which develops and manufactures investigational cell therapy and biologic products to support FDA-approved early phase clinical trials. 20,000 square feet of GMP-grade cleanrooms, laboratories, material and cryogenic storage are located just across the street from Anschutz Medical Campus research laboratories (http://www.gatesbiomanufacturing.com ) in the Fitzsimmons Innovation Zone. The facility currently produces CAR-T cells and other cell therapy biologics for clinical trials as well as protein-based biologics. The mission-based manufacturing facility serves academic researchers, clinicians and early-stage biotechnology companies, focuses on translation of discoveries into clinical-grade products, and completes the medical ecosystem from basic research through early commercialization.
About the Charles C. Gates Center for Regenerative Medicine
The Charles C. Gates Center for Regenerative Medicine was established in 2006 with a gift in memory of Denver industrialist and philanthropist, Charles C. Gates, who was captivated by the hope and benefit stem cell research promised for so many people in the world. The Gates Center aspires to honor what he envisioned–by doing everything possible to support the collaboration between basic scientific researchers and clinical faculty to transition scientific breakthroughs into clinical practice as quickly as possible.
Led by Founding Director Dennis Roop, Ph.D., the Gates Center is located at the University of Colorado’s Anschutz Medical Campus, the largest new biomedical and clinical campus in the United States. Operating as the only comprehensive Stem Cell Center within a 500-mile radius, the Gates Center shares its services and resources with an ever-enlarging membership of researchers and clinicians at the Anschutz Medical Campus, which includes University of Colorado Hospital, Children’s Hospital Colorado and the future Veterans Administration Medical Center, as well as the Boulder campus, Colorado State University, the Colorado School of Mines, and business startups. This collaboration is designed to draw on the widest possible array of scientific exploration relevant to stem cell technology focused on the delivery of innovative therapies in Colorado and beyond.