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   The Gates Biomanufacturing Facility (GBF) worked seamlessly with the Gates Center for Regenerative Medicine and clinical and regulatory colleagues across the CU Anschutz Medical Campus in 2019 to make remarkable progress toward initiating a fully integrated clinical trial in the coming year.
We are now producing the first cell-based immune therapy for which the basic science, regulatory approval, clean manufacturing process and infusion of patients will all have been done on the Anschutz Medical Campus. As a Good Manufacturing Practice (GMP) facility, the GBF is proud and honored to be a key link in this loop. We believe our ability to support on-campus clinical trials will lead to multiple similar efforts in the near future by other researchers and clinicians in a variety of disciplines and continue to bolster the reputation of the GBF and Anschutz as a leader in combined academic research and clinical translation.
“It’s an actualization of what we’ve been working on for years,” said Thomas Flaig, M.D., an oncologist and vice chancellor for research on the Anschutz Medical Campus. “This is a new space for us to get into. It’s one thing to have an idea, it’s another thing to figure out how to actually make the product, and then to deliver it. And we’ll have all that in the loop.”
The past year delivered a number of milestones at the GBF that similarly culminated years of organization, refinement of methodology and infusions of the right people in the right
positions to carry out the complex process of an Investigational New Drug (IND). Among our team’s accomplishments:
• Quadrupling the capacity to deliver clinical grade
• Producing clinic-ready materials in protein biologics,
natural killer cells, reprogrammed CAR-T cells, and a
combination of a protein reagent and a cell therapy.
• Hiring 12 key staff members, boosting our team by 30 percent, including new supply chain and project
management teams.
“We’ve made a sustainable nonprofit business here, where we have enough infrastructure and capability to move clinical trials forward at a relatively fast pace,” said Christopher Garbe, director of quality. “Now we can take on more academic clients at the University and get them into their clinical trials.” It’s extremely rewarding and exciting to picture that in 2020, the GBF will hand-deliver across campus modified CAR-T cells for injection into clinical trial patients at University of Colorado Hospital and Children’s Hospital Colorado. That work is led by initiating investigator and Gates Center member Terry Fry, M.D., Director of Cancer Immunotherapy on the Anschutz Medical Campus, and a leading national cancer researcher recruited from the National Cancer Institute.
Fry was one of the first investigators to genetically modify a patient’s own CAR-T cells to become cancer-fighters when reintroduced into the same patient’s body. The treatment
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