When the Gates Biomanufacturing Facility opened its doors in 2015, cell and gene therapy (CGT), was just beginning to come into its own. Chimeric antigen receptor (CAR) T-cell therapies were in human clinical trials at the National Cancer Institute and messenger RNA, or mRNA, technology was quickly advancing to deliver new vaccines and treatments. Thought leaders in Colorado were keen to advance CGT research at University of Colorado Anschutz, and knew that having biomanufacturing capabilities using FDA-compliant current Good Manufacturing Practice (cGMP) regulations would be key. CGMP establishes systems for the proper design, monitoring, and control of manufacturing processes and facilities. It ensures the identity, strength, quality, and purity of drug products by requiring that manufacturers to adequately control their operations.
The biomanufacturing facility, known internally as the GBF, is located at the Fitzsimons Innovation Community, steps away from campus. It is now part of the Gates Institute, which is celebrating the GBF’s decade of progress and its impact on transforming patients’ lives.
The Gates Institute formed in 2023 to provide the necessary campus infrastructure to create a CGT research pipeline, conduct preclinical testing, provide regulatory support and a clinical trials unit – complementing the biomanufacturing capabilities of the GBF.
One of the early employees, Jordan Krause, began as technical lead for the GBF’s protein group and is now assistant director of product management at Gates Institute.
“As with any new venture, everything was new and we encountered not only technical, but significant logistical challenges as we built systems from the ground up,” Krause recalls. “We started with pen-and-paper inventory tracking and grew into a sophisticated, predictive resource-planning system. In the early days, simply moving therapeutic products across campus to the hospital was a major hurdle; today, we’ve successfully treated nearly 50 patients at those very hospitals. With every hurdle, we leaned on our collective dedication to quality, innovation, and patient care and we found a way.”
One Patient’s Story
Ten-year-old Lucas is one of the patients to receive CAR T-cell therapy produced at the Gates Biomanufacturing Facility. On a recent weekday, nearly 10 years to the day that the GBF opened, he toured the facility with his mom, Michaela.
He was able to view the Prodigy, specialized machinery that sorts white blood cells drawn from a patient’s blood, a process called apheresis.
Receiving CAR T-cell therapy two years ago is a vague memory to Lucas, but his mother, Michaela Thompson, remembers it well. He was diagnosed with leukemia at age 4, went through two years of chemotherapy, relapsed, had a bone marrow transplant and relapsed again before participating in a clinical trial at Children’s Hospital Colorado.
“There have been tough moments through treatment, just trying to remain optimistic and hopeful about what the future would look like,” she says. “So to be at this point where, he is more stable and he is healthier and stronger has been an amazing thing to see for our entire family.”
“Getting to come here to meet the team who manufactured the cells was really cool for us.”
See a short video featuring Lucas’ visit to the GBF here.
Multidisciplinary Expertise
Among academic biomanufacturing facilities, it is somewhat unusual to offer both biologics and protein production alongside cell and gene therapy manufacturing. The GBF does both, by design.
“Having both biologics and CGT manufacturing capabilities co-located on campus provides not only operational, but scientific and strategic advantages that set the University of Colorado apart from most academic institutions,” says Chris Garbe, technical operations director for Gates Institute. “Having these specialized resources and subject matter expertise accessible to researchers enables the acceleration of more diverse and novel therapeutics from development into first in human clinical trials. Furthermore, the proximity of these distinct groups naturally encourages collaboration and cross-pollination of ideas and learnings between R+D, manufacturing, and analytical personnel.”
The GBF Biologics team specializes in expressing, purifying, and refolding difficult proteins in order to make them therapeutically active. Over the past 10 years, this expertise has been expanded to handle other tricky biologics like mRNA, nanoparticles and plasmids. Target indications for these molecules range from Alzheimer’s disease to brain cancer. Some of this work is done in collaboration with external clients, such as recent work with the Institute of Molecular Medicine, which is working on Phase I human clinical trials for an Alzheimer’s vaccine.
Also unique among biomanufacturing facilities is the ability to work with academic researchers whose processes are not yet fully developed, says Sonja Giguere-Ottenberg, research services project manager
“We can actually bring that information into our facility, establish it in a small scale, move it through a translation that will help to bring it into a clinical trial,” she says.
Patient Impact
The evolution of the GBF over the past 10 years reflects more than just progress—it reflects real impact. A few of the milestones achieved so far:
- To date, 47 patients participating in clinical trials at CU Anschutz have been treated with CAR T cells manufactured by the GBF.
- Six approved protocols have been developed under CU-sponsored investigational new drug applications. The first protocol, for a trial that has ended, is now closed to accruals, with five actively accruing protocols.
- 27 challenging proteins and biologics produced.
- 170+ GMP batches for both biologics and cell therapies.
“Looking back over the past decade at GBF, it’s remarkable to see how far we’ve come,” says Krause. “I had the unique privilege of being one of the first employees—a small team of scientists fueled by enthusiasm and a shared commitment to excellence. With little more than vision and determination, we began laying the foundation for what would become a GMP-compliant manufacturing facility built on the highest quality standards.”
