Librarians in the Lab: Gates Biomanufacturing Facility

This facility allows the production of both cell therapies and biologics and is the only one of this caliber in an 800-mile radius. There are 25 other academic facilities that follow Good Manufacturing Practices (GMP) in the United States, only 5 of which are comparable to the quality and functionality of GBF, making GBF both geographically and functionally unique.

Tobin Magle: Biomedical Sciences Research Support specialist at the Health Sciences Library

This is Tobin Magle, Biomedical Sciences Research Support specialist at the Health Sciences Library. I’m starting another blog series called “Librarians in the Lab” where I and other health sciences librarians visit labs on campus. This interaction will help us understand the type of work being done on campus, and give us some face time researchers that we serve so that they know better what we do. If you would like us to visit your lab, please contact tobin.magle@ucdenver.edu!

Last week, research librarian Lilian Hoffecker and I visited the Gates Biomanufacturing Facility (GBF) located in Biosciences Park Center on Montview that opened in April. This facility allows the production of both cell therapies and biologics and is the only one of this caliber in an 800-mile radius. There are 25 other academic facilities that follow Good Manufacturing Practices (GMP) in the United States, only 5 of which are comparable to the quality and functionality of GBF, making GBF both geographically and functionally unique.

Having this great resource on campus would not have been possible without the contributions of the late Charles C. Gates, a local engineer, entrepreneur, and stem cell visionary. Health problems late in his life inspired him to fund translational medicine.

A generous donation from his foundation allowed the creation of the Charles C. Gates Center for Regenerative Medicine. This center runs 3 core laboratories, including the GMP facility. In Gate’s entrepreneurial spirit, the center focuses on getting discoveries made on campus into hospitals and clinics, which requires the services that GBF provides. This facility meets FDA safety regulations for human use. The environment inside the processing labs contains 1000x less particulates in than regular air to make sure the products are safe to use in humans. Additionally, they have implemented robust quality management systems and standard operating procedures to assure the highest quality.

The Gates Biomanufacturing Facility addresses two very hot topics in biomedical research: translational research and personalized medicine. The research coming into GBF has already been tested in animal models, but needs to clear strict quality hurdles to be tested in humans. The ultraclean environment and strict reporting processes at GBF allows treatments that were successful in animal models to be translated to the clinic and scale up their production to allow them to run phase 1 clinical trials on both cell and protein products (biologics).

The truly amazing feature of GBF’s services is the applications to personalized medicine due to its association with the Gates Center for Regenerative Medicine. Stem cell therapies have been controversial in the past because of the use of embryonic stem cells (ESCs) for ethical reasons. Recent advances in stem cell research have made it possible to reprogram adult skin cells to create ESC-like cells. This strategy is advantageous for two reasons: it removes the ethical constraints around using ESCs and also reduces the risk of the patient’s body rejecting the cells. The GBF allows researchers to make clean cells from patient biopsy samples that can be reintroduced as a treatment. This technology can be used to treat conditions as diverse as macular degeneration, epidermolytic hyperkeratosis, repairing damaged heart tissue, cancer immunotherapies, bone and cartilage regeneration, not to mention producing human blood in the lab.

The services available at GMF are available to campus researchers at cost, which is a major advantage to anyone doing translational research on this campus. This activity will be subsidized by for profit work done in collaboration with biotech startup companies. This arrangement is mutually beneficial because it promotes campus research and is significantly more affordable than investigators building their own facility or outsourcing the work. Finally, having this facility on campus is important for recruiting top academic faculty who are interested in translational science and personalized medicine.

We received a tour of the facility and were able to see the cell products and biologics development areas and the quality control facilities. One of the most visually striking aspects of the facility is the wall art depicting some of the cell therapies that will be in development soon at GBF, which are dispersed throughout this post. We’re looking forward to hearing about all of the great discoveries that come out of the GBF. 

Gates Biomanufacturing Facility • 12635 E Montview Blvd. Suite 380 • Aurora, CO.80045

Contacts:

Thomas Payne Ph.D, Director of Cell Therapies-thomas.payne@ucdenver.edu -303.724.7779

Patrick Gaines, Business Development – patrick.gaines@ucdenver.edu – 720.281.2100

Timothy Gardner, Business Development – timothy.gardner@ucdenver.edu – 303.724.7049

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