AN ACADEMIC GMP WITH A CLEAR FOCUS
For biomedical researchers and biotechnology companies hoping to transition laboratory discoveries to cell therapies and protein biologics suitable for human clinical trials, a partnership with Gates Biomanufacturing Facility (GBF) goes well beyond what the term “manufacturing facility” might indicate. GBF was conceived, built and staffed as an academic Good Manufacturing Practice (GMP) aiming to closely collaborate with our clients for effective translation of new agents into ground breaking, first in human, phase I and II studies. The facility excels in the pre-clinical/process development setting to facilitate scale up for human use, reproducibility, product quality control, IND submission, meticulous materials management, state of the art GMP manufacturing. This technical capability is implement as a partnership with the help of a dedicated project management team.
BENEFITS OF PARTNERSHIPS
GBF’s clear focus, energy, autonomy and resources, are all byproducts of its partnership with a major research university, as well as its proximity to and close ties with the hospitals and clinics of the medical hub of the Mountain West.
FROM BENCH TO BEDSIDE
For GBF, the saying, “from bench to bedside” is more than a slogan. It’s an apt description of its ability, as a uniquely positioned Phase 1 CDMO, to develop new science into preclinical batches that can quite literally be walked to trials performed at The University of Colorado Hospital or Children’s Hospital Colorado.
VISION
An established and nationally recognized academic leader in development and manufacture of groundbreaking cellular, gene-modified and protein biologic therapies to enable pivotal human clinical trials for treatment of unmet medical needs.
GATES CENTER
“In my mind, it’s about working with doctors, researchers, scientists, patients to do clinical trials that will be either cures or help a body heal itself or will extend life or the quality of life.”
~Diane Gates Wallach, Founder & Co-Chair, Gates Center Advisory Board
