- Processes built resulted in high yields and titers, effective puriﬁcation schemes, and top-end formulation and analytical methodologies. The University of Colorado has been on the forefront in developing and characterizing protein formulations. We work with our partners to implement innovative formulation studies and conduct thorough biophysical characterization with qualified instrumentation.
- State-of-the-art refolding experience and technology, implementing traditional chemical refolds or applying enabling high pressure refolding technology. We’ve worked on over 150 refolding projects and can efficiently execute experiments to solve challenging refold problems.
“The Gates Biomanufacturing Facility was able to provide my company with high quality, active, preclinical material under a tight timeline after other CMOs had failed. The team took real ownership of the project and dealt with every challenge professionally, creatively and in a timely fashion. They were an invaluable resource for accelerating the development of our therapeutics.”
Geoff Davis PhD,
- We take pride in communicating the data we develop for our Clients in a frequent and clear manner. We implement appropriate experiments and controls and convey those results to the client.
- GBF chemists and management have run start-ups ourselves, so we understand the client’s needs for developing efficient processes quickly and in the need to adapt to changing technical demands.
Protein Process Development Laboratory
- Equipment mirrors cGMP processing equipment for seamless process transfer – 1:10 scale
- Two – 5 liter Microbial Fermenters
- Purification: AKTATM PURE, AKTATM PRIME
- Tangential flow filtration system
- Micro fluidizer
- High pressure refolding capability
“The Gates Biomanufacturing Facility is a valuable resource for the Anschutz Medical Campus. The team was responsive, conducting thorough fermentation and downstream protein purification experiments. The facility’s efficiency in helping us scale our early-stage processes accelerated our ability to conduct preclinical research.”
Jan P. Kraus PhD Professor,
Pediatrics and Cell and Developmental Biology, University of Colorado School of Medicine
- Microbial infrastructure – E.Coli
- 50 liter working volume fermenter with sterilization-in-place
- Clean-in-place skid
- Four ISO 7 and ISO 8 clean rooms operating at 20-40 air changes per hour with single-pass HEPA-filtered air supplied by a dedicated air handling unit
- Clean rooms for buffer preparation, clarification, protein purification, and aseptic formulation and fill of bulk drug substance
- Two – 50 liter magnetic mixers for buffer preparation
- Purification – 0.25 to 2 liter column chromatography capability in both gradient and step format
- Ultra-Filtration/Tangential-Flow Filtration