The BioTechnology Institute, College of Biological Sciences, and the University of Minnesota have invested significantly in the Biotechnology Resource Center’s facilities and equipment to provide contract development and manufacturing services to both external industry customers and internal and external academic customers. Our customers come to us from the fields of human therapeutics, veterinary, agriculture, biofuels, and industrial biotechnology. Customer products we have include biomass, recombinant proteins, and primary and secondary metabolites. In 2017, we provided process optimization, scale-up, and production services to industry clients ranging in size from virtual start-ups to Fortune 500 companies. The BRC provides services for processes and products utilizing a wide variety of bacteria, yeast, and algae, including
• Strain development and optimization
• Fermentation process development, optimization, and scale-up
• Recombinant protein expression in bacteria and yeast
• Pilot-scale production of bacteria, yeast, and algae
• Biomass harvest and concentration
• Cell disruption
• Inclusion body isolation, solubilization, and protein refolding
• Recombinant protein and secondary metabolite purification process development, optimization, and scale-up
• Chromatography (affinity, ion exchange, hydrophobic, multi-modal, size exclusion)
• Ultra- and dia- tangential flow filtration
• Freeze drying
• Analytical support including fermentation off-gas and metabolite analysis, product purity via gel electrophoresis, and HPLC.
The BRC operates under a fully established and externally audited quality system based on 21CFR211 and ICH Q7a. While the BRC does not provide cGMP services, intermediate products produced by the BRC have, after customer processing into drug substance and drug product, been used in phase I clinical trials.