The University of Nebraska-Lincoln Biological Process Development Facility (UNL BPDF) uses a synergistic multi-disciplinary approach to advance research-derived candidate vaccines and bio-therapeutics to Phase I/II clinical trials. BPDF research on fermentation processes is focused on modeling, optimizing, and controlling high cell density fermentations of Pichia pastoris, Saccharomyces cerevisiae, and E. coli for production of recombinant proteins. For over 12 years, we have provided customers with access to experienced biopharmaceutical process research & development scientists and engineers, state-of-the-art process development capabilities, and cGMP manufacturing facilities. The UNL BPDF is equipped with a state-of-the-art $11 million cGMP facility with 6,000 ft2 of modular clean rooms and 7,000 ft2 of support space, including a pure steam generator, a water-for-injection (WFI) condenser, a 1000 gal WFI storage tank, and ambient and hot WFI distribution loops. The cGMP facility has a bioreactor capacity of 150 L (working volume), and is able to accommodate a 1000 L fermentor. We are equipped for downstream processing of both secreted and intracellular products derived from yeast or bacteria. This facility is designed to produce Bulk Drug Substances. We also produce Master Cell Banks and Working Cell Banks.
We have performed process development of biologics, specializing in peptides and recombinant proteins, from microbial systems for over 18 years and have produced cGMP materials for over 12 years. During this time we produced over 50 products including vaccines, bio therapeutics, chemokines, and agricultural/industrial enzymes. For USAMRIID we developed processes to produce a ricin vaccine (RVEc) and are developing processes for each of the seven serotypes of the Clostridium botulinum neurotoxins. We produced cGMP ricin vaccine that is currently undergoing Phase I clinical trials. These and other projects involved process development, analytical methods development, process scale up, cGMP manufacturing, and stability studies.