The Biological Process Development Facility (BPDF) at the University of Nebraska offers biopharmaceutical process development and biomanufacturing services that transition discoveries into early phase clinical trials. BPDF capabilities include:
- Master and working cell banks;
- Upstream and downstream process development;
- Stability testing services;
- Analytical method development and qualification; and
- Microbial manufacture of biologics.
Fermentation processes focus on optimizing and controlling high cell-density fermentations of Pichia pastoris, Saccharomyces cerevisiae, and Escherichia coli for recombinant protein production. Activities are governed by a rigorous quality system as well as regulatory support.
The BPDF has produced a wide range of biologics – including vaccines, recombinant proteins, gene therapies, and other biotherapeutics – in partnership with government agencies, biotechnology companies, academic researchers, and non-profit organizations. The BPDF applies decades of expertise and experience to developing scalable and reproducible cGMP manufacturing processes.
