Biological Process Development Facility (BPDF)

Biological Process Development Facility

Offering biopharmaceutical process development and biomanufacturing services that transition discoveries to non-clinical studies and Phase I/II and early Phase III clinical trials.

BPDF Student In Lab

The Biological Process Development Facility (BPDF) at the University of Nebraska offers biopharmaceutical process development and biomanufacturing services that transition discoveries to non-clinical studies and Phase I/II and early Phase III clinical trials. BPDF capabilities include:

  • Master and working cell banks
  • Upstream and downstream process development
  • Stability testing services
  • Analytical method development and qualification
  • 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.