Biological Process Development Facility

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

A BPDF student in a lab setting

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.