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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.

A BPDF student in a lab setting

BPDF collaborates with National Strategic Research Initiative to support the development and production of defense-related biotherapeutics

With scientific breakthroughs, there is often a "eureka" moment when a researcher first realizes a process or technology can solve a problem. It’s no different with breakthroughs supporting the safety and well-being of warfighters.

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BPDF Producing Protein Therapeutic for Coronavirus Patients

Working with a preclinical drug discovery company using its proprietary genetic technology platform, the BPDF is in early-stage production of a recombinant protein as a potential biotherapeutic for COVID-19 patients who may have few options for treatment.

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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.