Biological Process Development Facility (BPDF)



The Biological Process Development Facility at the University of Nebraska (BPDF) offers biopharmaceutical process development designed for successful technology transfer from the bench to large-scale GMP manufacturing.

The BPDF develops scalable processes and manufactures material suitable for non-clinical and clinical studies. Specializing in recombinant peptides and proteins, the BPDF has produced GMP materials since 1998. During this time, processes for over 50 products including vaccines, other biotherapeutics, chemokines, and agricultural/industrial enzymes have been developed. BPDF fermentation processes focus on optimizing and controlling high cell-density fermentations of Pichia pastoris, Saccharomyces cerevisiae, and Escherichia coli for recombinant protein production. Current clients include government, industry, and philanthropic organizations. Most recently, the BPDF developed and scaled-up a process for GMP production of 5P12-RANTES, a microbicide effective in preventing transmission of HIV in vitro.

Offering the services of highly skilled and experienced professionals, the BPDF team members have an average of 8 years at the BPDF (range 1-18 years). The Quality Assurance and Scientific staff have an average of >18 years of experience in their respective fields (range 7-30 years).

Biological Process Development Facility completes its first cGMP production run in newly commissioned facility

The University of Nebraska-Lincoln Biological Process Development Facility (BPDF) achieved a major milestone by producing its first cGMP batch of bulk drug substance in the recently commissioned facility. At the request of the Mintaka Foundation (Geneva, Switzerland), the BPDF developed and scaled-up a process for cGMP production and purification of 5P12-Rantes, a microbicide effective in preventing transmission of HIV in vitro and SIV in vivo in non-human primate studies. The cGMP product will be shipped to the Mintaka Foundation for formulation as a vaginal cream for use in Phase I clinical trials. Read more.
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