Michael Meagher, Biological Process Development Facility, University of Nebraska, 304 Othmer Hall, 820 North 16th Street, Lincoln, NE 68588-0668
The University of Nebraska – Lincoln Biological Process Development Facility (BPDF) is a multidisciplinary “turn-key” facility focused on biopharmaceutical process research, development, and Phase I/II CGMP manufacturing of candidate vaccines and biotherapeutics derived from recombinant yeast and bacterial expression systems. The BPDF works with a host of different clients from the federal government to small virtual biotechnology companies and large biopharmaceutical companies. As a transitional facility our responsibility is to understand the goals of the clients, assess the client’s technology, perform a gap analysis, develop all aspects of a process to produce Phase I/II clinical material, assemble a technology transfer package, and insure this technology is effectively transferred. The key to successful transfer of technology is effective communication. Equally important is an understanding of the expectations of the process, the client’s expectations, the capabilities of the eventual commercial manufacture, and establishing the systems to make this all possible. This presentation describes how the BPDF works with our clients to meet their expectation of transitioning their biopharmaceutical from discovery to Phase I/II clinical testing.