Derek J. Hei, Waisman Clinical Biomanufacturing Facility, University of Wisconsin - Madison, Waisman Center, 1500 Highland Ave., Madison, WI 53719
The success of translation research depends on the efficient and successful transfer of technology from research labs to development and manufacturing groups and into human clinical trials. For early-stage biotech companies with limited resources, a misstep during tech transfer and early development could potentially result in the failure of the technology and of the company. The Waisman Clinical Biomanufacturing Facility (WCBF) at the University of Wisconsin-Madison specializes in working with academic investigators and spin-off biotech companies to address early-stage development issues and produce biotherapeutics for phase I/II human clinical trials. The WCBF supports the development of several classes of biotherapeutics including recombinant proteins, gene therapeutics (plasmid DNA, viral vectors), and cell therapeutics. The diversity of these therapeutics presents a spectrum of challenges from a tech transfer perspective. For gene therapeutics, the WCBF has established platform manufacturing processes that facilitate tech transfer and allow the development team to focus on a few critical issues for each product. Cell therapies, and in particular stem cell-based products, represent a more diverse class of therapeutics that pose unique challenges. In this presentation, I will provide an overview of the WCBF technology transfer process and present several unique strategies that have been employed to facilitate tech transfer for cell therapeutics including the National Stem Cell Bank (NSCB). The NSCB program can be viewed as a reverse tech transfer program with a goal of addressing potential future development issues for stem cell-based therapeutics at the research stage.
Web Page:
www.nationalstemcellbank.org, www.gmpbiomanufacturing.org