PhD, University of California, Berkeley
Senior Scientist, Waisman BioManufacturing
Principal Investigator, National Stem Cell Bank
1500 Highland Avenue, Room T411
Madison, WI 53705
Phone: (608) 263-5821
Web: Waisman Biomanufacturing
Web: National Stem Cell Bank
Derek Hei joined UW-Madison in January of 2000 as the technical director of Waisman Biomanufacturing–a state-of-the-art cleanroom facility designed for the development and production of cutting-edge biotherapeutics for human clinical trials with university and private industry partners. Waisman Biomanufacturing is designed to manufacture cell and gene therapeutics for early stage (Phase I and Phase II) human clinical trials according to the U.S. Food and Drug Administrations (FDA) current Good Manufacturing Practice (cGMP) guidelines. In addition to facilities and equipment for producing plasmid DNA and viral vectors for gene therapy, Waisman Biomanufacturing has facilities for processing cell therapeutics including embryonic and neural stem cells, filling of parenteral therapeutics, and producing recombinant proteins. This range of capabilities allows the Waisman Biomanufacturing to provide support to both academic and commercial groups that are involved in the development of complex, multi-component biotherapeutics such as engineered stem cells.
In September 2005, the National Stem Cell Bank (NSCB) was established in Madison, Wisconsin by a team of researchers at WiCell Research Institute and the University of Wisconsin at Madison. Hei currently serves as the Principal Investigator for this project. The NSCB (www.nationalstemcellbank.org) is an NIH-funded resource that supports human embryonic stem cell (hESC) research by distributing cell lines to researchers. In addition to distributing NIH-registered hESC lines, the NSCB is currently involved in the development of standardized hESC culture and characterization methods. The cell lines that are distributed by the NSCB undergo extensive testing including characterization studies that will provide detailed information on genetic stability, gene expression, and differentiation potential. This information will provide a better understanding of differences between hESC lines and the impact of culture methods on cell growth and differentiation. Additional research efforts for developing human ES cell based therapeutics include produce cell banks for clinical applications and developing large-scale methods for producing hESCs and differentiated cell types.
Hei is an instructor for Biotechnology Operations in the Masters in Biotechnology program. Biotechnology Operations provides students with a broad overview of challenges that are typically encountered in the development and manufacturing of biotechnology products. In addition to learning various manufacturing processes and issues related to process design and scale-up, students are given an overview of FDA regulations and how these regulations impact product and process development and design.
NieY,BergendahlV,HeiDJ,JonesJM,PalecekSP. (2009) Scalable culture and cryopreservation of human embryonic stem cells on microcarriers. BiotechnologyProgress.2009Jan-Feb;25(1):20-31.
Behrstock S, Ebert A, McHugh J, Vosberg S, Moore J, Schneider B, Capowski E, Hei D, Kordower J, Aebischer P, Svendsen CN. (2006) Human neural progenitors deliver glial cell line-derived neurotrophic factor to parkinsonian rodents and aged primates. Gene Therapy. 2006 Mar;13(5):379-88.
Hei, D.J., Grass, J., Lin, L., Cimino, G. (1999) Elimination of cytokine production in stored platelet concentrates following photochemical treatment with psoralen and UVA. Transfusion, 39: 239-248.
Lin, L., Alfonso, R., Behrman, B., Corten, L., Damonte, P.B., Dikeman, R., Dupuis, K., Hei, D.J., Lin, C.Y., Londe, H.F., Metchette, K., Phan, T., Reames, A.A., Rheinschmidt, M., Savoor, A., Tessman, J., Corash, L. (1998) Photochemical treatment of platelet concentrates with a novel psoralen and UVA to enhance the safety of platelet transfusions. Infusion Therapy and Transfusion Medicine, 25: 39-48.
Grass, J., Hei, D.J., Metchette, K., Cimino, G., Wiesehahn, G.P., Corash, L., Lin, L. (1998) Inactivation of leukocytes in platelet concentrates by photochemical treatment with psoralen plus UVA. Blood, 91(6): 2180-2188.
Michaels, P.M., Hei, D.J., Clark, D.S. (1996) Pressure effects on enzyme activity and stability at high temperatures. Advances in Protein Chemistry 48: 341-376.