Derek J Hei

Derek Hei, PhD

PhD, University of California, Berkeley
Director, Waisman Biomanufacturing

Contact Information:

Waisman Center
1500 Highland Avenue
Room T411
Madison, WI 53705
608.263.5821
hei@waisman.wisc.edu
Website: Waisman Biomanufacturing
National Stem Cell Bank

Research Statement

Derek Hei joined UW-Madison in January of 2000 as the 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.   Waisman Biomanufacturing works with academic investigators, biotechnology companies, and government agencies to develop, manufacture and test, 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 pluripotent stem cells, producing recombinant proteins, and filling of injectable therapeutics. This range of capabilities allows 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 2010, Waisman Biomanufacturing was awarded the Production Assistance for Cellular Therapies (PACT) contract.  This program is designed to support translation of cell-based therapies for heart, lung, and blood-associated diseased into Phase I/II clinical trials, through production of cGMP cell products and pre-clinical animal studies. This contract has enabled WB to broaden its specialties, recently adding Mesenchymal Stromal Cells (MSCs) and induced Pluripotent Stem Cells (iPS cells) to their portfolio, to respond to industry needs. WB continues to seek collaborative partnerships to benefit bench-to-bedside research. 

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.

Representative Publications

Bloom DD, Centanni JM, Bhatia N, Emler CA, Drier D, Leverson GE, McKenna DH Jr, Gee AP, Lindblad R, Hei DJ, Hematti P. (2015) A reproducible immunopotency assay to measure mesenchymal stromal cell-mediated T-cell suppression. Cytotherapy. 17(2):140-51. doi: 10.1016/j.jcyt.2014.10.002.

Wright LS, Phillips MJ, Pinilla I, Hei D, Gamm DM. (2014) Induced pluripotent stem cells as custom therapeutics for retinal repair: Progress and rationale. Experimental Eye Research. 123:161-72.

Raval AN, Schmuck EG, Tefera G, Leitzke C, Ark CV, Hei D, Centanni JM, de Silva R, Koch J, Chappell RG, Hematti P. (2014) Bilateral administration of autologous CD133+ cells in ambulatory patients with refractory critical limb ischemia: lessons learned from a pilot randomized, double-blind, placebo-controlled trial. Cytotherapy. 16(12):1720-32. doi: 10.1016/j.jcyt.2014.07.011.

Raval AN, Schmuck EG, Tefera G, Leitzke C, Ark CV, Hei D, Centanni JM, de Silva R, Koch J, Chappell RG, Hematti P. (2014) Bilateral administration of autologous CD133+ cells in ambulatory patients with refractory critical limb ischemia: lessons learned from a pilot randomized, double-blind, placebo-controlled trial. Cytotherapy. 16(12):1720-32. doi: 10.1016/j.jcyt.2014.07.011.

Matthay MA, Anversa P, Bhattacharya J, Burnett BK, Chapman HA, Hare JM, Hei DJ, Hoffman AM, Kourembanas S, McKenna DH, Ortiz LA, Ott HC, Tente W, Thébaud B, Trapnell BC, Weiss DJ, Yuan JX, Blaisdell CJ. (2013) Cell Therapy for Lung Diseases. Report from an NIH-NHLBI Workshop, November 13-14, 2012. American Journal of Respiratory and Critical Care Medicine. Aug 1;188(3):370-5.

Luong MX, Auerbach J, Crook JM, Daheron L, Hei D, Lomax G, Loring JF, Ludwig T, Schlaeger TM, Smith KP, Stacey G, Xu RH, Zeng F. (2011) A call for standardized naming and reporting of human ESC and iPSC lines. Cell Stem Cell. Apr 8;8(4):357-9.

Crook JM, Hei D, Stacey G. (2010) The International Stem Cell Banking Initiative (ISCBI): raising standards to bank on. In Vitro Cellular & Developmental Biology - Animal . Apr;46(3-4):169-72.

Nie Y, Bergendahl V, Hei DJ, Jones JM, Palecek SP. (2009) Scalable culture and cryopreservation of human embryonic stem cells on microcarriers. Biotechnology Progress. Jan-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 . Mar;13(5):379-88.