The Hei Laboratory
Faculty > Derek J. Hei
Derek J. Hei
Technical Director, WCBF, Waisman Center
hei@waisman.wisc.edu
Aligned Research Focus
Developing cell and gene therapeutics for human clinical trials
Relevant Research Description
The NSCB and WCBF – Support for HESC Research and Translation of HESC-Based Therapeutics to Human Clinical Trials
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. Derek 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.
While the NSCB provides support for hESC researchers, the Waisman Clinical Biomanufacturing Facility (WCBF, www.gmpbiomanufacturing.org) provides support for translation of research therapeutics into human clinical trials. Derek Hei leads the WCBF and serves as its technical director. The WCBF is a state-of-the-art cleanroom facility located at the University of Wisconsin-Madison’s Waisman Center. Its primary mission is to assist in developing novel cell and gene therapeutics and to catalyze the advancement of therapies into human clinical trials.
The WCBF is designed to manufacture cell and gene therapeutics for early stage (Phase I and Phase II) human clinical trials according to the FDA’s cGMP guidelines. The WCBF is capable of providing development and manufacturing services for a wide range of biotherapeutics. In addition to facilities and equipment for producing plasmid DNA and viral vectors for gene therapy, the WCBF 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 WCBF 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.