The Hei Laboratory
Faculty > Derek J. Hei
Derek J. Hei
Director, Waisman Biomanufacturing, Waisman Center
hei@waisman.wisc.edu
Aligned Research Focus
Developing cell and gene therapeutics for human clinical trials
Relevant Research Description
Dr. Hei is the Director of Waisman Biomanufacturing, which 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. This is a state-of-the-art cleanroom facility located at the University of Wisconsin-Madison’s Waisman Center. Waisman Biomanufacturing 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, 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 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. Additionally, Dr. Hei is currently the PI for the NIH-funded PACT (Product Assistance for Cellular Therapy) Program. He also previously served as PI for the NIH National Stem-Cell Bank contract with NCRR and the NIAMS contract “Development of a Production Facility for NIH 3T3 Cells”.
Waisman Biomanufacturing has been selected as one of five facilities nation-wide to serve as a Cell Processing Facility for the PACT (Production Assistance for Cellular Therapies) program. Under the PACT contract, Waisman Biomanufacturing provides product development support, Quality oversight, and produces clinical grade (cGMP) cell therapeutics including therapeutics derived from human embryonic stem cells and adult mesenchymal stromal cells. Waisman Biomanufacturing coordinates efforts with select researchers and clinicians to advance the use of these cGMP cell banks for clinical applications, with a focus on the use of stem cells for treating heart, lung and blood conditions/diseases. The PACT program is funded by the National Heart, Lung, and Blood Institute (NHLBI) with a primary mission of supporting translational investigators that are involved in moving promising new cell therapeutics into human clinical trials.
For the PACT program, Waisman Biomanufacturing has assembled a team of UW investigators that provides comprehensive support for cell therapy development including:
- Production of cell therapeutics under current Good Manufacturing Practice (cGMP) guidelines for use in pre-clinical animal studies and human clinical trials (Waisman Biomanufacturing)
- Production of Master Cell Banks of both Mesenchymal Stem Cells (Peiman Hematti, M.D.) and human Embryonic Stem Cells (WiCell Research Institute) under cGMPs
- Collection and processing, including cell sorting, of bone marrow and peripheral blood hematopoietic stem cells (Peiman Hematti, M.D.) in a FACT- certified clinical hematopoietic stem cell lab
- Pre-clinical animal testing including large animal disease models for cardiac (Timothy Hacker, Ph.D.) and pulmonary (Marlowe Eldridge, M.D.) indications—Cardiovascular Animal Surgery and Physiology Core: www2.medicine.wisc.edu/home/cardiology/oscar/
- Regulatory affairs support for filing of Investigational New Drug (IND) applications with the Food and Drug Administration (John Centanni, M.S., Amish Raval, M.D.)
The UW PACT team has a primary focus of Mesenchymal Stem Cell (MSC) and human Embryonic/Pluripotent Stem Cell-based therapeutics. Investigators with other potential cell therapeutics are encouraged to contact the UW PACT Team (Derek Hei, hei@waisman.wisc.edu). NHLBI may provide support for translational efforts in other areas outside of the normal scope of NHLBI funding. More information on the PACT program and the application process for PACT-funded projects can be found on the PACT website (www.pactgroup.net).