The National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health (NIH), is supporting the initiative for a Coordinating Center and five facilities for the production and testing of novel cell therapies. The facilities are the Baylor College of Medicine, Center for Cell and Gene Therapy (CAGT), Center for Human Cell Therapy Boston (CHCT), City of Hope - Center for Applied Technology Development (CATD), University of Minnesota, Molecular and Cellular Therapeutics facility (MCT), and the University of Wisconsin, Madison - Waisman Biomanufacturing (WB). The Coordinating Center is The EMMES Corporation. These institutions form the Production Assistance for Cellular Therapies (PACT) group.
The PACT program is designed to develop novel cellular therapies that will aid investigators by providing production assistance in areas ranging from translational development to the scale-up of a product that is intended for use in human clinical trials. The cell processing facilities are charged with implementing the rapid, safe, and equable transition of innovative treatment concepts to clinical practice as well as supplying clinical grade products produced in a manner that is compliant with applicable regulatory requirements. The facilities are committed to providing the investigator the data needed to support an Investigational New Drug (IND) application. The PACT Coordinating Center will serve as the monitor and coordinator for organizational and regulatory aspects of the program. The ultimate goal of the program is to find a way whereby a focus is placed on translational work involving immunomodulation research and to address the lack of assistance in transporting cellular therapies from the bench to the bedside. PACT has initiated an Education Training Program to promote the field of cellular therapy and to reach out to investigators new to the field and provide them with recommended applications of the current Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) guidelines.
- Baylor College of Medicine Center for Cell and Gene Therapy (CAGT)
- Center for Human Cell Therapy Boston (CHCT)
- City of Hope - Center for Applied Technology Development (CATD)
- Minnesota Molecular and Cellular Therapeutics Facility (MCT)
- University of Wisconsin, Madison