Production Assistance for Cellular Therapies (PACT)

The NHLBI-funded program, Production Assistance for Cellular Therapies (PACT), was formed to advance cellular therapy research in the areas of heart, lung and blood cellular therapy research. PACT is charged with providing assistance for cellular therapy translational research and the manufacture of cellular therapy products that aid in the repair and regeneration of damaged/diseased tissues, organs, and biologic systems. Additionally, PACT will provide support for proof-of-principle animal and early translational research.

PACT provides education and training via web seminars, on-site workshops and at national meetings. Education initiatives focus on three major areas: translational development; scale-up and manufacture of cell therapy products; and quality assurance and regulatory issues. Production assistance is provided through the funded contract manufacturing of therapeutic cell products at five PACT cell processing facilities. These cell processing facilities offer scale-up capability and expertise in the translational development needed to produce cell therapy products under cGMP and cGTP regulations. The Coordinating Center (CC), The EMMES Corporation coordinates the application submission and review process and provides regulatory support to approved applicants in the development of their FDA submissions, including INDs. The CC assists with the management and coordination of PACT, including the steering committee, education initiatives, technical projects and PACT-related publications in addition to facilitating communications between the facilities and NHLBI.