Production Assistance for Cellular Therapies - Cell Processing Facilities (PACT-CPF)

The National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI) established this Master IDIQ on July 29, 2016, to support clinical manufacturing and pre-clinical development of novel somatic cell therapies. Ordering closed on June 30, 2022, and the vehicle is no longer accepting new task orders.

The PACT program funds up to eight geographically dispersed Cell Processing Facilities (CPFs) and one Coordinating Center to develop cellular therapy manufacturing protocols, conduct preclinical studies, and provide regulatory expertise supporting IND applications. Work spans regenerative medicine for damaged or diseased tissues and organs, including therapies for heart, lung, and blood disorders. Task orders funded under PACT are priced on a cost-no-fee basis or firm-fixed-price model and are for non-clinical use within the United States.

The vehicle awarded 37 task orders between August 2016 and October 2020, with a combined potential value of $20.7 million and $19.6 million obligated (95% of potential value). Order velocity peaked in 2018 with 16 awards, declining to 3 in 2020. All 37 orders funded NHLBI programs with no set-aside designations applied. University of Miami holds 11 orders valued at $5.8 million, Beckman Research Institute of the City of Hope holds 6 orders valued at $5.5 million, H. Lee Moffitt Cancer Center holds 7 orders valued at $3.9 million, Regents of the University of Minnesota holds 8 orders valued at $3.5 million, and Baylor College of Medicine holds 5 orders valued at $2 million. Work spans cell manufacturing, process development, and regulatory support—including hESC- and iPSC-derived cardiomyocyte production, mesenchymal stem cell therapies, T-regulatory cell engineering, and cryopreservation studies. Task-order ceilings range from approximately $45,000 to $1.7 million.

The National Heart, Lung, and Blood Institute (NHLBI) is planning a second competitive renewal for the Production Assistance for Cellular Therapies (PACT) program for the development of clinical manufacturing protocols and production of novel somatic (biological) cell therapies for use in pre-clinical studies to be used in support of Investigational New Drug (IND) applications. The objective of this program is to continue to advance cellular therapy research in the areas of regeneration of damaged/diseased tissues, organs, biologic systems, and targeted treatments for serious diseases without effective therapies. This program will fund up to eight (8) geographically dispersed Cell Processing Facilities (CPFs) and one (1) Coordinating Center (CC) in the U.S. with the capacity to provide consulting, manufacturing, preclinical study, administrative, and regulatory expertise necessary for the development of novel cellular therapies in the area of heart, lung, and blood cellular therapy research. The PACT CPFs shall serve investigators within the scientific community as performance centers for translational research related to cellular therapies and manufacturers of cellular therapy products. PACT CPFs shall manufacture cellular therapy products for investigators from academia and industry needing manufacturing support. The cellular products manufactured by the CPFs are intended for non-clinical use within the United States.