Production Assistance for Cellular Therapies (PACT): four-year experience from the United States National Heart, Lung, and Blood Institute (NHLBI) contract research program in cell and tissue therapies.
BACKGROUND
In 2002, the US National Heart, Lung, and Blood Institute (NHLBI) conducted a workshop to determine needs of the cell therapy community. A consensus emerged that improved access to cGMP facilities, regulatory assistance, and training would foster the advancement of cellular therapy.


METHODS
A 2003 NHLBI request for proposals resulted in four contracts being awarded to three cell-manufacturing facilities (Baylor College of Medicine, University of Minnesota, and University of Pittsburgh) and one administrative center (The EMMES Corporation). As a result, Production Assistance for Cellular Therapies (PACT) was formed.


RESULTS
As of October 1, 2008, PACT has received 65 preliminary applications of which 45 have been approved for product manufacture. A variety of cell therapies are represented including T-regulatory cells, natural killer cells, adipose-derived stem cells, cardiac progenitor cells for cardiac disease, hematopoietic progenitor cells (HPCs) for central nervous system applications, cytotoxic T lymphocytes, and dendritic cells. A total of 169 products have been administered under 12 applications and 2 reagents were manufactured and delivered. Fourteen peer-reviewed publications and 15 abstracts have resulted from the PACT project to date. A cell therapy textbook is nearly complete. PACT technical projects have addressed assay development, rapid endotoxin testing, shipping of cell products, and CD34+ HPC isolation from low-volume marrow. Educational Web seminars and on-site training through workshops have been conducted.


CONCLUSIONS
PACT is an active and successful cell therapy manufacturing resource in the United States, addressing research and training while forging relationships among academia, industry, and participating institutions.
Reed
William
W
Blood Systems Research Institute, 270 Masonic Avenue, San Francisco, CA 94118, USA. william.reed@.ucsf.edu
Noga
Stephen J
SJ
Gee
Adrian P
AP
Rooney
Cliona M
CM
Wagner
John E
JE
McCullough
Jeffrey
J
McKenna
David H
DH
Whiteside
Theresa L
TL
Donnenberg
Albert D
AD
Baker
Acacia K
AK
Lindblad
Robert W
RW
Wagner
Elizabeth L
EL
Mondoro
Traci Heath
TH
D000465:Algorithms; D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence; D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D019411:Clinical Laboratory Techniques; D032982:Contracts; D004502:Education, Medical, Continuing / Q000379:methods; D006801:Humans; D054555:National Heart, Lung, and Blood Institute (U.S.) / Q000331:legislation & jurisprudence; D014481:United States