(COLUMBUS, Ohio) – Nationwide Children’s Hospital has received internationally-recognized accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT). Through demonstration of compliance with the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration, Nationwide Children’s has earned accreditation for its Biologics Manufacturing Resource, specifically its cellular therapy product processing with more than minimal manipulation.
“Achieving accreditation from FACT is a testament to Nationwide Children’s diligence in continuing to advance pediatric research by investing in the infrastructure necessary for cutting-edge growth,” said Larry Gazda, PhD, director of the Biologics Manufacturing Resource at Nationwide Children’s. “This defining milestone in the history of our program represents the dedication and commitment across our organization in providing the highest quality cell therapies for patients everywhere.”
Biologics Manufacturing at Nationwide Children’s comprises various laboratory suites, including production clean rooms, a quality control laboratory, process development laboratory, material storage and associated offices and equipment. These facilities, equipment and personnel are maintained for manufacturing a range of cellular therapeutic products for clinical trials.
FACT is an internationally-recognized accrediting body for hospitals and medical institutions offering cell-based therapies, and indicates the accredited institution has met the most rigorous standards. FACT-JACIE standards cover the entire spectrum of cell therapy, from clinical care to donor management, cell collection, processing, storage, transportation, administration, and cell release.
FACT-JACIE Standards are defined by leading experts based on the latest knowledge of the field of cellular therapy transplantation. Following on-site evaluation and review of submitted documentation, Nationwide Children’s Biologics Manufacturing has been found to be in compliance with these rigorous standards. Additionally, since 2005 Nationwide Children’s Apheresis and Blood and Marrow Transplant (BMT) clinical programs have held a combined FACT accreditation for cellular therapy product collection and administration.
About The Abigail Wexner Research Institute at Nationwide Children's Hospital
Named to the Top 10 Honor Roll on U.S. News & World Report’s 2025-26 list of “Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit free-standing pediatric health care systems providing unique expertise in pediatric population health, behavioral health, genomics and health equity as the next frontiers in pediatric medicine, leading to best outcomes for the health of the whole child. Integrated clinical and research programs are part of what allows Nationwide Children’s to advance its unique model of care. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s faculty train the next generation of pediatricians, scientists and pediatric specialists. The Abigail Wexner Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded free-standing pediatric research facilities in the U.S., supporting basic, clinical, translational, behavioral and population health research. The AWRI is comprised of multidisciplinary Centers of Emphasis paired with advanced infrastructure supporting capabilities such as technology commercialization for discoveries; gene- and cell-based therapies; and genome sequencing and analysis. More information is available at NationwideChildrens.org/Research.
About FACT
Founded in 1995, FACT establishes standards for high quality medical and laboratory practice in cellular thearpies. FACT is a non-profit corporation co-founded by the International Society for Cell and Gene Therapy (ISCT) and the American Society for Transplantation and Cellular Therapy (ASTCT) for the purposes of voluntary inspection and accreditation in the field of cellular therapy.