The Foundation for the Accreditation of Cellular Therapy (FACT) awarded accreditation without any deficiency citations to UNC Lineberger’s Advanced Cellular Therapeutics (ACT) Facility on Jan. 17.
“Earning FACT accreditation is a major milestone for any manufacturing facility and underscores our commitment to the highest standards in cellular therapy,” said Jonathan Serody, MD, the Elizabeth Thomas Professor of Medicine, Microbiology, and Immunology, chief of the Division of Hematology at UNC School of Medicine, and director of the UNC Medical Center’s Cellular Therapy Program. “This recognition reflects the dedication of our faculty and staff, as well as the rigor of our processes and procedures, which meet or exceed FACT’s stringent standards and governmental regulations.”
This was the first time the UNC ACT Facility underwent FACT review, and remarkably, no concerns were cited, Serody noted. “Achieving accreditation without a single issue identified by FACT inspectors is an extraordinary accomplishment,” Serody said. “It’s a testament to the outstanding work of our team and our unwavering commitment to providing the highest quality of care to our patients.”
Founded in 1995 by the International Society for Cell and Gene Therapy and the American Society for Transplantation and Cellular Therapy, FACT is a globally recognized accrediting body that sets rigorous quality standards for cellular therapy, stem cell transplantation, and cord blood banking. Its standards encompass the entire lifecycle of cellular therapy products, including donor selection, cell collection, processing, storage and administration. By maintaining strict oversight at every step, FACT ensures the highest level of patient safety and treatment efficacy.
“FACT standards are among the most comprehensive in cellular therapy, and their impact on patient care cannot be overstated,” said Kimberly Kasow, DO, professor of pediatrics, associate director for quality initiatives with the UNC Bone Marrow Transplant and Cellular Therapy Program, associate director for quality with the ACT Facility, and director of the UNC Pediatric Bone Marrow Transplant Program. “One of the most valuable aspects of FACT accreditation is its focus on continuous improvement.”
Kasow emphasized that accredited facilities must regularly assess and enhance their processes. “This culture of self-assessment and refinement ensures that patient care is always evolving. For the ACT Facility, this means not just meeting current standards but consistently striving to exceed them—always with patient safety and outcomes in mind.”
UNC Lineberger established the ACT Facility in 2015 to support clinical trials involving human cellular therapy products, including chimeric antigen receptor T-cells (CAR-T). Operating under strict Current Good Manufacturing Practices (cGMP), the facility manufactures all CAR-T products used in early-phase clinical trials led by UNC cancer researchers. UNC Lineberger’s CAR-T clinical trials program is the second largest among U.S. academic medical centers, solidifying its position as a leader in the field.
“Our cellular immunotherapy program is world-class due to its innovation, precision and collaboration,” said Barbara Savoldo, MD, PhD, the Champion Mitchell Distinguished Professor in Pediatric Oncology at UNC School of Medicine, co-director of the UNC Lineberger Immunotherapy Program, and the ACT Facility director. “With 16 active clinical trials, including groundbreaking ‘first-in-human’ studies for solid tumors like triple-negative breast cancer, we are at the forefront of cellular therapy advancement. The ACT Facility’s seamless coordination between manufacturing and quality teams ensures the production of patient-specific CAR T-cell therapies, offering hope to patients with limited treatment options.”
The facility’s successful accreditation was the result of efforts led by John West, PhD, director of cellular therapy production, Colin Mudd, assistant director of quality assurance and quality control, Savoldo and Kasow.
Savoldo, Kasow and Serody praised the ACT Facility team for their expertise, dedication to excellence and commitment to keeping UNC Lineberger a leader in cellular therapy, innovation and patient care.
ACT Facility Team
Manufacturing team, led by West
- Morgan Kershner, CAR-T cell production specialist
- Emily Williams, CAR-T cell production specialist
- Shan Stewart, CAR-T cell production specialist
- Alex Beasley, CAR-T cell production specialist
- Tammy Cavallo, vector production specialist
- Sunghyun Lee, vector production specialist
Quality assurance and quality controls team, led by Mudd
- Mackenzie Nelson, quality assurance
- Larry Jones, quality assurance
- Charlene Colbert, quality control
- Jessee Andrews, quality control
- Brittany Alston, quality control
- Yaxu Wu, quality control
- Renata Tracy, quality control