Robust Quality Infrastructure is Key to Safe and Effective Delivery of Immune Effector Cells: How FACT-Finding Can Help.

Immune effector cells (IEC) include a broad range of immune cells capable of modulating several disease states including malignant and non-malignant conditions. The growth in use of IECs as both investigational and commercially available products has required medical institutions to develop workflows/processes to safely implement and deliver this transformative therapy. Adding to the complexity of this therapy is the variety of targets, diseases, sources, and unique toxicities that a patient experiences following IEC therapy. For over 25 years the Foundation for the Accreditation of Cellular Therapy (FACT) has established the standard for use of cellular therapy, initially with hematopoietic cell transplant (HCT) and more recently with their development of standards to encompass IEC products such as chimeric antigen receptor (CAR) T cells. To date, IEC therapy has challenged the bandwidth and infrastructure of institutions offering this therapy. To address these challenges FACT has established a programmatic framework to improve the delivery of IEC therapy. In this manuscript we outline the current state of IEC program development, accreditation, and solutions to the challenges that programs face as they expand their application of novel IEC therapy.