Affiliation:
1. Center for Cellular Engineering, Department of Transfusion Medicine NIH Clinical Center Bethesda Maryland USA
Abstract
AbstractBackgroundHealthcare center‐based cell therapy laboratories (HC CTLs) evolved from solely processing hematopoietic stem cells for transplantation to manufacturing various advanced cellular therapies. With increasing interest in cellular therapy applications, off‐site manufactured products are becoming more common. HC CTLs play a critical role in supporting these products by shipping out cellular starting material (CSM) for further manufacturing and/or receiving, storing, and distributing final products. The experiences and challenges encountered by a single academic HC CTL in supporting these products are presented.MethodsAll off‐site manufacturing protocols supported before 2023 were reviewed. Collected data included protocol characteristics (treatment indication, product type), process logistics (shipping, receiving, storage, thawing, distribution, documentation), and product handling volumes (CSM shipping and final product infusions).ResultsBetween 2012 and 2022, 15 off‐site manufactured cellular therapy early‐phase, single‐ and multicenter clinical trials were supported. Trials were sponsored by academic/research and commercial entities. The number of protocols supported annually increased each year, with few ending. Products included cancer immunotherapies and gene therapies. Autologous CSM was collected and shipped, while autologous and allogeneic final products were received, stored, thawed, and distributed. Process differences among protocols included CSM shipping conditions, laboratory analyses, final product thaw conditions and procedures, number of treatments, and documentation.DiscussionHC CTLs must contend with several challenges in supporting off‐site manufacturing protocols. As demand for cellular therapies increases, stakeholders should collaborate from the early phases of clinical trials to streamline processes and standardize procedures to increase value, improve safety, and reduce the burden on HC CTLs.