Autologous chimeric antigen receptor-modified T-cells (CAR-T) provide meaningful benefit for otherwise refractory malignancies. As clinical indications for CAR-T cells are expanding, hospitals hitherto not active in the field of immune effector cell therapy will need to build capacity and expertise. The GoCART Coalition seeks to disseminate knowledge and skills to facilitate the introduction of CAR-T cells and to standardize management and documentation of CAR-T cell recipients, in order to optimize outcomes and to be able to benchmark clinical results against other centers. Apheresis generates the starting material for CAR-T cell manufacturing. This guide provides some initial suggestions for patient’s apheresis readiness and performance to collect starting material and should thus facilitate the implementation of a CAR-T-starting material apheresis facility. It cannot replace, of course, the extensive training needed to perform qualitative apheresis collections in compliance with national and international regulations and assess their cellular composition and biological safety.
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Collection efficiency (CE) is the fraction of the circulating cells that is extracted during apheresis and takes into consideration the cell concentration in the peripheral blood, processed blood volume and number of collected cells. CE1 uses the mean of pre- and post- target cell concentrations in the peripheral blood whereas CE2 uses only the pre-apheresis concentration of target cells.
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We thank Sofie Terwel and Yolanda Cabrerizo for organizing regular virtual meetings of the Apheresis Working Group of the GoCart project and supporting us with written summaries of these meetings.
The authors declare no competing interests.
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Worel, N., Holbro, A., Vrielink, H. et al. A guide to the collection of T-cells by apheresis for ATMP manufacturing—recommendations of the GoCART coalition apheresis working group. Bone Marrow Transplant (2023). https://doi.org/10.1038/s41409-023-01957-x