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A guide to the collection of T-cells by apheresis for ATMP manufacturing—recommendations of the GoCART coalition apheresis working group

Bone Marrow Transplantation (2023)Cite this article

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Abstract

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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Fig. 1: Apherithmetic describes the formulas used in a leukapheresis procedure.

Notes

  1. 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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Acknowledgements

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.

Author information

Authors and Affiliations

  1. Department for Transfusion Medicine and Cell Therapy, Medical University of Vienna, Vienna, Austria

    Nina Worel

  2. Regional Blood Transfusion Service, Swiss Red Cross, Basel, Switzerland

    Andreas Holbro

  3. Division of Hematology, University Hospital Basel and University Basel, Basel, Switzerland

    Andreas Holbro

  4. Innovation Focus Cell Therapies, University Hospital Basel, Basel, Switzerland

    Andreas Holbro

  5. Department for Transfusion Medicine, Sanquin Blood Supply, Amsterdam, The Netherlands

    Hans Vrielink & Kaatje Le Poole

  6. Department of Hematology, Leiden University Medical Centre, Leiden, The Netherlands

    Claudia Ootjers & Ingrid Beer-Wekking

  7. EBMT Executive Office, Barcelona, Spain

    Tuula Rintala

  8. Apheresis and Cellular Therapy Unit, Department of Hemotherapy and Hemostasis, University Clinic Hospital, IDIBAPS, University of Barcelona, Barcelona, Spain

    Miquel Lozano

  9. Institute for Transfusion Medicine and Immunohematology, Goethe University, Frankfurt a.M., Germany

    Halvard Bonig

  10. Department of Medicine, Division of Hematology, University of Washington, Seattle, WA, USA

    Halvard Bonig

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Contributions

NW and HB were responsible for writing the report, creating the figure and table, and reviewing and revising the report. AH, HV, CO, KLP, IBW, TR, and ML were responsible for writing, reviewing and revising the report.

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Correspondence to Nina Worel.

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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

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