Introduction

CAR-T cell manufacturing starts from a collection of mononuclear cells (MNCs, although specifically only T lymphocytes will be used for the preparation) from the patient using apheresis. Although several initiatives are working on the development of allogeneic CAR-T cells, currently only CAR-T therapies of autologous origin are approved in the European Union. The present chapter only discusses already or soon-to-be marketed autologous CAR-T cells and excludes investigational CAR-T cells or rare CAR-T cells approved in the context of hospital exemption, such as the ARI-001 product (Ortiz-Maldonado et al. 2021); on this topic, please refer to Chap. 3.

Institutions aspiring to be CAR-T centres must generate sufficient apheresis capacity to ensure immediate access to apheresis slots; apheresis capacity must grow in synchrony with the CAR-T program (Tables 6.1, 6.2, 6.3, 6.4, and 6.5).

Table 6.1 Before apheresis collection
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Table 6.2 Designing apheresis collection
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Table 6.3 Characteristics of the apheresis platforms typically used for collection
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Table 6.4 Collection requirements of different manufacturers of CAR-T therapies
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Table 6.5 Interim storage, cryopreservation, and logistics
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Key Points

  • Prepare for apheresis by assessing the clinical and biological condition of the patient.

  • Discontinue treatments that can lower immune effector cell numbers and functions.

  • Tailor apheresis parameters to the patient condition.

  • Tailor apheresis parameters to suit the manufacturer’s needs and requirements.

  • Tightly coordinate with the Cell Processing Facility to ensure smooth shipment to the manufacturing site, in compliance with the manufacturer’s needs and requirements.