Abstract
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 Chapter 3c.
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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).
Key Points
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Prepare for apheresis by assessing the clinical and biological condition of the patient.
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Discontinue treatments that can lower immune effector cell numbers and functions.
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Tailor apheresis parameters to the patient condition.
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Tailor apheresis parameters to suit the manufacturer’s needs and requirements.
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Tightly coordinate with the Cell Processing Facility to ensure smooth shipment to the manufacturing site, in compliance with the manufacturer’s needs and requirements.
References
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Bonig, H., Chabannon, C., Lozano, M. (2022). Providing the Starting Material to the Manufacturer of an Approved and Commercially Available Autologous CAR-T Cell Treatment. In: Kröger, N., Gribben, J., Chabannon, C., Yakoub-Agha, I., Einsele, H. (eds) The EBMT/EHA CAR-T Cell Handbook. Springer, Cham. https://doi.org/10.1007/978-3-030-94353-0_6
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