Providing the starting material to the manufacturer of an approved and commercially available autologous CAR-T cell treatment

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.