Analysis of global practices in CAR-T cell production organization and an example of implementation at the Dmitry Rogachev National Medical Research Center for Pediatric Hematology, Oncology, and Immunology

In oncology, there is a significant gap in access to advanced treatment methods, such as CAR-T therapy. Despite its high efficacy in treating refractory forms of cancer, CAR-T therapy often faces challenges due to high production costs and complex regulatory conditions. This article analyzes the global experience in CAR-T cell production and regulation, the experience of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology, and Immunology, and the prospects for CAR-T therapy development in Russia. The study identifies key factors for the successful implementation of this technology and develops recommendations for enhancing the regulatory framework and infrastructure. Special attention is given to organizing decentralized CAR-T cell production in medical centers, which we believe ensures quicker access to therapy and the development of local expertise. The study emphasizes the importance of refining the regulatory framework and continuing efforts to improve regulatory conditions and workforce training. The prospects for CAR-T therapy development in Russia are associated with expanding access to this innovative method, which can significantly improve patients’ quality of life and enhance the effectiveness of cancer treatment.