Regulatory aspects and legal framework for the manufacturing of CAR-T products in compounding pharmacies

Introduction. CAR-T cell therapy has proven to be an effective treatment for relapsed and refractory hematologic malignancies. However, its widespread adoption in Russia is hindered by high costs, complex regulatory procedures, and a limited number of specialized centers. Consequently, the feasibility of extemporaneous manufacturing as an alternative mechanism for CAR-T cell production to improve accessibility arises as a relevant question. Objective. To analyze the feasibility and potential implementation of extemporaneous manufacturing of CAR-T cell products in Russia, identify necessary legislative changes, and assess the potential risks and benefits of this approach. Results. Currently, CAR-T cells in Russia can be produced either as high-technology medicinal products, which require mandatory registration, or as individualized biomedical cell products, authorized by the Ministry of Health and available exclusively within the medical institutions where they were manufactured. An analysis of Russian legislation indicates that the recent precedent allowing pharmaceutical compounding of radiopharmaceutical medicinal products establishes a legal basis for potentially extending a similar approach to CAR-T cells. Potential benefits include improved accessibility, reduced costs, and the possibility of personalized manufacturing. However, implementation would require adapting regulations for pharmacy-compounded medicinal products, developing good compounding practice guidelines, establishing pharmacopoeial standards for cellular products, and creating mechanisms for quality control and biosafety assurance. Conclusion. The introduction of extemporaneous CAR-T cell manufacturing in Russia could significantly enhance the accessibility of personalized cell therapy. However, successful implementation requires regulatory amendments, the establishment of a certification and oversight system, and the training of qualified professionals. Further research should focus on developing regulatory standards and conducting pilot projects to evaluate the feasibility of this approach.