Regulatory aspects and legal framework for the manufacturing of CAR-T products in compounding pharmacies DOI
E. A. Badrin, Michael Maschan, N.V. Pyatigorskaya

et al.

Farmaciya (Pharmacy), Journal Year: 2025, Volume and Issue: unknown, P. 36 - 42

Published: May 12, 2025

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

Language: Английский

Regulatory aspects and legal framework for the manufacturing of CAR-T products in compounding pharmacies DOI
E. A. Badrin, Michael Maschan, N.V. Pyatigorskaya

et al.

Farmaciya (Pharmacy), Journal Year: 2025, Volume and Issue: unknown, P. 36 - 42

Published: May 12, 2025

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

Language: Английский

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