Optimizing CAR-T treatment: A T2EVOLVE guide to raw and starting material selection.

IF 12.1 1区 医学 Q1 BIOTECHNOLOGY & APPLIED MICROBIOLOGY
Sergio Navarro, Carole Moukheiber, Susana Inogés Sancho, Marta Ruiz Guillén, Ascensión López-Díaz de Cerio, Carmen Sanges, Toshimitsu Tanaka, Sylvain Arnould, Javier Briones, Harry Dolstra, Michael Hudecek, Rashmi Choudhary, Inga Schapitz, Manel Juan, Nina Worel, Delphine Ammar, Maik Luu, Mirko Müller, Bernd Schroeder, Hélène Negre, Paul Franz
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引用次数: 0

Abstract

Chimeric antigen receptor (CAR)-T cell products, classified as Advanced Therapy Medicinal Products (ATMPs), have shown promising outcomes in cancer immunotherapy. The quality of raw and starting materials used in manufacturing is critical to ensure the efficacy and safety of CAR-T cell products and depends primarily on the selection of the right materials and the right suppliers. It is essential to consider a long-term strategy when selecting raw and starting materials to prevent delays in the supply of innovative, high-quality, and safe therapies to patients. A thorough assessment will allow developers not only to select suppliers who comply with regulatory requirements but also to ensure a sustainable supply of materials throughout the development and the commercial phases. A careful selection of materials and suppliers can avoid the need of comparability studies due to changes in the supply of materials, impacting costs and causing significant delays in development and treatment readiness for patients. This work, coordinated by the T2EVOLVE IMI consortium, provides guidance for the selection and handling of raw and starting materials. By following these suggestions, developers can ensure that they use high quality raw and starting materials through the product development and life cycle, resulting in safe and effective CAR-T therapies for patients.

优化 CAR-T 治疗:T2EVOLVE 原料和起始材料选择指南》。
CAR-T 细胞产品被归类为高级治疗药物产品 (ATMP),在癌症免疫疗法中显示出良好的疗效。生产过程中使用的原材料和起始原料的质量对于确保 CAR-T 细胞产品的疗效和安全性至关重要,这主要取决于选择合适的材料和合适的供应商。在选择原材料和起始材料时,必须考虑长期战略,以防延误向患者提供创新、优质和安全的疗法。全面的评估不仅能让开发商选择符合监管要求的供应商,还能确保在整个开发和商业阶段都能持续供应材料。谨慎选择材料和供应商可避免因材料供应的变化而需要进行可比性研究,从而影响成本并导致开发和患者治疗准备工作的重大延误。这项工作由 T2EVOLVE IMI 联盟协调,为原材料和起始材料的选择和处理提供了指导。遵循这些建议,开发人员就能确保在产品开发和生命周期中使用高质量的原材料和起始材料,从而为患者提供安全有效的 CAR-T 疗法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Molecular Therapy
Molecular Therapy 医学-生物工程与应用微生物
CiteScore
19.20
自引率
3.20%
发文量
357
审稿时长
3 months
期刊介绍: Molecular Therapy is the leading journal for research in gene transfer, vector development, stem cell manipulation, and therapeutic interventions. It covers a broad spectrum of topics including genetic and acquired disease correction, vaccine development, pre-clinical validation, safety/efficacy studies, and clinical trials. With a focus on advancing genetics, medicine, and biotechnology, Molecular Therapy publishes peer-reviewed research, reviews, and commentaries to showcase the latest advancements in the field. With an impressive impact factor of 12.4 in 2022, it continues to attract top-tier contributions.
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