摘要
近年来随着科学技术的飞速发展,嵌合抗原受体T细胞(chimeric antigen receptor-T cell,CAR-T)产品从分子设计到制备技术均取得了突破性进展,疾病治疗范围从血液系统肿瘤逐步扩大至自身免疫性疾病及实体瘤。然而,生产成本高、产能低是目前CAR-T产品面临的最大现实问题,严重限制了其临床可及性。原辅料价格高昂、定制化生产导致的质检费用和公用设施设备投入无法摊薄、技术依赖下的高人力成本均是CAR-T产品成本居高不下的重要原因。对目前造成CAR-T产品高成本的具体因素及针对性解决方案进行分析,总结发展趋势,以期为CAR-T制备技术的降本增效提供一些参考和建议。基因转导工艺改良,特别是非病毒转导系统的开发、通用型细胞治疗产品的探究、国产自动化设备的布局,是未来CAR-T技术发展的重要方向。随着科研人员的持续攻坚,CAR-T产品成本下降将成为必然趋势,最终成为普通患者可及的“平民化”治疗药物,为重病患者提供更多治疗机会。
In recent years,with the rapid development of science and technology,chimeric antigen receptor T cell(CAR-T)products have made breakthroughs in molecular design and manufacturing technology.Meanwhile,the indications for CAR-T have gradually expanded from hematological cancers to autoimmune diseases and solid tumors.However,high costs and low capacity are the major practical problems facing CAR-T products nowadays,severely limiting their clinical application.The most important factors that lead to the high cost of CAR-T products include the high price of raw materials,the cost of quality control and facilities/equipment that cannot be diluted under the customized production model,and the high labor cost caused by technology dependence.In this paper,we have analyzed the specific factors that cause the high cost of CAR-T products,proposed some targeted solutions,and summarized the development trend to provide some references and suggestions for reducing the cost of CAR-T cell manufacturing.The improvement of gene transduction technology,especially the development of non-viral transduction systems,the exploration of universal cell therapy products,and the industridl layout of domestically produced automation equipment are all the important directions for the future development of CAR-T technology.It is believed that with the continuous efforts of researchers,the cost of CAR-T products will be greatly reduced,and the CAR-T products will eventually become a“civilian”treatment drug for patients,providing more treatment options for seriously ill patients.
作者
陈珂玲
曾顺泽
许鹏超
余艳
冯慧玲
李园
CHEN Keling;ZENG Shunze;XU Pengchao;YU Yan;FENG Huiling;LI Yuan(Scaled Manufacturing Center of Biological Products,Management Office of National Facility for Translational Medicine,West China Hospital of Sichuan University,Chengdu 610041,China)
出处
《中国生物工程杂志》
CAS
CSCD
北大核心
2024年第7期49-57,共9页
China Biotechnology
