摘要
目的:对比分析我国药典和国外主流药典中快速微生物检测方法在细胞治疗药品质量控制中的应用情况,对各方法的特点进行分析,为相关企业和监管部门提供思考。方法:通过查阅《中国药典》《美国药典-国家处方集》《欧洲药典》《日本药局方》中微生物检测的替代方法,总结适用于细胞治疗药品放行检测的快速微生物检测方法,并从各个方法的检测限、报告时间、样品量、注意事项等方面进行分析,提出改进建议。结果:多个国家和地区的药典收载了将呼吸信号法用于细胞类制品的快速放行检测标准。《美国药典-国家处方集》还收载了基于三磷酸腺苷(ATP)生物发光、固相细胞术的短效期产品放行检测方法,但适用于细胞治疗药品放行检测的参数尚待完善。此外,基于核酸扩增的短效期产品快速微生物检测方法已在产品检测中应用,但其应用于细胞治疗药品的方法学,各药典均未收载。结论:建议强化监管部门与企业的技术交流,完善基于ATP生物发光、固相细胞计数、核酸扩增等多原理的快速检测方法的技术标准和评价体系,进一步提升细胞治疗药品的监管效能,更好地满足人民群众安全用药需求。
Objective:This study aims to compare and analyze the application of rapid microbial methods for quality control of cell therapy medicinal products in the Chinese Pharmacopoeia and major international pharmacopoeias,and to evaluate their characteristics in order to offer suggestions for enterprises and regulatory authorities.Methods:Alternative microbiological testing methods documented in the Chinese Pharmacopoeia,United States Pharmacopeia-National Formulary,European Pharmacopoeia,and Japanese Pharmacopoeia were reviewed.Rapid microbial methods applicable to release testing of cell therapy products were summarized and analyzed in terms of detection limits,reporting time,sample volume,and relevant considerations.Recommendations for improvement were proposed.Results:Multiple national and regional pharmacopoeias have adopted the respiratory signal method as a rapid release testing standard for cell-based products.The United States Pharmacopeia-National Formulary additionally includes release methods for short-life products based on adenosine triphosphate(ATP)bioluminescence and solid-phase cytometry,though parameters specific to cell therapy products remain underdeveloped.Additionally,rapid microbial methods based on nucleic acid amplification have been applied in product testing,but methodologies tailored for cell therapy products have yet to be officially included in any pharmacopoeia.Conclusion:It is suggested to strengthen technical collaboration between regulatory bodies and enterprises,and to improve the technical standards and evaluation frameworks for rapid microbial methods based on ATP bioluminescence,solid-phase cytometry,and nucleic acid amplification.These efforts will enhance the regulatory efficiency of cell therapy product oversight and better address public needs for safe medication.
作者
马越
黄丽华
吴伟平
黄瑶
梁蔚阳
MA Yue;HUANG Li-hua;WU Wei-ping;HUANG Yao;LIANG Wei-yang(Guangdong Institute for Drug Control)
出处
《中国食品药品监管》
2025年第5期40-51,共12页
China Food & Drug Administration Magazine
基金
广东省医学科学技术研究基金项目(A2024242、B2023363、B2024159)
广东省药品监督管理局科技创新项目(2023YDZ04)。
关键词
细胞治疗药品
快速微生物检测方法
质量控制
应用与分析
放行检测
cell therapy medicinal products
rapid microbial methods
quality control
application and analysis
release testing
作者简介
马越,博士,广东省药品检验所,主管药师。专业方向:生物制品质量研究;通讯作者:梁蔚阳,广东省药品检验所,主任药师。专业方向:生化药品、生物制品质量研究。
