中国食品药品监管Issue(5)：40-51,12.DOI:10.3969/j.issn.1673-5390.2025.05.004
快速微生物检测方法在细胞治疗药品质量控制中的应用及分析
Application and Analysis of Rapid Microbial Methods in the Quality Control of Cell Therapy Medicinal Products
摘要
Abstract
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.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Key words
cell therapy medicinal products/rapid microbial methods/quality control/application and analysis/release testing分类
医药卫生引用本文复制引用
马越,黄丽华,吴伟平,黄瑶,梁蔚阳..快速微生物检测方法在细胞治疗药品质量控制中的应用及分析[J].中国食品药品监管,2025,(5):40-51,12.基金项目
广东省医学科学技术研究基金项目(A2024242、B2023363、B2024159) （A2024242、B2023363、B2024159）
广东省药品监督管理局科技创新项目(2023YDZ04) （2023YDZ04）
