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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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基因治疗产品的质量控制分析方法及研究进展

Research progress in quality control analysis methods for gene therapy products

分类号:R917
出版年·卷·期(页码):2020,40 (1):4-12
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

基因治疗产品近年来已成为国内外药物研发的热点。对研发阶段的基因治疗产品开展质量研究,建立相应的质量控制方法和质量标准,是产品安全、有效的重要保证和产业化进程中的重要环节之一。基因治疗产品的质量控制项目包括鉴别、含量、效价、纯度、杂质和其他常规检测项目等。本文较为详细地介绍了在各种基因治疗产品中这些质控项目可采用的分析方法。对于新型基因治疗产品,迫切需要研究适当的分析方法进行有效的质量控制,而已批准上市或进入临床研究产品的质控方法和标准则需要进一步的提高和完善。

-----英文摘要:---------------------------------------------------------------------------------------

In recent years, gene therapy products have become a hot spot in drug R&D at home and abroad. For the gene therapy products in R&D stage, quality research should be conducted to establish corresponding quality control methods and standards, which is an important guarantee for product safety and effectiveness and one of the important steps in the industrialization process. Quality control items of gene therapy products include identification,content,potency,purity, impurities and other routine test items,etc. This paper describes in detail the analytical methods that can be used for these quality control items in various gene therapy products. For novel gene therapy products, it is urgent to develop appropriate analytical methods for effective quality control, while the quality control methods and standards for products which have already been approved for market or clinical research need to be further improved and perfected.

-----参考文献:---------------------------------------------------------------------------------------

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