基于基因修饰细胞系的生物检定法研究进展

Research progress of genetically modified cell-based bioassays

以药物的作用机制为基础,采用细胞与分子生物学技术构建特定基因修饰细胞系并开发相应的检测方法,可用于相关产品的生物检定。这种基于基因修饰细胞系的生物检定法在药物的质量控制领域具有广泛的应用前景。本文探讨了基因修饰细胞系的构建策略及检测方法的基本原理,并概述了基于基因修饰细胞系的生物检定法在重组蛋白类、疫苗类、基因治疗类等不同产品质量评价中的研究进展及应用情况。

Based on the mechanism of action of drugs,specific gene modified cell lines are constructed using cell and molecular biology technologies,and corresponding test methods are developed,which can be used for biological assays of related products.These genetically modified cell-based bioassays have a wide application prospect in the field of pharmaceutical quality control.In this paper,the construction strategies of genetically modified cell lines and the basic principles of detection methods are discussed,and the research progress and application of genetically modified cell-based bioassays in the quality evaluation of recombinant proteins,vaccines,and gene therapy products are summarized.