Kozak R W
Division of Cytokine Biology, F.D.A., Bethesda, MD.
Dev Biol Stand. 1992;76:21-4.
Cell line characterization is an integral part of establishing quality control over the manufacturing process of a biological product. Characterizing the general and unique features of the continuous cell line and the absence or presence of contaminants establishes a fundamental knowledge about the raw material from which the biological product is being derived. Such information can be used for cell line selection, design of the purification scheme and extent of ensuing validation studies. Developing the selected cell line into a cell bank system allows for a constant source of starting material and decreases the likelihood of contamination. Characterization of the cell bank system may include a) identification of the cell line species of origin, b) identification of unique reference markers, and c) pre-testing for cross-contamination and adventitious agents. This paper introduces issues surrounding present and upcoming methods used for authenticity and characterization testing of cell banks.
细胞系鉴定是对生物制品生产过程建立质量控制的一个不可或缺的部分。鉴定连续细胞系的一般和独特特征以及污染物的有无，能建立起有关生物制品所源自的原材料的基础知识。这些信息可用于细胞系选择、纯化方案设计以及后续验证研究的范围确定。将选定的细胞系发展成细胞库系统，可提供恒定的起始材料来源，并降低污染的可能性。细胞库系统的鉴定可能包括：a）鉴定细胞系的起源物种，b）鉴定独特的参考标记，以及c）交叉污染和外源因子的预测试。本文介绍了围绕细胞库真实性和鉴定测试的现有及即将出现的方法的相关问题。
