Introduction to the issues: recently developed methods for characterizing cell lines.
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.
Kozak
R W
RW
Division of Cytokine Biology, F.D.A., Bethesda, MD.
D000818:Animals; D001688:Biological Products / Q000096:biosynthesis / Q000592:standards; D002460:Cell Line; D006801:Humans; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration
D001688:Biological Products