Cell Line Characterization
Research and development of biological products involving the use of cell lines require precise and extensive cell line characterization. This can be assured by periodic monitoring of cell line characteristics and possible contamination. In the absence of such monitoring, cell line contaminations are likely to occur and can result in the generation of mistaken conclusions or sub-quality products with an attendant loss of time, effort, and resources.
Requirements of cell line characterization depend on the species of cell lines (such as human, rodent, insect) and its intended use (such as vaccine production, recombinant protein production, gene therapy). The cell line source, development history, as well as the biological properties of cells determine which testing should be performed. Proper characterization assays of master cell bank (MCB) and manufacture’s working cell bank (MWCB) provide the groundwork for the future production of biological products.
Cell Line Characterization at Creative Animodel
Creative Animodel provides comprehensive cell line characterization services to support the acceptability of a cell line to produce a biological product. Based on a series of tests, we offer the final report including information about history of the cell line, general characteristics, cell bank system, and quality control testing results.
History of cell linesAge, sex, and species of the donorThe donor’s medical history for human cell linesCulture history of the cell line including isolation methods, passage history, and culture mediaPrevious identity testing resultsGeneral characteristicsThe growth patternMorphological appearanceSpecific markers (such as marker chromosomes and surface markers)The total number of population doubling levels through senescenceCell bank systemGeneration of cell banks (MCB or MWCB)Storage of the cell banksCell bank qualification
|MCB||Morphology, as determined by light and electron microscopy|
Species of origin
Data demonstrating that the cells can be used for their intended purpose
Identify testing of production cultures
|WMCB||Only needs to be spot checked for contaminants that may have been introduced from the culture media|
Quality control testingSterility testing: tests for the presence of bacteria and fungi.Mycoplasma detection: tests for both cultivable and non-cultivable mycoplasma. Biological products made in insect cell lines can be tested for both mycoplasma and spiroplasma.Viral testing: tests for the adventitious and endogenous viral agents.Tumorigenicity testing: human cells used for live virus vaccine production should be tested.
Creative Animodel is a leading provider of cell line characterization services. We have the technical expertise and excellent track record to meet the demands of the leading university, research institutes, as well as biotechnology and pharmaceutical companies worldwide. If you have any needs, please feel free to contact us.