Cell Line and Cell Bank Identification
Cell line and cell bank identification is a regulatory requirement. The cell lines and cell banks used in antibody drugs, protein drugs, and cell therapy products must ensure their quality, purity, and safety. Proper cell line and cell bank identification is crucial in the production of biopharmaceuticals.
Methods for Cell Line and Cell Bank Identification
Cell line and cell bank identification primarily targets master cell banks (MCBs) and working cell banks (WCBs). Additionally, research cell banks (RCBs) typically undergo mycobacterial and sterility checks before being incorporated into GMP facilities for MCB production. Manufacturers may also request specific virus testing.
According to current regulations (e.g., ICH Q5A/Q5B/Q5D), cell line and cell bank identification mainly includes the following aspects: cell identification, sterility testing, mycoplasma testing, testing for endogenous and exogenous viral contamination, and tumorigenicity testing. The testing items and methods provided by HyQure Biotech are described below:：
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Testing items |
Detection methods |
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Cell identification |
Isozymes, CO1, STRs, species identification |
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Bacterial and fungal examination |
Membrane filtration, direct inoculation, and respiratory signal method |
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Mycoplasma test |
Direct culture method, indicator cell culture method, qPCR method (for mycoplasma and spiroplasma testing) |
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Mycobacterium test |
Culture method, qPCR method |
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Exogenous and endogenous viral agent testing |
Cell morphology observation and blood adsorption |
Cell culture morphology observation and blood adsorption test |
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In vitro seeding of different indicator cells |
Cytopathic effect examination |
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In vivo inoculation of animals and hens' embryonated eggs |
Hens' embryonated eggs, suckling & adult mice, etc. |
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Retrovirus test |
Infectivity test, electron microscopy, reverse transcriptase activity (TEM-PERT) |
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Species-specific virus testing |
Mouse-derived, human-derived, monkey-derived |
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Bovine virus testing |
Cytopathic effect examination, qPCR method |
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Porcine virus testing |
Cytopathic effect examination, qPCR method |
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Other specific virus tests |
Mouse parvovirus test, etc. |
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Tumorigenicity examination |
Animal experiments |
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