Cell line characterization is crucial to ensure that accidentacontamination of the cell line does not occur during routinecell culture work. lt is particularly important to verify the identityand characteristics of cell lines during drug development, inorder to verify whether the parent cell line has been maintainedand to monitor the impact of new therapies on specifc cell lines. Our testing includes below items:
Category | Detection items | Standard |
Cellular Identification | Isoenzyme analysis | ChP, EP<5.2.3> |
STR | ||
Chromosome karyotyping | ||
Multiplex PCR species identification | ||
CO-1 | ||
dd PCR | ||
FISH(Fluorescence in situ hybridization) | ||
Sterility Testing | Membrane filtration | ChP <1101>, EP <2.6.1>,USP <71> |
Mycobacteria | Pouring method | ChP, EP<2.6.2> |
Mycoplasma | Direct culturing | ChP <3301> |
Indicator cell cultures | ||
Test In Vitro | Cell morphology observation and blood adsorption test | ChP <3604><3302>, USP <1237>, EP <5.2.3> |
28 days In vitro testing with 3 indicator cell cultures | ||
Retroviruses | ||
Detection of the bovine-derived virus (By CPE and IF) | ||
Detection of the bovine-derived virus | ||
Detection of the murine virus | ||
Porcine parvovirus examination | ||
Test In Vivo | In vivo assay of animals (Suckling mouse, adult mouse, guinea pig, rabbit) | ChP <3604><3302>, USP <1237>, EP <5.2.3> |
Embryonated hens’ egg | ||
MAP HAP and RAP | ||
Human-source virus detection |