약학회지
YAKHAK HOEJI
ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)

Table. 8.

Table. 8.

A test items for cell bank characterization of a animal cell line

Classification Test items MCB WCB EPC
Genetic stability Identity of the expression construct Fluorescence in situ hybridization(FISH)
Southern blot(structural analysis)
Northern blot(mRNA size, relative quantity)

Gene copy number Q-PCR(Quantitative-Polymerase Chain Reaction)
Southern blot

Gene sequencing DNA sequencing
Identification Cell growth(doubling time)
Morphology
Isoenzyme
Production of intended protein
Production rate

Purity Sterility
Mycoplasma

in vivo virus assay Suckling mice, adult mice, embryonated eggs

in vitro virus assay MRC-5, Vero, CHO-k1

Specific rodent virus HAP(Hamster Antibody Production)
MAP(Mouse Antibody Production)
RAP(Rat Antibody Production)
LCMV(Lymphocytic choriomeningitis virus) challenge of mice

Retrovirus and endogenous virus Retrovirus test
Co-cultivation with Mus dunni
Electron microscopy
Reverse transcriptase activity

Specific virus Bovine viruses (○)
Porcine viruses
MVM contamination
CVV(Cache valley virus)

Yakhak Hoeji 2021;65:1-9 https://doi.org/10.17480/psk.2021.65.1.1
© 2021 Yakhak Hoeji