Detection of residual E. coli host cell DNA by 23S ribosomal RNA gene-targeted quantitative polymerase chain reactions

Dehua Li,Qian Zhang,Guodi Liu,Linsong Zhang,Zhangjie Gu,Yingjiao Pan,Xingbing Cui, Peizi He, Xiang Li,Jibin Liu,Guoping Liu,Mu Yang,Xiaoli Tian

Journal of Pharmaceutical and Biomedical Analysis（2021）

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摘要

•E.coli host cell DNA in biological products is a safety risk for clinical therapy.•Rapid and accurate qPCR method was established to quantify E.coli host cell DNA.•The method was validated according to the guideline of regulatory agencies.

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关键词

Residual host DNA,E. coli 23S ribosomal RNA gene,qPCR,Validation study

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