A robust reporter assay for the determination of the bioactivity of IL-4R-targeted therapeutic antibodies

Journal of Pharmaceutical and Biomedical Analysis(2021)

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摘要
•HEK-293 cells stably expressing hSTAT6 controlled luciferase were established.•The optimal dose-response curve was demonstrated after assay parameter optimization.•Validation according to ICH-Q2 proved the excellent assay performance characteristics.•The established RGA is suitable for the bioactivity determination of anti-IL-4R mAbs.
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关键词
IL-4,Transgenic cell,Reporter gene assay,Monoclonal antibody,Method validation
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