Development of a novel reporter gene assay to evaluate antibody-dependent cellular phagocytosis for anti-CD20 therapeutic antibodies

International Immunopharmacology(2021)

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摘要
•Jurkat cells expressing CD32a-FcεRIγ and NFAT-controlled luciferase were engineered.•Reporter gene assay for ADCP was established with the engineered cells and rituximab.•Design of experiment (DoE) strategy was performed to optimize the bioassay.•Full validation according ICH-Q2 showed the good assay performance characteristics.
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关键词
Monoclonal antibody,CD20,Antibody-dependent cellular phagocytosis,Bioactivity,Reporter gene assay
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