Novel Fc Effector Function Reporter Bioassays for Rapid and Quantitative Characterization of Therapeutic Antibodies

摘要

Antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) are becoming increasingly recognized as important mechanisms of action (MOA) of therapeutic antibodies by both drug developers and regulatory authorities. Traditional ADCC and ADCP bioassays utilize primary cells are labor intensive and highly variable primarily due to use of primary effector cells. To enable less variable, easy and consistent analysis of these important MOA, we have developed a suite of highly specific, sensitive, accurate, and reproducible cell-based Fc effector function reporter bioassays. In these bioassays, the primary effector cell that is the major source of assay variability is replaced with an effector cell genetically engineered to express a specific Fc receptor and an NFAT- response element driven luciferase.