[EU BEBPA] Implementing MOA-Reflective ADCC Assays Using Ready-to-Use KILR Target and Effector Cells from Screening to Lot Release
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- EU BEBPA
The clinical success of an ever-increasing array of biologics has led to the development of a wide spectrum of immunomodulatory agents with distinct mechanisms-of-action (MOA) targeting novel antigens. During development of antibody-based biologics, evaluation of antibody (Fc) effector functions is required by regulators as is needed for antibody dependent cell-mediated cytotoxicity (ADCC). Increasingly regulators are requiring that ADCC assays, especially those used for lot release applications, measure immune cell-mediated killing rather than a surrogate endpoint for antibody engagement of antigen on target cells.