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  •   Resetting Expectations for CAR-T Potency Assessment – A Novel Target-Cell Killing Based Approach   

    PROMEGA

    Potency assays are an essential aspect of analyses of biotherapeutics, including CAR-T therapeutics. The potency assay format that will be used as a release assay for CTM (in a QC environment) needs to be as accurate, precise and robust as possible.

    Developing a robust potency assay for CAR-T therapeutics can be a long and complicated process.
    The mechanism of action of CAR-T cells – dubbed ‘living drugs’ – in-vivo is multi-faceted. Currently, target-cell killing and cytokine induction are two of the more prominent measures indicative of CAR-T potency in the cell therapy field.
    This webinar will provide the rationale and data that supports transitioning from current interpolation-based cytokine induction assays, with minimal number of dilutions (one), to full-curve analyses based upon MOA-reflective cellular responses.