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Resetting Expectations for CAR-T Potency Assessment – A Novel Target-Cell Killing Based Approach
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.
In this webinar, you will learn about:
- Limitations of existing CAR-T potency measurement approaches
- A new HiBiT target-cell killing based approach for CAR-T potency assessment
- Evaluation of HiBiT target-cell killing assay performance for use in a QC environment
Avinash Chinthala, Scientist, CMC Analytical Development, Precision BioSciences Inc.
Wednesday, October 5, 2022 @ 10am CDT / 11am EDT / 4pm London / 5pm Amsterdam-Paris
Thursday, October 6, 2022 @ 12pm Singapore / 2pm Sydney / 1pm Seoul / 9:30am New Delhi
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