Resetting Expectations for CAR-T Potency Assessment – A Novel Target Cell Killing-Based Approach
In this webinar, you will learn:
- 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
Summary
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.
Speaker
Avinash Chinthala
Scientist, CMC Analytical Development
Precision Biosciences
Avi works with the CMC Analytical Development team at Precision BioSciences. He leads assay development, qualification and analytical tech transfer across Precision’s Cell and Gene Therapy programs including CAR-T cell therapy, mRNA and AAV gene therapy programs, supporting process development and GMP manufacturing.