MIT, Bristol Myers Squibb, and LumaCyte utilized novel biophysical and optical characterization methods to identify at least two CQAs for human T cells and engineered CAR-T cell products that will be correlated with known preclinical positive characteristics.
This project lays the groundwork for data analysis and future experiments that correlate CQAs with positive therapeutic outcome in human clinical trials and marketed products, providing the first validated set of CAR T cell CQAs amenable to efficient production.
To the team’s knowledge, this is the first study identifying unique physical attributes of cell populations generated during CAR-T cell product manufacturing that can be used to monitor or predict quality of the resulting therapeutic product.
Laid groundwork for validated in-line process analytics leveraging label-free CQAs of CAR-T cell products
Demonstrated analysis and “sorting” of qualified donor cells and/or engineered cells to identify and select rapidly for critical quality attributes (CQAs) defining safety and efficacy
Established validated set of label-free CQAs for CAR-T cell, which industry can use to correlate with preclinical and clinical results
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Massachusetts Institute of Technology