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Label-free Critical Quality Attributes of CAR T-Cell Products

This NIIMBL project will utilize 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.
Categories
Cell and Gene therapies
Equipment and Supplies
Data
Project status
100% Completed

Industry Need

  • Cell therapy products comprising engineered T cells (e.g., CAR-T cells) require manufacturing innovation to identify and select for critical quality attributes (CQAs) defining safety and efficacy. 
  • CQAs that will enable analysis and “sorting” of qualified donor cells and/or the engineered cells – ideally without use of cell-labeling and amenable to analysis of low cell numbers and fluid volumes – can significantly improve product safety, efficacy, and production costs
  • While approaches using small-volume microfluidics, optic, and mechanics have been demonstrated for other cell types including human stem cells, this will be an innovative manufacturing technology approach for CAR-T cells. 


Solution

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. 

Updates, Related Publications, and Deliverables

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Project Lead

Massachusetts Institute of Technology

Massachusetts Institute of Technology

Participating Organizations

Bristol-Myers Squibb

Bristol-Myers Squibb

LumaCyte

LumaCyte