Optimizing Perfusion Parameters Using Quality By Design For The Intensified Production Of CAR-T Cells In A Single-Use Automated Stirred-Tank Bioreactor

By P. Springuel, T. Hood, F. Slingsby, N. Bevan, T. Schmidberger, W. Geis, J. Hengst, N. Dianat, and Q. Rafiq

The ex vivo expansion of patient chimeric antigen receptor (CAR) T cells to therapeutic doses is challenging and typically takes the longest out of all the phases of manufacturing.

To meet increasing demand while reducing costs, it is crucial to develop scalable expansion processes that boost CAR-T cell yields and minimize vein-to-vein time.

In this study, the optimization of perfusion parameters to maximize CAR-T cell growth and quality within a single-use, automated stirred-tank bioreactor is systematically investigated. The goal is to shorten the process time for personalized treatments and increase yields for allogeneic modalities.