Development Of A Modular, Semi-automated And Closed T-Cell Manufacturing Strategy

The rapid clinical advances of T-cell based immunotherapy necessitate robust manufacturing solutions that are suitable for commercial scale production. Here, we present a modular manufacturing process using commercially available equipment that is suitable for the production of CAR T-cells or other T-cell based therapies and amenable for rapid implementation to therapeutic developers’ specific processes. Our process is being developed to enable closed and automated unit operations that yield reproducible and optimal results for clinically relevant T-cell manufacturing.

Objectives
To develop a modular, semi automated workflow to:

• Enrich PBMC from either fresh and frozen leukapheresis in a closed automated device
• Isolate CD3+ cells and release bound magnetic particles
• Activate and expand isolated T-cells in a closed bioreactor
• Harvest expanded T-cells in a closed automated device and add cryoprotectant with a controlled injection rate
• Cryopreserve harvested cells using a liquid nitrogen free controlled rate freezer