There is considerable excitement surrounding the treatment potential of T cell immunotherapies. Amongst these, CAR-T cells have demonstrated impressive therapeutic efficacy in a subset of hematological malignancies, leading to the approval of KymriahTM and YescartaTM, and continue to be the focus of a growing clinical trial pipeline tackling a spectrum of liquid and solid tumor indications. Despite the clinical success of CAR-T cells, there remain challenges associated with routinely offering these products as treatment alternatives, including a costly manufacturing process that relies on lengthy and complex open workflows with high manual labor requirements that influence product variability. To address these challenges, we have investigated individual CAR-T unit operations to identify commercially available reagents and modular equipment that drive process closure and automation as a method to improve workflow efficiency and product consistency. Here an update is presented on development of our semi-automated closed CAR-T process, which includes the Smart-Max, SepaxTM C-Pro, XuriTM W25 bioreactor, SefiaTM and VIA FreezeTM equipment platform and achieves greater than 1.0E10 expanded T cells with upwards of 80% eGFP transduction efficiency across an 8-day manufacturing process.
1. Understand CAR-T manufacturing challenges
2. Identify closed automated solutions for commercial manufacturing of CAR-T therapies