SEP 27, 2018 12:00 PM PDT

Development of a Semi-Automated Closed CAR-T Manufacturing Process

Presented at: Cell Biology 2018
Speaker
  • Development Engineer / Scientist II, CCRM
    Biography
      Calley Hirsch has been a Development Engineer / Scientist II at CCRM in Toronto for 8 months, where she specializes in upstream lentiviral production and gene delivery technologies. Prior to working at CCRM, Calley was a postdoctoral fellow at the Lunenfeld-Tanenbaum Research Institute in Toronto and MD Anderson Cancer Center in Houston working on pluripotent stem cells and somatic cell reprogramming. Calley received her PhD from the University of Saskatchewan.

    Abstract

    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. 

    Learning Objectives: 

    1. Understand CAR-T manufacturing challenges
    2. Identify closed automated solutions for commercial manufacturing of CAR-T therapies


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