Driving CAR-T from Early-stage Development to Clinical Filing and Lot Release

This two-part case study video series uses HER2-targeting CAR-T cells as a model system for targeting solid tumors. The model, developed and used by Charles River, is broadly applicable for cell therapy development with the aims to guide cell therapy developers on their path from early-stage development to clinical filing and lot release.

Join our expert panel of presenters to discover:

  • The best approach to assess efficacy, potency, persistence, and safety in vitro
  • Lessons learned from evaluating efficacy and safety profile in vivo
  • Regulatory expectations and challenges selecting sustainable CAR-T cell potency assays that reflect the MoA and meet method validation requirements
  • Biological activity assays at play for CAR-T and how to approach determination for lot release of CAR-T cells

About the Presenters

Head shot of Dr. Ulrike Herbrand.
Dr. Ulrike Herbrand
Scientific Director, Global In Vitro Bioassays

 

Head shot of Dr. Julia Schüler.
Dr. Julia Schüler
Research Director

 

Head shot of Sophie Vermond.
Sophie Vermond
Senior Scientist