BioInsights - Driving CAR-T from early-stage development to clinical filing and lot release

Driving CAR-T from early-stage development to clinical filing and lot release

Cell & Gene Therapy Insights 2022; 8(5), 731;

DOI: 10.18609/cgti.2022.110

Published: 10 July 2022
Ulrike Herbrand, Julia Schueler, Sophie Vermond

Driving CAR-T from early-stage development to clinical filing and lot release 

  • Approach to assess the efficacy, potency, persistence, and safety of your CAR-T cell therapy in vitro
  • Evaluating the efficacy and safety profile of CAR T in vivo and lessons learned
  • Share regulatory expectations (guidelines and how to interpret them) and challenges with selecting sustainable CAR-T cell potency assays for development that reflect the MoA and are able to meet method validation requirements.   
  • Discuss biological activity assays at play for CAR-T and inform on how to approach determination for lot release of CAR-T cells will be presented as it plays a key role in defining the quality of the product.

Dr Ulrike Herbrand joined Charles River Laboratories in 2007. She is Scientific Director Global in vitro Bioassays and Head of the Bioassay Research & Development team at Charles River Laboratories’ site in Erkrath, Germany. She gained a PhD in biological sciences during her time at the Max-Planck-Institute for Molecular Physiology in Dortmund (Germany) and worked five years at post-doctoral positions at medical research centers in the field of cancer research. She is an expert in mechanism of action-reflecting bioassays.

Dr Julia Schüler studied veterinary medicine in Switzerland and Germany where she received her DVM. Afterwards, Julia joined the lab of Heiner Fiebig, at Oncotest GmbH, in Freiburg, Germany receiving her PhD on orthotopic implantation of solid cancer PDX. After a post-doc in innate immunity at the Max-Planck institute she re-joined Oncotest in 2002. Since then, she is driving the oncology model development strategy within Oncotest and since 2015 within Charles River. She currently holds the position of a research director at Charles River.

Sophie Vermond is a Senior Scientist at Charles River Laboratories in Leiden, the Netherlands. Her research focuses on efficacy and toxicity testing of novel drug therapies in human primary cell-based models. Her main focus is T cell therapy safety studies. Furthermore, she is head of the flow cytometry group.