Cell Therapy Potency Assay Summit reveals exclusive insights on regulatory interactions and potency assay development

Cartherics’ Acting Chief Scientific Officer, Dr Walid Azar recently attended the 2nd Cell Therapy Potency Assay Summit in Boston. The Summit gathered cell therapy experts working to rationally design better potency assays to smooth the path to regulatory approval and minimise product release times with scientifically rigorous and informative potency measurements.

Potency testing has been found to be one of the most challenging aspects of development for cell therapy products but despite the challenges involved, it remains critical to product development. The Cell Therapy Potency Assay Summit delivered exclusive insights on regulatory interactions and revealed how industry peers are approaching potency assay development.

The Summit covered key industry topics including:

  • Supporting clinical and regulatory success with rigorous potency assay development.
  • Evaluating the industry definition of potency to create standards across cell therapy.
  • Deconstructing regulatory guidelines for cell therapy potency assays.
  • Creating quantitative measurements of potency to conduct a thorough assessment.
  • Exploring cell manufacturing options to leverage potency assay development.
  • Discovering solutions to heterogeneity and reproducibility issues to overcome the complexities of cellular therapeutics.
  • Managing phase development considerations for cell therapy potency assays
  • Communicating effectively between the roles across process and analytical development functions.

The Summit revealed industry insights to where the field is heading in terms of designing appropriate potency assays. It discussed how to develop practical, QC friendly, compatible and reproducible potency workflows. The Summit also covered how to better characterise cell therapy products for targeted and untargeted, allogeneic and autologous platforms in oncology and non-oncology indications.

Dr Azar said: “The workshops, seminars, and meetings were focused, interactive and intimate, allowing me to connect with leading industry experts in the cell therapy space.

“Cartherics is currently developing an in-house potency assay for its lead allogeneic clinical candidate in ovarian cancer, CTH-401. The conference provided a great opportunity for brainstorming and discussing our current approach and the future direction of the field, including appropriate potency assay methods, regulatory requirements, and the common challenges that the industry is facing. It was a very insightful and productive conference – exciting times ahead for the field and Cartherics.”