Potency Assays and Functional Characterisation – Going Hand-in-Hand during Product Development up to Commercial Licensing

The potency assay is a highly critical assay for cell and gene therapy products and is one of the assays on the release specification. The potency assay needs to reflect the main mechanism of action/s of the product and the CQA. Using cellular function characterisation assays during development provides critical insights which help to establish the most relevant and appropriate potency assay for the product.

Presented by Therese Choquette, PhD. Head of Analytical and Translational Sciences at Tigen Pharma

With extensive experience in Cell Therapy and Analytical Development, Therese Choquette has been involved in every stage from early development to commercialization. At Novartis, she led the development of potency assays for the groundbreaking CAR-T product Kymriah, and she later transitioned to the role of analytical project leader. Following, she joined Janssen Pharmaceuticals as an Analytical Scientific Integrator, specializing in vaccines and cell therapy products. Later, she became the Director for Global QC at Iovance Biotherapeutics, focusing on TIL therapy. Currently, she is the Head of Analytical and Translational Sciences at Tigen Pharma focusing on autologous T-cell therapy products in early development. As a former Licensed Practical Nurse, her passion lies in providing high-quality cell therapies to patients. She constantly seeks to understand what makes a cell therapy product of the highest quality and strives to implement the best analytical methods for achieving this. In addition, she strives to develop release assays that require minimal manipulation and utilizes automated instruments for both assay execution and analysis.  During her PhD project and post-doc, her research focused on immune cells from both humans and mice, studying impact on the immune system from B-cell depletion by Rituximab in patients with lupus and impact of hyperglycemia in mice on host defense against Mycobacterium tuberculosis.