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.

Adressing the CQA Potency for ATMPs: A Risk-Based Phase-Appropriate Approach

Determining which attributes are critical to the quality of the product and the safety of the patient is individual to each product. During the lifecycle of an ATMP managing CQAs evolves through the different phases of development (early phases might focus on identifying potential CQAs and understanding their impact, while later phases involve more rigorous control and validation). Potency assays are a major challenge since often the mechanism of action (MoA) of the product is not fully understood in early phases. In those cases, a matrix approach with incremental development using less complex methods in the beginning can help to ensure avoiding delays on the path to market. Alignment with regulatory guidelines is crucial at any stage.

Presented by Ulrike Herbrand, Scientific Director Global in vitro Bioassays and Head of the Bioassay Research & Development team at Charles River Laboratories

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 for protein therapeutics as well as for advanced therapy medicinal products. She is member if the BEBPA Bioassay scientific committee and the ECA ATMP interest group as well as the BioPhorum ATMP group.

A Well-Characterized Starting Material Profile Ensures a Predictable and Potent Product

One of the main factors influencing cell therapy potency is the quality of cellular starting materials.The quality control (QC) landscape for cell and gene therapy (CGT) starting materials is evolving toward seamless, data-driven, and automated quality frameworks that can handle variability and complexity in both autologous and allogeneic therapies. As one of the main critical technologies, flow cytometry plays a dual and essential role in CGT product QC, supporting both cellular characterization and potency testing, and offering a bridge between the assessment of starting materials and the demonstration of biological activity in the final product. When implemented at the starting material phase, it helps to ensure input quality for predictable manufacturing, anticipate downstream potency variability, support batch acceptance/rejection criteria, and justify specifications for identity and potency. Furthermore, applying multiparametric single-cell analysis of potency relevant markers across starting material, in-process, and release stages supports data-rich, quantitative decision making in CGT workflows and integrates into GMP workflows with automated solutions like the Accellix Platform. These are not solely tools for identity – this is a regulatory acceptable method for assessing surrogate markers of potency when validated and justified within the context of CGT mechanism and should be incorporated early in the analytical strategy to ensure process predictability and regulatory success

Presented by Felix Montero Julian, Vice President of Scientific Affairs at Accellix

Félix joined Accellix in 2025 from bioMérieux, where he most recently served as Scientific Senior Director of Pharma Quality Control. He holds a PhD and Master of Science in Immunology from Aix-Marseille II University in France, and a degree in Industrial Biochemistry Engineering from Universidad Autónoma Metropolitana in Mexico. His deep scientific knowledge and leadership experience across cytometry, regulatory science, and pharmaceutical QC make him uniquely qualified to shape scientific strategy and partnerships and help to scale the impact of the Accellix Platform.

Prior to Accellix, his previous roles include Cytometry R&D Director at bioMérieux and Director of the Cellular Analysis Department at Beckman Coulter, underscoring a distinguished track record spanning biopharmaceuticals, industrial microbiology, and clinical diagnostics. He brings more than 30 years of international experience in scientific affairs, analytical development, and regulatory science to support Accellix’s strategic vision and innovation roadmap. A respected thought leader in the development and regulatory acceptance of analytical methods for advanced therapeutics and biomanufacturing, he has authored more than 60 scientific publications.

Félix leads Accellix’s scientific engagement strategy, driving cross-functional collaboration across R&D, regulatory, and commercial teams, and helping advance the company’s mission to make rapid, automated cytometry accessible and reliable for blood collection centers and cell therapy manufacturers.”

Followed by a live Question and Answer session

Sponsored by Charles River and Accellix

About Charles River Laboratories

For 30 years, Charles River has been dedicated to the development of precise, robust micro QC solutions that help bring your products to market safely and efficiently. Our mission is to provide industry-leading scientific and technological advances that not only meet ever-changing regulatory guidelines but set a new standard in the way you perform testing. We’ve purposely built our portfolio to bring you progressive products and services that deliver accurate, relevant and measurable data to fuel confident decisions on product quality for release. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture and protects your reputation.

About Accellix

Accellix was founded based on creating a rapid, easy-to-use, automated cell phenotyping platform tailored for point of need environments, focusing on cell therapy and blood characterization. This platform brings next-generation analytical capabilities to cell therapy development and manufacturing QC, enabling the measurement of critical quality attributes at every QC phenotyping interrogation point throughout the manufacturing process and the release of cell therapy products – when and where required. The application of this platform also includes the characterization of blood-derived apheresis products used as source material for infectious disease, autoimmune and inflammatory disease research, for donor screening, and for the development and manufacture of advanced therapies. Currently, these assays are performed on standard flow cytometers in centralized labs which require skilled technicians, high maintenance, a separate lab space, and a long turnaround time.

There is a growing need for simpler more automated technologies that can fit seamlessly into centralized and de-centralized point-of-need models. Accellix aims to bring the power of flow cytometry to blood collection centers and to the cell therapy GMP manufacturing floor, automating the entire cell phenotyping process from sample preparation to data analysis with the Accellix Platform. By delivering actionable, automated results at the point of need, Accellix supports more informed decision-making, improved operational efficiency, and ultimately, better outcomes for patients.