Utilizing Flow Cytometry For Humoral Immunogenicity Testing: Cell & Gene Therapy

Ruqi Wang’s presentation will provide a comprehensive exploration of the multifaceted challenges associated with evaluating immunogenicity in the context of cell and gene therapies. As these innovative modalities continue to transform the therapeutic landscape, understanding and accurately assessing immune responses has become both increasingly complex and critically important. The session will highlight not only the scientific and technical hurdles inherent in immunogenicity evaluation but also the regulatory and clinical implications of these assessments.

A central focus of the presentation will be the application of flow cytometry within anti-drug antibody (ADA) and neutralizing antibody (NAb) assays, with particular attention to how this powerful technique can be leveraged to characterize and quantify the humoral immune response. By illustrating both practical methodologies and nuanced interpretation of results, the discussion will underscore the role of flow cytometry in advancing assay sensitivity, specificity, and reliability.

In addition, Ruqi Wang will address essential considerations in the development and validation of ADA and NAb assays tailored for cell and gene therapy products. This will include best practices for assay design, optimization strategies to ensure robustness and reproducibility, and key factors to evaluate during validation to meet scientific rigor and regulatory expectations. Collectively, the presentation promises to deliver actionable insights for researchers, developers, and regulatory professionals seeking to navigate the unique immunogenicity challenges presented by next-generation therapeutics.