(From left to right) Stephan Krause, Kato Shum, Anoop Chandran, and Seth Peterson
In order to effectively characterize cell therapy heterogeneity and improve product safety, purity, and potency, it is crucial to advance analytical tools and maintain quality controls from early development through commercial manufacturing.
Cell & Gene Therapy Insights and Thermo Fisher Scientific assembled a panel of leading experts, including Stephan Krause (Executive Director for Analytical Strategy, Bristol Myers Squibb), Kato Shum (Global Product Quality Leader, Iovance Biotherapeutics), Anoop Chandran (Associate Director, Analytical Development, Adaptimmune), and Seth Peterson (Senior Manager of Application Scientists, Thermo Fisher Scientific), to discuss best practices for developing and implementing analytical assays in cell and gene therapy (CGT), highlighting challenges in early assay design, scalability, and regulatory expectations. They also explore the role of advanced technologies including rapid sterility testing, next-generation sequencing (NGS), and multiomics in improving product characterization, quality control, and correlation with clinical outcomes.
