This session brings together leading experts to explore the evolving landscape of release criteria for cell therapy products. Beginning with a comparative overview of release strategies across diverse cell therapy modalities, the discussion will highlight how product type influences requirements for identity, purity, safety, and potency assays, along with early efforts toward assay harmonization across sites. Building on this foundation, the second segment will delve into potency and stability considerations, emphasizing fit-for-purpose quality control (QC) strategies across the development lifecycle and the importance of stage-appropriate testing rigor. The session will conclude with a practical perspective on how cell therapy programs qualify and implement novel in-house release assays, offering insights into innovation while maintaining regulatory confidence. Together, these talks provide a cohesive framework for designing robust, scalable, and reliable release strategies.
#eventfeed