Case Study: Identifying Critical Quality Attributes to Ensure Clinical Safety and Efficacy

Time: 8:00 am
day: Day One


• Defining critical quality attributes for your cell therapy such as polyfunctionality, cytokine secretion, persistence in line with IHC guidelines
• Designing assays to measure critical quality attributes and ‘global picture’ of your cells, and finding the best markers
• Considering how critical quality attributes and the assays used to measure them translate to a clinical setting
• Feeding back from the clinic to inform assay design