Mastermind Session: Strategic Assay Development and Implementation for Effective Comparability

Time: 2:00 pm
day: Conference Day Two

Details:

• Addressing the challenges of having appropriate assays to demonstrate comparability between manufacturing and clinical batches
• The impact of process changes on the assessment and need for reliable assays during late-stage development
• Leveraging the experiences of companies and agency feedback in the development and acceptance of novel assays for gene therapy comparability