Panel Discussion: Navigating the Phase Appropriate Regulatory Prospective & Expectations of Potency Assays to Meet CQAs & CPIs to De-Risk Regulatory Submissions
Time: 12:00 pm
day: Conference Day One
Details:
- What is the phase appropriate expectation for potency assays? Protein expression versus activity-based methods
- What is the feedback on potency assays when using cell lines that do not match the site of indication?
- Debating the need to measure the potency of each component or drug substance of an mRNA-LNP, compared to just formulated drug product itself
