Roundtable Discussion: Exploring CMC Regulatory Challenges from Product Testing, Vector Characterization & Beyond

Time: 2:00 pm
day: Conference Day Two

Details:

• Exploring the route to standardized testing for more consistent vector characterization
• Integrating evolving technology into CMC regulation
• Ensuring more robust vector characterization sequencing technologies to ensure capsid stability for viral vectors and potency assay conditions are met under the new potency assay guidance
• Setting acceptance criteria for characterization testing depending on target product profile