Ensuring Safety to Achieve Rapid Release

Time: 3:00 pm
day: Day 1 Track 2 AM


• Discuss new tools that are required to fully characterize cell and gene therapy product purity, stability, and viability quickly, accurately, and simultaneously across all stages of biologic development
• Demonstrate how to use Aura for high throughput, low volume particle imaging to rapidly size, count, and identify biological particles
• Via membrane microscopy, effectively measure CQAs USP 788, 1046 and 1047 related to purity and stability, viability, and particulate controls
• Present case studies focused in subvisible particle content of AAV formulations at low volumes under different stress conditions, and a thorough particle characterization of cellular therapy products including cell aggregation, viability, and product impurities