ROUNDTABLE: Accelerating Cell-Based Bioassays for Robust Safety Assessment that Meets Regulatory Demands
Time: 2:45 pm
day: Regulatory Focus Day
Details:
- Introducing strategies to expedite the replication competent AAV qPCR assay timeline without compromising sensitivity
- Brainstorming techniques for overcoming detection limitations, increase the sensitivity of the assay and, enhance the detection of replication competent AAV
- Understanding regulatory guidelines surrounding rcAAV and residual WT AD5 safety testing to guide method development and implementation
- Determining the emerging role of NGS/ICHQ5a in safety testing: how likely is this to become an industry standard?
