Assessing Product Comparability Using Advanced Characterization Techniques
Time: 9:00 am
day: Conference Day Two
Details:
- Highlighting the challenge of assessing gene therapy product Critical Quality Attributes (CQA) that may appear similar but differ in potency or genome integrity
- Leveraging advanced characterization techniques like genome integrity or residual contamination analyses using multiplex ddPCR or NGS for effective product comparability studies
- Comparing empty/full/partial capsid content with genome heterogeneity for product comparability
