Roundtable Discussion: Current Tools & Practical Considerations for Capsid Characterisation Across Development & GMP QC
- Discussing opportunities for in-line characterisation as a low-cost, high throughput analytical method
- Establishing a GMP QC assay of percentage empty/partial/full capsids
- Defining fit-for-purpose reporting, through understanding why percentage full readings may be sufficient for regulatory submissions
- Interpreting percentage full and partial capsid data in the absence of defined thresholds, exploring what different distributions may indicate, where uncertainty remains, and how teams are currently contextualising results without clear industry benchmarks