Roundtable Discussion- Examining Regulatory Alignment & Validation of Analytical Methods for Exosome Therapeutics to Build Confidence in Clinical Grade Manufacturing
- Aligning analytical validation with regulatory expectations for accuracy, precision, specificity, and robustness in complex biologics
- Integrating analytical standardisation into GMP workflows for batch release and comparability assessments
- Supporting regulatory submissions with validated, reproducible datasets that demonstrate consistent product quality and safety