Establishing Core Endpoints That Truly Correlate with Biological Readouts to Validate mRNA Functionality
- Comparing in vitro, cell-based and engineered model systems to determine which assays should be standardized to best represent functional mRNA performance
- Differentiating between integrity, encapsulation, and total mRNA content to determine which attributes meaningfully correlate with biological activity
- Lessons learnt from CQAs that failed to predict immunogenicity or efficacy to streamline submission packages that prove mRNA functionality