Standardizing Potency & LNP Characterization for In-Vivo Gene Editing mRNA
- Define phase-appropriate potency strategies for editor mRNA payloads to generate data regulators will trust across IND through late stage
- Align LNP single-particle and bulk characterization readouts to improve cross-site comparability and decision-making
- Prioritize release and stability assays that balance scientific depth with QC practicality to accelerate clinical readiness