From Development to QC: Phase-Appropriate Validation & Reagent Qualification for Reproducible mRNA Assays
- Establish robust reference standards and qualified reagents early to enable long-term reproducibility across analytical sites
- Apply phase-appropriate validation to maintain flexibility in early development while ensuring regulatory readiness at later stages
- Control assay variability from IVT reagents, detection antibodies and instrumentation to safeguard data integrity and batch comparability