Building Measurement Confidence for mRNA Products: Turning Analytics into Regulatory-Ready Decisions
- Defining measurement confidence for mRNA products: moving beyond analytical sensitivity to decision-ready, regulator-trusted evidence
- Translating analytical data into robust quality decisions across the mRNA lifecycle, from early development through clinical and commercial manufacturing
- Designing fit-for-purpose CQAs for mRNA, saRNA, and emerging RNA modalities without over-engineering analytical packages
- The role and limitations of reference materials, pharmacopeial methods, and interlaboratory comparability in building regulatory confidence
- Common CMC evidence pitfalls in mRNA programmes, including false precision, misaligned assay strategies, and late-stage rework — and how to avoid them
- Practical strategies for aligning analytics, process understanding, and regulatory
expectations to enable smoother scientific advice, review, and approval