Analytical Readiness for mRNA therapeutics: Defining, Measuring & Assessing Quality
- Defining fit-for-purpose critical quality attributes (CQAs) for mRNA drug substance and drug products to support consistent quality assessment as programmes progress from early development into the clinic
- Comparing established and emerging analytical technologies used to assess mRNA therapeutics quality and batch consistency to highlight practical strengths, limitations and areas of divergence across current industry practice
- Identify gaps in analytical technologies for quality assessment of mRNA therapeutics