Key questions include:

• How do variations in mRNA structure, impurity profiles (e.g. dsRNA), and LNP formulation impact in vivo expression, immunogenicity, and reactogenicity?
• Which critical quality attributes (CQAs) are most predictive of clinical performance, and how early can these be confidently defined during development?
• How can teams better correlate analytical data with preclinical and clinical outcomes to reduce late-stage failure risk?