Ensuring GMP Readiness Through Robust Analytical Strategy: Building Phase-Appropriate Methods to Support mRNA Quality and Purity
- Establishing a risk-based analytical control strategy to meet GMP requirements across development stages.
- Balancing flexibility and compliance: when to validate versus qualify analytical methods in early vs late phase.
- Overcoming common pitfalls in method transfer to QC labs and CDMOs while maintaining data integrity.
- Building feedback loops between analytical and manufacturing teams to pre-empt deviations and batch release delays.