Replacing Fragmented Assays with NGS: A New Paradigm for Faster, Scalable mRNA QC
- Consolidation & Operational Efficiency: NGS is a robust, single-platform Multi-Attribute Method (MAM), capable of consolidating USP-recommended CQAs including Identity, Integrity, 5, Capping, and Poly(A) tail length into a single 4–8-hour workflow. By replacing fragmented, low-throughput orthogonal assays (CGE, HPLC, and MS), this approach significantly reduces analytical burden and operational complexity in CMC environments
- Superior Resolution through Single-Molecule Depth: NGS provides enhanced molecular resolution over bulk-averaging methods, resolving complex poly(A) heterogeneity and 5, truncations with >99%sequence accuracy
- Direct Impurity Traceability: NGS can traced a minor deletion from the mRNA product back to the synthetic DNA template