mRNA Integrity / Size Heterogeneity
Context in Practice: Example Specifications
From Specification: Typical mRNA (Drug Substance) Specifications
- Rationale: Confirms the presence and relative proportion of full-length mRNA and detects truncated or degraded species relevant to product quality, potency, and consistency.
- Acceptance Criteria: • % Full-length (main peak): ≥80–95% (typical) (Range depends on construct length, sequence complexity, and process capability)• Truncated species: No single impurity >X% (product-specific limit; typically <5% per species)
- Orthogonal Method(s): Ion-Pair Reverse Phase HPLC (IP-RP HPLC)