mRNA Concentration (Total)
Context in Practice: Example Specifications
From Specification: Typical mRNA (Drug Substance) Specifications
- Rationale: Quantifies total nucleic acid content for formulation calculations and dose preparation
- Acceptance Criteria: 90–110% of target concentration (e.g., 0.9–1.1 mg/mL for 1.0 mg/mL target) ; Established based on process capability and clinical dose requirements
- Orthogonal Method(s): Reverse Phase HPLC (RP-HPLC)