mRNA Analytical Services
Curia utilizes leading technological methods for analyzing mRNA to meet needs from discovery to regulatory requirements.
- Curia offers comprehensive platforms for analyzing your products from early stage through drug substance and drug product release criteria.
- We provide both GMP and non-GMP testing proficiencies, specifically tailored for each phase of development.
- Our team prioritizes close collaboration and transparent communication, enabling you to stay informed and engaged. With on-site analytics, we deliver rapid turnaround times to keep your project moving efficiently.
- Our integrated approach covers all phases of drug development, including routine early-phase testing to customize manufacturing processes and clinical batch release.
Drug Substance
Purpose | Assay |
Appearance | Visual Inspection |
Bacterial Endotoxin | Chromogenic LAL |
Bioburden (w/ BnF) | Direct Inoculation |
pH | pH |
Osmolality | Osmolality |
RNA Concentration | UV A260 |
RNA Identity | CE-Based |
Identity (as RNA) | Enzyme Degradation |
Sequencing | Sanger/NGS Sequencing |
Poly A Tail | HPLC |
Residual protein | T7 ELISA/microBCA |
Residual DNA | qPCR |
Residual DS RNA | ELISA |
RNA Integrity | CE-Based |
Functional Assay | Cell Based |
% Cap | LC/MS |
Drug Product
Purpose | Assay |
Particle Size/PDI | Dynamic Light Scattering |
Zeta Potential | Dynamic Light Scattering |
Encapsulation Efficiency | Ribogreen |
pH | pH |
Osmolality | Osmolality |
Viscosity | Viscometer |
Residual Solvents | Gas Chromatograph |
RNA Integrity | AGE/CE |
LNP Polydispersity | Dynamic Light Scattering |
Moisture Content | Karl Fischer |
Lipid ID | LC/MS |
Compound Conc. | HPLC |
Sterility | Inoculation |
Appearance | Visual Inspection |
Bacterial Endotoxin | Chromogenic LAL |