mRNA Analysis and Characterization

Seattle Genova provides comprehensive mRNA characterization and testing packages. At our laboratories, scientists can test an mRNA drug substance or drug product to ensure the quality of mRNA produced. 

We are adept in establishing well validated analytical methods, including general methods, such as identification, residual solvents, and elemental impurities, and compendial methods – including:  

• Appearance

• pH

• Osmolality

• Particulate Matter

• Container Closure Integrity

• Sterility

• Bacterial Endotoxins

Our laboratories supported both mRNA and RNAi development candidates from leading innovators with their broad testing service portfolio. 

Critical Quality Attributes for mRNA Products

• mRNA purity

• mRNA identity and sequence

• Poly-A tail and length

• 5’ capping efficiency

• Product and process related impurities

• Residual DNA template

• dsRNA contamination

Potency Assays for mRNA Therapies

We develop potency assays for mRNA therapies and vaccines based on the transfection of cell lines appropriate to the target construct. Relative potency is then demonstrated by quantitative and/or functional assays of the expressed protein. While the initial cell stage is often common between constructs, the readout typically requires the development of a bespoke functional assay or ELISA.

Lipid Nanoparticles (LNP)

Additional analytical methodologies are employed to characterize the lipid and drug product, including:

• % RNA encapsulation

• Lipids component identities

• Lipid ratios

• Lipid impurities

• Particle Size

By integrating advanced analytical technology with a heritage supporting pharmaceutical product development, our experts offer Total Quality Assurance to help you ensure the safety, efficacy, and quality of your mRNA products.