In Vitro Transcribed mRNA Services
mRNA Analysis and Characterization

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. 

mRNA Identity Analysis
The integrity and identification of mRNA are necessary to determine the faith of genetic diseases. Seattle Genova helps its customers to attain maximum integrity of mRNA.
Capping Efficiency and Poly(A) Tail Characterization
The main goal of our services is to provide variable aspects of the transcript, which are critical contributes of mRNA stability and half-life.
mRNA Purity and Impurities Analysis
Seattle Genova provides mRNA purification, which otherwise presents challenges to their chemical structures and related functionalities.
In Vitro Transcribed RNA Expression Analysis
Seattle Genova provides the solution to mRNA production streamlines through gene synthesis to IVT mRNA production and expression analysis.
Potency Test of mRNA
Seattle Genova is eager to provide various potency-indicating assays for the regulatory requirement of mRNA release.
Safety Evaluation of mRNA
Seattle Genova believes that the best practice to approach the analytical development of mRNA therapies involves utilizing orthogonal techniques that are ideally sensitive, accurate, and linear over a broad range.
Stability Assessment of mRNA
Seattle Genova provides different stability assessments to evaluate the quality of mRNA, which enforce efficacy standards.

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