Are you looking to analyse and characterize your mRNA molecules?
What is the analysis and characterisation of messenger ribonucleic acid (mRNA)?
mRNA characterization involves a thorough analysis of its sequence, purity, and structural integrity. This process also includes identifying impurities that may arise from transcription, degradation, or residual components from the manufacturing process, as well as validating chemical modifications (such as 5’ capping, polyadenylation, and nucleoside modifications) that enhance mRNA stability and translation efficiency.
Commonly used techniques for these analyses include mass spectrometry (LC-MS), liquid chromatography (HPLC), and capillary electrophoresis (CE). Additional attention is given to mRNA secondary structure, immunogenicity, and degradation patterns, which are crucial for its effectiveness in therapeutic applications.
Our solutions for mRNA analysis and characterization
Why choose FILAB?
At FILAB, we offer comprehensive analytical services tailored to the specific requirements of mRNA products. With extensive expertise in RNA technologies, we support you in the development, validation, and quality control of your mRNA molecules in compliance with regulatory guidelines.
We provide customized solutions at every stage of the development process, from mRNA synthesis to production, ensuring that critical quality attributes are met for optimal therapeutic outcomes.
mRNA analysis and characterization services
Sequence and structural characterization:
Sequence analysis by LC-MS/MS
Analysis of truncated or degraded mRNA products
Primary sequence: de novo sequencing
Secondary and tertiary structure: circular dichroism (CD)
Verification of modifications (5’ cap, poly(A) tail length, nucleoside modifications)
Primary sequence: peptide mapping
Determination of intact mass: molecular mass by HRMS and SEC-triple detection (LALS-RALS/UV/RI)
Glycosylation: monosaccharides, glycosylation and carbohydrate structure
Physicochemical property characterization
we provide detailed data on the molecular weight, size, and structural stability of mRNA :
Molecular weight and size (LC-MS, SEC)
Secondary structure analysis (circular dichroism, UV/Vis spectroscopy)
Solubility: critical concentration and stability in solution
Chromatographic profile (HPLC) : characteristic liquid fingerprint by IEX or SEC
Measurement of isoelectric point (pl): net charge of the protein
Thermal stability: melting temperature by DSC
Impurity identification and quantification :
Residual process-related impurities (HPLC, LC-MS)
Analysis of degradation products (enzymatic or chemical)
Analysis of solvent residues and culture medium (cell culture): measurement of residual amino acids, vitamins and saccharides
By-products from transcription reactions (cap analogs, incomplete poly(A) tails)
Characterisation of purity and heterogeneity
Quantification of aggregates
Identification and quantification of PTMs
Load variant analysis
Etude des fragments : formes réduites (HC, LC, Fab, Fc)
We also ensure compliance with ICH and USP standards, offering specific tests to assess the presence of elemental impurities, residual solvents, and other contaminants. Our services include stability testing and the evaluation of immunogenicity potential, essential for ensuring the safety of mRNA products.
Our FAQ
The analysis and characterization of messenger RNA (mRNA) are critical steps in ensuring the quality, efficacy, and safety of mRNA-based therapeutics, such as vaccines and gene therapies. mRNA-based technologies have gained significant attention due to their role in the development of vaccines and therapeutics for various diseases, including COVID-19. The production of mRNA requires precise control over its synthesis, sequence, and structure to ensure optimal performance in biological systems.
To get a quote, you can contact our teams via our contact form, by telephone or by e-mail.
Simply send us your requirements (type of material, desired analysis, any standards, urgency, quantity of samples, etc.). We will then send you a personalised technical and price proposal within 24-48 hours.
Turnaround times vary depending on the nature of the analysis and the complexity of the assessment project.
However, FILAB is committed to providing fast turnaround times tailored to your industrial constraints and urgent needs.
