Are you looking to analyse and characterize your mRNA molecules?
Why analyse and characterise messenger ribonucleic acid (mRNA)?
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.
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
Verification of modifications (5’ cap, poly(A) tail length, nucleoside modifications)
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)
Chromatographic profile (HPLC)
Impurity identification and quantification :
Residual process-related impurities (HPLC, LC-MS)
Analysis of degradation products (enzymatic or chemical)
By-products from transcription reactions (cap analogs, incomplete poly(A) tails)
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.
