Messenger RNA (mRNA) vaccines and therapeutics represent one of the most significant advances in modern medicine. Having demonstrated transformative potential during the COVID-19 pandemic, mRNA technology is now opening viable pathways for treating cancer, cardiovascular diseases, rare genetic disorders and autoimmune diseases.
mRNA-based products are typically delivered via lipid nanoparticles (LNPs), which protect the mRNA molecule and facilitate cellular uptake.
RSSL combine’s deep regulatory knowledge with cutting-edge analytical capabilities to support your mRNA product development from early characterisation through to GMP release testing. We deliver a comprehensive suite of mRNA characterisation and control services, aligned to the the USP and European Pharmacopoeia (EP).
We confirm mRNA identity and full sequence coverage through oligonucleotide mapping via liquid chromatography-mass spectrometry (LC-MS) or reverse-transcriptase PCR (RT-PCR). mRNA size can also be monitored as an identity test using electrophoretic methods.
RSSL measure end-capping efficiency through RNase digestion followed by ion-pair reversed-phase liquid chromatography and mass spectrometry, providing precise quantification of capped versus uncapped species.
The poly(A) tail directly influences mRNA stability and translational activity. We determine average poly(A) tail length and length distribution through RNase digestion followed by ion-pair chromatography and mass spectrometry. Data are deconvoluted using bespoke instrument manufacturer software to deliver accurate mass information.
Total RNA content is quantified using UV absorption spectrophotometry (RiboGreen fluorescent assay) or reverse transcription quantitative PCR (RT-qPCR)
mRNA integrity is a critical quality attribute. We assess integrity using electrophoretic methods including capillary gel electrophoresis (CGE) and agarose gel electrophoresis, providing clear resolution of intact versus degraded species.
We detect and quantify product-related impurities including:
dsRNA is a critical impurity that can trigger innate immune responses, making its control essential for product safety.
The ultimate measure of mRNA quality is its ability to be translated into the correct protein. We confirm mRNA functionality by measuring protein expression using ELISA, Western blot or cell-based assays.
Deep experience in Ph. Eur. United states & Japanese Pharmacopeias
Experienced team providing support across identity, integrity, purity and functionality testing
Strong process knowledge and regulatory awareness built into every method
Rapid and accurate analytical testing without compromising your data integrity
Our services cover every product stage, from raw materials to finished product
mRNA characterisation testing is a suite of analytical methods used to confirm the identity, purity, integrity, and functionality of messenger RNA used in vaccines and therapeutics. These tests establish critical quality attributes required by regulatory authorities including the USP and European Pharmacopoeia.
The 5' cap structure protects mRNA from degradation and is essential for ribosomal recognition and efficient translation into protein. Incomplete capping reduces vaccine potency.
mRNA integrity is measured using electrophoretic methods such as capillary gel electrophoresis or agarose gel electrophoresis. These methods separate intact mRNA from degraded fragments, providing a clear integrity profile.
Process-related impurities are residual materials from the manufacturing process, including residual DNA template, residual enzymes (e.g., T7 RNA polymerase), and residual proteins. These must be controlled to defined limits to ensure patient safety.
Double-stranded RNA (dsRNA) is an unwanted by-product of in vitro transcription that can activate innate immune receptors, potentially causing adverse inflammatory responses. RSSL detects dsRNA using specific immunoblot and ELISA assays.
The poly(A) tail stabilises mRNA and enhances translation efficiency. Measuring its average length and distribution ensures batch-to-batch consistency and confirms the mRNA will perform as intended.
Yes. RSSL operates under a robust cGMP quality system and has been inspected by the FDA and MHRA. Our mRNA analytical services support GMP release testing, stability studies, and regulatory submissions.
Yes. We provide analytical testing for lipid nanoparticle delivery systems used in mRNA vaccines and therapeutics.
Contact our team to discuss your specific mRNA characterisation requirements. We will work with you to design a tailored analytical programme aligned to your development stage and regulatory strategy.
