mRNA
Messenger RNA (mRNA) therapies are transforming drug development by enabling patients’ own cells to produce therapeutic proteins. From vaccines to gene editing, these advanced modalities requires rigorous, regulatory-compliant analytical testing to their quality, safety and efficacy. From next-generation vaccines to breakthrough cancer treatments and rare disease solutions, mRNA offers unparalleled flexibility and rapid development timelines.
Precise by design, complex to control
Advanced mRNA therapies are typically formulated using lipid nanoparticles (LNPs), which serve as highly efficient delivery vehicles. The characterisation of these complex systems requires a comprehensive suite of state-of-the-art analytical techniques. Every component, ranging from the nucleotide sequence, cap structure, and poly(A) tail to the excipients and final formulation, presents distinct analytical challenges and demands precise analytical control.
At Quality Assistance, we support your mRNA product development with a complete analytical continuum. Whether you're working with drug substance or formulated mRNA, our team designs robust, phase-appropriate strategies to ensure identity, purity, stability, potency and safety, all under one roof, from early development through to market release.
Related products
Analytical challenges we help you solve
Developing and validating analytical methods for mRNA products requires a strong understanding of their structural complexity and dynamic nature.
Our team combines orthogonal techniques and deep scientific expertise to deliver reliable, decision-enabling data. This includes:
| Oligonucleotide mapping | (U)HPLC (MS) |
|---|---|
| Sequence | RT-PCR, NGS |
| Content (RNA concentration) | UV spectroscopy / SoloVPE / IEX / RT-qPCR / RT-ddPCR |
|---|
| mRNA purity, integrity, fragment mRNA | ddPCR / cGE (LIF) / IEX (UV) / IP-RP-(U)HPLC (UV) |
|---|---|
| 5’ Capping efficiency | (U)HPLC (UV, MS) |
| 3’ poly(A) tail length and percentage | (U)HPLC (UV, MS) |
| Residual dsRNA | ELISA |
| Aggregates | SEC (UV, RI, MALS) |
| % Tailed mRNA | ddPCR / cGE (LIF) / IEX / IP-RP-(U)HPLC (UV) |
| Expression of target protein | Cell-based assay with different readouts |
| Residual DNA template | qPCR |
|---|---|
| Process contaminants | CE / GC (FID, MS) / (U)HPLC (UV, MS, Fluo, CAD, Conductimetry) / ELISA / ICP (OES, MS) |
| Residual solvents | HS-GC (FID, MS) / (U)HPLC (UV, MS) |
| Elemental impurities | ICP (OES, MS) |
| Microbiology | Bioburden / Sterility (filtration, direct inoculation) |
| Endotoxins | LAL (kinetic, endpoint) / MAT / rFC |
| LNP size distribution and polydispersity | DLS / AF4 (UV, RI, MALS) |
|---|---|
| Surface charge / zeta potential | M3-PALS (Zetasizer) |
| RNA content | Fluorescence-based assay |
| Encapsulation efficiency | Fluorescence-based assay |
| Lipid analysis (identity, content & impurities) | (U)HPLC (CAD, MS) |
| Leachables | GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS) |
|---|---|
| Container Closure System Integrity | Bubbling / Dye ingress / Microbial ingress |
| Cytotoxicity / Biological reactivity | USP <87> |
| Break Loose and Glide Force (BLGF) for prefilled syringes |
Integrated analytical technologies for mRNA products
We integrate state-of-the-art equipment within our unique laboratory:
- NGS and RT-ddPCR for sequence confirmation
- High-resolution mass spectrometry to confirm poly(A) tail length and 5’ capping efficiency
- CGE-LIF, SEC and RP-(U)HPLC for mRNA integrity and purity profiling
- DLS, Zeta potential, AF4-MALS for LNP characterisation
Bioanalytical services
Our bioanalytical services support the quantification of mRNA in biological matrices (plasma, tissues) using qRT-PCR or RT-ddPCR and the detection of expressed proteins using ligand-binding assays. These methods are essential for pharmacokinetic evaluation and immunogenicity testing in support of mRNA drug development.
All assays are validated or qualified under GCLP to support your non-clinical and clinical studies, ensuring you can track biodistribution, translation efficiency, and immune response with confidence.
Why innovators choose us
At Quality Assistance, your mRNA programme benefits from more than technical capabilities, it gains a strategic partner focused on your success.
We bring together all the analytical expertise you need, from CMC to bioanalysis, within a single GxP-compliant site. This means faster decisions, seamless project coordination and data you can rely on. By centralising your analytical strategy with us, you reduce uncertainty, save time and move forward with clarity and confidence.
Accelerate your mRNA programme
Ready to unlock the full potential of your mRNA product? Partner with our team to design a tailored analytical strategy and accelerate your journey from sequence to patient.