mRNA vaccines
mRNA vaccines have transformed the landscape of infectious disease control. Rather than injecting an antigen directly, these innovative vaccines deliver genetic instructions that enable the body to generate its own immune response. This groundbreaking approach proved its effectiveness during the COVID-19 pandemic and continues to shape the future of vaccine development.
Your specialist in mRNA vaccines
Thanks to their rapid design, scalable manufacturing, and ability to elicit both humoral and cellular immune responses, mRNA vaccines have become a cornerstone of modern vaccinology. Their complex composition, including chemically modified synthetic RNA, and lipid nanoparticle delivery systems requires advanced analytical solutions.
At Quality Assistance, we provide tailored analytical solutions to help you characterise, monitor and validate every aspect of your mRNA vaccine.
Key analytical capacities for mRNA vaccines
Our services cover all critical aspects of mRNA vaccine development, such as:
- Detailed characterisation of synthetic RNA, including assessment of critical quality attributes such as polyadenylation and 5' capping efficiency.
- Comprehensive analysis of lipid nanoparticle (LNP) formulations and delivery systems, covering a range of parameters including particle size distribution and chemical composition
| 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 |
We cover all major vaccine technologies
Ensuring quality and stability across vaccine platforms
In addition to assays tailored for the mRNA and the lipid nanoparticle (LNP) components, we provide fundamental analytical services essential for regulatory compliance, such as general quality assessment and comprehensive stability studies.
Our vaccines page details the full spectrum of our integrated capabilities for these novel therapies.
Related services
Beyond vaccines
mRNA vaccines face many of the same analytical challenges as other mRNA-based therapeutics, from verifying sequence integrity and capping efficiency to detecting residual impurities and assessment of potency.
Visit our dedicated mRNA product page to discover how our integrated expertise supports both vaccine and non-vaccine applications, with a consistent, regulatory-compliant approach from discovery to market.
Ready to move your mRNA vaccine candidate forward?
From navigating the complexity of mRNA constructs to generating reliable analytical data, we provide the scientific and technical expertise you need to accelerate development of your mRNA vaccines. Talk to our experts today and move your mRNA vaccine project forward with clarity and precision.
Get in touch with our team of experts