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Overview
Comprehensive solutions for characterization, confirmation, and monitoring of your vaccine
Thermo Fisher Scientific is your trusted partner to help ensure your vaccine quality with speed at every stage of the development process – from discovery to commercial production – so that you can go to market quickly and confidently.
mRNA vaccines work by introducing an mRNA sequence which is coded for a disease specific antigen. Once produced within the body, the antigen is recognized by the immune system, preparing it to fight the virus if presented. Because mRNA is transient in the body, synthetic mRNA products require modifications to protect the product from natural degradation.
mRNA vaccines are produced using a DNA plasmid template in a process called in vitro transcription (IVT RNA). Because of the transient nature of mRNA, focus is on properly modifying mRNA and the delivery vehicle for the product to survive the body’s natural defences. Lipid delivery systems are currently being explored.
For vaccines to be acceptable to regulatory agencies, in-depth analytical characterization and criteria defined for purity/impurity monitoring (CQAs) is needed to ensure safety and efficacy. This means impurities need to be understood through characterization, acceptable levels defined, and then monitored for safety and efficacy.
Evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases: regulatory considerations
Read WHO document
mRNA Toolkit
Access this toolkit to learn about innovative analytical solutions that cover a wide range of analytical needs, and to achieve confident characterization of an extensive list of critical quality attributes (CQAs) to meet regulatory requirements.
Key Thermo Scientific products for vaccine analysis
Biomolecule separations | HPLC Systems | Mass Spectrometry | Chromatography | Software |
|---|---|---|---|---|
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|  |  |
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| BioLC Columns | Vanquish Horizon and Vanquish Flex UHPLC Systems | Orbitrap Exploris Mass Spectrometer | Chromeleon 7.3 CDS |
Analytical support for your vaccine analysis
Characterize the full diversity of your vaccine biomolecules
Get high resolution, high efficiency separation of your vaccine associated biological samples. Our unique column chemistries for biological samples have been specifically designed for the separation of proteins, peptides, monoclonal antibodies, carbohydrates, nucleic acids, and more.
Chromatography Consumables Resources and Information
Select the Correct Chemistry for Your Analysis
Accelerate your vaccine development with confidence
Thermo Scientific Vanquish HPLC and UHPLC systems are the most advanced liquid chromatography instruments available. The Vanquish LC platform improves performance, repeatability, and dependability with no trade-offs in quality or ease-of-use. Vanquish LC systems provide the versatility to solve the toughest vaccine analytics challenges.
Ensuring the safety of your final vaccine products
A highly flexible Thermo Scientific Dionex ion chromatography (IC) system provides customers with the freedom to develop, explore, and run different methods simultaneously. Utilizing unique IC technologies with unparalleled robustness and capabilities, one can accurately identify and monitor formulation and process residual components and ensure appropriate adjuvant concentrations, with ease.
Universal detection and quantification for non-chromophore containing adjuvants and formulations
Utilize the increased separation speed and resolution of the Thermo Scientific Vanquish UHPLC system with charged aerosol detection (CAD). CAD can detect and quantify virtually any substance with enhanced linear dynamic range and accurate, consistent response. Measure low-level impurities and active pharmaceutical ingredients (APIs) simultaneously, as well as other compounds, regardless of chemical structure using CAD.
Comprehensive vaccine characterization
Thermo Scientific Orbitrap Exploris mass spectrometry system is quantitative high-resolution, accurate-mass (HRAM) liquid chromatography mass spectrometry (LC-MS) with record-setting performance for your next-generation of vaccine products. Extraordinary power is now available in an expanded portfolio to meet your exact analytical requirements, deliver comprehensive characterization of your most advanced vaccine drug products, and accelerate their development.
Track everything, simplify compliance, and boost productivity
Achieve productivity and compliance with one software platform. As an integral part of your laboratory's IT structure, the latest Thermo Scientific Chromeleon 7.3 Chromatography Data System (CDS) is vital for compliant, efficient, and reliable handling of today’s chromatography and mass spectrometry data. It ensures data quality and manages all the analytical processes from instrument control, to raw data storage and processing, to generating the final results.
Characterize the full diversity of your vaccine biomolecules
Get high resolution, high efficiency separation of your vaccine associated biological samples. Our unique column chemistries for biological samples have been specifically designed for the separation of proteins, peptides, monoclonal antibodies, carbohydrates, nucleic acids, and more.
Chromatography Consumables Resources and Information
Select the Correct Chemistry for Your Analysis
Accelerate your vaccine development with confidence
Thermo Scientific Vanquish HPLC and UHPLC systems are the most advanced liquid chromatography instruments available. The Vanquish LC platform improves performance, repeatability, and dependability with no trade-offs in quality or ease-of-use. Vanquish LC systems provide the versatility to solve the toughest vaccine analytics challenges.
Ensuring the safety of your final vaccine products
A highly flexible Thermo Scientific Dionex ion chromatography (IC) system provides customers with the freedom to develop, explore, and run different methods simultaneously. Utilizing unique IC technologies with unparalleled robustness and capabilities, one can accurately identify and monitor formulation and process residual components and ensure appropriate adjuvant concentrations, with ease.
Universal detection and quantification for non-chromophore containing adjuvants and formulations
Utilize the increased separation speed and resolution of the Thermo Scientific Vanquish UHPLC system with charged aerosol detection (CAD). CAD can detect and quantify virtually any substance with enhanced linear dynamic range and accurate, consistent response. Measure low-level impurities and active pharmaceutical ingredients (APIs) simultaneously, as well as other compounds, regardless of chemical structure using CAD.
Comprehensive vaccine characterization
Thermo Scientific Orbitrap Exploris mass spectrometry system is quantitative high-resolution, accurate-mass (HRAM) liquid chromatography mass spectrometry (LC-MS) with record-setting performance for your next-generation of vaccine products. Extraordinary power is now available in an expanded portfolio to meet your exact analytical requirements, deliver comprehensive characterization of your most advanced vaccine drug products, and accelerate their development.
Track everything, simplify compliance, and boost productivity
Achieve productivity and compliance with one software platform. As an integral part of your laboratory's IT structure, the latest Thermo Scientific Chromeleon 7.3 Chromatography Data System (CDS) is vital for compliant, efficient, and reliable handling of today’s chromatography and mass spectrometry data. It ensures data quality and manages all the analytical processes from instrument control, to raw data storage and processing, to generating the final results.
Analytical workflows for your mRNA vaccine
From product characterization through process development and QC
mRNA Vaccine Impurity analysis
The presence of a 5’ cap structure is essential for subsequent steps in the life cycle of mRNA in eukaryotic cells. Therefore, the capping efficiency must be determined and monitored throughout development.
LC-MS analysis of RNase H cleaved 5’ -end of target mRNA provides the required sensitivity and accuracy to determine capping efficiency.
In order to maximize gene expression, the purity of mRNA must be determined, impurities characterized, and then monitored throughout the process. This includes aborted sequences, double stranded RNA, and residual plasmid DNA.
DNAPac RP reversed phase (RP) column is specifically designed for separation of oligonucleotides and DNA/RNA fragments. Operating with mobile phases compatible with direct mass spectrometry, analysis can be carried out using both LC-UV and/or LC-MS approaches.
mRNA Vaccine Identity Analysis
The purity of mRNA can be determined by mRNA sequence mapping. Following nuclease enzymatic digestion of the full-length mRNA, the resulting fragments can be separated and identified using LC-MS, providing comprehensive characterization.
Resources
Characterization and sequence mapping of large RNA and mRNA therapeutics using mass spectrometry
Characterization of mRNA 5’ capping products using an LC-HRAM-MS/MS analytical platform and Thermo Scientific BioPharma Finder software solution
Characterization of lipid nanoparticle (LNP) composition using UHPLC-CAD
Characterization of in vitro-transcribed (IVT) mRNA poly(A) tail by LC-HRAM-MS and BioPharma Finder 5.0 software
Resources
Solution guide
Application notes
Publications
Product information
Webinars
Sign up to attend workshops of interest
- BioPharma Finder software for characterization of protein and oligonucleotide biotherapeutics
- BioPharma Finder software for in-depth protein characterization, intact mass analysis, peptide mapping, and new host cell protein workflow
- BioPharma Finder software for in-depth oligonucleotide characterization, intact mass analysis, oligonucleotide analysis and mRNA mapping
- GlycanExplorer software for high throughput biotherapeutic glycan characterization
- Proteome Discoverer software for increasing proteoform level insight with quantitative top-down proteomics
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