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.
Featuring tips on scaling up mRNA production and analytical solutions for mRNA vaccines and therapeutics.
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.
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 |
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
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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