Whether you have a viral vector vaccine or a non-viral vector 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. See below for our proven portfolio of comprehensive analytical solutions for characterization, confirmation, and monitoring of your vaccine.
Biomolecule separations | HPLC Systems | Mass Spectrometry | Chromatography | UHMR | Software |
|---|---|---|---|---|---|
 BioLC Columns |  Orbitrap Exploris Mass Spectrometer |  Chromeleon 7.3 CDS |
Q Exactive UHMR Hybrid Quadrupole-Orbitrap Mass Spectrometer |
|
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.
The Expanding Role of Mass Spectrometry in the Field of Vaccine 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.
The Expanding Role of Mass Spectrometry in the Field of Vaccine 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.
Viral vector vaccine uses live virus to deliver DNA of the target pathogen into a cell for production of antigenic proteins to stimulate an immune response. This vaccine type combines the positive qualities of DNA vaccines with those of live vaccines.
A plasmid must be manufactured and purified. In cells (ex. HEK293), the DNA is combined with the viral vector (transfection) and replicated. The viral vector then needs to be purified. Product quality of DNA plasmid and transfected viral vector need to be monitored throughout the manufacturing process. There are several viral vectors used specifically for vaccines.
It is important to completely characterize capsid proteins including sequence and post-translational modifications (PTMs) to ensure product quality and consistency. To ensure safety and efficacy; critical quality attributes of viral vector proteins must be monitored through production.
Intact mass and peptide mapping analysis with mass spectrometry can be used to produce results quickly and with greater specificity.
Due to immunogenicity risks of aggregates, this is a critical quality attribute which must be fully defined and monitored. Aggregates are formed during production, storage and shipment.
Size exclusion chromatography using HPLC methods provide an inexpensive approach to monitoring aggregation in a high throughput manner.
Empty capsids, capsids containing truncated vector genomes or non-vector DNA
Empty capsids and incomplete encapsidation affects efficacy per dose and provide a source of unnecessary, potentially antigenic material, which may elicit unwanted immune response to the vector itself and therefore must be characterized and monitored.
HPLC methods for this type of impurity analysis are being explored.
Non-viral vector DNA vaccines incorporate plasmids, that contain the sequence(s) for one or more protein antigens and replicate autonomously from the cell chromosome. When the DNA plasmid is introduced into human cells, the human cells express the protein encoded on the plasmid, stimulating an immune response against the encoded antigen. Because they have so far failed to provide a strong immune response, DNA vaccines are being explored as prime boosters that are given before a different vaccination.
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.
Impurity: Open circular and linear forms of plasmid, RNA
The monitoring of supercoiled plasmid DNA and its impurities such as open circular and linear forms is important for the assessment of final product quality, safety, and efficacy.
Chromatographic methods in development include HIC, RP, and AEX.
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