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. Use our proven portfolio of comprehensive analytical solutions for characterization, confirmation, and monitoring—whether you are working on a whole inactivated, live attenuated, protein based, virus-like particle (VLP), mRNA, viral vector, or non-viral vector DNA vaccines.
The analytical approaches for testing vaccine formulation and process residual components are provided below.
Vanquish Core | Dionex Ion | HPLC Charged | Trace elemental analysis | Chromatography |
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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.
For all vaccines, formulation and process residual components must be tested. The components vary from product to product, and there are multiple techniques used to monitor these residuals.
Modern vaccines are highly purified which can lead to instability in their immunogenicity. To help retain antigen immunogenicity, adjuvants can be incorporated into the vaccine formulation. Adjuvants interact with the immune system through various mechanisms thereby enhancing the immune response. Currently, the most utilized adjuvants in licensed products are aluminum salts, typically aluminum phosphate and squalene-based oil-in-water emulsions.
Formulation of vaccines is multi-step to ensure stability. This is controlled by pH, ionic strength and buffers, and excipients can be added to provide further stability. Typically, GRAS (generally regarded as safe) excipients are used, but levels in products must be monitored.
A summary of applications and helpful information to show how liquid chromatography combined with a charged aerosol detector can be used to meet the needs of scientists working with excipients and active pharmaceutical ingredients or when impurity profiling is needed.
Learn how charged aerosol detectors (CAD) deliver sensitive, universal detection with a near-uniform response. CAD measure a wide range of analytes with flexibility and performance. See why CAD simplicity and reproducibility benefit manufacturing QC/QA applications.
Processes used in the production of the vaccine may lead to process residuals that must be monitored. These include bioreactor processes where metal leaching may occur, formaldehyde in the inactivation of whole vaccines, and cyanide in vaccine production steps, for example. Multiple analytical approaches can be used to monitor these, including:
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