疫苗
Biophysical tools to accelerate the development of safe and effective vaccines
Advances in molecular biology are enabling the exploration of novel approaches to vaccine development and production. Conventional methods that use killed or attenuated organisms, or their antigenic proteins, now sit alongside new and often still experimental techniques involving, for example, recombinant DNA, mRNA, protein subunits and polysaccharide conjugates. The drive to respond rapidly in a pandemic situation is amplifying the need for progress.
Whatever the approach, the goal is to develop safe, stable vaccines that can induce an effective immune response in recipients, and which can be manufactured in a suitable dosage form at scale. Malvern Panalytical provides a range of physicochemical characterization tools that are used from the initial characterization of biological materials through to final manufacturing and quality control, and which deliver information essential to ensuring the stability and efficacy of the vaccine product.
Vaccine development solutions across the workflow
Malvern Panalytical’s physicochemical characterization techniques have applications at numerous stages in vaccine development, from fundamental vaccine research and characterization through to formulation and process development and into the monitoring of production, process and lot consistency.
Techniques such as Differential Scanning Calorimetry (DSC), Dynamic Light Scattering (DLS), Electrophoretic Light Scattering (ELS), Laser Diffraction particle sizing, Multi-Angle Dynamic Light Scattering (MADLS), Nanoparticle Tracking Analysis (NTA) and Size Exclusion Chromatography (SEC) enable measurement and monitoring of key characteristics:
Thermal stability
Differential Scanning Calorimetry (DSC) enables understanding and monitoring of the higher-order structure (HOS) and thermal stability of proteins at every stage of virus-based vaccine development, and during process development for recombinant products. DSC is also used to understand the thermal stability of liposomes used as carriers in nucleic acid-based vaccines.
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MicroCal DSC 系列
适用于监管环境的蛋白质稳定性分析金标准
Focus on Vaccine Development 1 – Value of DSC as a Complementary and Insightful Technique for Structural Characterization of a Multi-Domain Protein Antigen
Webinar
Focus on Vaccine Development 2: How Stable is Stable? Combining biophysical techniques and advanced kinetics to support formulation development
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Focus on Pharma: Biophysical Characterization of an RSV Antigen at Low Temperatures
Webinar
Sample homogeneity
Dynamic Light Scattering and laser diffraction have wide-ranging application for the measurement of particle size and size distribution, to detect the presence of aggregates and ensure sample homogeneity in the development of vaccines of all types.
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Colloidal stability
Electrophoretic light scattering is used in the characterization and formulation development of products such as mRNA vaccines that use virus-like particles (VLPs), liposomes and other nanoparticles as carriers, to determine size and colloidal stability.
Particle concentration
Particle concentration is critical when using carriers such as VLPs, liposomes and other nanoparticles. Nanoparticle Tracking Analysis and Multi-Angle Dynamic Light Scattering are used to measure particle concentration during characterization and formulation development stages.
Recombinant protein candidate selection and stability prediction
Differential Scanning Calorimetry is a fundamental tool for characterizing proteins and plays a key role in the understanding of protein stability under various conditions. Dynamic Light Scattering is used to investigate and predict protein stability and to provide stability-indicating data that is used throughout development.
MicroCal DSC 系列
适用于监管环境的蛋白质稳定性分析金标准
Value of DSC in characterization and optimization of protein stability as compared to other thermal stability assays
Webinar
蛋白质稳定性测量平台的采购指南
Whitepaper
Differential scanning calorimetry: Robust and powerful physical characterization of therapeutic protein products
Webinar
Adjuvant selection and suitability
Many vaccines require the presence of an adjuvant in the formulation to ensure an effective immune response. Depending on the vaccine type, Electrophoretic Light Scattering, laser diffraction, Nanoparticle Tracking Analysis and Differential Scanning Calorimetry all have roles in optimizing formulation with adjuvants.
Polysaccharide composition
Size Exclusion Chromatography with advanced detection aids in the compositional analysis of the protein and polysaccharide content of polysaccharide-conjugate vaccines during process development and manufacturing.
凝胶渗透色谱仪OMNISEC系统
全球领先的多检测器 GPC/SEC 系统
Delving Deeper Into AAV Attributes: Enhanced Characterization Using Multiple Technologies
Webinar
How Size Exclusion Chromatography can improve processes and quality in biopharmaceutical development
Webinar
Multi-detector GPC/SEC analysis of polysaccharides using OMNISEC
Application Note
