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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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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Viral titer

Depending on the particle size involved, Multi-Angle Dynamic Light Scattering and Nanoparticle Tracking Analysis are used to measure viral titer throughout the development lifecycle for virus-based vaccines.

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.

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.?

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