Vaccine Characterization

Direct determination of the morphology, size distribution, shape and concentration of vaccine antigens, such as virus particles, is vital for sample characterization during pharmaceutical and biotechnology process development and formulations analysis. NanoImaging Services performs full characterization of vaccine antigens using advanced transmission electron microscopy methods. Characterization methods include determination of particle shape and size distribution, titer determination, and 3D structural analysis using single particle or tomographic methods.

  • Particle volume
  • 3D Shape
  • Encapsulation efficiency
  • Aggregate characterization
  • Adjuvant interaction
  • Epitope mapping

Liposome and Emulsion Characterization

Nanoparticle delivery systems pose characterization challenges in formulation development. NanoImaging Services has defined state of the art Molecular Microscopy methods to characterize liposome and polymeric micelle formulations. Our studies provide direct observation and measurement of size, shape, lamellarity, stability, and degree of aggregation. Our services have assisted nanoparticle formulation discovery, development and commercialization.

  • Size
  • Shape
  • Lamellarity
  • Aggregation
  • Surface Modification
  • Encapsulation Efficiency

Proteins and Protein Complex Characterization

Direct visualization of proteins and protein complexes in solution can save hundreds of thousands of dollars spent in time and reagents during process development and formulation analysis. NanoImaging Services performs full characterization of proteins and protein complexes in solution using state of the art Molecular Microscopy methods developed specifically to preserve the native structure of your sample and provide a direct measure of protein and protein complex morphology, aggregation state, and structure. Our services have assisted in the development of protein drug product formulations.

  • Morphology
  • Degree of Aggregation
  • Size and Symmetry
  • Antibody Labeling
  • Adjuvant Interactions
  • 2D Structure
  • 3D Structure

Virus and Virus-like Particle Characterization

Transmission Electron Microscopy is the method of choice for the characterization of viruses, virus-like particles (VLP), vaccines and vaccine adjuvants. NanoImaging Services studies provide visual quantification of content, concentration, morphology, particle size, lot to lot comparisons, and biosimilarity. Our services have benefited vaccine development in preclinical and CMC manufacturing studies.

  • Size, shape, morphology
  • Stability and preservation
  • Analysis of complex mixtures
  • 3D structure
  • Aggregation
  • Antibody interactions
  • Viral particle titer

Regulatory Review and Validation

We provide supplemental and potentially critical data for demonstrating procedures to ensure stability, batch-to-batch uniformity, and overall quality for IND and NDA submissions.

Qualified evidence of established protocols and specifications for production process as well as demonstration of bioequivalence when manufacturing protocols are modified or improved.