Characterization of Biopharmaceuticals: Gardasil®


The Challenge: Characterization of Vaccine, Virus, and VLP Drug Products

A comprehensive characterization data set for vaccine, virus, and VLP drug products is important for supporting selection of the potency assay, justifying specifications for the product and its impurity profile, defining the process, and establishing historical comparability and therapeutic/clinical equivalence.  Structural characterization is an important aspect of this analytical assessment and can be included in regulatory filings to demonstrate understanding of the product.

The Solution: Molecular Microscopy

Using advanced automated data collection and analysis methods developed by the founders of NanoImaging Services, Molecular Microscopy was used to characterize Gardasil®, a quadrivalent Human Papilloma Virus (HPV) vaccine.  Molecular Microscopy complements other analytical tools by directly visualizing HPV particles to provide exact data on VLP size distribution, quaternary structure, and interaction with adjuvant.

Particle Sizing and Counting Differentiates Between HPV Serotypes:

Standard nanoparticle sizing methods such as dynamic light scattering (DLS) can be plagued by biases introduced by contaminants.  Direct visualization of nanoparticles (HPV in the figure above) in solution by Molecular Microscopy allows exact determination of particle size, shape, and count
 

Quaternary Structure Localizes Fab Binding Sites:

CryoTEM images and associated 3D reconstruction of HPV VLPs without (left) and with (right) Fab binding.


3D Difference mapping allows localization of the Fab binding sites.

3D structures of HPV VLPs with Fab1 (left) and Fab2 (right) bound. Different Fabs localize to different epitopes.
 

HPV Particle Morphology Remains Intact When Interacting With Adjuvant:

 
Direct visualization of VLP-adjuvant 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 VLP-adjuvant 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 VLP-adjuvant complex morphology, aggregation state, and structure.
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Characterization of Biopharmaceuticals:
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