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The Challenge: Characterization of Biopharmaceuticals: Gardasil®

The characterization of a recombinant protein pharmaceutical requires the application of an extensive panel of analytical procedures to the product, and the characterization data set is included in regulatory filings to demonstrate understanding of the product. A comprehensive characterization data set is important for supporting selection of the potency assay, justifying specifications for the product and the impurity profile, characterizing the process, and establishing the “historical” comparability and therapeutic/clinical equivalence of the product in the event of process or facility changes. Structural characterization is an important aspect of this analytical assessment.

The Solution: CryoTEM (Transmission Electron Microscopy)

CryoTEM was used to characterize the size distribution of VLPs in a quadrivalent HPV vaccine and to provide quaternary structural information for selected subsets of the imaged VLPs. CryoTEM can complement other methods of VLP analysis by providing direct visualization of the particles. The cryoTEM structural analysis yields an accurate measurement of selected VLPs for comparison with theoretical and experimental models and provides a direct visualization of aggregation that could potentially influence light scatter measurements.

CryoTEM image of Human Papilloma virus like particles

Three dimensional reconstruction of Fab binding on Human Papilloma virus like particles


Case Studies