Whitepaper:
How VLP Structural Insights from Cryo-TEM Helped Characterize the GARDASIL® Vaccine
Read this whitepaper to learn how characterization insights about Virus-Like Particle (VLP) structures from NIS cryo transmission electron microscopy (cryo-TEM) services helped characterize the GARDASIL® HPV vaccine.
NIS offers easy access to cryo-TEM, enabling analytical scientists to evaluate VLP vaccine intermediates in their hydrated state, which wasn’t feasible with other characterization tools. With the insights gained from investigating morphology, particle integrity, and aggregation, researchers were able to identify potential structural problems earlier in the formulation process.
Cryo-TEM structural information also contributed to the comprehensive data set that supports the selection of the potency assay and that justifies specifications for the product and the impurity profile. The data set also establishes “historical” comparability and therapeutic/clinical product equivalence.