For the field of viral safety in biologically derived medicines, viral clearance is a requirement in a risk mitigation strategy, which entails the validation of virus removal in a given downstream process.  While there are several unit operations that have historically proven to provide effective virus removal, one process step that is seeing continued evaluation for viral clearance capability is hydrophobic interaction column (HIC) chromatography.  Though it has been assumed that a virus’ specific hydrophobic nature plays an important role in the mechanism of viral clearance, HIC chromatography and it’s mechanisms remain poorly understood as the relative hydrophobicity of virus species have been an unknown.  In this collaboration, we have developed a chromatographic method to quantify the relative hydrophobicity of several different virus species.  Using HIC in a high-salt matrix has allowed us to ascertain the relative hydrophobicity values of three bacteriophage models along with four mammalian viruses as benchmarked to protein standards previously characterized for hydrophobicity, allowing to one day create predictive tool in viral clearance capability.

Development of a chromatography-based hydrophobicity assay for viral particles

255th National Meeting (2018)

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