PEGylation is used to extend half-lives for many new biologics as well as conventional low molecular drugs, and this potent therapeutic had a very long half-life.

Due to environmental exposure, a significant portion of the general population has pre-existing anti-PEG antibodies. In most cases, these antibodies are clinically benign, but there have been occurrences where they play a role in serious adverse reactions upon drug exposure. For that reason, regulatory agencies are requiring the monitoring of anti-PEG prevalence and attenuation upon exposure to PEGylated therapeutics. In this study, BioAgilytix had to assess the immunogenicity of the PEGlayted therapeutic with an approach that could maximize drug tolerance while maintaining high sensitivity.