Development of an assay to measure free IgE as a solution for PK/PD assessment of omalizumab

Omalizumab is a humanised monoclonal that binds to the FcεR1 of IgE that is used as a treatment for severe allergic reactions. The measurement of free IgE is an important pharmacodynamic measure since it is an indication of the receptor down regulation on basophils, mast cells and dendritic cells. 

This work will highlight the development of an automated microfluidic immunoassay technique to measure free IgE in human serum. One issue with conventional plate-based immunoassay techniques is that long incubation times and sample dilution has the potential to impact accurate determination of the free molecule depending on the affinity of the interaction. Since omalizumab binds with relative low affinity (nM) the aim was to develop the assay in 100% matrix to prevent dissociation of any complex during the analytical method.

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