A Novel In Vitro Assay to Predict Neonatal Fc Receptor-Mediated Human IgG Half-Life

Souders C, et al., 7(5):912-21, MAbs, 2015

The neonatal Fc receptor (FcRn) binding to therapeutic IgG and the pH-dependence of this process had been investigated in depth. Using the BLI platform, the authors performed a high throughput assay to determine the association rate at an acidic pH and the dissociation rate at physiological pH and correlated those rates to half-lives obtained from a phase I clinical study. This method development used an Octet QK system equipped with nickel-nitrilotriacetic acid (Ni-NTA) biosensors. FcRn was immobilized on to the biosensor probes and the mAb solutions were loaded onto a 96-well plate for binding assessments.

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