Development of homogeneous plasmonic potency assay using gold nanoparticle immunocomplexes.

We evaluated the use of gold nanoparticles (AuNPs) platform in a homogenous assay for a potency measurement of a therapeutic monoclonal antibody (mAb). The recombinant human ligand protein to the therapeutic mAb was immobilized on AuNPs via functionalized self-assembled monolayers. Binding of the mAb to ligand lead to plasmonic signals that were detected faster in a homogeneous assay than the conventional enzyme-linked immunosorbent assay (ELISA). In this study, we demonstrated that the AuNP-based homogeneous plasmonic immunoassay (HPI) generated comparable potency values of a therapeutic mAb to a conventional binding ELISA in relatively shorter assay time and steps. Binding HPI can be potentially implemented as a potency assay for therapeutic mAbs in quality control laboratories.