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.

中文翻译：

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使用金纳米粒子免疫复合物的均质等离子体效能测定方法的发展。

我们评估了均相测定中金纳米颗粒（AuNPs）平台在治疗性单克隆抗体（mAb）效价测量中的使用。通过功能化的自组装单层将治疗性单抗的重组人配体蛋白固定在AuNPs上。mAb与配体的结合导致了等离子体信号，该信号在均相测定中比常规酶联免疫吸附测定（ELISA）更快。在这项研究中，我们证明了基于AuNP的均质等离子体免疫测定（HPI）在相对较短的测定时间和步骤中产生了与传统结合ELISA相当的治疗性mAb效能值。结合HPI可能在质量控制实验室中用作治疗性单克隆抗体的效价测定。