Biologics Analytical Research & Development, MRL, Merck & Co., Inc., Kenilworth, NJ 07033, United States.
Biologics Analytical Research & Development, MRL, Merck & Co., Inc., Kenilworth, NJ 07033, United States.
J Pharm Biomed Anal. 2020 Mar 20;181:113101. doi: 10.1016/j.jpba.2020.113101. Epub 2020 Jan 10.
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.
我们评估了金纳米粒子（AuNPs）平台在均相测定法中用于测量治疗性单克隆抗体（mAb）效价的用途。通过功能化的自组装单层将治疗性 mAb 的重组人配体蛋白固定在 AuNPs 上。mAb 与配体的结合导致等离子体信号，该信号在均相测定中比传统的酶联免疫吸附测定（ELISA）更快地被检测到。在这项研究中，我们证明基于 AuNP 的均相等离子体免疫测定（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 的效价值。结合 HPI 可潜在地作为质量控制实验室中治疗性 mAb 的效价测定方法。
