Youjiang Medical University for Nationalities, Baise, China.
Key Laboratory of Pediatric Hematology and Oncology Ministry of Health and Pediatric Translational Medicine Institute, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Appl Biochem Biotechnol. 2023 Nov;195(11):7075-7085. doi: 10.1007/s12010-023-04471-4. Epub 2023 Mar 28.
Antibody drugs have been widely used to treat many diseases and are the fastest-growing drug class. IgG1 is the most common type of antibody because of its good serum stability; however, effective methods for the rapid detection of IgG1-type antibodies are lacking. In this study, we designed two aptamer molecules derived from the reported aptamer probe that has been proven to bind to the Fc fragment of the IgG1 antibody. The results showed that Fc-1S could specifically bind to the human IgG1 Fc proteins. In addition, we modified the structure of Fc-1S and constructed three aptamer molecular beacons that could quantitatively detect IgG1-type antibodies within a short time. Furthermore, we unveiled that the Fc-1S37R beacon has the highest sensitivity for IgG1-type antibodies with a detection limit of 48.82813 ng/mL and can accurately detect serum antibody concentrations in vivo with consistent results to ELISA. Therefore, Fc-1S37R is an efficient method for the production monitoring and quality control of IgG1-type antibodies to enable the large-scale production and application of antibody drugs.
抗体药物已被广泛用于治疗多种疾病，是增长最快的药物类别。由于 IgG1 具有良好的血清稳定性，因此它是最常见的抗体类型；然而，缺乏快速检测 IgG1 型抗体的有效方法。在这项研究中，我们设计了两个适体分子，它们源自已被证明能与 IgG1 抗体的 Fc 片段结合的报道适体探针。结果表明，Fc-1S 能够特异性结合人 IgG1 Fc 蛋白。此外，我们修改了 Fc-1S 的结构，并构建了三个适体分子信标，能够在短时间内定量检测 IgG1 型抗体。此外，我们揭示 Fc-1S37R 信标对 IgG1 型抗体具有最高的灵敏度，检测限为 48.82813 ng/mL，并且可以准确地检测体内血清抗体浓度，结果与 ELISA 一致。因此，Fc-1S37R 是一种用于 IgG1 型抗体生产监测和质量控制的有效方法，能够实现抗体药物的大规模生产和应用。
