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Biological therapeutic proteins can induce the production of anti-drug antibodies (ADA), including neutralizing antibodies (NAb), and consequently result in unwanted immune response in recipients. Although both ligand binding assay and cell-based assay have been used to measure NAb activity, the Food and Drug Administration (FDA) regulations recommend using a cell-based bioassay format for detecting NAb. In this report, a cell-based assay was developed using luciferase reporter-gene bioassays and validated for the detection of NAb activity which was produced by rhesus monkeys after injection of Aflibercept. Twelve serum samples of rhesus monkeys with positive ADA were tested for NAb by the cell-based bioassay. The results showed that all the samples were negative for NAb. However, the results of a competitive enzyme-linked immunosorbent assay (ELISA) based on Meso Scale Discovery (MSD) and electrochemiluminescence (ECL) showed all the samples were positive for NAb. The reason for this result was that the standard deviation of the cell-based assay is larger than that of the ECL ELISA, resulting in a higher cut-point of the cell-based assay and therefore low sensitivity. These basic studies will provide references for the determination of NAb in Aflibercept and even other antiVEGF therapies in the future. However, the sensitivity in cell-based assay needs to be further improved. *Correspondence to: Fei Yu, School of Pharmacy, Yantai University, Qingquan road, Laishan Distric, Yantai, China, E-mail: yufei@luye.com

Development and validation of a novel cell-based assay for the detection of neutralizing antibodies of Aflibercept