Development and comparison of three cell-based potency assays for anti-respiratory syncytial virus monoclonal antibody

单克隆抗体 效力 病毒学 病毒 抗体 表位 毛细支气管炎 中和 生物 免疫学 体外 生物化学
作者
Dengyun Sun,Amy Hsu,Jorge Quiroz,Xi He,Melissa C. Whiteman,Kevin B. Gurney,Shara Dellatore
出处
期刊:Biologicals [Elsevier]
卷期号:74: 1-9 被引量:8
标识
DOI:10.1016/j.biologicals.2021.10.001
摘要

There is an increasing demand for monoclonal antibody (mAb) therapies to confer passive immunity against viral diseases. Respiratory syncytial virus (RSV) is the most common cause of bronchiolitis, lower respiratory tract infections, and hospitalization in infants. Currently, there is no RSV vaccine but a humanized mAb available for high risk infants. MK-1654 is a fully human mAb with YTE mutation in the fragment crystallizable (Fc) region to extend the half-life in circulation. It binds to a highly conserved epitope of RSV Fusion protein with high affinity and neutralizes RSV infection. A functional cell-based assay is a regulatory requirement for clinical development, commercial release, and stability testing of MK-1654. In this study, we have evaluated three RSV neutralization assays to test the potency of MK-1654, including an imaging-based virus reduction neutralization test (VRNT) and two reporter virus-based assays (RSV-GFP and RSV-NLucP). All three methods showed good dose response curves of MK-1654 with similar EC50 values. RSV-NLucP method was chosen for further development because it is simple and can be easily adapted to quality control testing laboratories. After optimization, the RSV-NLucP assay was pre-qualified with good linearity, relative accuracy, intermediate precision, and specificity, therefore suitable for a cell-based potency assay.
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