Biomarker and Clinical Bioanalysis, Sanofi North America, Framingham, Massachusetts, USA.
Yurogen Biosystem LLC, Worcester, Massachusetts, USA.
Monoclon Antib Immunodiagn Immunother. 2020 Oct;39(5):175-183. doi: 10.1089/mab.2020.0024. Epub 2020 Sep 30.
During preclinical studies, there is a great need to develop monoclonal antibodies (mAbs) that are specific to human immunoglobulin (IgG), without binding to monkey IgG, to detect therapeutic human mAb in non-human primates. We took advantage of the latest rabbit B cell cloning technology to develop six unique rabbit anti-human IgG mAb clones for this purpose. These clones are capable of binding to both human IgG and Fab with high affinity without nonspecific binding to cynomolgus monkey IgG. These clones have been evaluated as a generic capture reagent for the detection of human IgG and Fab, in the presence of cynomolgus monkey serum, by Gyrolab™ immunoassay. They may be used in singlet or as pairs for the detection of human IgG, in any host animal, to meet the need for therapeutic mAb development in preclinical studies.
在临床前研究中，非常需要开发特异性结合人免疫球蛋白 (IgG)、不结合猴 IgG 的单克隆抗体 (mAb)，以检测非人类灵长类动物中的治疗性人 mAb。我们利用最新的兔 B 细胞克隆技术，开发了 6 种独特的兔抗人 IgG mAb 克隆，用于此目的。这些克隆能够与人类 IgG 和 Fab 高亲和力结合，而不与食蟹猴 IgG 非特异性结合。这些克隆已通过 Gyrolab™免疫分析评估为在存在食蟹猴血清时检测人 IgG 和 Fab 的通用捕获试剂。它们可以在任何宿主动物中单独或成对用于检测人 IgG，以满足临床前研究中治疗性 mAb 开发的需求。
