Abstract：
CM310 is a recombinant humanized monoclonal antibody targeting Interleukin (IL)-4 receptor alpha (IL-4Rα). IL-4Rα blockade prevents IL-4 and IL-13 from binding to their receptor, thereby inhibiting downstream signaling pathways that drive Type 2 helper T-cell (Th2) inflammation. CM310 holds potential for treating Th2-related inflammatory diseases, such as asthma, atopic dermatitis and chronic sinusitis with nasal polyposis. In this study, a direct enzyme-linked immunosorbent assay (ELISA) was developed to measure the concentrations of CM310 in rat serum. Seven calibration standards (ranging from 25 to 1600 ng/mL) and three quality controls (70, 500 and 1250 ng/mL) were defined. The limit of detection (LOD), lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ) were 13, 25 and 1600 ng/mL, respectively. The method exhibited excellent precision and accuracy and successfully applied to in vitro serum stability and pharmacokinetic (PK) studies. In conclusion, we have developed and validated a highly sensitive and selective method for measuring CM310 in Sprague-Dawley rats. The development and validation ELISA method met the acceptable criteria, which suggested that these can be applied to quantify CM310, as well as in PK studies.
摘要：
CM310是靶向白细胞介素(IL)-4受体α(IL-4Rα)的重组人源化单克隆抗体。IL-4Rα阻断阻止IL-4和IL-13与其受体结合，从而抑制驱动2型辅助性T细胞(Th2)炎症的下游信号传导途径。CM310具有治疗Th2相关炎性疾病的潜力，比如哮喘,特应性皮炎和慢性鼻窦炎伴鼻息肉。在这项研究中,建立了直接酶联免疫吸附试验（ELISA）来测量大鼠血清中CM310的浓度。定义了七个校准标准（范围从25到1600ng/mL）和三个质量对照（70、500和1250ng/mL）。检测限（LOD），定量下限（LLOQ）和定量上限（ULOQ）分别为13、25和1600ng/mL，分别。该方法具有出色的精密度和准确性，并成功应用于体外血清稳定性和药代动力学（PK）研究。总之,我们已经开发并验证了一种高度灵敏和选择性的方法来测量Sprague-Dawley大鼠的CM310。开发和验证ELISA方法符合可接受的标准，这表明这些可以应用于定量CM310，以及在PK研究。
