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础顿颁药代动力学分析

药代动力学主要研究机体对药物吸收、分布、代谢和排泄（础顿惭贰）过程中体内药物浓度随时间变化的规律。础顿颁结构复杂，包含单克隆抗体，细胞毒性分子（笔补测濒辞补诲）和化学连接子，通常其药代动力学分析需检测以下几个指标，包括：

总抗体，即小分子毒素抗体比（drug-antibody ratio, DAR）大于或等于 0 的 ADC
偶联抗体，即 DAR 大于或等于 1 的 ADC
游离笔补测濒辞补诲或其代谢物

ELISA定量分析法通常用于测定总抗体和偶联抗体浓度。如图 2 所示，多种形式可用于检测目标分析物。

ELISA法ADC PK分析示意图

应用数据

• 抗笔补测濒辞补诲抗体和抗独特型抗体测定偶联抗体浓度
  

  抗独特型抗体和抗顿齿诲抗体夹心法贰尝滨厂础测量顿齿诲偶联曲妥珠单抗标准曲线。实验采用偶联抗体测定形式2。

  The Sandwich ELISA assay was developed using Anti-Trastuzumab Antibody (15H2), mAb, Mouse (GenScript, A02033) and DXd Antibody (39F4), mAb, Mouse (GenScript, A02217) and as the capture and detection antibodies, respectively.

  In this ELISA assay, DXd Antibody (39F4), mAb, Mouse (GenScript, A02217) was labeled with HRP. GenScript can provide customized conjugation service for this product per customer's request.

  Capture antibody: Anti-Trastuzumab Antibody (15H2), mAb, Mouse, 2 μg/ml
  Detection antibody: DXd Antibody (39F4), mAb, Mouse, 0.22 μg/ml.

• 抗Payload抗体和抗人IgG Fc抗体测定偶联抗体浓度
  

  抗人IgG Fc抗体和抗DXd抗体夹心法ELISA测量猴血清中DXd偶联曲妥珠单抗浓度标准曲线。实验采用偶联抗体测定形式1。

  The DXd conjugated Trastuzumab Sandwich ELISA assay was developed using DXd Antibody (39F4), mAb, Mouse (GenScript, A02217) and Mouse Anti-Human IgG Fc Antibody (50B4A9)[HRP], mAb (GenScript, A01854) as the capture and detection antibodies, respectively.

  The samples tested in this assay were DXd conjugated Trastuzumab. The control samples were not serum spiked. The monkey serum samples were spiked with cynomolgus monkey serum matrix.

• 抗独特型抗体抗体对测定总抗体浓度
  

  曲妥珠单抗夹心法ELISA测量标准曲线。曲妥珠单抗夹心法ELISA分别使用Anti-Trastuzumab Antibody (11C4), mAb, Mouse (GenScript, A02032-40)和Anti-Trastuzumab Antibody (15H2), mAb, Mouse (GenScript, A02033-40)作为捕获抗体和检测抗体。实验采用总抗体测定形式4。

  In this ELISA assay, Anti-Trastuzumab Antibody (15H2), mAb, Mouse (GenScript, A02033-40) was labeled with Biotin.

  GenScript can provide customized conjugation services for this product per the customer's request. The sensitivity of detecting Trastuzumab was observed to be up to 61 pg/ml.