黄金城集团

ADC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（ADME）过程中体内药物浓度随时间变化的规律ཧ。ADC结构复杂，包含单克隆抗体，细胞毒性分子（Payload）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Payload或其代谢物

 ELIꦚSA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Payload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DXd抗体夹心法ELISA测量DXd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 antibodi🧸es, respectively.

  In this ELISA assay, DXd Antibody (39F4), ﷽mAb, Mouse (GenScript, A02217) was labeleဣd 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: DX📖d Antibody (39🅠F4), 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 detection𝓀 antibo🍎dies, respectively.

  The samples tested in this assay 𒆙were 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 lab♈eled with Biotin.

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