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ADC藥代動力學分析

藥代動力學主要研究機體對藥物吸收、分布、代謝和排泄（ADME）過程中體內藥物濃度隨時間變化的規律。ADC結構復雜，包含單克隆抗體，細胞毒性分子（Payload）和化學連接子，通常其藥代動力學分析需檢測以下幾個指標，包括：

總抗體，即小分子毒素抗體比（drug-antibody ratio, DAR）大于或等于 0 的 ADC
偶聯抗體，即 DAR 大于或等于 1 的 ADC
游離Payload或其代謝物

ELISA定量分析法通常用于測定總抗體和偶聯抗體濃度。如圖 2 所示，多種形式可用于檢測目標分析物。

ELISA法ADC PK分析示意圖

應用數據

• 抗Payload抗體和抗獨特型抗體測定偶聯抗體濃度
  

  抗獨特型抗體和抗DXd抗體夾心法ELISA測量DXd偶聯曲妥珠單抗標準曲線。實驗采用偶聯抗體測定形式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抗體和抗人IgG Fc抗體測定偶聯抗體濃度
  

  抗人IgG Fc抗體和抗DXd抗體夾心法ELISA測量猴血清中DXd偶聯曲妥珠單抗濃度標準曲線。實驗采用偶聯抗體測定形式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.

• 抗獨特型抗體抗體對測定總抗體濃度
  

  曲妥珠單抗夾心法ELISA測量標準曲線。曲妥珠單抗夾心法ELISA分別使用Anti-Trastuzumab Antibody (11C4), mAb, Mouse (GenScript, A02032-40)和Anti-Trastuzumab Antibody (15H2), mAb, Mouse (GenScript, A02033-40)作為捕獲抗體和檢測抗體。實驗采用總抗體測定形式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.