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ADC藥代動(dòng)力學(xué)分析

藥代動(dòng)力學(xué)主要研究機(jī)體對(duì)藥物吸收、分布、代謝和排泄（ADME）過程中體內(nèi)藥物濃度隨時(shí)間變化的規(guī)律。ADC結(jié)構(gòu)復(fù)雜，包含單克隆抗體，細(xì)胞毒性分子（Payload）和化學(xué)連接子，通常其藥代動(dòng)力學(xué)分析需檢測(cè)以下幾個(gè)指標(biāo)，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(lián)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(cè)定總抗體和偶聯(lián)抗體濃度。如圖 2 所示，多種形式可用于檢測(cè)目標(biāo)分析物。

ELISA法ADC PK分析示意圖

應(yīng)用數(shù)據(jù)

• 抗Payload抗體和抗獨(dú)特型抗體測(cè)定偶聯(lián)抗體濃度
  

  抗獨(dú)特型抗體和抗DXd抗體夾心法ELISA測(cè)量DXd偶聯(lián)曲妥珠單抗標(biāo)準(zhǔn)曲線。實(shí)驗(yàn)采用偶聯(lián)抗體測(cè)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(cè)定偶聯(lián)抗體濃度
  

  抗人IgG Fc抗體和抗DXd抗體夾心法ELISA測(cè)量猴血清中DXd偶聯(lián)曲妥珠單抗?jié)舛葮?biāo)準(zhǔn)曲線。實(shí)驗(yàn)采用偶聯(lián)抗體測(cè)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(dú)特型抗體抗體對(duì)測(cè)定總抗體濃度
  

  曲妥珠單抗夾心法ELISA測(cè)量標(biāo)準(zhǔn)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(cè)抗體。實(shí)驗(yàn)采用總抗體測(cè)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.