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抗独特型抗体

背景
抗独特型抗体(anti-idiotypic antibody)是能够识别另一抗体可变区,并产生特异性结合的抗体。抗独特型抗体在药物开发中的应用非常广泛,可以作为免疫原性(immunogenicity)分析的重要参照,同时也可以特异性检测体内抗体药水平,是药代动力学(pharmacokinetics)研究的重要试剂。
为了支持上述研究,ACROBiosystems公司开发了一系列高亲和力、高特异性的抗独特型抗体,应用于免疫原性分析和药代动力学研究。对于每一个抗独特型抗体,我们都会根据不同的应用场景开发相应的实验方案,希望最大程度上加速药物研发的进程。目前产品已覆盖adalimumab, rituximab, cetuximab, trastuzumab, bevacizumab等多个已上市的热门抗体药。
产品列表
Cat.No. Antigen Neutralizing Activity Affinity KD, nM Application
ADB-Y19 Adalimumab F(ab')2 Neutralizing Antibody 0.0013 ADA assay
Neutralizing assay
Indirect ELISA
CEB-Y28 Cetuximab F(ab')2 Neutralizing Antibody 0.0015 ADA assay
Neutralizing assay
Indirect ELISA
CEB-Y31 Cetuximab F(ab')2 Non-Neutralizing Antibody 0.421 ADA assay
Indirect ELISA
RIB-Y35 Rituximab F(ab')2 Neutralizing Antibody 0.03 ADA assay
Neutralizing assay
Indirect ELISA
BEB-Y12 Bevacizumab F(ab')2 Neutralizing Antibody 0.0828 Neutralizing assay
Indirect ELISA
BEB-Y9 Bevacizumab F(ab')2 Neutralizing Antibody 1.92 ADA assay
Indirect ELISA
应用
几乎所有的生物制品都会产生一定的抗药抗体(anti-drug antibody, ADA),ADA的产生可能会降低药物疗效或导致严重的不良反应。临床前研究表明,ADA能对药物暴露、药物毒性作用、药物代谢动力学、药物效应动力学等造成影响。为了评估生物制品分子的免疫原性,以及将实验结果与临床事件联系起来,在临床前研究和临床研究中,有必要开发可靠的能够有效评估ADA反应的实验方法。
ADA的检测方法通常是非定量实验,因为没有可用的标准化的ADA作为校正标准品。阳性对照一般都是内部开发的单克隆抗体或多克隆抗体,非常耗时。为了解决这一问题,ACROBiosystems开发了一系列ADA作为标准品,用于对应抗体及其生物类似药的ADA检测。
应用案例1- Anti-Adalimumab Antibodies (ADB-Y19

Anti-Adalimumab Antibodies bridging ELISA for Anti-Drug Antibody (ADA) assay development. Immobilized adalimumab at 1 µg/ml, add increasing concentrations of Anti-Adalimumab Antibodies (Cat. No. ADB-Y19, 10% human serum) and then add biotinylated adalimumab at 5 µg/ml. Detection was performed using HRP-conjugated streptavidin with a sensitivity of 0.6 ng/mL.

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Measured by its neutralizing ability in a functional ELISA. Immobilized adalimumab at 0.5 μg/mL (100 μL/well) can bind pre-mixed Anti-Adalimumab Antibodies (Cat. No. ADB-Y19) and Biotinylated Human TNF-alpha (Cat. No. TNA-H82E3) with an inhibition rate of 100%.

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应用案例2- Anti-Rituximab Antibodies (RIB-Y35

Anti-Rituximab Antibodies bridging ELISA for Anti-Drug Antibody (ADA) assay development. Immobilized rituximab at 5 µg/ml, add increasing concentrations of Anti-Rituximab Antibodies (Cat. No. RIB-Y35, 10% human serum) and then add biotinylated rituximab at 5 µg/ml. Detection was performed using HRP-conjugated streptavidin with a sensitivity of 20 ng/mL.

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Measured by its neutralizing ability in FACS. The data shows that the binding of rituximab to 293F overexpressing CD20 was inhibited by increasing concentrations of Anti-Rituximab Antibodies (Cat. No. RIB-Y35). The concentration of rituximab used is 10 ng/ml. The IC50 is 0.013 μg/ml.

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PK assay -特异性检测体内抗体药水平
ELISA是抗体药血药浓度检测中最常用的技术,而indirect ELISA是其中最为简单、常见的方法。该方法具有操作简单、灵敏度高等优点。但是,由于二抗通常选择Anti-Human IgG,导致非特异背景较高,必须对基质稀释1000倍以上才能避免基质干扰。为了解决这一问题,我们用抗独特型抗体来检测基质中的抗体药水平。具体来讲,采用bridging ELISA形式,用抗独特型抗体对来检测抗体药水平,能显著降低非特异背景。

Comparison between anti-idiotypic capture ELISA and anti-idiotypic bridging ELISA for rituximab detection in patient samples. Left: anti-idiotypic capture ELISA; Right: anti-idiotypic bridging ELISA.

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对于一些抗原较难获得的特殊靶点(如CD20),可以用抗独特型抗体包板,提高和抗体药的亲和力,建立稳定可靠的检测方法。

Detection of rituximab by anti-idiotypic capture ELISA in serum. Immobilized Anti-Rituximab Antibodies (Cat. No. RIB-Y35) at 0.5 μg/mL (100 μL/well), add increasing concentrations of rituximab (0.1% human serum). Detection was performed using goat anti-human IgG with a sensitivity of 0.156 μg/mL.

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产品特点
高亲和力
亲和力代表了抗原和抗体间的结合强度,用KD值表示,KD值越小,抗体的亲和力越强。我们用SPR方法检测了所有抗独特型抗体的亲和力,了解这一指标,有助于在方法学建立过程中预测方法的灵敏度。

Anti-Adalimumab Antibodies (mouse IgG1, Cat. No. ADB-Y19) captured on CM5 chip via anti-mouse antibodies surface, can bind human adalimumab with an affinity constant of 1.36 pM.

高特异性
对于每一个产品,我们都进行了特异性检测,包括对应的抗体药、抗体药靶点、不同IgG亚型和同亚型其他抗体药,只有结合对应的抗体药,而不结合其他蛋白或抗体的产品才会被放行。

Demonstration of the specificity of Anti-Cetuximab Antibodies (Cat. No. CEB-Y28) to the cetuximab.

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高稳定性
为确保产品稳定性,ACROBiosystems会做加速实验和冻融实验来验证产品稳定性,只有经过测试证实质量和活性没有任何影响的产品才会被放行。

Reconstituted Anti-Trastuzumab Antibodies were diluted to 0.4 mg/ml, aliquoted and placed at 37°C. Aliquots were removed from 37°C at every time point and placed at 4°C along with the control. No significant loss of activity was observed.

Anti-Trastuzumab Antibodies were subjected to the indicated number of freeze-thaw cycles (FT). No significant loss of activity was observed.

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