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ELISA Assay Kit for Anti-PD-1 h-mAb in Mouse Serum

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  • ID Components Size (96 tests) Size (480 tests)
    PK201-213 Human PD-1 15 μg 60 μg
    PK202-213 Biotinylated anti-PD-1 antibody 10 μg 10 μg
    PK203-213 Streptavidin-HRP 5 μg 25 μg
    PK204-213 Anti-PD-1 antibody 30 μg 30 μg
  • Assay Principles/原理

    The enclosed ELISA assay kit for anti-PD-1 h-mAb in mouse serum is based on an enzyme immunoassay (ELISA) between recombinant PD-1 protein (ECD) and a biotinylated anti-PD-1 monoclonal antibody. The method employs the principle of competitive ELISA, allowing quantification of monoclonal anti-PD-1 antibodies in mouse serum.

    The assay only involves the following steps:

    1. 1. Coat the plate with human PD-1;
    2. 2. Add the mixture of your sample and biotinylated anti-PD-1 antibody;
    3. 3. Add Streptavidin-HRP followed by TMB or other colorimetric HRP substrate;
    4. 4. Record the OD readings and analyze the serum concentration.


  • Reconstitution/重构方法

    See Certificate of Analysis for details of reconstitution instruction and specific concentration.

  • Advantages/产品优势

    Wide Coverage

    This kit has been tested for multiple investigational PD-1 antibodies, as well as the commercially available Keytruda® and Opdivo®. There is no requirement for the species and subtype of the antibody.

    Easy Process

    There is no longer a need to generate anti-drug antibodies for PK studies.

    Clean Result

    The use of the biotinylated antibody in the competitive ELISA significantly alleviates the issue of background noise issue that often occurs in traditional ELISA method.

  • Storage/存储

    Upon receipt, please store all items at -20°C.
    After reconstitution, the stock solution should be kept at -80°C.
    It is recommended not to freeze thaw more than 3 times. This product is stable after storage at:

    1. Room temperature (RT) for 1 month in lyophilized state;
    2. -20°C for 1 year in lyophilized state;
    3. -80°C for 4 months under sterile conditions after reconstitution.


  • 质量管理控制体系(QMS)

    1. 质量管理体系(ISO, GMP)
    2. 质量优势
    3. 质控流程

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  • Typical Data/典型数据

    EPM-V1-E1

    Serial dilutions of the Therapeutic Anti-PD-1 Antibody (1:2 serial dilutions, from 20 μg/mL to 0.039 μg/mL) was added into PD-1: Biotinylated Anti-PD-1 Antibody binding reactions.

    Protocol
  • Name
    Pembrolizumab
    Nivolumab
    Therapeutic PD-1 Antibody J, Human IgG4
    Therapeutic PD-1 Antibody X, Human IgG4
    Therapeutic PD-1 Antibody H, Human IgG4
    Detection Range (μg/ml)
    0.03125-20
    0.03125-20
    0.03125-20
    0.03125-20
    0.03125-20
    Sensitivity (μg/ml)
    0.15625
    0.15625
    0.15625
    0.15625
    0.15625
    %Recovery
    90-105
    87-115
    94-109
    89-112
    97-109

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背景介绍

How a therapeutic antibody is metabolized in the body is pertinently relevant to its efficacy. Therefore, pharmacokinetics study is an important part of the drug development. PD-1 is probably the most targeted molecule in today’s pharmaceutical industry, thanking to the clinical success of Keytruda® and Opdivo®. Many investigational anti-PD-1 mAbs are being developed. There is a growing need for a standard assay that can be used to facilitate the study of their pharmacokinetics.

前沿进展

 
药物研发进展
  • 英文全称:

    Programmed cell death protein 1

  • 中文全称:

    细胞程序性死亡-1

  • 种类:

  • 上市药物数量:

    20 详情

  • 临床药物数量:

    167 详情

  • 最高研发阶段:

    临床三期

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