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

For research use only.

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Materials Provided
IDComponentsSize (96 tests)Size (480 tests)
PK201-213Human PD-115 μg60 μg
PK202-213Biotinylated anti-PD-1 antibody10 μg10 μg
PK203-213Streptavidin-HRP5 μg25 μg
PK204-213Anti-PD-1 antibody30 μg30 μg
  • Background

    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.

  • Assay Principles

    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. Coat the plate with human PD-1;

    2. Add the mixture of your sample and biotinylated anti-PD-1 antibody;

    3. Add Streptavidin-HRP followed by TMB or other colorimetric HRP substrate;

    4. Record the OD readings and analyze the serum concentration.

  • Reconstitution

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

  • Advantages

    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

    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.

Typical Data

Quantitative Analysis Five Different Therapeutic Anti-PD-1 Antibody in Mouse Serum Samples.

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.

NamePembrolizumabNivolumabTherapeutic PD-1 Antibody J, Human IgG4Therapeutic PD-1 Antibody X, Human IgG4Therapeutic PD-1 Antibody H, Human IgG4
Detection
Range (μg/ml)
0.03125-200.03125-200.03125-200.03125-200.03125-20
Sensitivity
(μg/ml)
0.156250.156250.156250.156250.15625
%Recovery90-10587-11594-10989-11297-109

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Drug Development Status

  • Number of Launched Drugs:17 Details
  • Number of Drugs in Clinical Trials:141 Details
  • Latest Research Phase:Approved

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