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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 |
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.
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.
See Certificate of Analysis for details of reconstitution instruction and specific concentration.
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.
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:
Room temperature (RT) for 1 month in lyophilized state;
-20°C for 1 year in lyophilized state;
-80°C for 4 months under sterile conditions after reconstitution.
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.
| 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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