Background/背景
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. HER-2 is probably the most targeted molecule in today’s pharmaceutical industry, thanking to the clinical success of Herceptin®. Many investigational anti-HER-2 mAbs are being developed. There is a growing need for a standard assay that can be used to facilitate the study of their pharmacokinetics.
Application/应用
It is for research use only.
Reconstitution/重构方法
See Certificate of Analysis for details of reconstitution instruction and specific concentration.
Storage/存储
Upon receipt, please store all items at -20℃. After reconstitution, the stock solution should be kept at -80℃.
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℃ for 1 year in lyophilized state; -80℃ for 4 months under sterile conditions after reconstitution.
Assay Principles/原理
The enclosed ELISA assay kit for anti-HER-2 h-mAb in monkey serum is based on an enzyme immunoassay (ELISA) between recombinant HER-2 protein (ECD) and a biotinylated anti-HER-2 monoclonal antibody. The method employs the principle of competitive ELISA, allowing quantification of monoclonal anti-HER-2 antibodies in monkey serum.
The assay only involves the following steps:
1. Coat the plate with human HER-2;
2. Add the mixture of your sample and biotinylated anti-HER-2 antibody;
3. Add Streptavidin-HRP followed by TMB or other colorimetric HRP substrate;
4. Record the OD readings and analyze the serum concentration.
