ELISA Assay Kit for Anti-HER-2 h-mAb in Mouse Serum

产品概述（Product Overview）

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.

应用说明（Application）

This kit is developed for detect the anti-HER-2 h-mAb binding to Herceptin (Trastuzumab) for research pharmacokinetics.

It is for research use only.

重构方法（Reconstitution）

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

存储（Storage）

-20℃

原理（Assay Principles）

The enclosed ELISA assay kit for anti-HER-2 h-mAb in mouse 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 mouse 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.

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