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）

1. Unopened kit should be stored at -25~-15℃ upon receiving.

2. Find the expiration date on the outside packaging and do not use reagents past their expiration date.

3. The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.

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