ELISA/assay

Anti-Trastuzumab (HERCEPTIN) ELISA

KBI2017

1 x 96 well

Anti-Trastuzumab (HERCEPTIN) ELISA

Trastuzumab is humanized monoclonal antibody which targets HER-2/neu receptor. Trastuzumab is approved for the use in treating Breast Cancer and is being tested for other cancers that over express HER-2/neu. Anti-Drug Antibodies (ADA) may induce unwanted side effects in biopharmaceuticals. Hence, ADA has been subjected to increase in scrutiny by the regulatory authorities using immunogenicity safety studies. ADA has been observed in pre-clinical and clinical studies, resulting in significant changes in toxicology, pharmacokinetics and efficacy. These effects result from the generation of drug-induced (neutralizing) autoantibodies against Trastuzumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects antibodies for Anti-Trastuzumab and may be used for monitoring immunogenicity.

The method employs the quantitative sandwich enzyme immunoassay technique. Trastuzumab is pre-coated onto microwells. Samples and standards are pipetted into microwells and antibodies to Trastuzumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Trastuzumab is pipetted and incubated. After washing microwells in order to remove any nonspecific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Anti-Trastuzumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

ELISA

Assay Kits

Therapeutic Drug Monitoring

1 x 96 well

Anti-Trastuzumab

Anti-Trastuzumab

<10 ng/mL

10-640 ng/ml

100 uL

Serum, Plasma, Cell Culture Supernatants

2.25 hours

RUO

wet

2-8C