Description
Introduction:
Golimumab (CNTO 148) is a human monoclonal antibody which is used as an immunosuppressive drug and marketed under the brand name Simponi. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a proinflammatory molecule and hence is a TNF inhibitor. Profound reduction in C-reactive protein (CRP) levels, interleukin (IL)-6, intercellaular adhesion molecules (ICAM)-1, matrix metalloproteinase (MMP)-3, and vascular endothelial growth factor (VEGF) demonstrates golimumab as an effective modulator of inflammatory markers and bone metabolism. 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 Anti-Golimumab antibodies and may be used for monitoring immunogenicity.
Intended Use:
The KRIBIOLISA Anti-Golimumab ELISA is used as an analytical tool for quantitative determination of Anti-Golimumab antibodies in serum, plasma and cell culture supernatant.
Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Golimumab is pre-coated onto microwells. Samples and standards are pipetted into microwells and antibodies to Golimumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Golimumab 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-Golimumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm
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