Description
Anti-Vedolizumab ELISA for the quantitative estimation of antibodies to Vedolizumab in human serum and plasma. Vedolizumab is a recombinant humanized IgG1 monoclonal antibody directed against the human lymphocyte 7 integrin, a key mediator of gastrointestinal inflammation. It is used in the treatment of moderate to severe active ulcerative colitis and Crohns disease for patients who have had an inadequate response with or lost response to, or were intolerant to inhibitors of tumor necrosis factor-alpha (TNF-alpha) or other conventional therapies. By blocking its primary target alpha beta 7 integrin, vedolizumab reduces inflammation in the gut. 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-Vedolizumab antibodies and may be used for monitoring immunogenicity.
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