Omalizumab bridging ELISA for pharmacokinetic (PK) assay development
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Human Anti-IgE Antibody, clone huMaE11 is a research grade biosimilar of the monoclonal antibody drug omalizumab. It is a recombinant human IgG1 kappa antibody with variable regions from the therapeutic antibody omalizumab. Human Anti-IgE Antibody is for research use only. It is suitable as a reference standard in a pharmacokinetic (PK) bridging ELISA with anti-omalizumab antibodies, for example HCA235P and HCA236. It can also be used as capture and detection reagent in an anti-drug antibody (ADA) bridging ELISA, with an anti-omalizumab antibody in IgG1 format as reference standard, for example HCA235. Omalizumab (Xolair) is a recombinant humanized IgG1 kappa monoclonal antibody used in the treatment of patients with moderate or severe asthma. Allergic asthma is mediated by immunoglobulin E (IgE) released by B cells in response to allergen. Circulating IgE binds to the high-affinity IgE Fc receptor (FcεRI) expressed on basophils and mast cells, triggering the release of histamine, leukotrienes and other mediators associated with the pathophysiology of asthma. Omalizumab is directed against the Fc region of human IgE. By binding to circulating IgE at the site of FcεRI binding, this therapeutic antibody prevents the interaction of IgE with its receptor thus limiting mediator release. This product is NOT FOR THERAPEUTIC USE.View a summary of supporting anti-omalizumab antibody products
