Anti-Human IgE (Omalizumab) – Fc Muted™

Unknown

This biosimilar antibody is aseptically packaged and formulated in 0.01 M phosphate buffered saline (150 mM NaCl) PBS pH 7.2 - 7.4 with no carrier protein, potassium, calcium or preservatives added. Due to inherent biochemical properties of antibodies, certain products may be prone to precipitation over time. Precipitation may be removed by aseptic centrifugation and/or filtration.

Liquid

Recombinant biosimilar antibodies are manufactured in an animal free facility using only in vitro protein free cell culture techniques and are purified by a multi-step process including the use of protein A or G to assure extremely low levels of endotoxins, leachable protein A or aggregates.

To protect mouse colonies from infection by pathogens and to assure that experimental preclinical data is not affected by such pathogens, all of Leinco’s recombinant biosimilar antibodies are tested and guaranteed to be negative for all pathogens in the IDEXX IMPACT I Mouse Profile.

Functional grade preclinical antibodies may be stored sterile as received at 2-8°C for up to one month. For longer term storage, aseptically aliquot in working volumes without diluting and store at ≤ -70°C. Avoid Repeated Freeze Thaw Cycles.

Research Use Only

2 – 8° C Wet Ice

This non-therapeutic biosimilar antibody uses the same variable region sequence as the therapeutic antibody Omalizumab. Omalizumab (RG-3648) is a recombinant DNA- derived humanized IgG1 monoclonal antibody that specifically targets immunoglobulin E (IgE).

IgE is a pivotal antibody in allergic responses, crucially involved in conditions like allergic asthma. It binds to high-affinity receptors on mast cells and basophils, triggering the release of inflammatory mediators. The pathogenic role of IgE in allergic inflammation is well- documented, with multivalent allergens binding to allergen-specific IgEs on sensitized effector cells, leading to effector cell activation and the release of potent inflammatory mediators. Therapies targeting IgE, such as omalizumab, have shown efficacy in reducing exacerbations, symptoms, and medication use in allergic asthma, highlighting the significance of IgE in allergic diseases^1,2.

RG-3648, commonly known as Omalizumab, is a humanized monoclonal antibody that targets IgE, a key player in allergic responses. Approved for severe allergic asthma and chronic spontaneous urticaria, Omalizumab binds to serum IgE, preventing its interaction with cellular IgE receptors. By downregulating high-affinity IgE receptors on inflammatory cells and reducing eosinophil numbers, Omalizumab improves respiratory symptoms, and quality of life, and reduces asthma exacerbations. Despite generally being well-tolerated, rare anaphylactic reactions have been reported. Omalizumab's efficacy extends to various conditions like allergic rhinitis, atopic dermatitis, and nasal polyps, showcasing its therapeutic versatility^3,4.

IgE is primarily found in the lungs, skin, and mucosal membranes.

FcεRI, Fc epsilon RII

1. Yamazaki T, Inui M, Hiemori K, et al. J Biol Chem. 2019;294(17):6659-6669.
2. Sn K, P K, Dh J, et al. Microbiology spectrum. 2013;1(1).
3. Pelaia G, Gallelli L, Renda T, et al. J Asthma Allergy. 2011;4:49-59.
4. G P, T R, P R, Mt B, R M. Therapeutic advances in respiratory disease. 2008;2(6).
5. Anti Omalizumab Antibody, clone AbD20669. Bio-Rad. Accessed October 5, 2024. https://www.bio-rad-antibodies.com/monoclonal/omalizumab-antibody-abd20669-hca236.html
6. Omalizumab mAb-Based ELISA Assay. Eagle Biosciences. Accessed October 5, 2024. https://eaglebio.com/product/omalizumab-mab-based-elisa-assay/