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中文名稱:OMALIZUMAB中文同義詞:奧馬珠單抗英文名稱:OMALIZUMAB英文同義詞:OMALIZUMAB;Xolair;Omalizumab - buffer solution產品描述奧馬珠單抗類似物是一種選擇性與人IgE結合的重組DNA人源化單克隆抗體,分子量約149kDa,由中國倉鼠卵巢細胞懸浮培養生產。 性質Name Biosimilar of OmalizumabCAS NO. 242138-07-4Type Whole antibodySource Humanized (from mouse)Target IgE Fc regionClone MonocloneMolecular Weight 149 kDaFormula C6450H9916N1714O2023S38Antibody Form Purified immunoglobulinPhysical Form SolutionGrade Standard Medicine GradeStorage -70±15℃ for long-term storage, 2-8℃ for short-term storage, away from light.生物活性奧馬珠單抗Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes. Omalizumab inhibits the binding of IgE to FcεRI on mast cells and basophils by binding to an antigenic epitope on IgE that overlaps with the site to which FcεRI binds. When IgE is bound to the receptor, the antigenic epitope on IgE to which omalizumab binds is sterically hindered by the receptor and is not accessible to omalizumab binding, thus averting the anaphylactic effects presumably unavoidable with an ordinary anti-IgE antibody . Furthermore, although the peptide elements on IgE involved in binding to low affinity IgE receptor (FcεRII) on many cell types are different from the peptide elements involved in binding to FcεRI, omalizumab, by steric hindrance, also prevents binding of IgE to FcεRII.不同實驗動物依據體表面積的等效劑量轉換表(數據來源于FDA指南) 小鼠 大鼠 兔 豚鼠 倉鼠 狗重量 (kg) 0.02 0.15 1.8 0.4 0.08 10體表面積 (m2) 0.007 0.025 0.15 0.05 0.02 0.5Km 系數 3 6 12 8 5 20動物 A (mg/kg) = 動物 B (mg/kg) × 動物 B的Km系數動物 A的Km系數例如,依據體表面積折算法,將白藜蘆醇用于小鼠的劑量22.4 mg/kg 換算成大鼠的劑量,需要將22.4 mg/kg 乘以小鼠的Km系數(3),再除以大鼠的Km系數(6),得到白藜蘆醇用于大鼠的等效劑量為11.2 mg/kg。儲備液配制以下數據基于產品分子量,對于特殊產品,請參照COA中的儲備液配制條件和說明進行操作。Concentration / Solvent Volume / Mass 1 mg 5 mg 10 mg1 mM 0.0069 mL 0.0345 mL 0.0689 mL5 mM 0.0014 mL 0.0069 mL 0.0138 mL10 mM 0.0007 mL 0.0034 mL 0.0069 mL參考文獻Anti-IgE antibodies for the treatment of IgE-mediated allergic diseases.Chang TW, et al. Adv Immunol. 2007;93:63-119. PMID: 17383539.Development of a monoclonal anti-immunoglobulin E antibody (omalizumab) for the treatment of allergic respiratory disorders.Schulman ES. Am J Respir Crit Care Med. 2001 Oct 15;164(8 Pt 2):S6-11. PMID: 11704611單抗藥物對照品貝伐單抗,Bevacizumab 納武單抗,Nivolumab帕妥珠單抗,Pertuzumab 曲妥珠單抗,Trastuzumab阿達木單抗,Adalimumab 帕姆單抗,Pembrolizumab迪諾蘇單抗,Denosumab 阿替唑單抗,Atezolizumab優特克諾單抗,Ustekinumab 維多珠單抗,Vedolizumab1、33個產品,三種規格:1mg,2mg,5mg;2、價格優,全現貨;3、科研產品,僅用科研,禁用臨床;Supplier供應商:BioVector NTCC質粒載體菌株細胞蛋白抗體基因保藏中心電話:010-53513060網址http://www.biovector.net
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