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    • 3. 发明申请
    • METHODS TO PRODUCE SINGLE GLYCOFORM ANTIBODIES
    • 生产单糖抗体的方法
    • US20170051328A1
    • 2017-02-23
    • US15118664
    • 2015-02-18
    • The University of Manitoba
    • Venkata TayiMichael Butler
    • C12P21/00C07K16/24C07K1/22C07K16/28
    • C12P21/005C07K1/22C07K16/00C07K16/244C07K16/2863C07K2317/24C07K2317/41C12P19/18
    • An enzymatic method is provided for restructuring an affinity ligand bound heterogenous glycoform antibody sample to a substantially homogenous single desired glycoform antibody sample for therapeutic uses and kits for performing the methods. A method for enzymatically altering the Fc region of an affinity ligand bound antibody from a heterogenous glycoform to a substantially homogenous single glycoform comprises: contacting the affinity ligand bound heterogeneous glycoform antibody with a reaction buffer designed for a particular glycoform modification for a time sufficient and under conditions to modify the glycoform of the Fc region to a substantially homogeneous single form; optionally adding one or more nucleotide sugars and/or cofactors; and releasing the substantially homogeneous single glycoform antibody sample from said affinity ligand. The invention also encompasses biopharmaceuticals comprising single glycoform mAbs and polyclonal antibodies enzymatically produced for the treatment of cancers and immune disorders as well as compositions comprising the single glycoform antibodies as a biopharmaceutical.
    • 提供了一种酶法,用于将亲和配体结合的异源糖基抗体样品重组为用于治疗用途的基本均匀的单一所需糖形抗体样品和用于进行所述方法的试剂盒。 将亲和配体结合的抗体的Fc区酶从酶促改变为基本均匀的单糖形式的方法包括:将亲和配体结合的异源糖基抗体与设计用于特定糖形式修饰的反应缓冲液接触足够的时间 将Fc区的糖形式修饰成基本均匀的单一形式的条件; 任选地加入一种或多种核苷酸糖和/或辅因子; 并从所述亲和配体释放基本均匀的单一糖基抗体样品。 本发明还包括生物药物,其包含单个糖基单克隆抗体和酶解产生用于治疗癌症和免疫病症的多克隆抗体以及包含单一糖形抗体作为生物药物的组合物。