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    • 3. 发明申请
    • FORMULATIONS OF MODIFIED ANTIBODIES AND METHODS OF MAKING THE SAME
    • 改良抗体的制剂及其制备方法
    • WO2004019860A3
    • 2004-07-22
    • PCT/US0324413
    • 2003-08-05
    • PHARMACIA CORPLEWIS LAVINIA MQI HONGJOHNSON ROBERT E
    • LEWIS LAVINIA MQI HONGJOHNSON ROBERT E
    • A61K20060101A61K39/395A61K47/48C07K16/00C07K16/12C12P21/08
    • C07K16/1289A61K47/60C07K2317/55
    • The present invention is directed to novel formulations of modified antibodies and to methods of producing the same. The modified antibodies formulated according to the present invention each comprise an antibody fragment covalently attached to at least one nonproteinaceous polymer, such as poly(ethyleneglycol). CDP870 is an example of one such modified antibody, a therapeutic modified antibody. One method disclosed herein involves the removal from a solution of the modified antibody of molecules capable of adversely affecting the stability or solubility of the modified antibody after lyophilization (e.g., by dialysis or diafiltration), followed by lyophilization of the modified antibody. Another method involves concentration of a modified antibody solution by equilibrium dialysis. The methods of the present invention can be used to produce formulations suitable for use in subcutaneous and parenteral injection, including high concentration formulations.
    • 本发明涉及修饰抗体的新型制剂及其制备方法。 根据本发明配制的经修饰的抗体各自包含与至少一种非蛋白质聚合物如聚(乙二醇)共价连接的抗体片段。 CDP870是一种这样的修饰抗体,治疗性修饰抗体的实例。 本文公开的一种方法涉及从冻干(例如通过透析或渗滤)后可以不利地影响修饰抗体的稳定性或溶解度的分子的修饰抗体的溶液中除去,然后冻干该修饰的抗体。 另一种方法包括通过平衡透析浓缩修饰的抗体溶液。 本发明的方法可用于制备适用于皮下和肠胃外注射的制剂,包括高浓度制剂。
    • 4. 发明申请
    • MIXING TOOL
    • 混合工具
    • WO2008134570A3
    • 2008-12-31
    • PCT/US2008061653
    • 2008-04-25
    • AMYLIN PHARMACEUTICALS INCSMITH CHRISTINEHALILI REYQI HONG
    • SMITH CHRISTINEHALILI REYQI HONG
    • A61M5/178
    • A61J1/2096A61J1/201A61M5/002
    • The present invention provides devices and methods for mixing a formulation containing two or more constituents, such as a drug product and a diluent. The devices have a chamber for securing a container of the drug product. Various embodiments are presented. In one embodiment the device has two or more sides connected by a hinge, the two or more sides defining the chamber between them, and a handle for grasping and manipulating the device. In another embodiment the device has a housing with two or more side bars defining the chamber, the container being visible from outside the housing between the side bars and having a stopping element at the distal end, and a handle having two arms for grasping.
    • 本发明提供了用于混合含有两种或更多种成分(例如药物产品和稀释剂)的制剂的装置和方法。 这些装置具有用于固定药物产品的容器的腔室。 呈现各种实施例。 在一个实施例中,该装置具有通过铰链连接的两个或多个侧面,两个或多个侧面在它们之间限定室,以及用于抓握和操纵该装置的手柄。 在另一个实施例中,该装置具有壳体,其具有限定腔室的两个或多个侧杆,容器从侧杆之间的壳体外部可见,并且在远端具有止动元件,以及具有用于抓握的两个臂的手柄。