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    • 6. 发明申请
    • Buffered formulations for concentrating antibodies and methods of use thereof
    • 用于浓缩抗体的缓冲制剂及其使用方法
    • US20060182740A1
    • 2006-08-17
    • US10518434
    • 2003-06-23
    • Tzung-Horng YangMichael BacicaMichael Labarre
    • Tzung-Horng YangMichael BacicaMichael Labarre
    • A61K39/395
    • C07K16/065A61K9/0019A61K39/39591A61K47/12A61K47/183C07K16/00
    • The present invention provides a method for producing a concentrated antibody preparation that includes the steps of: (a) obtaining an initial antibody preparation that is an aqueous solution of antibodies and histidine or acetate buffer at a concentration in the range of from about 2 mM to about 48 mM; and (b) subjecting the antibody preparation to membrane filtration so as to remove water and buffer but not antibodies from the antibody preparation, thereby producing an antibody preparation having a higher concentration of antibodies than the initial antibody preparation. The concentrated antibody preparations produced by the method have lower viscosity and are more stable than those of other formulations. The invention further includes concentrated antibody preparations produced by the method, pharmaceutical compositions made using such preparations, and therapeutic methods in which such pharmaceutical compositions are administered to treat diseases.
    • 本发明提供了一种生产浓缩抗体制剂的方法,其包括以下步骤:(a)获得初始抗体制剂,其为浓度为约2mM至约2mM的组合或乙酸盐缓冲液的抗体水溶液 约48mM; 和(b)使抗体制剂进行膜过滤以从抗体制剂中除去水和缓冲剂而不是抗体,从而产生具有比初始抗体制备更高的抗体浓度的抗体制剂。 通过该方法制备的浓缩抗体制剂具有较低的粘度,并且比其它配方更稳定。 本发明还包括通过该方法制备的浓缩抗体制剂,使用这种制剂制备的药物组合物,以及其中施用这些药物组合物以治疗疾病的治疗方法。