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    • 8. 发明申请
    • STABILIZED ANTIBODY FORMULATIONS AND USES THEREOF
    • 稳定的抗体制剂及其用途
    • WO2008039761A2
    • 2008-04-03
    • PCT/US2007079403
    • 2007-09-25
    • MEDIMMUNE INCCARPENTER JOHNSATHISH HASIGERANDOLPH THEODORESALINAS BRANDENALLAN CHRISTIANBISHOP STEVEN
    • CARPENTER JOHNSATHISH HASIGERANDOLPH THEODORESALINAS BRANDENALLAN CHRISTIANBISHOP STEVEN
    • A61K39/395
    • C07K16/244A61K9/0019A61K39/39591A61K2039/505C07K16/00C07K2317/56C07K2317/565
    • The present invention provides methods of optimizing certain stable liquid formulations of antibodies that immunospecifically bind to antigens of interest. Such formulations are suitable for parenteral administration to a subject, and exhibit increased stability, low to undetectable levels of aggregation, low to undetectable levels of antibody fragmentation/degradation, and very little to no loss of the biological activities of the antibodies, even during long periods of storage. The methods of the invention provide formulations that offer multiple advantages over formulations produced by non-optimized methods, including less stringent or more readily available transportation and storage conditions, less frequent dosing, and/or smaller dosage amounts in the therapeutic, prophylactic and diagnostic uses of such formulations. The invention further provides methods of identifying antibodies exhibiting certain phase behaviors such that the antibodies can be formulated by the methods of the invention. Also provided are prophylactic, therapeutic, and diagnostic uses of such antibody formulations.
    • 本发明提供了优化免疫特异性结合目标抗原的抗体的某些稳定液体制剂的方法。 这样的制剂适合于肠胃外施用于受试者,并且表现出增加的稳定性,低至不可检测的聚集水平,低至不可检测水平的抗体片段化/降解以及即使在长期 储存期。 本发明的方法提供了制剂,其提供了多种优于由非优化方法产生的制剂的优点,包括在治疗,预防和诊断用途中较不严格或更容易获得的运输和储存条件,较少频率的剂量和/或较小剂量 的这种制剂。 本发明进一步提供鉴定表现出某些相行为的抗体的方法,使得抗体可以通过本发明的方法配制。 还提供了这些抗体制剂的预防,治疗和诊断用途。