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    METHOD AND FORMULATION FOR REDUCING AGGREGATION OF A MACROMOLECULE UNDER PHYSIOLOGICAL CONDITIONS
    2.
    发明申请
    METHOD AND FORMULATION FOR REDUCING AGGREGATION OF A MACROMOLECULE UNDER PHYSIOLOGICAL CONDITIONS 审中-公开
    在生理条件下降低大分子聚集的方法和制剂

    公开(公告)号：US20140308270A1

    公开(公告)日：2014-10-16

    申请号：US14090259

    申请日：2013-11-26

    Applicant: Genentech, Inc.

    Inventor： Brian Lobo ,  Sabrina Lo ,  Aditya Wakankar ,  Yuchang John Wang ,  Rita L. Wong ,  Pierre Goldbach ,  Hanns-Christian Mahler

    IPC: A61K47/32 ,  C07K16/28

    CPC classification number: A61K47/32 ,  A61K9/0019 ,  A61K2039/505 ,  A61K2039/545 ,  C07K16/2887 ,  C07K2317/24

    Abstract: The invention provides a method for reducing aggregation and inhibiting flocculation of a macromolecule, such as a protein, under physiological conditions, by the addition of 5% to 20% polyvinylpyrrolidone (PVP) with a molecular weight range of 2000 to 54,000 daltons. The invention further provides a method to minimize inflammation at the injection site during subcutaneous administration of a macromolecule. In further aspects, the invention provides pharmaceutical formulations for subcutaneous administration of a macromolecule, and methods of treating a CD20 positive cancer or an autoimmune disease, comprising administering a humanized anti-CD20 antibody in a pharmaceutical formulation of the invention. The invention further provides an in vitro dialysis method to evaluate the ability of an excipient to reduce aggregation of an antibody or other macromolecule under physiological conditions.

    Abstract translation: 本发明提供了一种通过加入分子量范围为2000至54,000道尔顿的5％至20％的聚乙烯吡咯烷酮（PVP），在生理条件下减少聚合并抑制大分子如蛋白质的絮凝的方法。 本发明还提供了一种在大分子皮下给药期间最小化注射部位的炎症的方法。 在另外的方面，本发明提供用于皮下施用大分子的药物制剂，以及治疗CD20阳性癌症或自身免疫性疾病的方法，包括在本发明的药物制剂中施用人源化抗CD20抗体。 本发明还提供一种体外透析方法，用于评价赋形剂在生理条件下减少抗体或其它大分子聚集的能力。

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