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    ANTI-HUMAN PD-1 ANTIBODY CRYSTALS AND METHODS OF USE THEREOF
    9.
    发明申请
    ANTI-HUMAN PD-1 ANTIBODY CRYSTALS AND METHODS OF USE THEREOF 有权

    公开(公告)号：US20210317215A1

    公开(公告)日：2021-10-14

    申请号：US17287588

    申请日：2019-10-28

    申请人： Merck Sharp & Dohme Corp.

    发明人： Paul Reichert ,  Winifred W. Prosise ,  Xiaoyu Yang ,  Corey Strickland ,  Chakravarthy Nachu Narasimhan ,  Thierry O. Fischmann ,  Erika R. Walsh ,  Yongchao Su

    IPC分类号： C07K16/28 ,  A61K47/10 ,  A61K47/68 ,  A61K31/522 ,  A61K45/06

    摘要： The invention provides methods for producing crystalline an anti-PD-1 monoclonal antibody (mAb), wherein the mAb is pembrolizumab or a pembrolizumab variant, comprising (1) mixing a solution comprising (a) the mAb, (b) polyethylene glycol (PEG), and (c) an additive selected from the group consisting of: caffeine, theophylline, 2′ deoxyguanosine-5′-monophosphate, a bioactive gibberellin, and a pharmaceutically acceptable salt of said bioactive gibberellin, to form a crystallization solution, (2) incubating the crystallization solution for a period of time sufficient for crystal formation; and (3) optionally harvesting the crystalline anti-PD-1 mAb from the solution. In specific embodiments, the PEG is PEG 3350 and the additive is caffeine. The invention also relates to the novel anti-human PD-1 mAb crystals produced by the methods described herein. Characterization of re-dissolved crystalline suspensions using several biochemical methods showed the bio-physical properties of the re-dissolved mAb crystals were consistent with the intact antibody starting sample. The crystals and methods of the invention are amenable to multiple pharmaceutical applications such as purification, storage, formulation, and drug delivery.

    Crystalline anti-human IL-23p19 antibodies
    10.
    发明授权
    Crystalline anti-human IL-23p19 antibodies 有权

    公开(公告)号：US09803010B2

    公开(公告)日：2017-10-31

    申请号：US14407319

    申请日：2013-06-25

    申请人： Merck Sharp & Dohme Corp.

    发明人： Paul Reichert ,  Winifred W. Prosise ,  Peter Orth ,  Chakravarthy Nachu Narasimhan ,  Ramesh S. Kashi

    IPC分类号： C07K16/24 ,  A61K39/395

    CPC分类号： C07K16/244 ,  A61K39/39591 ,  C07K2299/00 ,  C07K2317/565 ,  C07K2317/76 ,  C07K2317/92

    摘要： Crystalline forms of antibodies to human IL-23, such as antibodies to human IL-23p19 , are provided, as well as methods of producing such crystalline forms, and uses of such crystalline forms, e.g. in treatment of inflammatory, autoimmune, and proliferative disorders. In various embodiments, the anti-hulL-23 antibody crystals, such as anti-hulL-23p19 antibody crystals of the present invention are obtainable by batch crystallization methods, vapor diffusion methods, liquid-liquid diffusion methods, and dialysis. In other aspects, the invention relates to suspensions of the crystalline anti-hulL-23 antibodies of the present invention, including those at higher concentrations and lower viscosities than would be possible with a corresponding non-crystalline solution at the same concentration of antibody. In other embodiments, the anti-huiL-23 antibody crystals of the present invention have increased stability, i.e. they maintain biological activity of the anti-huiL-23 antibody, such as anti-huiL-23p 19 antibody, longer than corresponding solution formulations.