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    ANTI-HUMAN PD-1 ANTIBODY CRYSTALS AND METHODS OF USE THEREOF
    1.
    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

    Applicant: Merck Sharp & Dohme Corp.

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

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

    Abstract: 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
    2.
    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

    Applicant: Merck Sharp & Dohme Corp.

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

    IPC: C07K16/24 ,  A61K39/395

    CPC classification number: C07K16/244 ,  A61K39/39591 ,  C07K2299/00 ,  C07K2317/565 ,  C07K2317/76 ,  C07K2317/92

    Abstract: 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.

    RAPID METHOD TO PREDICT STABILITIES OF PHARMACEUTICAL COMPOSITIONS CONTAINING PROTEIN THERAPEUTICS AND NON-REDUCING SUGARS
    3.
    发明申请
    RAPID METHOD TO PREDICT STABILITIES OF PHARMACEUTICAL COMPOSITIONS CONTAINING PROTEIN THERAPEUTICS AND NON-REDUCING SUGARS 有权

    公开(公告)号：US20210236640A1

    公开(公告)日：2021-08-05

    申请号：US17052687

    申请日：2019-05-06

    Applicant: Merck Sharp & Dohme Corp.

    Inventor： Arnab De ,  Chakravarthy Nachu Narasimhan

    IPC: A61K47/26 ,  A61K9/08 ,  A61K47/18

    Abstract: Provided is a method of determining the stability increase provided by a non-reducing sugar in a pharmaceutical composition containing a protein therapeutic, the method comprising: (i) providing: a first pharmaceutical composition comprising an aqueous solution of the protein therapeutic in the substantial absence of a non-reducing sugar, wherein the first pharmaceutical composition has a first B22 value and a second pharmaceutical composition comprising an aqueous solution of the protein therapeutic and the non-reducing sugar, wherein the second pharmaceutical composition has a second B22 value; (ii) determining the difference between the first and second B22 values; and (iii) predicting the stability increase provided by the non-reducing sugar based on the difference in B22 values.

    CRYSTALLINE ANTI-HUMAN IL-23 ANTIBODIES
    9.
    发明申请
    CRYSTALLINE ANTI-HUMAN IL-23 ANTIBODIES 有权
    结晶抗人IL-23抗体

    公开(公告)号：US20150147337A1

    公开(公告)日：2015-05-28

    申请号：US14407319

    申请日：2013-06-25

    Applicant: Merck Sharp & Dohme Corp.

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

    IPC: C07K16/24

    CPC classification number: C07K16/244 ,  A61K39/39591 ,  C07K2299/00 ,  C07K2317/565 ,  C07K2317/76 ,  C07K2317/92

    Abstract: 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.

    Abstract translation: 提供了对人IL-23的抗体的结晶形式，例如针对人IL-23p19的抗体，以及产生此类结晶形式的方法，以及使用这种结晶形式，例如， 治疗炎症，自身免疫和增殖性疾病。 在各种实施方案中，本发明的抗hulL-23p19抗体晶体可以通过分批结晶法，蒸气扩散法，液 - 液扩散法和透析法获得。 在其它方面，本发明涉及本发明的结晶抗hLL-23抗体的悬浮液，包括在相同抗体浓度下与相应的非结晶溶液相比可能的浓度更高和粘度更低的那些。 在其它实施方案中，本发明的抗-HLL-23抗体晶体具有提高的稳定性，即它们比抗相对应的溶液制剂更长时间保持抗-HuiL-23抗体（例如抗-HLL-23p19抗体）的生物学活性。

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