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    METHOD FOR OBTAINING AN EXCIPIENT-FREE ANTIBODY SOLUTION
    1.
    发明申请
    METHOD FOR OBTAINING AN EXCIPIENT-FREE ANTIBODY SOLUTION 审中-公开
    获得无特殊抗体溶液的方法

    公开(公告)号：US20110236391A1

    公开(公告)日：2011-09-29

    申请号：US13132809

    申请日：2009-12-03

    申请人： Hanns-Christian Mahler ,  Robert Mueller

    发明人： Hanns-Christian Mahler ,  Robert Mueller

    IPC分类号： A61K39/395

    CPC分类号： C07K16/065 ,  A61K39/39591 ,  C07K16/18 ,  C07K16/22 ,  C07K16/3092

    摘要： The present invention relates to a method of ultra- and dialfiltrating an antibody solution containing at least one solute in addition to the antibody, which comprises diafiltrating the antibody solution with a solvent and bringing said mixture into contact with a semi-permeable membrane so as to allow the at least one solute present in the antibody solution and having a molecular weight lower than the molecular weight cut-off of the membrane to pass through the membrane, whilst retaining the antibody so that a modified antibody solution is obtained that only contains the antibody and the solvent.

    摘要翻译： 本发明涉及除了抗体之外还含有至少一种溶质的抗体溶液的超滤和渗透方法，该方法包括用溶剂渗透抗体溶液并使所述混合物与半透膜接触，以便 允许抗体溶液中存在的至少一种溶质并且具有低于膜的分子量截止值的分子量通过膜，同时保留抗体，使得获得仅含有抗体的修饰的抗体溶液 和溶剂。

    PHARMACEUTICAL COMPOSITIONS OF IGF/I PROTEINS
    2.
    发明申请
    PHARMACEUTICAL COMPOSITIONS OF IGF/I PROTEINS 审中-公开
    IGF / I蛋白的药物组合物

    公开(公告)号：US20110152188A1

    公开(公告)日：2011-06-23

    申请号：US12969619

    申请日：2010-12-16

    申请人： Hanns-Christian Mahler ,  Astrid Pappenberger

    发明人： Hanns-Christian Mahler ,  Astrid Pappenberger

    IPC分类号： A61K38/30 ,  A61P25/28 ,  A61P25/00

    CPC分类号： A61K9/08 ,  A61K9/0019 ,  A61K38/30

    摘要： The present invention relates to a pharmaceutical composition, comprising an Insulin-like growth factor I (IGF-I) protein as active pharmaceutical ingredient (API), a tonicity agent and a buffer. This composition may be administered as injection or infusion and is especially useful for the treatment, prevention and/or delay of progression of neurodegenerative disorders, in particular Alzheimer's Disease (AD), a motor neuron disease (MND), in particular amyotrophic lateral sclerosis (ALS) or Spinal Muscular Atrophy (SMA) or a Muscular Dystrophy (MD), in particular Duchenne Muscular Dystrophy (DMD) or Myotonic Dystrophy (MMD).

    摘要翻译： 本发明涉及包含作为活性药物成分（API）的胰岛素样生长因子I（IGF-I）蛋白质，张力剂和缓冲剂的药物组合物。 该组合物可以作为注射或输注施用，并且特别可用于治疗，预防和/或延缓神经变性疾病，特别是阿尔茨海默病（AD），运动神经元疾病（MND），特别是肌萎缩性侧索硬化（ ALS）或脊髓性肌萎缩（SMA）或肌营养不良（MD），特别是Duchenne肌营养不良（DMD）或肌强直性营养不良（MMD）。

    Solid forms of anti-EGFR antibodies
    3.
    发明授权
    Solid forms of anti-EGFR antibodies 失效
    固体形式的抗EGFR抗体

    公开(公告)号：US07960516B2

    公开(公告)日：2011-06-14

    申请号：US10580563

    申请日：2004-11-12

    申请人： Susanne Matheus ,  Hanns-Christian Mahler

    发明人： Susanne Matheus ,  Hanns-Christian Mahler

    IPC分类号： C12P21/08 ,  C07K16/00

    CPC分类号： C07K16/2863 ,  A61K9/143 ,  A61K9/145 ,  A61K39/39591 ,  A61K2039/505 ,  C07K2299/00 ,  C07K2317/24 ,  C30B7/00

    摘要： The invention relates to solid forms of antibodies against the EGF receptor, in particular precipitates and crystals of monoclonal antibodies against the EGF receptor, particularly preferably of Mab C225 (cetuximab) and Mab h425 (EMD 72000), which result in biologically active antibody protein through dissolution or suspension in aqueous medium, obtainable by precipitation of the antibody and/or one of its variants and/or fragments dissolved or suspended in aqueous medium by means of a precipitation reagent. The invention furthermore relates to pharmaceutical preparations comprising at least one solid form of above-mentioned antibodies in precipitated non-crystalline, precipitated crystalline or in soluble or suspended form, and optionally excipients and/or adjuvants and/or further pharmaceutical active ingredients, and to a process for the preparation of solid forms of anti-EGFR antibodies according to the invention.

    摘要翻译： 本发明涉及针对EGF受体的抗体的固体形式，特别是针对EGF受体，特别优选Mab C225（西妥昔单抗）和Mab h425（EMD 72000）的单克隆抗体的沉淀物和晶体，其导致生物活性的抗体蛋白质通过 溶解或悬浮在水性介质中，可通过使沉淀试剂沉淀溶解或悬浮在水性介质中的抗体和/或其变体和/或片段获得。 本发明还涉及包含沉淀的非结晶，沉淀结晶或可溶或悬浮形式的至少一种固体形式的上述抗体的药物制剂，以及任选的赋形剂和/或佐剂和/或其它药物活性成分，以及 根据本发明的用于制备固体形式的抗EGFR抗体的方法。

    Highly Concentrated Pharmaceutical Formulations
    4.
    发明申请
    Highly Concentrated Pharmaceutical Formulations 审中-公开
    高浓度药物制剂

    公开(公告)号：US20110076273A1

    公开(公告)日：2011-03-31

    申请号：US12879486

    申请日：2010-09-10

    申请人： Michael Adler ,  Hanns-Christian Mahler ,  Oliver Boris Stauch

    发明人： Michael Adler ,  Hanns-Christian Mahler ,  Oliver Boris Stauch

    IPC分类号： A61K39/395 ,  A61P35/00

    CPC分类号： C07K16/2887 ,  A61K9/0019 ,  A61K9/19 ,  A61K38/47 ,  A61K39/3955 ,  A61K45/06 ,  A61K47/10 ,  A61K47/183 ,  A61K47/20 ,  A61K47/22 ,  A61K47/26 ,  A61K47/42 ,  A61K2039/505 ,  C07K16/3061 ,  C07K2317/21 ,  C07K2317/24 ,  C07K2317/734 ,  C07K2317/94

    摘要： The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as e.g. Rituximab, Ocrelizumab, or HuMab , or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-CD20 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The said formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. α,α-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

    摘要翻译： 本发明涉及药物活性抗CD20抗体的高浓度，稳定的药物制剂，例如， 利妥昔单抗，奥昔布单抗或HuMab ，或用于皮下注射的这种抗体分子的混合物。 特别地，本发明涉及除了合适量的抗CD20抗体外，还包含有效量的至少一种作为组合制剂的透明质酸酶或用于共同制剂形式的制剂。 所述制剂还包含至少一种缓冲剂，例如， 组氨酸缓冲液，稳定剂或两种或更多种稳定剂的混合物（例如糖，例如α，α-海藻糖二水合物或蔗糖，以及任选的甲硫氨酸作为第二稳定剂），非离子表面活性剂和有效量的至少 一种透明质酸酶。 还提供了制备这些制剂的方法及其用途。

    Subcutaneous anti-HER2 antibody formulations and uses thereof
    9.
    发明授权
    Subcutaneous anti-HER2 antibody formulations and uses thereof 有权
    皮下抗HER2抗体制剂及其用途

    公开(公告)号：US09345661B2

    公开(公告)日：2016-05-24

    申请号：US12804703

    申请日：2010-07-27

    申请人： Michael Adler ,  Ulla Grauschopf ,  Hanns-Christian Mahler ,  Oliver Boris Stauch

    发明人： Michael Adler ,  Ulla Grauschopf ,  Hanns-Christian Mahler ,  Oliver Boris Stauch

    IPC分类号： C07K16/00 ,  A61K9/00 ,  A61K9/19 ,  A61K39/395 ,  A61K47/18 ,  A61K47/26 ,  A61K47/42 ,  C07K16/32

    CPC分类号： A61K39/39558 ,  A61K9/0019 ,  A61K9/08 ,  A61K9/19 ,  A61K38/47 ,  A61K39/39591 ,  A61K45/06 ,  A61K47/18 ,  A61K47/183 ,  A61K47/26 ,  A61K47/42 ,  C07K16/32 ,  C12Y302/01035

    摘要： The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. α,α-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

    摘要翻译： 本发明涉及药物活性抗HER2抗体的高浓度，稳定的药物制剂，例如， 曲妥珠单抗（HERCEPTIN TM），Pertuzumab或T-DM1，或用于皮下注射的这种抗体分子的混合物。 特别地，本发明涉及包含除合适量的抗HER2抗体之外的有效量的至少一种透明质酸酶作为组合制剂或用于共同制剂形式的制剂。 制剂还包含至少一种缓冲剂，例如， 组氨酸缓冲液，稳定剂或两种或更多种稳定剂的混合物（例如糖，例如α，α-海藻糖二水合物或蔗糖，以及任选的甲硫氨酸作为第二稳定剂），非离子表面活性剂和有效量的至少 一种透明质酸酶。 还提供了制备这些制剂的方法及其用途。