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RU2012139181A - Стабильная композиция, содержащая антитело - Google Patents

Стабильная композиция, содержащая антитело Download PDF

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Publication number
RU2012139181A
RU2012139181A RU2012139181/15A RU2012139181A RU2012139181A RU 2012139181 A RU2012139181 A RU 2012139181A RU 2012139181/15 A RU2012139181/15 A RU 2012139181/15A RU 2012139181 A RU2012139181 A RU 2012139181A RU 2012139181 A RU2012139181 A RU 2012139181A
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antibody
composition according
composition
monoclonal anti
concentration
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RU2012139181/15A
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Хенрик ПАРШАД
Дорте Кот ЭНГЕЛУНД
Малин Т. ГУСТАВССОН
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Ново Нордиск А/С
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2851Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/38Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against protease inhibitors of peptide structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
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  • Biophysics (AREA)
  • Microbiology (AREA)
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  • Diabetes (AREA)
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  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

1. Стабильная жидкая композиция, содержащая белок, соль и/или буфер, характеризующаяся тем, что общая концентрация указанной соли и/или буфера составляет менее 100 мМ.2. Композиция по п.1, где суммарная концентрация указанной соли и/или буфера составляет менее 60 мМ.3. Композиция по п.1, которая не содержит поверхностно-активное вещество.4. Композиция по п.1, где белок присутствует в композиции в концентрации от 100 мкг/мл до 300 мг/мл.5. Композиция по п.1, где указанная композиция стабильна при комнатной температуре.6. Композиция по п.1, которая имеет вязкость, измеренную при 25°С, 50 сП или менее.7. Стабильная жидкая композиция, содержащая антитело и аргинин, где аргинин присутствует в концентрации от 5 мМ до 100 мМ.8. Стабильная жидкая композиция по п.7, в которой концентрация аргинина составляет от 5 мМ до 30 мМ.9. Композиция по любому из пп.1-8, где белок представляет собой антитело.10. Композиция по п.9, где антитело имеет подтип IgG4.11. Композиция по п.9, в которой моноклональное антитело представляет собой моноклональное анти-IL20-антитело, моноклональное анти-C5aR-антитело, моноклональное анти-NKG2D-антитело или моноклональное анти-NKG2A-антитело.12. Композиция по п.9, в которой моноклональное антитело представляет собой моноклональное анти-TFPI-антитело.13. Способ лечения воспалительного заболевания, который включает введение пациенту терапевтически эффективного количества композиции по п.11.14. Способ лечения коагулопатии, который включает введение пациенту терапевтически эффективного количества композиции по п.12.

Claims (14)

1. Стабильная жидкая композиция, содержащая белок, соль и/или буфер, характеризующаяся тем, что общая концентрация указанной соли и/или буфера составляет менее 100 мМ.
2. Композиция по п.1, где суммарная концентрация указанной соли и/или буфера составляет менее 60 мМ.
3. Композиция по п.1, которая не содержит поверхностно-активное вещество.
4. Композиция по п.1, где белок присутствует в композиции в концентрации от 100 мкг/мл до 300 мг/мл.
5. Композиция по п.1, где указанная композиция стабильна при комнатной температуре.
6. Композиция по п.1, которая имеет вязкость, измеренную при 25°С, 50 сП или менее.
7. Стабильная жидкая композиция, содержащая антитело и аргинин, где аргинин присутствует в концентрации от 5 мМ до 100 мМ.
8. Стабильная жидкая композиция по п.7, в которой концентрация аргинина составляет от 5 мМ до 30 мМ.
9. Композиция по любому из пп.1-8, где белок представляет собой антитело.
10. Композиция по п.9, где антитело имеет подтип IgG4.
11. Композиция по п.9, в которой моноклональное антитело представляет собой моноклональное анти-IL20-антитело, моноклональное анти-C5aR-антитело, моноклональное анти-NKG2D-антитело или моноклональное анти-NKG2A-антитело.
12. Композиция по п.9, в которой моноклональное антитело представляет собой моноклональное анти-TFPI-антитело.
13. Способ лечения воспалительного заболевания, который включает введение пациенту терапевтически эффективного количества композиции по п.11.
14. Способ лечения коагулопатии, который включает введение пациенту терапевтически эффективного количества композиции по п.12.
RU2012139181/15A 2010-02-26 2011-02-28 Стабильная композиция, содержащая антитело RU2012139181A (ru)

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Application Number Priority Date Filing Date Title
EP10154771.9 2010-02-26
EP10154771 2010-02-26
US31048010P 2010-03-04 2010-03-04
US61/310,480 2010-03-04
PCT/EP2011/052914 WO2011104381A2 (en) 2010-02-26 2011-02-28 Stable antibody containing compositions

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US (2) US9795674B2 (ru)
EP (4) EP3216462A3 (ru)
JP (3) JP2013520476A (ru)
KR (1) KR20120130757A (ru)
CN (3) CN103037899A (ru)
AU (1) AU2011219715B2 (ru)
BR (1) BR112012021576A2 (ru)
CA (1) CA2789061A1 (ru)
MX (1) MX2012009755A (ru)
RS (1) RS61082B1 (ru)
RU (1) RU2012139181A (ru)
SI (1) SI3409289T1 (ru)
WO (1) WO2011104381A2 (ru)

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RS61901B1 (sr) 2016-01-21 2021-06-30 Innate Pharma Neutralizacija inhibitornih puteva u limfocitima

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