RU2012139181A - Стабильная композиция, содержащая антитело - Google Patents
Стабильная композиция, содержащая антитело Download PDFInfo
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- 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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- 239000004475 Arginine Substances 0.000 claims abstract 6
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims abstract 6
- 239000007788 liquid Substances 0.000 claims abstract 6
- 102000004169 proteins and genes Human genes 0.000 claims abstract 6
- 108090000623 proteins and genes Proteins 0.000 claims abstract 6
- 150000003839 salts Chemical class 0.000 claims abstract 6
- 206010053567 Coagulopathies Diseases 0.000 claims abstract 2
- 208000015294 blood coagulation disease Diseases 0.000 claims abstract 2
- 208000027866 inflammatory disease Diseases 0.000 claims abstract 2
- 239000004094 surface-active agent Substances 0.000 claims abstract 2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2851—Immunoglobulins [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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2896—Immunoglobulins [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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/38—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against protease inhibitors of peptide structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
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- Immunology (AREA)
- Veterinary Medicine (AREA)
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- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Epidemiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- 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.
Applications Claiming Priority (5)
| 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 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2012139181A true RU2012139181A (ru) | 2014-04-10 |
Family
ID=42275836
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2012139181/15A RU2012139181A (ru) | 2010-02-26 | 2011-02-28 | Стабильная композиция, содержащая антитело |
Country Status (13)
| Country | Link |
|---|---|
| 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) |
Families Citing this family (97)
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|---|---|---|---|---|
| CN1642983A (zh) | 2002-01-25 | 2005-07-20 | G2治疗有限公司 | 抗C5aR抗体及其应用 |
| EP3026063A1 (en) | 2004-12-28 | 2016-06-01 | Innate Pharma S.A. | Monoclonal antibodies against nkg2a |
| CN101970494B (zh) | 2008-02-20 | 2015-01-21 | G2炎症私人有限公司 | 人源化抗-C5aR抗体 |
| JP2011526591A (ja) | 2008-06-30 | 2011-10-13 | ノボ・ノルデイスク・エー/エス | 抗ヒトインターロイキン−20抗体 |
| US8454956B2 (en) | 2009-08-31 | 2013-06-04 | National Cheng Kung University | Methods for treating rheumatoid arthritis and osteoporosis with anti-IL-20 antibodies |
| BR112012021576A2 (pt) | 2010-02-26 | 2016-10-25 | Novo Nordisk As | composições estáveis contendo anticorpo. |
| EA201892184A1 (ru) | 2010-03-01 | 2019-03-29 | БАЙЕР ХЕЛЬСКЕР ЛЛСи | Оптимизированные моноклональные антитела против ингибитора пути тканевого фактора |
| US20130136733A1 (en) | 2010-05-28 | 2013-05-30 | Novo Nordisk A/S | Stable Multi-Dose Compositions Comprising an Antibody and a Preservative |
| JP2013540757A (ja) | 2010-09-24 | 2013-11-07 | ザ ブリガム アンド ウィメンズ ホスピタル インコーポレイテッド | カプセル化された作用物質の放出を制御する能力を有するナノ構造ゲル |
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| WO2013174936A1 (en) * | 2012-05-25 | 2013-11-28 | Novartis Ag | Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition |
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- 2011-02-28 SI SI201131930T patent/SI3409289T1/sl unknown
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- 2011-02-28 MX MX2012009755A patent/MX2012009755A/es not_active Application Discontinuation
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- 2011-02-28 AU AU2011219715A patent/AU2011219715B2/en not_active Withdrawn - After Issue
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- 2011-02-28 RU RU2012139181/15A patent/RU2012139181A/ru unknown
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| US9795674B2 (en) | 2017-10-24 |
| EP3409289B1 (en) | 2020-09-30 |
| JP2013520476A (ja) | 2013-06-06 |
| KR20120130757A (ko) | 2012-12-03 |
| WO2011104381A3 (en) | 2012-10-11 |
| AU2011219715A1 (en) | 2012-08-16 |
| EP3409289A3 (en) | 2019-01-23 |
| EP3708190A1 (en) | 2020-09-16 |
| AU2011219715B2 (en) | 2014-12-11 |
| JP6742290B2 (ja) | 2020-08-19 |
| US10709782B2 (en) | 2020-07-14 |
| EP2538973A2 (en) | 2013-01-02 |
| CN107496917B (zh) | 2021-06-11 |
| US20130028907A1 (en) | 2013-01-31 |
| EP3409289A2 (en) | 2018-12-05 |
| CN107693791A (zh) | 2018-02-16 |
| CA2789061A1 (en) | 2011-09-01 |
| SI3409289T1 (sl) | 2020-12-31 |
| BR112012021576A2 (pt) | 2016-10-25 |
| JP2018100262A (ja) | 2018-06-28 |
| CN103037899A (zh) | 2013-04-10 |
| WO2011104381A2 (en) | 2011-09-01 |
| JP2016047858A (ja) | 2016-04-07 |
| RS61082B1 (sr) | 2020-12-31 |
| MX2012009755A (es) | 2012-09-12 |
| US20180000935A1 (en) | 2018-01-04 |
| EP3216462A3 (en) | 2017-12-20 |
| CN107693791B (zh) | 2022-06-07 |
| CN107496917A (zh) | 2017-12-22 |
| EP3216462A2 (en) | 2017-09-13 |
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