RU2013137740A - Жидкая композиция, содержащая антитело высокой концентрации - Google Patents
Жидкая композиция, содержащая антитело высокой концентрации Download PDFInfo
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- RU2013137740A RU2013137740A RU2013137740/15A RU2013137740A RU2013137740A RU 2013137740 A RU2013137740 A RU 2013137740A RU 2013137740/15 A RU2013137740/15 A RU 2013137740/15A RU 2013137740 A RU2013137740 A RU 2013137740A RU 2013137740 A RU2013137740 A RU 2013137740A
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- 239000007788 liquid Substances 0.000 title claims abstract 9
- 239000004475 Arginine Substances 0.000 claims abstract 8
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims abstract 8
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims abstract 5
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims abstract 5
- 229930182817 methionine Natural products 0.000 claims abstract 5
- 102000010781 Interleukin-6 Receptors Human genes 0.000 claims abstract 3
- 108010038501 Interleukin-6 Receptors Proteins 0.000 claims abstract 3
- 230000006240 deamidation Effects 0.000 claims abstract 3
- 238000006471 dimerization reaction Methods 0.000 claims abstract 3
- QIVBCDIJIAJPQS-VIFPVBQESA-N L-tryptophane Chemical compound C1=CC=C2C(C[C@H](N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-VIFPVBQESA-N 0.000 claims abstract 2
- QIVBCDIJIAJPQS-UHFFFAOYSA-N Tryptophan Natural products C1=CC=C2C(CC(N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-UHFFFAOYSA-N 0.000 claims abstract 2
- 239000006172 buffering agent Substances 0.000 claims abstract 2
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims abstract 2
- 238000007920 subcutaneous administration Methods 0.000 claims abstract 2
- 239000004094 surface-active agent Substances 0.000 claims abstract 2
- 230000002401 inhibitory effect Effects 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 102000005962 receptors Human genes 0.000 abstract 1
- 108020003175 receptors Proteins 0.000 abstract 1
Classifications
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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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
-
- 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
-
- 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
-
- 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
-
- 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
-
- 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
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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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)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Endocrinology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Analytical Chemistry (AREA)
- Dermatology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Abstract
1. Стабильная антителосодержащая жидкая композиция, характеризующаяся тем, что она содержит аргинин и метионин.2. Композиция по п. 1, дополнительно содержащая гистидиновый буферный агент.3. Композиция по п. 2, дополнительно содержащая поверхностно-активное вещество.4. Композиция по любому из пп. 1-3, содержащая антитело в количестве, по меньшей мере, 50 мг/мл.5. Композиция по любому из пп. 1-3, содержащая антитело в количестве, по меньшей мере, 100 мг/мл.6. Композиция по любому из пп. 1-3, содержащая антитело в количестве, по меньшей мере, 120 мг/мл.7. Композиция по любому из пп. 1-3, где антитело является антителом к рецептору IL-6.8. Стабильная жидкая композиция, содержащая антитело к рецептору IL-6, отличающаяся тем, что она содержит либо аргинин, либо метионин.9. Композиция по любому из пп. 1, 2, 3 и 8, где антитело является гуманизированным антителом или антителом человека.10. Композиция по любому из пп. 1, 2, 3 и 8, дополнительно содержащая триптофан.11. Композиция по любому из пп. 1, 2, 3 и 8, имеющая рН в диапазоне от 4 до 8.12. Композиция по любому из пп. 1, 2, 3 и 8, где аргинин присутствует в количестве от 50 до 1500 мМ.13. Композиция по любому из пп. 1, 2, 3 и 8, имеющаявязкость от 2 до 15 мПа·с.14. Композиция по любому из пп. 1, 2, 3 и 8, которая стабильна при 22-28°C в течение, по меньшей мере, 6 месяцев.15. Композиция по любому из пп. 1, 2, 3 и 8, отличающаяся тем, что димеризация молекул антител ингибируется.16. Композиция по любому из пп. 1, 2, 3 и 8, отличающаяся тем, что деамидирование молекул антител ингибируется.17. Композиция по любому из пп. 1, 2, 3 и 8, которая предназначена для подкожного введения.18. Композиция по любому из пп. 1, 2, 3 и 8, которая не подвергалась лиофилизации во время приготов
Claims (20)
1. Стабильная антителосодержащая жидкая композиция, характеризующаяся тем, что она содержит аргинин и метионин.
2. Композиция по п. 1, дополнительно содержащая гистидиновый буферный агент.
3. Композиция по п. 2, дополнительно содержащая поверхностно-активное вещество.
4. Композиция по любому из пп. 1-3, содержащая антитело в количестве, по меньшей мере, 50 мг/мл.
5. Композиция по любому из пп. 1-3, содержащая антитело в количестве, по меньшей мере, 100 мг/мл.
6. Композиция по любому из пп. 1-3, содержащая антитело в количестве, по меньшей мере, 120 мг/мл.
7. Композиция по любому из пп. 1-3, где антитело является антителом к рецептору IL-6.
8. Стабильная жидкая композиция, содержащая антитело к рецептору IL-6, отличающаяся тем, что она содержит либо аргинин, либо метионин.
9. Композиция по любому из пп. 1, 2, 3 и 8, где антитело является гуманизированным антителом или антителом человека.
10. Композиция по любому из пп. 1, 2, 3 и 8, дополнительно содержащая триптофан.
11. Композиция по любому из пп. 1, 2, 3 и 8, имеющая рН в диапазоне от 4 до 8.
12. Композиция по любому из пп. 1, 2, 3 и 8, где аргинин присутствует в количестве от 50 до 1500 мМ.
13. Композиция по любому из пп. 1, 2, 3 и 8, имеющая
вязкость от 2 до 15 мПа·с.
14. Композиция по любому из пп. 1, 2, 3 и 8, которая стабильна при 22-28°C в течение, по меньшей мере, 6 месяцев.
15. Композиция по любому из пп. 1, 2, 3 и 8, отличающаяся тем, что димеризация молекул антител ингибируется.
16. Композиция по любому из пп. 1, 2, 3 и 8, отличающаяся тем, что деамидирование молекул антител ингибируется.
17. Композиция по любому из пп. 1, 2, 3 и 8, которая предназначена для подкожного введения.
18. Композиция по любому из пп. 1, 2, 3 и 8, которая не подвергалась лиофилизации во время приготовления этой композиции.
19. Способ ингибирования деамидирования молекул антитела в жидкой композиции, содержащей антитело, предусматривающий добавление аргинина к этой жидкой композиции.
20. Способ ингибирования димеризации молекул антитела в жидкой композиции, содержащей антитело, предусматривающий добавление аргинина и метионина к этой жидкой композиции.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2007-336310 | 2007-12-27 | ||
| JP2007336310 | 2007-12-27 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2010131179/15A Division RU2497544C2 (ru) | 2007-12-27 | 2008-12-26 | Жидкая композиция, содержащая антитело высокой концентрации |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2019128863A Division RU2795116C2 (ru) | 2007-12-27 | 2019-09-13 | Жидкая композиция, содержащая антитело высокой концентрации |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2013137740A true RU2013137740A (ru) | 2015-02-20 |
| RU2701181C2 RU2701181C2 (ru) | 2019-09-25 |
Family
ID=40824372
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2010131179/15A RU2497544C2 (ru) | 2007-12-27 | 2008-12-26 | Жидкая композиция, содержащая антитело высокой концентрации |
| RU2013137740A RU2701181C2 (ru) | 2007-12-27 | 2013-08-12 | Жидкая композиция, содержащая антитело высокой концентрации |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2010131179/15A RU2497544C2 (ru) | 2007-12-27 | 2008-12-26 | Жидкая композиция, содержащая антитело высокой концентрации |
Country Status (31)
| Country | Link |
|---|---|
| US (12) | US8568720B2 (ru) |
| EP (1) | EP2238985B2 (ru) |
| JP (9) | JP4937358B2 (ru) |
| KR (1) | KR101083616B1 (ru) |
| CN (2) | CN101883588B (ru) |
| AR (3) | AR069969A1 (ru) |
| AU (1) | AU2008344292B2 (ru) |
| BR (1) | BRPI0818903B8 (ru) |
| CA (1) | CA2708627C (ru) |
| CL (1) | CL2008003910A1 (ru) |
| CO (1) | CO6450630A2 (ru) |
| CR (1) | CR11594A (ru) |
| CY (1) | CY1113616T1 (ru) |
| DK (1) | DK2238985T4 (ru) |
| EC (1) | ECSP10010370A (ru) |
| ES (1) | ES2389881T5 (ru) |
| HR (1) | HRP20120903T4 (ru) |
| IL (2) | IL206548A (ru) |
| MA (1) | MA31934B1 (ru) |
| MX (1) | MX2010004399A (ru) |
| MY (1) | MY159450A (ru) |
| NZ (1) | NZ586378A (ru) |
| PE (1) | PE20091174A1 (ru) |
| PL (1) | PL2238985T5 (ru) |
| PT (1) | PT2238985E (ru) |
| RU (2) | RU2497544C2 (ru) |
| SG (1) | SG2013049325A (ru) |
| SI (1) | SI2238985T2 (ru) |
| TW (1) | TWI375566B (ru) |
| UA (1) | UA104134C2 (ru) |
| WO (1) | WO2009084659A1 (ru) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| ES2382488T3 (es) | 1997-03-21 | 2012-06-08 | Chugai Seiyaku Kabushiki Kaisha | Un agente preventivo o terapéutico para enfermedades mediadas por células t sensibilizadas que comprende un antagonista de il-6 como ingrediente activo |
| UA80091C2 (en) | 2001-04-02 | 2007-08-27 | Chugai Pharmaceutical Co Ltd | Remedies for infant chronic arthritis-relating diseases and still's disease which contain an interleukin-6 (il-6) antagonist |
| KR101080021B1 (ko) | 2002-02-14 | 2011-11-04 | 추가이 세이야쿠 가부시키가이샤 | 항체함유 용액제제 |
| GB2401040A (en) * | 2003-04-28 | 2004-11-03 | Chugai Pharmaceutical Co Ltd | Method for treating interleukin-6 related diseases |
| US8398980B2 (en) * | 2004-03-24 | 2013-03-19 | Chugai Seiyaku Kabushiki Kaisha | Subtypes of humanized antibody against interleuken-6 receptor |
| JO3000B1 (ar) | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| TWI671403B (zh) | 2005-03-31 | 2019-09-11 | 中外製藥股份有限公司 | 控制組裝之多肽的製造方法 |
| EP1977763A4 (en) * | 2005-12-28 | 2010-06-02 | Chugai Pharmaceutical Co Ltd | ANTIBODY-CONTAINING STABILIZING PREPARATION |
| DK2009101T3 (en) | 2006-03-31 | 2018-01-15 | Chugai Pharmaceutical Co Ltd | Antibody modification method for purification of a bispecific antibody |
| DK3056568T3 (da) | 2006-03-31 | 2021-11-01 | Chugai Pharmaceutical Co Ltd | Fremgangsmåder til kontrollering af antistoffers blodfarmakokinetik |
| EP3689912A1 (en) | 2007-09-26 | 2020-08-05 | Chugai Seiyaku Kabushiki Kaisha | Method of modifying isoelectric point of antibody via amino acid substitution in cdr |
| PE20091174A1 (es) * | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| JO3672B1 (ar) | 2008-12-15 | 2020-08-27 | Regeneron Pharma | أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9). |
| US9345661B2 (en) | 2009-07-31 | 2016-05-24 | Genentech, Inc. | Subcutaneous anti-HER2 antibody formulations and uses thereof |
| AR078161A1 (es) | 2009-09-11 | 2011-10-19 | Hoffmann La Roche | Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento. |
| EP2493922B1 (en) | 2009-10-26 | 2017-02-15 | F. Hoffmann-La Roche AG | Method for the production of a glycosylated immunoglobulin |
| KR101989628B1 (ko) * | 2009-12-21 | 2019-06-14 | 제넨테크, 인크. | 항체 제제 |
| AU2013202276B2 (en) * | 2009-12-21 | 2016-03-24 | Genentech, Inc. | Antibody formulation |
| JO3417B1 (ar) | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
| EP3354280B1 (en) * | 2010-10-06 | 2020-07-29 | Regeneron Pharmaceuticals, Inc. | Stabilized formulations containing anti-interleukin-4 receptor (il-4r) antibodies |
| KR20220070586A (ko) | 2010-11-08 | 2022-05-31 | 제넨테크, 인크. | 피하 투여용 항―ｉｌ―6 수용체 항체 |
| CA2817964C (en) | 2010-11-17 | 2018-06-12 | Chugai Seiyaku Kabushiki Kaisha | Multi-specific antigen-binding molecule having alternative function to function of blood coagulation factor viii |
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