RU2011104955A - Композиции антител - Google Patents
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- RU2011104955A RU2011104955A RU2011104955/15A RU2011104955A RU2011104955A RU 2011104955 A RU2011104955 A RU 2011104955A RU 2011104955/15 A RU2011104955/15 A RU 2011104955/15A RU 2011104955 A RU2011104955 A RU 2011104955A RU 2011104955 A RU2011104955 A RU 2011104955A
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- 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
- A61K39/39541—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against normal tissues, cells
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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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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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
- A61K47/06—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
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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
- A61K47/26—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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2878—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 NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
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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
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
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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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- 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
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
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Abstract
1. Стабильная фармацевтическая композиция, содержащая моноклональное антитело в гистидин-ацетатном буфере, pH от 5,5 до 6,5. ! 2. Композиция по п.1, в которой значение pH составляет от 5,8 до 6,2. ! 3. Композиция по п.1, в которой концентрация гистидин-ацетатного буфера составляет от приблизительно 1 мМ до приблизительно 200 мМ, включая от приблизительно 10 мМ до приблизительно 40 мМ. ! 4. Композиция по п.1, в которой концентрация антитела составляет от приблизительно 10 мг/мл до приблизительно 250 мг/мл, включая от приблизительно 20 мг/мл до приблизительно 40 мг/мл и включая от приблизительно 80 мг/мл до приблизительно 250 мг/мл. ! 5. Композиция по п.1, дополнительно содержащая сахарид, включая трегалозу или сахарозу. ! 6. Композиция по п.5, в которой концентрация сахарида составляет от приблизительно 10 мМ до приблизительно 1M, включая от приблизительно 60 мМ до приблизительно 250 мМ. ! 7. Композиция по п.1, дополнительно содержащая поверхностно-активное вещество, включая полисорбат и включая полисорбат-20. ! 8. Композиция по п.7, в которой концентрация поверхностно-активного вещества составляет от приблизительно 0,0001% до приблизительно 1,0%, включая от приблизительно 0,01% до приблизительно 0,1%. ! 9. Композиция по п.1, в которой моноклональное антитело представляет собой полноразмерное антитело, антитело IgG1, гуманизированное антитело, фрагмент антитела, содержащий антигенсвязывающий участок, Fab-фрагмент и/или F(ab')2-фрагмент. ! 10. Композиция по п.1, которая является стерильной. ! 11. Композиция по п.1, в которой моноклональное антитело связывает антиген, выбранный из группы, состоящей из HER2, CD20, DR5, BR3, IgE и VEGF. ! 12. Композиция по п.11, в которой антиген представляет собо�
Claims (25)
1. Стабильная фармацевтическая композиция, содержащая моноклональное антитело в гистидин-ацетатном буфере, pH от 5,5 до 6,5.
2. Композиция по п.1, в которой значение pH составляет от 5,8 до 6,2.
3. Композиция по п.1, в которой концентрация гистидин-ацетатного буфера составляет от приблизительно 1 мМ до приблизительно 200 мМ, включая от приблизительно 10 мМ до приблизительно 40 мМ.
4. Композиция по п.1, в которой концентрация антитела составляет от приблизительно 10 мг/мл до приблизительно 250 мг/мл, включая от приблизительно 20 мг/мл до приблизительно 40 мг/мл и включая от приблизительно 80 мг/мл до приблизительно 250 мг/мл.
5. Композиция по п.1, дополнительно содержащая сахарид, включая трегалозу или сахарозу.
6. Композиция по п.5, в которой концентрация сахарида составляет от приблизительно 10 мМ до приблизительно 1M, включая от приблизительно 60 мМ до приблизительно 250 мМ.
7. Композиция по п.1, дополнительно содержащая поверхностно-активное вещество, включая полисорбат и включая полисорбат-20.
8. Композиция по п.7, в которой концентрация поверхностно-активного вещества составляет от приблизительно 0,0001% до приблизительно 1,0%, включая от приблизительно 0,01% до приблизительно 0,1%.
9. Композиция по п.1, в которой моноклональное антитело представляет собой полноразмерное антитело, антитело IgG1, гуманизированное антитело, фрагмент антитела, содержащий антигенсвязывающий участок, Fab-фрагмент и/или F(ab')2-фрагмент.
10. Композиция по п.1, которая является стерильной.
11. Композиция по п.1, в которой моноклональное антитело связывает антиген, выбранный из группы, состоящей из HER2, CD20, DR5, BR3, IgE и VEGF.
12. Композиция по п.11, в которой антиген представляет собой CD20, и моноклональное антитело представляет собой гуманизированное 2H7, или антиген представляет собой VEGF, и моноклональное антитело представляет собой бевацизумаб.
13. Композиция по п.1, в которой моноклональное антитело подвержено дезамидированию или агрегации.
14. Композиция по п.1, которая является стабильной при хранении при приблизительно 40°C в течение, по меньшей мере, 4 недель, стабильной при хранении приблизительно при 5°C или приблизительно при 15°C в течение, по меньшей мере, 3 месяцев, стабильной при хранении приблизительно при -20°C в течение, по меньшей мере, 3 месяцев и/или стабильной при замораживании и размораживании.
15. Композиция по п.1, которая является водной, замороженной, нелиофилизированной и которую ранее не подвергали лиофилизации, или водной и которую вводят субъекту.
16. Композиция по п.1, которая предназначена для внутривенного (в/в), подкожного (п/к) или внутримышечного (в/м) введения.
17. Композиция по п.16, которая предназначена для в/в введения, и в которой концентрация антитела составляет от приблизительно 20 мг/мл до приблизительно 40 мг/мл, или которая предназначена для п/к введения, и в которой концентрация антитела составляет от приблизительно 80 мг/мл до приблизительно 250 мг/мл.
18. Флакон с пробкой, поддающейся прокалыванию шприцем, содержащий внутри флакона композицию по п.1.
19. Флакон по п.18, который хранят приблизительно при 2-8°C и/или который представляет собой флакон объемом 20 см3 или 50 см3.
20. Емкость из нержавеющей стали, содержащая внутри емкости композицию по п.1, включая случай, когда указанная композиция является замороженной.
21. Способ лечения у субъекта заболевания или нарушения, включающий введение композиции по п.1 субъекту в количестве, эффективном для лечения заболевания или нарушения.
22. Фармацевтическая композиция, содержащая:
(a) полноразмерное антитело IgG1, подверженное дезамидированию или агрегации, в количестве от приблизительно 10 мг/мл до приблизительно 250 мг/мл;
(b) гистидин-ацетатный буфер, pH от 5,5 до 6,5;
(c) сахарид, выбранный из группы, состоящей из трегалозы и сахарозы, в количестве от приблизительно 60 мМ до приблизительно 250 мМ; и
(d) полисорбат-20 в количестве от приблизительно 0,01% до приблизительно 0,1%.
23. Способ снижения дезамидирования или агрегации терапевтического моноклонального антитела, включающий в себя получение композиции антитела в гистидин-ацетатном буфере, pH от 5,5 до 6,5, необязательно включающий оценку любого дезамидирования или агрегации антитела до и после получения композиции антитела.
24. Фармацевтическая композиция, содержащая антитело, которое связывается с доменом II HER2 в гистидиновом буфере при значениях pH от приблизительно 5,5 до приблизительно 6,5, сахарид, и поверхностно-активное вещество.
25. Композиция по п.24, в которой антитело включает пертузумаб.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US62041304P | 2004-10-20 | 2004-10-20 | |
| US60/620,413 | 2004-10-20 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2007118648/15A Division RU2426554C2 (ru) | 2004-10-20 | 2005-10-19 | Композиции антител |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2011104955A true RU2011104955A (ru) | 2012-08-20 |
Family
ID=36203665
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2007118648/15A RU2426554C2 (ru) | 2004-10-20 | 2005-10-19 | Композиции антител |
| RU2011104955/15A RU2011104955A (ru) | 2004-10-20 | 2011-02-10 | Композиции антител |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2007118648/15A RU2426554C2 (ru) | 2004-10-20 | 2005-10-19 | Композиции антител |
Country Status (35)
| Country | Link |
|---|---|
| US (7) | US20060088523A1 (ru) |
| EP (3) | EP2371388A3 (ru) |
| JP (4) | JP5025482B2 (ru) |
| KR (1) | KR101243590B1 (ru) |
| CN (2) | CN102319430A (ru) |
| AU (1) | AU2005295394B2 (ru) |
| BR (1) | BRPI0516299B8 (ru) |
| CA (1) | CA2579861C (ru) |
| CR (1) | CR9129A (ru) |
| DK (1) | DK1802344T3 (ru) |
| EC (1) | ECSP077308A (ru) |
| ES (1) | ES2389911T3 (ru) |
| GT (1) | GT200500298A (ru) |
| HK (2) | HK1104483A1 (ru) |
| HR (1) | HRP20120893T1 (ru) |
| IL (3) | IL181738A (ru) |
| JO (1) | JO3000B1 (ru) |
| MA (1) | MA29014B1 (ru) |
| MY (1) | MY146100A (ru) |
| NO (1) | NO343683B1 (ru) |
| NZ (1) | NZ553625A (ru) |
| PA (1) | PA8650001A1 (ru) |
| PE (2) | PE20061043A1 (ru) |
| PL (1) | PL1802344T3 (ru) |
| PT (1) | PT1802344E (ru) |
| RS (1) | RS52512B (ru) |
| RU (2) | RU2426554C2 (ru) |
| SG (1) | SG196859A1 (ru) |
| SI (1) | SI1802344T1 (ru) |
| SV (1) | SV2006002275A (ru) |
| TN (1) | TNSN07088A1 (ru) |
| TW (1) | TWI394582B (ru) |
| UA (1) | UA89798C2 (ru) |
| WO (1) | WO2006044908A2 (ru) |
| ZA (1) | ZA200702521B (ru) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2737727C2 (ru) * | 2013-04-16 | 2020-12-02 | Дженентек, Инк. | Варианты пертузумаба и их аналитическая характеристика |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ZA9811162B (en) | 1997-12-12 | 2000-06-07 | Genentech Inc | Treatment with anti-ERBB2 antibodies. |
| US20040013667A1 (en) * | 1999-06-25 | 2004-01-22 | Genentech, Inc. | Treatment with anti-ErbB2 antibodies |
| US6949245B1 (en) * | 1999-06-25 | 2005-09-27 | Genentech, Inc. | Humanized anti-ErbB2 antibodies and treatment with anti-ErbB2 antibodies |
| US20030086924A1 (en) * | 1999-06-25 | 2003-05-08 | Genentech, Inc. | Treatment with anti-ErbB2 antibodies |
| US20030228309A1 (en) * | 2000-11-08 | 2003-12-11 | Theodora Salcedo | Antibodies that immunospecifically bind to TRAIL receptors |
| US20060062786A1 (en) * | 2000-11-08 | 2006-03-23 | Human Genome Sciences, Inc. | Antibodies that immunospecifically bind to TRAIL receptors |
| US20100056762A1 (en) | 2001-05-11 | 2010-03-04 | Old Lloyd J | Specific binding proteins and uses thereof |
| EP2335728A1 (en) | 2001-05-11 | 2011-06-22 | Ludwig Institute for Cancer Research Ltd. | Specific binding proteins and uses thereof |
| US20050129616A1 (en) * | 2001-05-25 | 2005-06-16 | Human Genome Sciences, Inc. | Antibodies that immunospecifically bind to TRAIL receptors |
| US7361341B2 (en) * | 2001-05-25 | 2008-04-22 | Human Genome Sciences, Inc. | Methods of treating cancer using antibodies that immunospecifically bind to trail receptors |
| US7348003B2 (en) | 2001-05-25 | 2008-03-25 | Human Genome Sciences, Inc. | Methods of treating cancer using antibodies that immunospecifically bind to TRAIL receptors |
| US20050214209A1 (en) * | 2001-05-25 | 2005-09-29 | Human Genome Sciences, Inc. | Antibodies that immunospecifically bind to TRAIL receptors |
| US20030180296A1 (en) * | 2001-12-20 | 2003-09-25 | Theodora Salcedo | Antibodies that immunospecifically bind to trail receptors |
| BR0316737A (pt) * | 2002-11-27 | 2005-12-13 | Irm Llc | Métodos e composições para induzir apoptose em células cancerosas |
| HUE025347T2 (en) | 2003-03-19 | 2016-02-29 | Biogen Ma Inc | NOGO receptor binding protein |
| JP2007530588A (ja) | 2004-03-23 | 2007-11-01 | バイオジェン・アイデック・エムエイ・インコーポレイテッド | レセプターカップリング剤およびその治療用途 |
| SV2006002143A (es) * | 2004-06-16 | 2006-01-26 | Genentech Inc | Uso de un anticuerpo para el tratamiento del cancer resistente al platino |
| ES2395094T3 (es) | 2004-06-24 | 2013-02-08 | Biogen Idec Ma Inc. | Tratamiento de afecciones que implican la desmielinización |
| ES2521140T3 (es) | 2004-07-22 | 2014-11-12 | Genentech, Inc. | Composición de anticuerpos de HER2 |
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2020
- 2020-02-07 US US16/784,467 patent/US20200179515A1/en not_active Abandoned
-
2022
- 2022-06-21 US US17/808,029 patent/US20230263895A1/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2737727C2 (ru) * | 2013-04-16 | 2020-12-02 | Дженентек, Инк. | Варианты пертузумаба и их аналитическая характеристика |
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| Date | Code | Title | Description |
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| FA92 | Acknowledgement of application withdrawn (lack of supplementary materials submitted) |
Effective date: 20160801 |