RU2011126338A - Стабильные композиции антител и способы их стабилизации - Google Patents
Стабильные композиции антител и способы их стабилизации Download PDFInfo
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Abstract
1. Способ ингибирования или предупреждения расщепления молекулы, содержащей по меньшей мере фрагмент легкой лямбда-цепи, в композиции, содержащей гистидин, где способ включает стадию ингибирования или предупреждения способности ионов металлов расщеплять молекулу.2. Способ по п.1, в котором ингибирование или предупреждение включает введение по меньшей мере одного хелатообразователя, реагирующего с ионами металла, в композицию.3. Способ по п.1, в котором ингибирование или предупреждение включает проведение с композицией по меньшей мере одной операции, выбранной из группы, состоящей из фильтрования, буферного обмена, хроматографии и хроматографии на ионообменной смоле.4. Способ детектирования расщепления молекулы, содержащей по меньшей мере фрагмент легкой лямбда-цепи в композиции, содержащей гистидин, где способ включает стадии включения по меньшей мере одного хелатообразователя, реагирующего с ионами металла, в композицию и анализа по меньшей мере фрагмента молекулы на расщепление.5. Стабильная композиция, содержащая молекулу, содержащую по меньшей мере фрагмент легкой лямбда-цепи и буферную систему, содержащую гистидин, где указанная композиция, по существу, не содержит ионов металлов.6. Композиция по п.4, в которой ионом металла является Feи Fe.7. Стабильная композиция, содержащая молекулу, содержащую по меньшей мере фрагмент легкой лямбда-цепи, буферную систему, содержащую имидазол, и ион металла, в которой молекула не расщепляется в шарнирной области в присутствии иона металла.8. Стабильная композиция, содержащая молекулу, содержащую по меньшей мере фрагмент легкой лямбда-цепи, буферную систему, содержащую
Claims (25)
1. Способ ингибирования или предупреждения расщепления молекулы, содержащей по меньшей мере фрагмент легкой лямбда-цепи, в композиции, содержащей гистидин, где способ включает стадию ингибирования или предупреждения способности ионов металлов расщеплять молекулу.
2. Способ по п.1, в котором ингибирование или предупреждение включает введение по меньшей мере одного хелатообразователя, реагирующего с ионами металла, в композицию.
3. Способ по п.1, в котором ингибирование или предупреждение включает проведение с композицией по меньшей мере одной операции, выбранной из группы, состоящей из фильтрования, буферного обмена, хроматографии и хроматографии на ионообменной смоле.
4. Способ детектирования расщепления молекулы, содержащей по меньшей мере фрагмент легкой лямбда-цепи в композиции, содержащей гистидин, где способ включает стадии включения по меньшей мере одного хелатообразователя, реагирующего с ионами металла, в композицию и анализа по меньшей мере фрагмента молекулы на расщепление.
5. Стабильная композиция, содержащая молекулу, содержащую по меньшей мере фрагмент легкой лямбда-цепи и буферную систему, содержащую гистидин, где указанная композиция, по существу, не содержит ионов металлов.
6. Композиция по п.4, в которой ионом металла является Fe2+ и Fe3+.
7. Стабильная композиция, содержащая молекулу, содержащую по меньшей мере фрагмент легкой лямбда-цепи, буферную систему, содержащую имидазол, и ион металла, в которой молекула не расщепляется в шарнирной области в присутствии иона металла.
8. Стабильная композиция, содержащая молекулу, содержащую по меньшей мере фрагмент легкой лямбда-цепи, буферную систему, содержащую гистидин, и хелатообразователь, реагирующий с ионами металла, в которой молекула не расщепляется в шарнирной области или расщепляется в шарнирной области на уровне, который ниже уровня расщепления, наблюдаемого в отсутствии хелатообразователя, реагирующего с ионами металла.
9. Стабильная композиция, содержащая терапевтически эффективное количество антитела, содержащего легкую лямбда-цепь в забуференном растворе, содержащем гистидин, с рН примерно от 5 до примерно 7, в которой ион металла находится в концентрации, которая не приводит к расщеплению легкой лямбда-цепи в присутствии гистидина.
10. Композиция по п.9, в которой расщепление происходит в шарнирной области лямбда-цепи.
11. Композиция по п.9, в которой ионом металла является Fe2+ или Fe3+.
12. Водная фармацевтическая композиция, содержащая:
(а) 1-250 мг/мл антитела человека, которое связывается с эпитопом субъединицы р40 IL-12/IL-23;
(b) 1-10% маннита;
(с) 0,001-0,1% полисорбата 80;
(d) 1-50 мМ метионина и
(е) 1-100 мМ гистидина с рН 5-7,
где композиция, по существу, не содержит ионов металла.
13. Композиция по п.12, в которой ион металла находится в концентрации, выбранной из группы, состоящей из концентрации ниже, чем примерно 5060 ppb, ниже, чем примерно 1060 ppb, ниже, чем примерно 560 ppb, ниже, чем примерно 310 ppb, ниже, чем примерно 160 ppb, ниже, чем примерно 110 ppb и ниже, чем примерно 70 ppb.
14. Композиция по п.13, в которой ион металла находится в концентрации ниже, чем примерно 160 ppb.
15. Композиция по п.13, в которой ион металла находится в концентрации ниже, чем примерно 70 ppb.
16. Водная фармацевтическая композиция, содержащая:
(а) примерно 100 мг/мл антитела человека, которое связывается с эпитопом субъединицы р40 IL-12/IL-23;
(b) примерно 4% маннита;
(с) примерно 0,01% полисорбата 80;
(d) примерно 10 мМ метионина и
(е) примерно 10 мМ гистидина с рН примерно 6.
17. Композиция по п.16, в которой антитело человека, или его антигенсвязывающий участок, связывается с эпитопом субъединицы р40 IL-12/IL-23, к которому антитело выбрано из группы, состоящей из антитела Y61 и J695.
18. Композиция по п.17, в которой антитело человека представляет антитело J695 или его антигенсвязывающий участок.
19. Композиция по одному из пп.16-18, которая по существу не содержит ионов металла.
20. Композиция по одному из пп.16-18, дополнительно содержащая хелатообразователь, реагирующий с ионами металла.
21. Композиция по п.16, в которой ион металла находится в концентрации, выбранной из группы, состоящей из концентрации ниже, чем примерно 5060 ppb, ниже, чем примерно 1060 ppb, ниже, чем примерно 560 ppb, ниже, чем примерно 310 ppb, ниже, чем примерно 160 ppb, ниже, чем примерно 110 ppb и ниже, чем примерно 70 ppb.
22. Композиция по п.21, в которой ион металла находится в концентрации ниже, чем примерно 160 ppb.
23. Композиция по п.21, в которой ион металла находится в концентрации ниже, чем примерно 70 ppb.
24. Композиция по одному из пп.16-18, которая имеет срок хранения по меньшей мере 24 месяца.
25. Композиция по одному из пп.16-18, которая сохраняет стабильность по меньшей мере после 5 циклов замораживания/оттаивания композиции.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11852808P | 2008-11-28 | 2008-11-28 | |
| US61/118,528 | 2008-11-28 | ||
| PCT/US2009/065714 WO2010062896A1 (en) | 2008-11-28 | 2009-11-24 | Stable antibody compositions and methods for stabilizing same |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2011126338A true RU2011126338A (ru) | 2013-01-10 |
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| CA2618068C (en) * | 2005-08-05 | 2016-02-16 | Amgen Inc. | Stable aqueous protein or antibody pharmaceutical formulations and their preparation |
| KR20080074120A (ko) * | 2005-10-13 | 2008-08-12 | 휴먼 게놈 사이언시즈, 인코포레이티드 | 자가항체 양성 질환 환자의 치료에 유용한 방법 및 조성물 |
| JP5405122B2 (ja) * | 2005-12-21 | 2014-02-05 | ワイス・エルエルシー | 低粘度のタンパク質製剤およびその用途 |
| JP2009525986A (ja) * | 2006-02-03 | 2009-07-16 | メディミューン,エルエルシー | タンパク質製剤 |
| DE102006030164A1 (de) * | 2006-06-29 | 2008-01-03 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Inhalative Pulver |
| CA2665567C (en) * | 2006-10-06 | 2012-07-03 | Amgen Inc. | Stable formulations |
| US7705132B2 (en) * | 2006-10-20 | 2010-04-27 | Amgen Inc. | Stable polypeptide formulations |
| BRPI0720125A2 (pt) * | 2006-12-06 | 2014-01-28 | Wyeth Corp | Método para armazenar uma formulação líquida; método para a preparação de uma formulação líquida; composição; e método para inibir a agregação induzida por manitol de uma proteína em uma formulação líquida. |
| CA2681752A1 (en) * | 2007-03-29 | 2008-10-09 | Abbott Laboratories | Crystalline anti-human 1l-12 antibodies |
| EP2150537A4 (en) * | 2007-06-01 | 2010-09-22 | Acologix Inc | STABLE PEPTIDE FORMULATION AT HIGH TEMPERATURE |
| KR20100126515A (ko) * | 2008-03-18 | 2010-12-01 | 아보트 러보러터리즈 | 건선의 치료방법 |
| US20120189637A1 (en) * | 2010-10-06 | 2012-07-26 | Valdes Joaquin Mario | Methods for treating psoriasis |
-
2009
- 2009-11-24 MX MX2011005672A patent/MX2011005672A/es not_active Application Discontinuation
- 2009-11-24 CN CN201410540178.5A patent/CN104398471A/zh active Pending
- 2009-11-24 WO PCT/US2009/065714 patent/WO2010062896A1/en not_active Ceased
- 2009-11-24 BR BRPI0921320-1A patent/BRPI0921320A2/pt not_active IP Right Cessation
- 2009-11-24 EP EP09829752A patent/EP2350649A4/en not_active Withdrawn
- 2009-11-24 NZ NZ606283A patent/NZ606283A/en not_active IP Right Cessation
- 2009-11-24 RU RU2011126338/15A patent/RU2011126338A/ru unknown
- 2009-11-24 NZ NZ592644A patent/NZ592644A/xx not_active IP Right Cessation
- 2009-11-24 CN CN200980155528.3A patent/CN102301235B/zh not_active Expired - Fee Related
- 2009-11-24 US US12/625,057 patent/US20100172862A1/en not_active Abandoned
- 2009-11-24 AU AU2009319856A patent/AU2009319856A1/en not_active Abandoned
- 2009-11-24 KR KR1020117014777A patent/KR20110096553A/ko not_active Withdrawn
- 2009-11-24 JP JP2011538673A patent/JP2012510468A/ja active Pending
- 2009-11-24 CA CA2742791A patent/CA2742791A1/en active Pending
- 2009-11-27 TW TW098140719A patent/TW201036627A/zh unknown
- 2009-11-30 AR ARP090104607A patent/AR074427A1/es unknown
- 2009-11-30 UY UY0001032279A patent/UY32279A/es not_active Application Discontinuation
-
2011
- 2011-05-26 IL IL213186A patent/IL213186A0/en unknown
-
2013
- 2013-10-15 IL IL228897A patent/IL228897A0/en unknown
-
2014
- 2014-11-06 US US14/534,776 patent/US20150071944A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| IL213186A0 (en) | 2011-07-31 |
| US20100172862A1 (en) | 2010-07-08 |
| BRPI0921320A2 (pt) | 2018-05-22 |
| US20150071944A1 (en) | 2015-03-12 |
| CN102301235A (zh) | 2011-12-28 |
| WO2010062896A1 (en) | 2010-06-03 |
| KR20110096553A (ko) | 2011-08-30 |
| CN102301235B (zh) | 2014-11-19 |
| EP2350649A4 (en) | 2012-11-14 |
| JP2012510468A (ja) | 2012-05-10 |
| NZ592644A (en) | 2013-09-27 |
| EP2350649A1 (en) | 2011-08-03 |
| IL228897A0 (en) | 2013-12-31 |
| MX2011005672A (es) | 2011-06-20 |
| UY32279A (es) | 2010-06-30 |
| CN104398471A (zh) | 2015-03-11 |
| AR074427A1 (es) | 2011-01-19 |
| CA2742791A1 (en) | 2010-06-03 |
| AU2009319856A1 (en) | 2010-06-03 |
| TW201036627A (en) | 2010-10-16 |
| NZ606283A (en) | 2014-08-29 |
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