JP2015517506A5 - - Google Patents
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- Publication number
- JP2015517506A5 JP2015517506A5 JP2015511961A JP2015511961A JP2015517506A5 JP 2015517506 A5 JP2015517506 A5 JP 2015517506A5 JP 2015511961 A JP2015511961 A JP 2015511961A JP 2015511961 A JP2015511961 A JP 2015511961A JP 2015517506 A5 JP2015517506 A5 JP 2015517506A5
- Authority
- JP
- Japan
- Prior art keywords
- protein
- antibody
- concentration
- solution
- ultrafiltration
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 102000004169 proteins and genes Human genes 0.000 claims 12
- 108090000623 proteins and genes Proteins 0.000 claims 12
- 238000000108 ultra-filtration Methods 0.000 claims 7
- 102000004965 antibodies Human genes 0.000 claims 6
- 108090001123 antibodies Proteins 0.000 claims 6
- 239000000243 solution Substances 0.000 claims 4
- CZMRCDWAGMRECN-UGDNZRGBSA-N D-sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 3
- CZMRCDWAGMRECN-GDQSFJPYSA-N Sucrose Natural products O([C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](CO)O1)[C@@]1(CO)[C@H](O)[C@@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-GDQSFJPYSA-N 0.000 claims 3
- 239000012460 protein solution Substances 0.000 claims 3
- 239000012465 retentate Substances 0.000 claims 3
- 239000005720 sucrose Substances 0.000 claims 3
- 102000005614 monoclonal antibodies Human genes 0.000 claims 2
- 108010045030 monoclonal antibodies Proteins 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 238000011084 recovery Methods 0.000 claims 2
- 200000000018 inflammatory disease Diseases 0.000 claims 1
Claims (13)
- 高濃度タンパク質溶液を限外濾過する方法であって、前記溶液のタンパク質濃度が40から60g/Lの間であるときにスクロースを前記溶液に添加した後で、限外濾過によりさらに濃縮する、方法。
- 高濃度限外濾過保持液中の計算タンパク質濃度と測定タンパク質濃度との間の差を減少させる、請求項1に記載の方法。
- 高濃度限外濾過保持液中の計算タンパク質濃度と測定タンパク質濃度との間の差が30%未満である、請求項1または2に記載の方法。
- スクロースの添加が、限外濾過される高濃度溶液を安定化する、請求項1に記載の方法。
- 高濃度限外濾過保持液中のHMWP凝集物のレベルが1%または1%未満である、請求項1または4に記載の方法。
- 限外濾過中のタンパク質の回収率を増大させる、請求項1に記載の方法。
- 限外濾過中のタンパク質の回収率が、限外濾過される高濃度タンパク質溶液中のタンパク質の全量の94%以上である、請求項1または6に記載の方法。
- 前記スクロースを高濃度タンパク質溶液に50mMから300mMの間の濃度で添加する、請求項1から7のいずれか一項に記載の方法。
- 前記タンパク質が抗体である、請求項1から8のいずれか一項に記載の方法。
- 前記抗体がモノクローナル抗体である、請求項1から9のいずれか一項に記載の方法。
- 前記抗体が抗IL-20モノクローナル抗体である、請求項1から10のいずれか一項に記載の方法。
- 医薬組成物に使用するための、請求項1から11までのいずれか一項に記載のタンパク質または抗体溶液中のタンパク質または抗体を濃縮する方法。
- 請求項1から12のいずれか一項に記載の方法によって取得可能なタンパク質または抗体を含む、炎症性疾患を治療するための医薬組成物。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP12167958 | 2012-05-14 | ||
EP12167958.3 | 2012-05-14 | ||
US201261651598P | 2012-05-25 | 2012-05-25 | |
US61/651,598 | 2012-05-25 | ||
PCT/EP2013/055390 WO2013170977A1 (en) | 2012-05-14 | 2013-03-15 | Stabilised protein solutions |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2015517506A JP2015517506A (ja) | 2015-06-22 |
JP2015517506A5 true JP2015517506A5 (ja) | 2016-05-12 |
JP6681711B2 JP6681711B2 (ja) | 2020-04-15 |
Family
ID=49583182
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2015511961A Active JP6681711B2 (ja) | 2012-05-14 | 2013-03-15 | 安定化されたタンパク質溶液 |
Country Status (10)
Country | Link |
---|---|
US (2) | US11466051B2 (ja) |
EP (2) | EP3184542A1 (ja) |
JP (1) | JP6681711B2 (ja) |
CN (1) | CN104271600B (ja) |
AU (1) | AU2013262083A1 (ja) |
BR (1) | BR112014028129A2 (ja) |
CA (1) | CA2873647A1 (ja) |
ES (1) | ES2622558T3 (ja) |
MX (1) | MX2014013508A (ja) |
WO (1) | WO2013170977A1 (ja) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP3274359B1 (en) | 2015-03-23 | 2022-11-02 | Alexion Pharmaceuticals, Inc. | Virus filtration |
CN111018968B (zh) * | 2019-12-16 | 2021-07-27 | 兴盟生物医药(苏州)有限公司 | 一种通过超滤浓缩制备高浓度抗体制剂的方法 |
Family Cites Families (20)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
DE3619565A1 (de) | 1986-06-11 | 1987-12-17 | Behringwerke Ag | Verfahren zur herstellung einer pasteurisierten immunglobulinpraeparation |
US5248767A (en) * | 1986-06-11 | 1993-09-28 | Behringwerke Aktiengesellschaft | Process for the preparation of a pasteurized immunoglobulin preparation using ethanol |
US5656730A (en) | 1995-04-07 | 1997-08-12 | Enzon, Inc. | Stabilized monomeric protein compositions |
CN1151174C (zh) | 1998-12-21 | 2004-05-26 | 蒋盘宏 | 抗人淋巴细胞球蛋白制备方法 |
PT1314437E (pt) | 2000-08-11 | 2014-08-29 | Chugai Pharmaceutical Co Ltd | Preparações estabilizadas contendo anticorpo |
GB0113179D0 (en) * | 2001-05-31 | 2001-07-25 | Novartis Ag | Organic compounds |
ES2353496T3 (es) | 2002-02-14 | 2011-03-02 | Chugai Seiyaku Kabushiki Kaisha | Productos farmacéuticos en solución que contienen anticuerpos. |
US20060182740A1 (en) | 2002-06-21 | 2006-08-17 | Biogen Idec, Inc. | Buffered formulations for concentrating antibodies and methods of use thereof |
DK1610820T4 (da) * | 2003-04-04 | 2013-11-04 | Genentech Inc | Høj-koncentration antistof- og proteinformuleringer |
DE102004052729A1 (de) | 2004-10-30 | 2006-05-04 | Roche Diagnostics Gmbh | Immunkomplex-spezifsicher Antikörper zur Reduktion des Nullwerts beim Nachweis von Antigen-spezifisch gebundenen Antikörpern einer bestimmten Immunglobulinklasse in Array-Testformaten |
US7645860B2 (en) * | 2006-03-31 | 2010-01-12 | Baxter Healthcare S.A. | Factor VIII polymer conjugates |
US20080200656A1 (en) | 2007-02-16 | 2008-08-21 | Wyeth | Use Of Sucrose To Suppress Mannitol-Induced Protein Aggregation |
WO2009090189A1 (en) * | 2008-01-15 | 2009-07-23 | Abbott Gmbh & Co.Kg | Powdered protein compositions and methods of making same |
KR20110039218A (ko) | 2008-06-30 | 2011-04-15 | 노보 노르디스크 에이/에스 | 항-인간 인터루킨-20 항체 |
WO2010141039A1 (en) | 2008-10-20 | 2010-12-09 | Abbott Laboratories | Isolation and purification of antibodies using protein a affinity chromatography |
RU2011120178A (ru) * | 2008-10-20 | 2012-11-27 | Эбботт Лэборетриз | Антитела, которые связываются с il-12, и способы их очистки |
KR20110079693A (ko) | 2008-10-29 | 2011-07-07 | 와이어쓰 엘엘씨 | 단일 도메인 항원 결합 분자의 정제 방법 |
EA031209B9 (ru) | 2010-01-15 | 2021-11-19 | Кирин-Эмджен, Инк. | Фармацевтический состав антитела для лечения воспалительного заболевания и способы его применения |
EP3409289B1 (en) | 2010-02-26 | 2020-09-30 | Novo Nordisk A/S | Stable antibody containing compositions |
-
2013
- 2013-03-15 ES ES13712722.1T patent/ES2622558T3/es active Active
- 2013-03-15 EP EP17150977.1A patent/EP3184542A1/en not_active Withdrawn
- 2013-03-15 WO PCT/EP2013/055390 patent/WO2013170977A1/en active Application Filing
- 2013-03-15 JP JP2015511961A patent/JP6681711B2/ja active Active
- 2013-03-15 CN CN201380024981.7A patent/CN104271600B/zh active Active
- 2013-03-15 CA CA2873647A patent/CA2873647A1/en not_active Withdrawn
- 2013-03-15 BR BR112014028129A patent/BR112014028129A2/pt not_active IP Right Cessation
- 2013-03-15 EP EP13712722.1A patent/EP2850099B1/en active Active
- 2013-03-15 MX MX2014013508A patent/MX2014013508A/es unknown
- 2013-03-15 AU AU2013262083A patent/AU2013262083A1/en not_active Withdrawn
- 2013-03-15 US US14/396,389 patent/US11466051B2/en active Active
-
2022
- 2022-09-06 US US17/903,252 patent/US20230002443A1/en active Pending
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