JP2013511566A5 - - Google Patents
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- Publication number
- JP2013511566A5 JP2013511566A5 JP2012540414A JP2012540414A JP2013511566A5 JP 2013511566 A5 JP2013511566 A5 JP 2013511566A5 JP 2012540414 A JP2012540414 A JP 2012540414A JP 2012540414 A JP2012540414 A JP 2012540414A JP 2013511566 A5 JP2013511566 A5 JP 2013511566A5
- Authority
- JP
- Japan
- Prior art keywords
- protein
- factor
- pegylated protein
- buffer
- purified
- 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
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- 108091005990 PEGylated Proteins Proteins 0.000 claims 6
- QTBSBXVTEAMEQO-UHFFFAOYSA-N acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 6
- 230000002378 acidificating Effects 0.000 claims 4
- 239000012535 impurity Substances 0.000 claims 4
- 102100006624 F9 Human genes 0.000 claims 3
- 108010076282 Factor IX Proteins 0.000 claims 3
- UIIMBOGNXHQVGW-UHFFFAOYSA-M buffer Substances [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 3
- 229960004222 factor IX Drugs 0.000 claims 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 3
- 238000005406 washing Methods 0.000 claims 3
- 102100009906 F7 Human genes 0.000 claims 2
- 108010023321 Factor VII Proteins 0.000 claims 2
- 108010014173 Factor X Proteins 0.000 claims 2
- 108010094028 Prothrombin Proteins 0.000 claims 2
- 238000005349 anion exchange Methods 0.000 claims 2
- 238000011067 equilibration Methods 0.000 claims 2
- 239000006167 equilibration buffer Substances 0.000 claims 2
- 229940012413 factor VII Drugs 0.000 claims 2
- 229940012426 factor X Drugs 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 206010061992 Haemophilia Diseases 0.000 claims 1
- 208000009292 Hemophilia A Diseases 0.000 claims 1
- 102000017975 Protein C Human genes 0.000 claims 1
- 229960000856 Protein C Drugs 0.000 claims 1
- 102000029610 Protein S Human genes 0.000 claims 1
- 229940096437 Protein S Drugs 0.000 claims 1
- 108010066124 Protein S Proteins 0.000 claims 1
- BDKZHNJTLHOSDW-UHFFFAOYSA-N [Na].CC(O)=O Chemical compound [Na].CC(O)=O BDKZHNJTLHOSDW-UHFFFAOYSA-N 0.000 claims 1
- 238000005571 anion exchange chromatography Methods 0.000 claims 1
- 238000004587 chromatography analysis Methods 0.000 claims 1
- 238000010828 elution Methods 0.000 claims 1
- 239000012149 elution buffer Substances 0.000 claims 1
- 239000000463 material Substances 0.000 claims 1
- 238000007670 refining Methods 0.000 claims 1
- VMHLLURERBWHNL-UHFFFAOYSA-M sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims 1
- 239000001632 sodium acetate Substances 0.000 claims 1
- 235000017281 sodium acetate Nutrition 0.000 claims 1
- VFRHSOGUONIUOR-CTFMUGKASA-M sodium;[(2R,4S,5R)-5-acetamido-2-carboxy-4-hydroxy-6-[(1R,2R)-1,2,3-trihydroxypropyl]oxan-2-yl] [(2R,3S,4R,5R)-5-(4-amino-2-oxopyrimidin-1-yl)-3,4-dihydroxyoxolan-2-yl]methyl phosphate Chemical compound [Na+].O1C([C@H](O)[C@H](O)CO)[C@H](NC(=O)C)[C@@H](O)C[C@]1(C(O)=O)OP([O-])(=O)OC[C@@H]1[C@@H](O)[C@@H](O)[C@H](N2C(N=C(N)C=C2)=O)O1 VFRHSOGUONIUOR-CTFMUGKASA-M 0.000 claims 1
Claims (15)
- 溶出バッファーを用いて陰イオン交換クロマトグラフィーを行う工程を含む、PEG化タンパク質の精製方法であって、前記クロマトグラフィーは、溶出の前に不純物除去工程を含むことを特徴とし、前記不純物除去工程は、酸性バッファーを用いて前記陰イオン交換カラムを洗浄する工程を含む、方法。
- 前記不純物がST3Gal3である、請求項1に記載の方法。
- 不純物除去工程が3.9から4.5の間のpHで酸性バッファーを用いて洗浄する工程を含む、請求項1または2に記載の方法。
- 酸性バッファーが、酢酸ナトリウムおよび／または酢酸を含む、請求項1から3のいずれか一項に記載の方法。
- 平衡工程が酸性洗浄工程の前に実施される、請求項1から4のいずれか一項に記載の方法。
- 平衡工程が5から7のpHでの平衡バッファーの適用を含む、請求項5に記載の方法。
- 平衡バッファーが、酢酸および酢酸ナトリウムを含む、請求項5または6に記載の方法。
- PEG化タンパク質が、第II因子(FII), 第VII因子(FVII), 第IX因子(FIX), 第X因子(FX), プロテインSおよびプロテインCから選択される、請求項1から7のいずれか一項に記載の方法。
- 陰イオン交換物質がHQを含む、請求項1から8のいずれか一項に記載の方法。
- 請求項1から9のいずれか一項に記載の方法によって得ることができる精製PEG化タンパク質。
- 実質的にST3Gal3が存在しない、請求項10に記載の精製PEG化タンパク質。
- 実質的にCMP-NANが存在しない、請求項10または11に記載の精製PEG化タンパク質。
- 請求項10から12のいずれか一項に記載の精製PEG化タンパク質を含む医薬組成物。
- 治療上有効量の、請求項10から12のいずれか一項に記載の精製PEG化タンパク質を含む、血友病の治療用の医薬組成物。
- 前記精製PEG化タンパク質が、請求項1から9のいずれか一項に記載の方法によって得ることができる精製第IX因子である、請求項13または14に記載の医薬組成物。
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP09176881 | 2009-11-24 | ||
| EP09176881.2 | 2009-11-24 | ||
| US26448609P | 2009-11-25 | 2009-11-25 | |
| US61/264,486 | 2009-11-25 | ||
| PCT/EP2010/068112 WO2011064247A1 (en) | 2009-11-24 | 2010-11-24 | Method of purifying pegylated proteins |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2013511566A JP2013511566A (ja) | 2013-04-04 |
| JP2013511566A5 true JP2013511566A5 (ja) | 2014-01-16 |
| JP5827955B2 JP5827955B2 (ja) | 2015-12-02 |
Family
ID=41401820
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012540414A Active JP5827955B2 (ja) | 2009-11-24 | 2010-11-24 | Ｐｅｇ化タンパク質の精製方法 |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US8697844B2 (ja) |
| EP (1) | EP2504349B1 (ja) |
| JP (1) | JP5827955B2 (ja) |
| CN (2) | CN102639553A (ja) |
| WO (1) | WO2011064247A1 (ja) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP7137625B2 (ja) | 2017-12-29 | 2022-09-14 | エフ．ホフマン－ラ ロシュ アーゲー | Ｐｅｇ化タンパク質組成物を提供するための方法 |
| JP7227633B2 (ja) | 2017-12-29 | 2023-02-22 | エフ． ホフマン－ラ ロシュ エージー． | Ｐｅｇ化タンパク質組成物を提供するための方法 |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103804489A (zh) | 2006-12-15 | 2014-05-21 | 巴克斯特国际公司 | 具有延长的体内半衰期的因子VIIa-聚唾液酸结合物 |
| US8809501B2 (en) | 2009-07-27 | 2014-08-19 | Baxter International Inc. | Nucleophilic catalysts for oxime linkage |
| US8642737B2 (en) | 2010-07-26 | 2014-02-04 | Baxter International Inc. | Nucleophilic catalysts for oxime linkage |
| CN102573920B (zh) | 2009-07-27 | 2015-01-14 | 利普森技术有限公司 | 非凝血蛋白的糖基多唾液酸化 |
| DK2459224T3 (en) | 2009-07-27 | 2016-07-25 | Baxalta GmbH | Blodstørkningsproteinkonjugater |
| HUE028056T2 (en) | 2009-07-27 | 2016-11-28 | Baxalta GmbH | Blood coagulation protein conjugates |
| CA2822591C (en) | 2010-12-22 | 2020-12-29 | Baxter International Inc. | Materials and methods for conjugating a water soluble fatty acid derivative to a protein |
| KR102020995B1 (ko) * | 2017-10-30 | 2019-09-16 | 한국코러스 주식회사 | 콜로니자극인자와 폴리올이 접합된 접합물을 고수율로 제조하는 방법 |
| SG11202006140TA (en) | 2017-12-29 | 2020-07-29 | Hoffmann La Roche | Process for providing pegylated protein composition |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU6255096A (en) | 1995-06-07 | 1996-12-30 | Mount Sinai School Of Medicine Of The City University Of New York, The | Pegylated modified proteins |
| US5714583A (en) | 1995-06-07 | 1998-02-03 | Genetics Institute, Inc. | Factor IX purification methods |
| AU760048B2 (en) * | 1998-05-06 | 2003-05-08 | Genentech Inc. | Protein purification by ion exchange chromatography |
| ES2228052T3 (es) | 1998-06-01 | 2005-04-01 | Genentech, Inc. | Separacion demonomeros de anticuerpos de sus multimeros utilizando cromatografia de intercambio de iones. |
| US7795210B2 (en) | 2001-10-10 | 2010-09-14 | Novo Nordisk A/S | Protein remodeling methods and proteins/peptides produced by the methods |
| EP2292271A3 (en) | 2001-10-10 | 2011-09-14 | BioGeneriX AG | Remodelling and glycoconjugation of an antibody |
| US7265084B2 (en) | 2001-10-10 | 2007-09-04 | Neose Technologies, Inc. | Glycopegylation methods and proteins/peptides produced by the methods |
| US7179617B2 (en) | 2001-10-10 | 2007-02-20 | Neose Technologies, Inc. | Factor IX: remolding and glycoconjugation of Factor IX |
| US7473680B2 (en) | 2001-11-28 | 2009-01-06 | Neose Technologies, Inc. | Remodeling and glycoconjugation of peptides |
| ZA200502320B (en) * | 2002-09-20 | 2006-10-25 | Pharmacia Corp | Process for decreasing aggregate levels of pegylated protein |
| SG155777A1 (en) | 2003-04-09 | 2009-10-29 | Neose Technologies Inc | Glycopegylation methods and proteins/peptides produced by the methods |
| NZ546733A (en) * | 2003-12-03 | 2009-07-31 | Novo Nordisk As | Glycopegylated factor IX |
| US20060040856A1 (en) | 2003-12-03 | 2006-02-23 | Neose Technologies, Inc. | Glycopegylated factor IX |
| US20080255026A1 (en) | 2005-05-25 | 2008-10-16 | Glycopegylated Factor 1X | Glycopegylated Factor Ix |
| US20070105755A1 (en) * | 2005-10-26 | 2007-05-10 | Neose Technologies, Inc. | One pot desialylation and glycopegylation of therapeutic peptides |
| AU2006280932A1 (en) * | 2005-08-19 | 2007-02-22 | Novo Nordisk A/S | Glycopegylated factor VII and factor Vila |
| WO2008104372A1 (en) | 2007-02-28 | 2008-09-04 | Baxter International Inc. | Method for the purification of recombinant blood coagulation factor ix enriched in sulfated and/or phosphorylated molecules |
| WO2008119815A1 (en) | 2007-04-02 | 2008-10-09 | Novo Nordisk A/S | Subcutaneous administration of coagulation factor ix |
-
2010
- 2010-11-24 US US13/509,867 patent/US8697844B2/en active Active
- 2010-11-24 CN CN2010800532840A patent/CN102639553A/zh active Pending
- 2010-11-24 JP JP2012540414A patent/JP5827955B2/ja active Active
- 2010-11-24 EP EP10784769.1A patent/EP2504349B1/en active Active
- 2010-11-24 WO PCT/EP2010/068112 patent/WO2011064247A1/en active Application Filing
- 2010-11-24 CN CN201710713355.9A patent/CN107383158A/zh active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP7137625B2 (ja) | 2017-12-29 | 2022-09-14 | エフ．ホフマン－ラ ロシュ アーゲー | Ｐｅｇ化タンパク質組成物を提供するための方法 |
| JP7227633B2 (ja) | 2017-12-29 | 2023-02-22 | エフ． ホフマン－ラ ロシュ エージー． | Ｐｅｇ化タンパク質組成物を提供するための方法 |
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