JP2011524343A5 - - Google Patents
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- JP2011524343A5 JP2011524343A5 JP2011511643A JP2011511643A JP2011524343A5 JP 2011524343 A5 JP2011524343 A5 JP 2011524343A5 JP 2011511643 A JP2011511643 A JP 2011511643A JP 2011511643 A JP2011511643 A JP 2011511643A JP 2011524343 A5 JP2011524343 A5 JP 2011524343A5
- Authority
- JP
- Japan
- Prior art keywords
- protein
- chromatography
- iαip
- plasma fraction
- alpha
- 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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- 102000004169 proteins and genes Human genes 0.000 claims 17
- 108090000623 proteins and genes Proteins 0.000 claims 17
- 210000002381 Plasma Anatomy 0.000 claims 8
- 238000004587 chromatography analysis Methods 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 5
- 206010022114 Injury Diseases 0.000 claims 4
- 238000005571 anion exchange chromatography Methods 0.000 claims 4
- UIIMBOGNXHQVGW-UHFFFAOYSA-M buffer Substances [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 4
- 201000011510 cancer Diseases 0.000 claims 4
- 230000002401 inhibitory effect Effects 0.000 claims 4
- 238000005406 washing Methods 0.000 claims 4
- 210000004369 Blood Anatomy 0.000 claims 3
- 239000008280 blood Substances 0.000 claims 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 3
- 239000011534 wash buffer Substances 0.000 claims 3
- 241000282472 Canis lupus familiaris Species 0.000 claims 2
- 241000283707 Capra Species 0.000 claims 2
- 241000282326 Felis catus Species 0.000 claims 2
- 206010027476 Metastasis Diseases 0.000 claims 2
- 241000288906 Primates Species 0.000 claims 2
- 206010039073 Rheumatoid arthritis Diseases 0.000 claims 2
- 206010040070 Septic shock Diseases 0.000 claims 2
- 241000700605 Viruses Species 0.000 claims 2
- 230000001154 acute Effects 0.000 claims 2
- 239000000969 carrier Substances 0.000 claims 2
- 201000009910 diseases by infectious agent Diseases 0.000 claims 2
- 230000002779 inactivation Effects 0.000 claims 2
- 200000000018 inflammatory disease Diseases 0.000 claims 2
- 238000001728 nano-filtration Methods 0.000 claims 2
- 230000036303 septic shock Effects 0.000 claims 2
- 230000035939 shock Effects 0.000 claims 2
- ZMANZCXQSJIPKH-UHFFFAOYSA-N triethylamine Chemical group CCN(CC)CC ZMANZCXQSJIPKH-UHFFFAOYSA-N 0.000 claims 2
- 241000283690 Bos taurus Species 0.000 claims 1
- 238000002965 ELISA Methods 0.000 claims 1
- 102000004190 Enzymes Human genes 0.000 claims 1
- 108090000790 Enzymes Proteins 0.000 claims 1
- 241000283086 Equidae Species 0.000 claims 1
- 241000283073 Equus caballus Species 0.000 claims 1
- 241000282414 Homo sapiens Species 0.000 claims 1
- 102000012479 Serine Proteases Human genes 0.000 claims 1
- 108010022999 Serine Proteases Proteins 0.000 claims 1
- 241000282887 Suidae Species 0.000 claims 1
- 241000282898 Sus scrofa Species 0.000 claims 1
- 150000001412 amines Chemical group 0.000 claims 1
- 230000000975 bioactive Effects 0.000 claims 1
- 238000004440 column chromatography Methods 0.000 claims 1
- 230000002860 competitive Effects 0.000 claims 1
- 238000003018 immunoassay Methods 0.000 claims 1
- 238000004811 liquid chromatography Methods 0.000 claims 1
- 238000002414 normal-phase solid-phase extraction Methods 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 1
Claims (24)
- 方法が、IαIpタンパク質を4.0、3.6若しくは3.3以下、又は3.3〜2.9のpHの条件に曝露する工程を含有してなる、インター−アルファ−阻害タンパク質(IαIpタンパク質)を精製する方法。
- クロマトグラフィー工程又は固相抽出工程を含有してなる、請求項1に記載の方法。
- クロマトグラフィー工程が、液体クロマトグラフィー、カラムクロマトグラフィー、陰イオン交換クロマトグラフィー、又はこれらの組み合わせを含有している、請求項2に記載の方法。
- クロマトグラフィーが、モノリシック担体又は粒子ベースの担体の使用を含有している、請求項3に記載の方法。
- 陰イオン交換クロマトグラフィーが、ジエチルアミノエタン(DEAE)陰イオン交換クロマトグラフィー又は4級アミン(Q)陰イオン交換クロマトグラフィーである、請求項3又は4に記載の方法。
- 少なくとも1つの緩衝液洗浄工程を含有してなり、そこで少なくとも1つの緩衝液洗浄工程の洗浄緩衝液が4.0、3.6若しくは3.3以下、又は3.3〜2.9のpHを有している、請求項1〜5の何れか一項に記載の方法。
- 少なくとも1つの緩衝液洗浄工程を含有してなり、そこで少なくとも1つの緩衝液洗浄工程の洗浄緩衝液が250mM NaCL以上の塩濃度を有している、請求項1〜6の何れか一項に記載の方法。
- IαIpタンパク質が血液、血漿、血漿画分、脱クリオ血漿又は中間血漿画分から精製される、請求項1〜7の何れか一項に記載の方法。
- 中間血漿画分がIαIp含有画分である、請求項8に記載の方法。
- 血液、血漿画分、又は中間血漿画分が、ヒト、霊長類、ウシ、ウマ、ブタ、ヤギ、ネコ、イヌのもの又はそれらの組み合わせである、請求項8又は9に記載の方法。
- IαIpタンパク質が60〜280kDaの見掛けの分子量、生物活性、サイトカイン阻害活性、ケモカイン阻害活性、セリンプロテアーゼ阻害活性、又は85%〜100%の収率を有している、請求項1〜10の何れか一項に記載の方法。
- ウィルス不活性化工程又はナノろ過工程を更に含有してなる、請求項1〜11の何れか一項に記載の方法。
- ウィルス不活性化工程又はナノろ過工程が、クロマトグラフィー工程の前又はクロマトグラフィー工程の後に存在する、請求項12に記載の方法。
- 方法が:
血液、血漿画分、又は中間血漿画分をクロマトグラフィーカラムに付すこと、
カラムを4.0以下のpHを有する洗浄緩衝液に曝すこと:
を含有してなる、インター−アルファ−阻害タンパク質(IαIpタンパク質)を精製する方法。 - インター−アルファ−阻害タンパク質(IαIpタンパク質)がカラムに結合する、請求項14に記載の方法。
- インター−アルファ−阻害タンパク質(IαIpタンパク質)が単離される、請求項14又は15に記載の方法。
- 請求項1〜16の何れか一項に記載の方法で作られた、精製したインター−アルファ−阻害タンパク質(IαIpタンパク質)。
- IαIpタンパク質が、競合的酵素免疫測定法(ELISA)で対照と比較して1、1.5、2、3、4、5、又は10倍を越えて増大した結合を有していると測定される、又は85%〜100%の純度範囲を有している、請求項17に記載のIαIpタンパク質。
- 請求項1〜16の何れか1項に記載の方法によって精製されたIαIpタンパク質を含有してなる、組成物。
- 請求項1〜16の何れか1項に記載の方法によって精製されたIαIpタンパク質を含有してなる、医薬組成物。
- ヒト、霊長類、ウシ、ウマ、ブタ、ヤギ、ネコ、又はイヌを処置するための、請求項20に記載の医薬組成物。
- 急性炎症性疾患、敗血症、重度のショック、敗血性ショック、関節リウマチ、癌、癌転移、外傷/損傷、感染性疾患、又は早期陣痛の治療のための、請求項20又は21に記載の医薬組成物。
- 治療の必要がある対象を判定するための、請求項19に記載の組成物。
- 対象が、急性炎症性疾患、敗血症、重度のショック、敗血性ショック、関節リウマチ、癌、癌転移、外傷/損傷、感染性疾患、又は早期陣痛の治療が必要であると判定される、請求項23に記載の組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13026908P | 2008-05-28 | 2008-05-28 | |
US61/130,269 | 2008-05-28 | ||
PCT/US2009/003291 WO2009154695A1 (en) | 2008-05-28 | 2009-05-28 | Preparation and composition of inter-alpha inhibitor proteins from blood |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2015080358A Division JP6309915B2 (ja) | 2008-05-28 | 2015-04-09 | 血液由来インター−アルファ−阻害タンパク質の調製及び組成物。 |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2011524343A JP2011524343A (ja) | 2011-09-01 |
JP2011524343A5 true JP2011524343A5 (ja) | 2012-07-12 |
JP5793076B2 JP5793076B2 (ja) | 2015-10-14 |
Family
ID=41434346
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2011511643A Active JP5793076B2 (ja) | 2008-05-28 | 2009-05-28 | 血液由来インター−アルファ−阻害タンパク質の調製及び組成物。 |
JP2015080358A Active JP6309915B2 (ja) | 2008-05-28 | 2015-04-09 | 血液由来インター−アルファ−阻害タンパク質の調製及び組成物。 |
JP2017124777A Pending JP2018008941A (ja) | 2008-05-28 | 2017-06-27 | 血液由来インター−アルファ−阻害タンパク質の調製及び組成物。 |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2015080358A Active JP6309915B2 (ja) | 2008-05-28 | 2015-04-09 | 血液由来インター−アルファ−阻害タンパク質の調製及び組成物。 |
JP2017124777A Pending JP2018008941A (ja) | 2008-05-28 | 2017-06-27 | 血液由来インター−アルファ−阻害タンパク質の調製及び組成物。 |
Country Status (13)
Country | Link |
---|---|
US (3) | US9139641B2 (ja) |
EP (1) | EP2291654B1 (ja) |
JP (3) | JP5793076B2 (ja) |
KR (3) | KR101828433B1 (ja) |
CN (2) | CN102112876B (ja) |
AU (1) | AU2009260822B2 (ja) |
BR (2) | BRPI0913949A2 (ja) |
CA (1) | CA2726281C (ja) |
DK (1) | DK2291654T3 (ja) |
ES (1) | ES2673005T3 (ja) |
PT (1) | PT2291654T (ja) |
TR (1) | TR201808152T4 (ja) |
WO (1) | WO2009154695A1 (ja) |
Families Citing this family (18)
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AU2004289252C1 (en) | 2003-11-08 | 2013-06-20 | Prothera Biologics, Inc. | Preparation and composition of Inter-alpha inhibitor proteins from human plasma for therapeutic use |
PT2291654T (pt) | 2008-05-28 | 2018-06-15 | Prothera Biologics Inc | Preparação e composição de proteínas inibidoras de interalfa do sangue |
WO2011150284A2 (en) | 2010-05-26 | 2011-12-01 | Baxter International Inc. | Removal of serine proteases by treatment with finely divided silicon dioxide |
AU2010202125B1 (en) | 2010-05-26 | 2010-09-02 | Takeda Pharmaceutical Company Limited | A method to produce an immunoglobulin preparation with improved yield |
BR112013001753A2 (pt) * | 2010-07-23 | 2016-05-31 | Baxter Healthcare Sa | método para preparar uma composição d einter-alfa-inibidor (iaip) eriquecida de plasma, solução aquosa de iaip, e, método para tratar uma doença ou distúrbio associado com disfunção de iaip e associado com atividadede protease de serina no plasma aumentada. |
KR101443257B1 (ko) * | 2011-10-18 | 2014-09-19 | 주식회사 종근당 | 낮은 등전점을 갖는 에리스로포이에틴 유사체의 정제방법 |
WO2014039987A2 (en) | 2012-09-09 | 2014-03-13 | Prothera Biologics, Inc. | Treatment of disease using inter-alpha inhibitor proteins |
US20140206844A1 (en) * | 2013-01-18 | 2014-07-24 | Prothera Biologics | Methods for isolating blood products from an inter-alpha inhibitor protein-depleted blood product material |
SG11201510788XA (en) * | 2013-09-04 | 2016-01-28 | Emd Millipore Corp | Protein a chromatography |
US10611794B2 (en) * | 2013-09-25 | 2020-04-07 | Bioverativ Therapeutics Inc. | On-column viral inactivation methods |
CN104138374A (zh) * | 2014-07-26 | 2014-11-12 | 滨州医学院 | 硫酸阿扎那韦在制备预防或治疗内毒素血症和脓毒症的药物中的应用 |
WO2017066683A1 (en) * | 2015-10-15 | 2017-04-20 | Plasma Technologies, Llc | Methods for extracting proteins from blood plasma |
BR112019022358A2 (pt) * | 2017-04-25 | 2020-05-19 | Prothera Biologics Inc | métodos para quantificar proteínas inibidoras inter-alfa |
CN111630148A (zh) * | 2017-11-20 | 2020-09-04 | 隆萨有限公司 | 在防止乳酸积累的同时繁殖细胞培养物的过程和系统 |
JP7461348B2 (ja) * | 2018-10-24 | 2024-04-03 | プロセラ バイオロジクス, インコーポレイテッド | インターアルファインヒビタータンパク質及びその使用方法 |
CN109900689B (zh) * | 2019-03-28 | 2021-12-10 | 复星诊断科技(长沙)有限公司 | 抗干扰膜及肝功能联合测试条 |
EP4244629A1 (en) | 2020-11-16 | 2023-09-20 | Prothera Biologics, Inc. | Methods for purifying inter-alpha inhibitor proteins |
WO2023089503A1 (en) * | 2021-11-16 | 2023-05-25 | Takeda Pharmaceutical Company Limited | Inter-alpha inhibitor protein formulations |
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-
2009
- 2009-05-28 PT PT97670087T patent/PT2291654T/pt unknown
- 2009-05-28 DK DK09767008.7T patent/DK2291654T3/en active
- 2009-05-28 CN CN200980129119.6A patent/CN102112876B/zh active Active
- 2009-05-28 KR KR1020167030334A patent/KR101828433B1/ko active IP Right Grant
- 2009-05-28 KR KR1020177027338A patent/KR20170116196A/ko not_active Application Discontinuation
- 2009-05-28 AU AU2009260822A patent/AU2009260822B2/en active Active
- 2009-05-28 KR KR1020107029406A patent/KR101714008B1/ko active IP Right Grant
- 2009-05-28 EP EP09767008.7A patent/EP2291654B1/en active Active
- 2009-05-28 TR TR2018/08152T patent/TR201808152T4/tr unknown
- 2009-05-28 BR BRPI0913949A patent/BRPI0913949A2/pt not_active Application Discontinuation
- 2009-05-28 ES ES09767008.7T patent/ES2673005T3/es active Active
- 2009-05-28 JP JP2011511643A patent/JP5793076B2/ja active Active
- 2009-05-28 WO PCT/US2009/003291 patent/WO2009154695A1/en active Application Filing
- 2009-05-28 CA CA2726281A patent/CA2726281C/en active Active
- 2009-05-28 US US12/995,141 patent/US9139641B2/en active Active
- 2009-05-28 BR BR122020017577-0A patent/BR122020017577B1/pt active IP Right Grant
- 2009-05-28 CN CN201710066775.2A patent/CN106928346B/zh active Active
-
2015
- 2015-04-09 JP JP2015080358A patent/JP6309915B2/ja active Active
- 2015-09-21 US US14/859,705 patent/US9758570B2/en active Active
-
2017
- 2017-02-22 US US15/439,328 patent/US10076559B2/en active Active
- 2017-06-27 JP JP2017124777A patent/JP2018008941A/ja active Pending
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