JP2013535468A5 - - Google Patents
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- Publication number
- JP2013535468A5 JP2013535468A5 JP2013521858A JP2013521858A JP2013535468A5 JP 2013535468 A5 JP2013535468 A5 JP 2013535468A5 JP 2013521858 A JP2013521858 A JP 2013521858A JP 2013521858 A JP2013521858 A JP 2013521858A JP 2013535468 A5 JP2013535468 A5 JP 2013535468A5
- Authority
- JP
- Japan
- Prior art keywords
- iaip
- fraction
- iii
- alcohol
- precipitate
- 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
- 238000000034 method Methods 0.000 claims description 87
- 239000002244 precipitate Substances 0.000 claims description 53
- 238000001556 precipitation Methods 0.000 claims description 39
- 239000000203 mixture Substances 0.000 claims description 33
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 30
- 230000001376 precipitating effect Effects 0.000 claims description 19
- 239000006228 supernatant Substances 0.000 claims description 17
- 239000011536 extraction buffer Substances 0.000 claims description 14
- 239000000725 suspension Substances 0.000 claims description 14
- 108010093564 inter-alpha-inhibitor Proteins 0.000 claims description 12
- 239000003480 eluent Substances 0.000 claims description 10
- 239000012065 filter cake Substances 0.000 claims description 9
- 102000004169 proteins and genes Human genes 0.000 claims description 9
- 108090000623 proteins and genes Proteins 0.000 claims description 9
- 239000000243 solution Substances 0.000 claims description 9
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 8
- 239000007790 solid phase Substances 0.000 claims description 8
- 241000894007 species Species 0.000 claims description 8
- 239000003957 anion exchange resin Substances 0.000 claims description 7
- 239000012149 elution buffer Substances 0.000 claims description 7
- 239000011347 resin Substances 0.000 claims description 7
- 229920005989 resin Polymers 0.000 claims description 7
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 claims description 6
- 229960002897 heparin Drugs 0.000 claims description 6
- 229920000669 heparin Polymers 0.000 claims description 6
- 239000003002 pH adjusting agent Substances 0.000 claims description 6
- 239000007921 spray Substances 0.000 claims description 6
- 229910004298 SiO 2 Inorganic materials 0.000 claims description 4
- 241000700605 Viruses Species 0.000 claims description 4
- 230000002779 inactivation Effects 0.000 claims description 4
- 108010037710 pre-alpha-trypsin inhibitor Proteins 0.000 claims description 4
- 235000012239 silicon dioxide Nutrition 0.000 claims description 4
- 239000000377 silicon dioxide Substances 0.000 claims description 4
- 239000012535 impurity Substances 0.000 claims description 3
- 239000003599 detergent Substances 0.000 claims description 2
- 238000001914 filtration Methods 0.000 claims description 2
- 238000010438 heat treatment Methods 0.000 claims description 2
- 238000011534 incubation Methods 0.000 claims description 2
- 238000002156 mixing Methods 0.000 claims description 2
- 238000001728 nano-filtration Methods 0.000 claims description 2
- 238000004064 recycling Methods 0.000 claims description 2
- 239000002904 solvent Substances 0.000 claims description 2
- 241000209149 Zea Species 0.000 claims 2
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 claims 2
- 235000002017 Zea mays subsp mays Nutrition 0.000 claims 2
- 235000005822 corn Nutrition 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 9
- 102000016550 Complement Factor H Human genes 0.000 description 7
- 108010053085 Complement Factor H Proteins 0.000 description 7
- 201000010099 disease Diseases 0.000 description 5
- 208000035475 disorder Diseases 0.000 description 4
- 238000005194 fractionation Methods 0.000 description 4
- 239000008194 pharmaceutical composition Substances 0.000 description 4
- 239000010836 blood and blood product Substances 0.000 description 3
- 229940125691 blood product Drugs 0.000 description 3
- 206010040070 Septic Shock Diseases 0.000 description 2
- 102000012479 Serine Proteases Human genes 0.000 description 2
- 108010022999 Serine Proteases Proteins 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 230000015271 coagulation Effects 0.000 description 2
- 238000005345 coagulation Methods 0.000 description 2
- 230000004064 dysfunction Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 102000009027 Albumins Human genes 0.000 description 1
- 108010088751 Albumins Proteins 0.000 description 1
- 241000193738 Bacillus anthracis Species 0.000 description 1
- 206010016654 Fibrosis Diseases 0.000 description 1
- 108060003951 Immunoglobulin Proteins 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 206010027476 Metastases Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 206010040047 Sepsis Diseases 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 238000012869 ethanol precipitation Methods 0.000 description 1
- 230000004761 fibrosis Effects 0.000 description 1
- 102000018358 immunoglobulin Human genes 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 239000012931 lyophilized formulation Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000009401 metastasis Effects 0.000 description 1
- 231100000572 poisoning Toxicity 0.000 description 1
- 230000000607 poisoning effect Effects 0.000 description 1
- 238000011176 pooling Methods 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000036303 septic shock Effects 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 208000037816 tissue injury Diseases 0.000 description 1
- 208000019553 vascular disease Diseases 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US36733110P | 2010-07-23 | 2010-07-23 | |
| US61/367,331 | 2010-07-23 | ||
| PCT/US2011/045099 WO2012012773A1 (en) | 2010-07-23 | 2011-07-22 | Manufacture of inter -alpha - inhibitor proteins (iaip) from plasma |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2013535468A JP2013535468A (ja) | 2013-09-12 |
| JP2013535468A5 true JP2013535468A5 (https=) | 2014-09-11 |
| JP5830096B2 JP5830096B2 (ja) | 2015-12-09 |
Family
ID=44534634
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013521858A Active JP5830096B2 (ja) | 2010-07-23 | 2011-07-22 | 血漿由来インターα阻害タンパク質（ＩａＩｐ）の製造方法 |
Country Status (14)
| Country | Link |
|---|---|
| US (2) | US8841248B2 (https=) |
| EP (1) | EP2596014B1 (https=) |
| JP (1) | JP5830096B2 (https=) |
| KR (1) | KR20130093607A (https=) |
| CN (1) | CN103119058A (https=) |
| AU (1) | AU2011280907B2 (https=) |
| BR (1) | BR112013001753A2 (https=) |
| CA (1) | CA2806645A1 (https=) |
| CO (1) | CO6680653A2 (https=) |
| EA (1) | EA201390156A1 (https=) |
| ES (1) | ES2717177T3 (https=) |
| MX (1) | MX2013000958A (https=) |
| SG (1) | SG187599A1 (https=) |
| WO (1) | WO2012012773A1 (https=) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1691820A4 (en) | 2003-11-08 | 2010-03-03 | Prothera Biolog | PREPARATION AND COMPOSITION OF INTER ALPHA HEMMER PROTEINS FROM HUMAN PLASMA FOR THERAPEUTIC USE |
| CN106928346B (zh) | 2008-05-28 | 2021-09-07 | 普罗瑟拉生物公司 | 来自血液的间-α抑制物蛋白的制备和组合物 |
| 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 |
| ES2717177T3 (es) | 2010-07-23 | 2019-06-19 | Baxalta GmbH | Fabricación de proteínas inhibidoras inter-alfa (IaIp) a partir de plasma |
| TWI629283B (zh) | 2012-02-23 | 2018-07-11 | 巴克斯歐塔公司 | 來自血漿中的免疫球蛋白之ｉ-ｉｖ-１部分沉澱 |
| 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 |
| US20170232079A1 (en) * | 2015-10-06 | 2017-08-17 | Kieu Hoang | Method of manufacturing prothrombin complex concentrate from fraction iii and non-prothrombin complex concentrate from fraction iv |
| CN109789193A (zh) | 2016-09-13 | 2019-05-21 | 普罗瑟拉生物公司 | 使用间α抑制蛋白治疗肺病的方法 |
| EP3615937B1 (en) | 2017-04-25 | 2026-01-28 | Prothera Biologics, Inc. | Methods for quantifying inter-alpha inhibitor proteins |
| ES2991988T3 (es) | 2017-10-30 | 2024-12-05 | Takeda Pharmaceuticals Co | Detergentes compatibles con el medio ambiente para la inactivación de virus con envoltura lipídica |
| EP3870147A4 (en) * | 2018-10-24 | 2022-08-31 | Prothera Biologics, Inc. | INTER-ALPHA INHIBITOR PROTEINS AND METHODS OF USE THEREOF |
| CN109867717A (zh) * | 2019-04-01 | 2019-06-11 | 山西瑞亚力生物技术有限公司 | 一种血浆中α1微球蛋白的提取方法 |
| EP3994165A1 (en) * | 2019-07-04 | 2022-05-11 | CSL Behring GmbH | Process for purifying c1-inh |
| WO2021202373A1 (en) * | 2020-03-31 | 2021-10-07 | Baxalta Incorporated | A method to produce an immunoglobulin preparation from c-1 inhibitor depleted plasma |
| JP2025512143A (ja) * | 2020-11-09 | 2025-04-17 | 武田薬品工業株式会社 | 酸化ケイ素吸着を使用する血漿からのｆｖｉｉｉの精製 |
| CA3198925A1 (en) | 2020-11-16 | 2022-05-19 | Yow-Pin Lim | Methods for purifying inter-alpha inhibitor proteins |
| CN119300842A (zh) * | 2022-05-02 | 2025-01-10 | 武田药品工业株式会社 | 通过超滤从血浆制备科恩池浓缩物的方法 |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2390074A (en) * | 1942-02-09 | 1945-12-04 | Research Corp | Protein product and process |
| DK166763C (da) | 1983-03-16 | 1993-07-12 | Immuno Ag | Immunoglobulin-g-holdig fraktion |
| US5055447A (en) * | 1988-07-28 | 1991-10-08 | Genentech, Inc. | Method and compositions for the treatment and prevention of septic shock |
| US5177194A (en) | 1990-02-01 | 1993-01-05 | Baxter International, Inc. | Process for purifying immune serum globulins |
| FR2711371B1 (fr) * | 1993-10-18 | 1995-12-29 | Aetsrn | Procédé de préparation d'un concentré d'inter-alpha-trypsine inhibiteur à usage thérapeutique et concentré obtenu. |
| ATE211486T1 (de) * | 1995-09-22 | 2002-01-15 | Zlb Bioplasma Ag | Verfahren zur gewinnung von immunglobulinen aus fraktionen, die bei der fraktionierung von menschlichem blutplasma entstehen |
| AU2002216968A1 (en) | 2000-10-13 | 2002-04-22 | Octapharma Ag | Plasma fraction containing bikunin, method for the production thereof and use of the same |
| EP1691820A4 (en) | 2003-11-08 | 2010-03-03 | Prothera Biolog | PREPARATION AND COMPOSITION OF INTER ALPHA HEMMER PROTEINS FROM HUMAN PLASMA FOR THERAPEUTIC USE |
| CN101160133B (zh) * | 2004-11-05 | 2013-01-09 | 普罗瑟拉生物公司 | 治疗用途的来自人血浆的内-α抑制剂蛋白质的制备和组合物 |
| WO2008113589A1 (en) * | 2007-03-20 | 2008-09-25 | Csl Behring Gmbh | Methods for industrial scale production of therapeutic complement factor h preparations from human plasma |
| CN106928346B (zh) | 2008-05-28 | 2021-09-07 | 普罗瑟拉生物公司 | 来自血液的间-α抑制物蛋白的制备和组合物 |
| AT516600B1 (de) * | 2009-07-23 | 2016-07-15 | Baxter Int | Herstellung von faktor h (fh) und fh-derivaten aus plasma |
| AU2010202125B1 (en) * | 2010-05-26 | 2010-09-02 | Takeda Pharmaceutical Company Limited | A method to produce an immunoglobulin preparation with improved yield |
| ES2717177T3 (es) | 2010-07-23 | 2019-06-19 | Baxalta GmbH | Fabricación de proteínas inhibidoras inter-alfa (IaIp) a partir de plasma |
-
2011
- 2011-07-22 ES ES11749976T patent/ES2717177T3/es active Active
- 2011-07-22 BR BR112013001753A patent/BR112013001753A2/pt not_active Application Discontinuation
- 2011-07-22 EP EP11749976.4A patent/EP2596014B1/en active Active
- 2011-07-22 EA EA201390156A patent/EA201390156A1/ru unknown
- 2011-07-22 AU AU2011280907A patent/AU2011280907B2/en active Active
- 2011-07-22 SG SG2013005640A patent/SG187599A1/en unknown
- 2011-07-22 WO PCT/US2011/045099 patent/WO2012012773A1/en not_active Ceased
- 2011-07-22 CN CN2011800457670A patent/CN103119058A/zh active Pending
- 2011-07-22 JP JP2013521858A patent/JP5830096B2/ja active Active
- 2011-07-22 CA CA2806645A patent/CA2806645A1/en not_active Abandoned
- 2011-07-22 KR KR1020137004453A patent/KR20130093607A/ko not_active Withdrawn
- 2011-07-22 US US13/189,390 patent/US8841248B2/en active Active
- 2011-07-22 MX MX2013000958A patent/MX2013000958A/es not_active Application Discontinuation
-
2013
- 2013-02-21 CO CO13035387A patent/CO6680653A2/es not_active Application Discontinuation
-
2014
- 2014-08-19 US US14/463,533 patent/US9505814B2/en active Active
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