DE69127384T2 - Verfahren zur Reinigung von Immunserumglobulinen - Google Patents
Verfahren zur Reinigung von ImmunserumglobulinenInfo
- Publication number
- DE69127384T2 DE69127384T2 DE69127384T DE69127384T DE69127384T2 DE 69127384 T2 DE69127384 T2 DE 69127384T2 DE 69127384 T DE69127384 T DE 69127384T DE 69127384 T DE69127384 T DE 69127384T DE 69127384 T2 DE69127384 T2 DE 69127384T2
- Authority
- DE
- Germany
- Prior art keywords
- serum globulin
- immune
- immune serum
- serum
- globulins
- 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.)
- Expired - Lifetime
Links
- 108010045362 Serum Globulins Proteins 0.000 title abstract 10
- 102000005686 Serum Globulins Human genes 0.000 title abstract 10
- 238000000034 method Methods 0.000 title abstract 4
- 238000000746 purification Methods 0.000 title 1
- 239000000356 contaminant Substances 0.000 abstract 3
- 239000003957 anion exchange resin Substances 0.000 abstract 2
- 239000012141 concentrate Substances 0.000 abstract 2
- 108010058237 plasma protein fraction Proteins 0.000 abstract 2
- 229940081857 plasma protein fraction Drugs 0.000 abstract 2
- 239000011347 resin Substances 0.000 abstract 2
- 229920005989 resin Polymers 0.000 abstract 2
- 238000005406 washing Methods 0.000 abstract 2
- NWUYHJFMYQTDRP-UHFFFAOYSA-N 1,2-bis(ethenyl)benzene;1-ethenyl-2-ethylbenzene;styrene Chemical compound C=CC1=CC=CC=C1.CCC1=CC=CC=C1C=C.C=CC1=CC=CC=C1C=C NWUYHJFMYQTDRP-UHFFFAOYSA-N 0.000 abstract 1
- 102000006395 Globulins Human genes 0.000 abstract 1
- 108010044091 Globulins Proteins 0.000 abstract 1
- 241000700605 Viruses Species 0.000 abstract 1
- 239000007900 aqueous suspension Substances 0.000 abstract 1
- 239000003729 cation exchange resin Substances 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 239000000706 filtrate Substances 0.000 abstract 1
- 238000011031 large-scale manufacturing process Methods 0.000 abstract 1
- 150000002632 lipids Chemical class 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 239000013627 low molecular weight specie Substances 0.000 abstract 1
- 230000001376 precipitating effect Effects 0.000 abstract 1
- 102000004196 processed proteins & peptides Human genes 0.000 abstract 1
- 108090000765 processed proteins & peptides Proteins 0.000 abstract 1
- 239000000047 product Substances 0.000 abstract 1
- 102000004169 proteins and genes Human genes 0.000 abstract 1
- 108090000623 proteins and genes Proteins 0.000 abstract 1
- 238000000108 ultra-filtration Methods 0.000 abstract 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/473,559 US5177194A (en) | 1990-02-01 | 1990-02-01 | Process for purifying immune serum globulins |
US473559 | 1990-02-01 |
Publications (3)
Publication Number | Publication Date |
---|---|
DE69127384D1 DE69127384D1 (de) | 1997-10-02 |
DE69127384T2 true DE69127384T2 (de) | 1998-03-26 |
DE69127384T3 DE69127384T3 (de) | 2004-05-19 |
Family
ID=23880046
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE69127384T Expired - Lifetime DE69127384T3 (de) | 1990-02-01 | 1991-01-31 | Verfahren zur Reinigung von Immunserumglobulinen |
Country Status (6)
Country | Link |
---|---|
US (1) | US5177194A (de) |
EP (1) | EP0440483B2 (de) |
JP (1) | JP3094167B2 (de) |
AT (1) | ATE157373T1 (de) |
DE (1) | DE69127384T3 (de) |
ES (1) | ES2108704T3 (de) |
Families Citing this family (53)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5945098A (en) * | 1990-02-01 | 1999-08-31 | Baxter International Inc. | Stable intravenously-administrable immune globulin preparation |
US5525519A (en) * | 1992-01-07 | 1996-06-11 | Middlesex Sciences, Inc. | Method for isolating biomolecules from a biological sample with linear polymers |
FR2706466B1 (fr) * | 1993-06-14 | 1995-08-25 | Aetsrn | Concentré d'immunoglobulines G à usage thérapeutique et procédé de production dudit concentré. |
ATE175979T1 (de) * | 1993-12-27 | 1999-02-15 | Rotkreuzstiftung Zentrallab | Verfahren zur herstellung eines konzentrates von anti-d-immunoglobulin g und pharmazeutische zusammensetzung, die dieses enthält |
TW541179B (en) * | 1997-03-19 | 2003-07-11 | Green Cross Corp | Process for preparing immunoglobulin preparation |
US5886154A (en) * | 1997-06-20 | 1999-03-23 | Lebing; Wytold R. | Chromatographic method for high yield purification and viral inactivation of antibodies |
US6955917B2 (en) * | 1997-06-20 | 2005-10-18 | Bayer Healthcare Llc | Chromatographic method for high yield purification and viral inactivation of antibodies |
IL121900A (en) * | 1997-10-07 | 2001-12-23 | Omrix Biopharmaceuticals Ltd | A method for the purification of immunoglobulins |
PT911037E (pt) * | 1997-10-23 | 2002-12-31 | Mitsubishi Pharma Corp | Preparacao de imunoglobulina armazenavel a temperatura ambiente para injeccao intravenosa |
UA64742C2 (uk) * | 1997-12-24 | 2004-03-15 | Альфа Терапевтик Корпорейшн | СПОСІБ ОДЕРЖАННЯ РОЗЧИНУ <font face="Symbol">g</font>-ГЛОБУЛІНУ, ПРИЗНАЧЕНОГО ДЛЯ ВНУТРІШНЬОВЕННОГО ВВЕДЕННЯ, І ПРОДУКТ, ЩО ОДЕРЖУЄТЬСЯ У ЦЕЙ СПОСІБ (ВАРІАНТИ) |
AU760048B2 (en) * | 1998-05-06 | 2003-05-08 | Genentech Inc. | Protein purification by ion exchange chromatography |
ES2527915T3 (es) * | 1998-06-09 | 2015-02-02 | Csl Behring Ag | Producto de inmunoglobulina G (IgG) líquido |
US6214221B1 (en) | 1999-02-22 | 2001-04-10 | Henry B. Kopf | Method and apparatus for purification of biological substances |
AU756832B2 (en) | 1999-02-22 | 2003-01-23 | Ncsrt, Inc. | Purification of biological substances |
DE19916352A1 (de) * | 1999-04-12 | 2000-10-19 | Braun Melsungen Ag | Entfernung von hüllehaltigen Viren aus Blut, Plasma oder Serum |
US6441144B1 (en) | 1999-05-20 | 2002-08-27 | Alpha Therapeutic Corporation | Method for repairing dual virally inactivated immune globulin for intravenous administration |
KR100416483B1 (ko) * | 2000-08-08 | 2004-01-31 | 주식회사 웰진 | 동물세포 배양용 혈청의 단계적 여과 시스템 |
US6962700B1 (en) | 2000-09-13 | 2005-11-08 | Atopix Pharmaceuticals Corporation | Method of manufacturing immune globulin |
ES2184594B1 (es) * | 2001-01-17 | 2004-01-01 | Probitas Pharma Sa | Procedimiento para la produccion de gammaglobulina g humana inactivada de virus. |
JP4317744B2 (ja) * | 2001-05-30 | 2009-08-19 | ナノキャリア株式会社 | 高分子化合物末端への導入物結合方法 |
US8420789B2 (en) | 2002-09-11 | 2013-04-16 | Chugai Seiyaku Kabushiki Kaisha | Method for removing DNA contaminants from a protein-containing sample |
EP1532983A1 (de) | 2003-11-18 | 2005-05-25 | ZLB Bioplasma AG | Immunoglobulinpräparationen mit erhöhter Stabilität |
US20060051347A1 (en) * | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
TWI391399B (zh) | 2005-05-25 | 2013-04-01 | Hoffmann La Roche | 測定溶離多肽之鹽濃度之方法 |
KR20080031684A (ko) | 2005-06-14 | 2008-04-10 | 암젠 인코포레이티드 | 자가 - 완충성 단백질 제형 |
US7879332B2 (en) * | 2005-09-01 | 2011-02-01 | Plasma Technologies, Llc | Ultra-high yield intravenous immune globulin preparation |
US20070049732A1 (en) * | 2005-09-01 | 2007-03-01 | Zurlo Eugene J | Ultra-high yield intravenous immune globulin preparation |
US8293242B2 (en) * | 2005-09-01 | 2012-10-23 | Plasma Technologies, Llc | Ultra-high yield of alpha-1-anti-trypsin |
US20070128693A1 (en) * | 2005-12-06 | 2007-06-07 | Advantek Serum Laboratories Limited3/F | Method for the inactivation and removal of dengue virus from biological samples |
EP2522755B1 (de) | 2007-08-13 | 2014-04-02 | Baxter International Inc. | IVIg-Modulation von Chemokinen zur Behandlung von Multipler Sklerose, Morbus Alzheimer und Morbus Parkinson |
TWI489994B (zh) | 2008-03-17 | 2015-07-01 | Baxter Healthcare Sa | 供免疫球蛋白及玻尿酸酶之皮下投藥之用的組合及方法 |
ES2406029T3 (es) | 2008-04-15 | 2013-06-05 | Grifols Therapeutics Inc. | Ultrafiltración/diafiltración en dos fases |
EA023382B1 (ru) | 2009-05-27 | 2016-05-31 | Бакстер Интернэшнл Инк. | Способ получения высококонцентрированного препарата иммуноглобулина для подкожного применения |
WO2010148117A1 (en) | 2009-06-17 | 2010-12-23 | Scantibodies Laboratory, Inc. | Therapeutic and diagnostic affinity purified specific polyclonal antibodies |
US8304524B2 (en) | 2009-07-23 | 2012-11-06 | Baxter International Inc. | Manufacture of factor H (FH) and FH-derivatives from plasma |
HUE028832T2 (en) | 2009-09-17 | 2017-01-30 | Baxalta Inc | Stable co-formulation of hyaluronidase and immunoglobulin, as well as a process for its preparation |
IT1397061B1 (it) * | 2009-12-28 | 2012-12-28 | Kedrion Spa | Nuovo processo di purificazione su scala industriale di gammaglobuline da plasma umano per uso industriale. |
TR201903403T4 (tr) | 2010-02-04 | 2019-04-22 | Csl Behring Ag | İmmünoglobulin preparatı. |
EP2361636A1 (de) | 2010-02-26 | 2011-08-31 | CSL Behring AG | Immunglobulinpräparat und Aufbewahrungssystem für ein Immunglobulinpräparat |
US8796430B2 (en) | 2010-05-26 | 2014-08-05 | Baxter International Inc. | Method to produce an immunoglobulin preparation with improved yield |
AU2010202125B1 (en) | 2010-05-26 | 2010-09-02 | Takeda Pharmaceutical Company Limited | A method to produce an immunoglobulin preparation with improved yield |
WO2011150284A2 (en) | 2010-05-26 | 2011-12-01 | Baxter International Inc. | Removal of serine proteases by treatment with finely divided silicon dioxide |
CN103119058A (zh) | 2010-07-23 | 2013-05-22 | 巴克斯特国际公司 | 由血浆生产间-α-抑制蛋白(IAIP) |
EP4289445A3 (de) | 2010-09-17 | 2024-02-21 | Takeda Pharmaceutical Company Limited | Stabilisierung von immunglobulinen anhand einer wässrigen formulierung mit histidin bei schwach sauren bis neutralem ph-wert |
EP3395825B1 (de) | 2010-12-16 | 2021-11-10 | Takeda Pharmaceutical Company Limited | Echtzeitüberwachung und steuerung von proteinproduktionsverfahren unter verwendung von impedanzspektroskopie |
PL2734544T3 (pl) | 2011-07-18 | 2021-05-31 | The United States Of America As Represented By The Secretary, Department Of Health And Human Services | Sposoby i kompozycje do hamowania patologii związanej z poliomawirusem |
EP2748193B1 (de) * | 2011-08-26 | 2017-02-01 | Baxalta GmbH | Verfahren zur reduzierung des thromboembolischen potentials einer aus plasma gewonnenen immunoglobulinzusammensetzung |
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 |
IL274512B1 (en) | 2012-02-29 | 2024-03-01 | Baxalta Inc | IgG-stimulated remodeling of peripheral nerve myelin |
AU2014350370B2 (en) * | 2013-11-15 | 2017-04-13 | Novartis Ag | Removal of residual cell culture impurities |
MX2018009331A (es) | 2016-02-03 | 2018-11-09 | Plasma Tech Llc | Metodos para extraer proteinas a partir de un material a base de sangre. |
BR112019007858A2 (pt) | 2016-10-21 | 2019-07-02 | Amgen Inc | formulações farmacêuticas e métodos para produzir as mesmas |
US10815270B1 (en) | 2019-09-20 | 2020-10-27 | Plasma Technologies, Llc | Compositions and methods for high efficiency protein precipitation |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3869436A (en) * | 1971-06-01 | 1975-03-04 | Statens Bakteriologiska Lab | Method for fractionating plasma proteins using peg and ion-exchangers |
US3962421A (en) * | 1973-06-18 | 1976-06-08 | American Home Products Corporation | Method for the disruption of lipid-containing viruses |
US4315919A (en) * | 1980-10-06 | 1982-02-16 | Edward Shanbrom | Depyrogenation process |
US4314997A (en) * | 1980-10-06 | 1982-02-09 | Edward Shanbrom | Purification of plasma protein products |
US4540573A (en) * | 1983-07-14 | 1985-09-10 | New York Blood Center, Inc. | Undenatured virus-free biologically active protein derivatives |
US4719290A (en) * | 1983-09-02 | 1988-01-12 | Armour Pharmaceutical Corporation | Composition of intravenous immune globulin |
US4683294A (en) * | 1985-04-03 | 1987-07-28 | Smith Kline Rit, S.A. | Process for the extraction and purification of proteins from culture media producing them |
US4606825A (en) * | 1985-04-22 | 1986-08-19 | J. T. Baker Chemical Company | Purification of immunoglobulin G |
DE3640513A1 (de) * | 1986-11-27 | 1988-06-09 | Biotest Pharma Gmbh | Verfahren zur herstellung eines virussicheren, lagerstabilen und intravenoes vertraeglichen immunglobulin-g-praeparates |
DE3730533A1 (de) * | 1987-09-11 | 1989-03-30 | Biotest Pharma Gmbh | Verfahren zur sterilisation von plasma oder plasmafraktionen |
-
1990
- 1990-02-01 US US07/473,559 patent/US5177194A/en not_active Expired - Lifetime
-
1991
- 1991-01-31 EP EP91300790A patent/EP0440483B2/de not_active Expired - Lifetime
- 1991-01-31 DE DE69127384T patent/DE69127384T3/de not_active Expired - Lifetime
- 1991-01-31 ES ES91300790T patent/ES2108704T3/es not_active Expired - Lifetime
- 1991-01-31 AT AT91300790T patent/ATE157373T1/de not_active IP Right Cessation
- 1991-02-01 JP JP03033682A patent/JP3094167B2/ja not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
JP3094167B2 (ja) | 2000-10-03 |
DE69127384D1 (de) | 1997-10-02 |
DE69127384T3 (de) | 2004-05-19 |
EP0440483A3 (en) | 1992-09-23 |
ES2108704T3 (es) | 1998-01-01 |
EP0440483B1 (de) | 1997-08-27 |
EP0440483A2 (de) | 1991-08-07 |
US5177194A (en) | 1993-01-05 |
EP0440483B2 (de) | 2003-06-18 |
ATE157373T1 (de) | 1997-09-15 |
JPH06136000A (ja) | 1994-05-17 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
8363 | Opposition against the patent | ||
8366 | Restricted maintained after opposition proceedings |