DK1718675T3 - Fremgangsmåde til at tilvejebringe en oprenset virussikker antistoftilberedning - Google Patents
Fremgangsmåde til at tilvejebringe en oprenset virussikker antistoftilberedningInfo
- Publication number
- DK1718675T3 DK1718675T3 DK05716804.9T DK05716804T DK1718675T3 DK 1718675 T3 DK1718675 T3 DK 1718675T3 DK 05716804 T DK05716804 T DK 05716804T DK 1718675 T3 DK1718675 T3 DK 1718675T3
- Authority
- DK
- Denmark
- Prior art keywords
- providing
- antibody preparation
- purified virus
- safe antibody
- safe
- Prior art date
Links
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
-
- 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
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/022—Filtration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
-
- A61L2103/05—
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US54810704P | 2004-02-27 | 2004-02-27 | |
| PCT/EP2005/050812 WO2005082937A2 (en) | 2004-02-27 | 2005-02-25 | A method of providing a purified, virus safe antibody preparation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK1718675T3 true DK1718675T3 (da) | 2013-07-15 |
Family
ID=34910983
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK05716804.9T DK1718675T3 (da) | 2004-02-27 | 2005-02-25 | Fremgangsmåde til at tilvejebringe en oprenset virussikker antistoftilberedning |
Country Status (18)
| Country | Link |
|---|---|
| US (1) | US7553938B2 (da) |
| EP (2) | EP1718675B2 (da) |
| JP (1) | JP5042817B2 (da) |
| KR (1) | KR101206788B1 (da) |
| CN (1) | CN1922207B (da) |
| AU (1) | AU2005217148B2 (da) |
| BR (1) | BRPI0508096B8 (da) |
| CA (1) | CA2557229C (da) |
| DK (1) | DK1718675T3 (da) |
| ES (1) | ES2407380T5 (da) |
| IL (1) | IL177541A (da) |
| NO (1) | NO20063784L (da) |
| PL (1) | PL1718675T3 (da) |
| PT (1) | PT1718675E (da) |
| RU (1) | RU2337109C2 (da) |
| UA (1) | UA87836C2 (da) |
| WO (1) | WO2005082937A2 (da) |
| ZA (1) | ZA200607119B (da) |
Families Citing this family (55)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009017491A1 (en) * | 2006-06-14 | 2009-02-05 | Smithkline Beecham Corporation | Methods for purifying antibodies using ceramic hydroxyapatite |
| EP1958626B1 (en) | 2007-02-13 | 2014-07-23 | Ajinomoto Co., Inc. | Method for inactivating viruses by addition of slightly acidic arginine |
| EP2271374B1 (en) * | 2008-03-28 | 2014-03-05 | Research Foundation For Medical Devices | Method of viral inactivation of biological fluids by solvent/detergent-treatment |
| EP2762492A3 (en) | 2009-05-27 | 2015-03-18 | Baxter International Inc | A method to produce a highly concentrated immunoglobulin preparation for subcutaneous use |
| EP2519537A4 (en) * | 2009-12-29 | 2013-07-10 | Reddys Lab Ltd Dr | CLEANING PROTEINS |
| GB201006753D0 (en) | 2010-04-22 | 2010-06-09 | Biotest Ag | Process for preparing an immunolobulin composition |
| 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 |
| US8796430B2 (en) | 2010-05-26 | 2014-08-05 | Baxter International Inc. | Method to produce an immunoglobulin preparation with improved yield |
| EP2399613A1 (en) * | 2010-06-22 | 2011-12-28 | Research Foundation For Medical Devices | Fractionation of plasma using caprylic acid |
| RU2610667C2 (ru) * | 2010-10-11 | 2017-02-14 | Эббви Бахамаз Лтд., | Способ очистки белков |
| WO2012049245A1 (en) | 2010-10-13 | 2012-04-19 | Octapharma Ag | Method for purification of complement factor h |
| TR201807926T4 (tr) | 2011-02-04 | 2018-06-21 | Octapharma Ag | Koagülasyon faktörlerinin çökeltme yoluyla etkisizleştirilmesine/çıkarılmasına yönelik usul. |
| FR2977893B1 (fr) * | 2011-07-11 | 2015-02-20 | Lab Francais Du Fractionnement | Procede de preparation d'un concentre d'immunoglobulines polyvalentes |
| CN102286099B (zh) * | 2011-08-05 | 2014-04-09 | 深圳市卫光生物制品股份有限公司 | 静注巨细胞病毒人免疫球蛋白及其制备方法 |
| 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 |
| DK3590960T3 (da) | 2012-02-29 | 2023-04-24 | Takeda Pharmaceuticals Co | Igg-stimuleret remyelinisering af perifere nerver |
| EP2855504B1 (en) * | 2012-05-31 | 2018-10-24 | Agency For Science, Technology And Research | Chromatographic purification of immunoglobulin g preparations with particles having multimodal functionalities |
| CN102757496B (zh) * | 2012-06-07 | 2014-06-18 | 山东泉港药业有限公司 | 一种抗vegf抗体片段的纯化制备方法 |
| LT2864346T (lt) * | 2012-06-21 | 2019-01-25 | Synthon Biopharmaceuticals B.V. | Antikūnų gryninimo metodas |
| AU2013205138B2 (en) | 2012-08-09 | 2015-06-25 | Grifols, S.A. | Caprylate Viral Deactivation |
| SG11201505192RA (en) * | 2013-02-28 | 2015-08-28 | Agency Science Tech & Res | Chromatographic purification of antibodies from chromatin-deficient cell culture harvests |
| CA2902854C (en) | 2013-03-08 | 2024-01-23 | Genzyme Corporation | Integrated continuous manufacturing of therapeutic protein drug substances |
| SG11201506494XA (en) * | 2013-03-15 | 2015-09-29 | Glaxosmithkline Ip No 2 Ltd | Methods for purifying antibodies |
| CN105745218B (zh) | 2013-11-15 | 2020-11-06 | 诺华股份有限公司 | 去除残留细胞培养杂质 |
| RU2561596C2 (ru) * | 2013-12-18 | 2015-08-27 | Федеральное государственное унитарное предприятие "Научно-производственное объединение по медицинским иммунобиологическим препаратам "Микроген" Министерства здравоохранения Российской Федерации | Способ приготовления вирусинактивированных растворов иммуноглобулинов с низким остаточным содержанием каприловой кислоты |
| TWI709569B (zh) | 2014-01-17 | 2020-11-11 | 美商健臻公司 | 無菌層析樹脂及其用於製造方法的用途 |
| TWI709570B (zh) | 2014-01-17 | 2020-11-11 | 美商健臻公司 | 無菌層析法及製法 |
| JP2017507149A (ja) * | 2014-02-27 | 2017-03-16 | エイジェンシー・フォー・サイエンス,テクノロジー・アンド・リサーチ | 抗体精製方法 |
| CN106414476B (zh) * | 2014-03-11 | 2019-12-31 | 株式会社绿十字控股 | 用于纯化免疫球蛋白的方法 |
| CN106459142B (zh) * | 2014-04-30 | 2021-07-13 | 诺和诺德股份有限公司 | 使用辛酸纯化蛋白质的方法 |
| WO2015195452A2 (en) | 2014-06-16 | 2015-12-23 | Emd Millipore Corporation | Single-pass filtration systems and processes |
| WO2015195453A2 (en) | 2014-06-16 | 2015-12-23 | Emd Millipore Corporation | Methods for increasing the capacity of flow-through processes |
| SG10201908746UA (en) | 2014-06-25 | 2019-10-30 | Emd Millipore Corp | Compact spiral-wound filter elements, modules and systems |
| KR102235952B1 (ko) | 2014-08-29 | 2021-04-07 | 이엠디 밀리포어 코포레이션 | 잔류물의 재순환을 이용한 싱글 패스 접선 유동 여과 시스템 및 접선 유동 여과 시스템 |
| KR102061553B1 (ko) | 2014-08-29 | 2020-02-11 | 이엠디 밀리포어 코포레이션 | 잔류물의 재순환에 의한 싱글 패스 접선 유동 여과 시스템 및 접선 유동 여과 시스템을 사용하여 액체를 여과하는 공정 |
| SI4209499T1 (sl) | 2015-08-13 | 2025-01-31 | Amgen Inc. | Globinsko nabito filtriranje proteinov, ki vežejo antigen |
| PT3135687T (pt) | 2015-08-31 | 2019-05-21 | Inst Grifols S A | Método para preparação de imunoglobulinas |
| CA3077712C (en) | 2016-06-09 | 2022-03-22 | Emd Millipore Corporation | Radial-path filter elements, systems and methods of using same |
| EP3254671B1 (en) | 2016-06-10 | 2019-11-13 | Octapharma AG | High concentration immunoglobulin composition for pharmaceutical application |
| IT201600079328A1 (it) * | 2016-07-28 | 2018-01-28 | Altergon Sa | Metodo migliorato per la decontaminazione di materiale biologico mediante partizione e inattivazione |
| SG11201901059QA (en) | 2016-09-07 | 2019-03-28 | Glaxosmithkline Ip Dev Ltd | Methods for purifying antibodies |
| RU2708394C2 (ru) * | 2016-09-26 | 2019-12-06 | Институто Грифольс,С.А. | Способ получения иммуноглобулинов |
| JP6370853B2 (ja) * | 2016-09-26 | 2018-08-08 | インスティトゥト グリフォルス,ソシエダ アノニマ | 免疫グロブリンの調製方法 |
| WO2019219890A1 (en) | 2018-05-17 | 2019-11-21 | Csl Behring Ag | Method and system of protein extraction |
| SG11202101860UA (en) | 2018-08-31 | 2021-03-30 | Genzyme Corp | Sterile chromatography resin and use thereof in manufacturing processes |
| CN110627892B (zh) * | 2019-09-05 | 2023-04-14 | 江苏康禾生物制药有限公司 | 一种重组人血小板生成因子原液的制备方法 |
| CN110590931B (zh) * | 2019-09-05 | 2023-04-07 | 江苏康禾生物制药有限公司 | 去除和/或灭活重组人血小板生成因子原液中病毒的方法 |
| AU2021249040A1 (en) | 2020-03-31 | 2022-09-15 | Takeda Pharmaceutical Company Limited | A method to produce an immunoglobulin preparation from C-1 inhibitor depleted plasma |
| CN111991571B (zh) * | 2020-08-12 | 2022-04-05 | 湖州师范学院 | 一种柱上低pH病毒灭活的方法 |
| JP7606185B2 (ja) * | 2020-09-03 | 2024-12-25 | 日機装株式会社 | フェノールレッド吸着剤およびフェノールレッドの除去方法 |
| CA3203540A1 (en) * | 2020-12-28 | 2022-07-07 | Eugene ZURLO | Systems and methods for process scale isolation of immunoglobulin g |
| IL308819A (en) * | 2021-05-26 | 2024-01-01 | Csl Behring Ag | Separation of plasma components by continuous extraction |
| BE1029863B1 (nl) * | 2022-05-10 | 2023-05-12 | Prothya Biosolutions Belgium | WERKWIJZEN VOOR HET PRODUCEREN VAN IMMUNOGLOBULINE G (IgG) PREPARATEN EN/OF OPLOSSINGEN |
| WO2025068923A2 (en) | 2023-09-26 | 2025-04-03 | Takeda Pharmaceutical Company Limited | IMMUNOGLOBULIN FORMULATIONS DEPLETED IN IgA |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SU836831A1 (ru) * | 1978-07-19 | 1982-04-23 | Научно-исследовательский институт эпидемиологии и микробиологии | Способ получени иммуноглобулинового препарата |
| CA1201063A (en) | 1982-07-20 | 1986-02-25 | Winnipeg Rh Institute Inc., (The) | Process for preparing purified immune globulin (igg) |
| US4540573A (en) | 1983-07-14 | 1985-09-10 | New York Blood Center, Inc. | Undenatured virus-free biologically active protein derivatives |
| GB8807380D0 (en) | 1988-03-29 | 1988-05-05 | Gunn A | Blood processing apparatus |
| US4939176A (en) | 1988-12-20 | 1990-07-03 | Miles Inc. | Viral inactivation process |
| DE4125625C2 (de) | 1991-08-02 | 1999-12-02 | Octapharma Ag Glarus | Verfahren zur Herstellung von virusinaktivierten Immunglobulinlösungen |
| WO1997003706A1 (fr) | 1995-07-14 | 1997-02-06 | Croix-Rouge De Belgique | Procede et installation d'inactivation de contaminants presents dans des produits sanguins |
| US5808011A (en) | 1996-07-01 | 1998-09-15 | Biopure Corporation | Method for chromatographic removal of prions |
| TW491855B (en) | 1996-08-07 | 2002-06-21 | Csl Ltd | Purification of immunoglobulins |
| US5886154A (en) * | 1997-06-20 | 1999-03-23 | Lebing; Wytold R. | Chromatographic method for high yield purification and viral inactivation of antibodies |
| JP4685238B2 (ja) * | 1998-06-09 | 2011-05-18 | ツエー・エス・エル・ベーリング・アクチエンゲゼルシヤフト | 静脈投与用免疫グロブリン及び他の免疫グロブリン生成物の製造法 |
| CN1151174C (zh) * | 1998-12-21 | 2004-05-26 | 蒋盘宏 | 抗人淋巴细胞球蛋白制备方法 |
| EP1709077A1 (en) * | 2004-01-30 | 2006-10-11 | Suomen Punainen Risti Veripalvelu | Process for the manufacture of virus safe immunoglobulin |
-
2005
- 2005-02-25 DK DK05716804.9T patent/DK1718675T3/da active
- 2005-02-25 CA CA2557229A patent/CA2557229C/en not_active Expired - Fee Related
- 2005-02-25 US US10/590,900 patent/US7553938B2/en not_active Expired - Lifetime
- 2005-02-25 EP EP05716804.9A patent/EP1718675B2/en not_active Expired - Lifetime
- 2005-02-25 ES ES05716804.9T patent/ES2407380T5/es not_active Expired - Lifetime
- 2005-02-25 BR BRPI0508096A patent/BRPI0508096B8/pt not_active IP Right Cessation
- 2005-02-25 JP JP2007500224A patent/JP5042817B2/ja not_active Expired - Fee Related
- 2005-02-25 RU RU2006134285/13A patent/RU2337109C2/ru active
- 2005-02-25 CN CN2005800058459A patent/CN1922207B/zh not_active Expired - Lifetime
- 2005-02-25 WO PCT/EP2005/050812 patent/WO2005082937A2/en not_active Ceased
- 2005-02-25 PL PL05716804T patent/PL1718675T3/pl unknown
- 2005-02-25 AU AU2005217148A patent/AU2005217148B2/en not_active Expired
- 2005-02-25 UA UAA200610282A patent/UA87836C2/ru unknown
- 2005-02-25 KR KR1020067019926A patent/KR101206788B1/ko not_active Expired - Fee Related
- 2005-02-25 PT PT57168049T patent/PT1718675E/pt unknown
- 2005-02-25 EP EP10179436A patent/EP2277915A1/en not_active Ceased
-
2006
- 2006-08-17 IL IL177541A patent/IL177541A/en active IP Right Grant
- 2006-08-24 NO NO20063784A patent/NO20063784L/no not_active Application Discontinuation
- 2006-08-25 ZA ZA200607119A patent/ZA200607119B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| AU2005217148A1 (en) | 2005-09-09 |
| CA2557229C (en) | 2012-07-10 |
| WO2005082937A3 (en) | 2005-11-17 |
| BRPI0508096B1 (pt) | 2019-04-02 |
| ES2407380T5 (es) | 2017-07-07 |
| JP2007533660A (ja) | 2007-11-22 |
| ES2407380T3 (es) | 2013-06-12 |
| EP1718675B1 (en) | 2013-04-10 |
| UA87836C2 (ru) | 2009-08-25 |
| EP1718675B2 (en) | 2017-01-25 |
| BRPI0508096B8 (pt) | 2021-05-25 |
| IL177541A (en) | 2014-09-30 |
| CA2557229A1 (en) | 2005-09-09 |
| US20070173638A1 (en) | 2007-07-26 |
| WO2005082937A2 (en) | 2005-09-09 |
| CN1922207B (zh) | 2012-06-06 |
| EP1718675A2 (en) | 2006-11-08 |
| NO20063784L (no) | 2006-09-25 |
| US7553938B2 (en) | 2009-06-30 |
| PL1718675T3 (pl) | 2013-09-30 |
| JP5042817B2 (ja) | 2012-10-03 |
| ZA200607119B (en) | 2007-04-25 |
| KR101206788B1 (ko) | 2012-11-30 |
| KR20060131920A (ko) | 2006-12-20 |
| IL177541A0 (en) | 2006-12-10 |
| RU2337109C2 (ru) | 2008-10-27 |
| CN1922207A (zh) | 2007-02-28 |
| EP2277915A1 (en) | 2011-01-26 |
| RU2006134285A (ru) | 2008-04-10 |
| BRPI0508096A (pt) | 2007-07-17 |
| PT1718675E (pt) | 2013-05-21 |
| AU2005217148B2 (en) | 2011-09-08 |
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