NO20063784L - Fremgangsmate for a tilveiebringe et virusfritt antistoffpreparat - Google Patents
Fremgangsmate for a tilveiebringe et virusfritt antistoffpreparatInfo
- Publication number
- NO20063784L NO20063784L NO20063784A NO20063784A NO20063784L NO 20063784 L NO20063784 L NO 20063784L NO 20063784 A NO20063784 A NO 20063784A NO 20063784 A NO20063784 A NO 20063784A NO 20063784 L NO20063784 L NO 20063784L
- Authority
- NO
- Norway
- Prior art keywords
- approx
- solution
- virus
- antibody preparation
- antibodies
- 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
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
-
- 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
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0017—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
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0023—Heat
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (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)
Abstract
Sammendrag En fremgangsmåte for fremstilling av et renset, virus inaktivert og virusfritt antistoffpreparat fra en startløsning omfattende antistoffer og forurensinger, fremgangsmåten omfatter trinnene av: 5 (a) justering av pH til startløsningen til ca. 4,6 til ca. 4,95 spesielt til ca. 4,8 til ca. 4,95 for å produsere en intermediat-løsning; (b) tilsette kaprylat- og/eller heptanoat-ioner til intermediat-løsningen og vedlikeholding av pH på ca. 4,6 til ca. 4,95 spesielt pH på ca. 4,8 til ca. 4,95, hvor et bunnfall dannes og antistoffene vesentlig blir 10 presentert i supernatanten; (c) inkubering av supernatant-løsningen under betingelser av kaprylatog/eller heptanoat-ionekonsentrasjon, tid, pH og temperatur valgfritt konsentrering og diafiltrating av filtrat-løsningen før pH-justering; (d) påføre den filtrerte løsningen på minst en anionbytter-resin og 15 valgfritt med to forskjellige anionbytter-resiner under betingelser som tillater binding av forurensninger til resinet mens ikke tillater signifikant binding av antistoffene til resinet, hvori et renset, virus inaktivert og virusfritt antistoffpreparat blir produsert.
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 |
---|---|
NO20063784L true NO20063784L (no) | 2006-09-25 |
Family
ID=34910983
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
NO20063784A NO20063784L (no) | 2004-02-27 | 2006-08-24 | Fremgangsmate for a tilveiebringe et virusfritt antistoffpreparat |
Country Status (18)
Country | Link |
---|---|
US (1) | US7553938B2 (no) |
EP (2) | EP2277915A1 (no) |
JP (1) | JP5042817B2 (no) |
KR (1) | KR101206788B1 (no) |
CN (1) | CN1922207B (no) |
AU (1) | AU2005217148B2 (no) |
BR (1) | BRPI0508096B8 (no) |
CA (1) | CA2557229C (no) |
DK (1) | DK1718675T3 (no) |
ES (1) | ES2407380T5 (no) |
IL (1) | IL177541A (no) |
NO (1) | NO20063784L (no) |
PL (1) | PL1718675T3 (no) |
PT (1) | PT1718675E (no) |
RU (1) | RU2337109C2 (no) |
UA (1) | UA87836C2 (no) |
WO (1) | WO2005082937A2 (no) |
ZA (1) | ZA200607119B (no) |
Families Citing this family (50)
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EP2069387A4 (en) * | 2006-06-14 | 2011-02-02 | Glaxosmithkline Llc | METHODS OF PURIFYING ANTIBODIES USING HYDROXYAPATITE CERAMIC |
JP5505853B2 (ja) | 2007-02-13 | 2014-05-28 | 味の素株式会社 | 微酸性アルギニンを添加剤とするウイルス不活化法 |
WO2009118331A1 (en) * | 2008-03-28 | 2009-10-01 | Research Foundation For Medical Devices | Method of viral inactivation of biological fluids by solvent/detergent-treatment |
EP3708581A3 (en) | 2009-05-27 | 2021-10-20 | Takeda Pharmaceutical Company Limited | 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 |
JP6023715B2 (ja) * | 2010-10-11 | 2016-11-09 | アッヴィ・バハマズ・リミテッド | タンパク質の精製方法 |
KR20130128382A (ko) | 2010-10-13 | 2013-11-26 | 옥타파마 아게 | 보체 인자 h의 정제 방법 |
EP2670429B1 (en) | 2011-02-04 | 2018-04-04 | Octapharma AG | Method for inactivation/removal of coagulation factors by precipitation |
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 |
CN110343171A (zh) | 2012-02-29 | 2019-10-18 | 百深公司 | 周围神经的IgG刺激髓鞘再生 |
SG11201407809QA (en) | 2012-05-31 | 2014-12-30 | Agency Science Tech & Res | 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 |
EP2864346B1 (en) * | 2012-06-21 | 2018-10-17 | Synthon Biopharmaceuticals B.V. | Method of purifying an antibody |
AU2013205138B2 (en) | 2012-08-09 | 2015-06-25 | Grifols, S.A. | Caprylate Viral Deactivation |
KR20150123796A (ko) * | 2013-02-28 | 2015-11-04 | 에이전시 포 사이언스, 테크놀로지 앤드 리서치 | 크로마틴 결핍 세포 배양 수확물로부터의 항체들의 크로마토그래프 정제 |
BR112015021495A2 (pt) | 2013-03-08 | 2017-07-18 | Genzyme Corp | fabricação contínua integrada de substâncias de droga de proteína terapêutica |
DK3680000T3 (da) * | 2013-03-15 | 2024-04-02 | Glaxosmithkline Ip Dev Ltd | Fremgangsmåder til oprensning af antistoffer |
US20160287693A1 (en) | 2013-11-15 | 2016-10-06 | Novartis Ag | Removal of residual cell culture impurities |
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 |
TWI671312B (zh) | 2014-01-17 | 2019-09-11 | 美商健臻公司 | 無菌層析法及製法 |
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 |
CN106164086A (zh) * | 2014-02-27 | 2016-11-23 | 新加坡科技研究局 | 抗体纯化方法 |
EP3118210B1 (en) * | 2014-03-11 | 2019-11-13 | Green Cross Holdings Corporation | Method for purifying immunoglobulin |
ES2857582T3 (es) * | 2014-04-30 | 2021-09-29 | Novo Nordisk As | Métodos para la purificación de proteínas mediante el uso de ácido caprílico |
WO2015195453A2 (en) | 2014-06-16 | 2015-12-23 | Emd Millipore Corporation | Methods for increasing the capacity of flow-through processes |
US10207225B2 (en) | 2014-06-16 | 2019-02-19 | Emd Millipore Corporation | Single-pass filtration systems and processes |
WO2015200691A1 (en) | 2014-06-25 | 2015-12-30 | Emd Millipore Corporation | Compact spiral-wound filter elements, modules and systems |
EP3185996B1 (en) | 2014-08-29 | 2022-06-15 | EMD Millipore Corporation | Single pass tangential flow filtration systems and tangential flow filtration systems with recirculation of retentate |
SG11201508665QA (en) | 2014-08-29 | 2016-03-30 | Emd Millipore Corp | Processes For Filtering Liquids Using Single Pass Tangential Flow Filtration Systems AndTangential Flow Filtration Systems With Recirculation of Retentate |
PL3135687T3 (pl) | 2015-08-31 | 2019-09-30 | Instituto Grifols, S.A. | Sposób wytwarzania immunoglobulin |
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 |
CN109689675A (zh) | 2016-09-07 | 2019-04-26 | 葛兰素史密斯克莱知识产权发展有限公司 | 纯化抗体的方法 |
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 |
US11369703B2 (en) | 2018-08-31 | 2022-06-28 | Genzyme Corporation | Sterile chromatography resin and use thereof in manufacturing processes |
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 |
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 |
EP4126930A1 (en) | 2020-03-31 | 2023-02-08 | 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 |
CA3203540A1 (en) * | 2020-12-28 | 2022-07-07 | Eugene ZURLO | Systems and methods for process scale isolation of immunoglobulin g |
AU2022281187A1 (en) * | 2021-05-26 | 2023-12-07 | Csl Behring Ag | Plasma fractionation 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 |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
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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 |
EP1842561A1 (fr) | 1995-07-14 | 2007-10-10 | CAF - DCF cvba - scrl | Procédé et installation d'inactivation UV de virus 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 |
US6281336B1 (en) * | 1998-06-09 | 2001-08-28 | Statens Serum Institut | Process for producing immunoglobulins for intravenous administration and other immunoglobulin products |
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 WO PCT/EP2005/050812 patent/WO2005082937A2/en active Application Filing
- 2005-02-25 PL PL05716804T patent/PL1718675T3/pl unknown
- 2005-02-25 US US10/590,900 patent/US7553938B2/en active Active
- 2005-02-25 RU RU2006134285/13A patent/RU2337109C2/ru active
- 2005-02-25 JP JP2007500224A patent/JP5042817B2/ja not_active Expired - Fee Related
- 2005-02-25 EP EP10179436A patent/EP2277915A1/en not_active Ceased
- 2005-02-25 DK DK05716804.9T patent/DK1718675T3/da active
- 2005-02-25 EP EP05716804.9A patent/EP1718675B2/en active Active
- 2005-02-25 KR KR1020067019926A patent/KR101206788B1/ko not_active IP Right Cessation
- 2005-02-25 CA CA2557229A patent/CA2557229C/en not_active Expired - Fee Related
- 2005-02-25 UA UAA200610282A patent/UA87836C2/ru unknown
- 2005-02-25 BR BRPI0508096A patent/BRPI0508096B8/pt active IP Right Grant
- 2005-02-25 PT PT57168049T patent/PT1718675E/pt unknown
- 2005-02-25 CN CN2005800058459A patent/CN1922207B/zh active Active
- 2005-02-25 AU AU2005217148A patent/AU2005217148B2/en active Active
- 2005-02-25 ES ES05716804.9T patent/ES2407380T5/es active Active
-
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 |
---|---|
DK1718675T3 (da) | 2013-07-15 |
EP1718675A2 (en) | 2006-11-08 |
RU2006134285A (ru) | 2008-04-10 |
CN1922207A (zh) | 2007-02-28 |
EP1718675B2 (en) | 2017-01-25 |
BRPI0508096B1 (pt) | 2019-04-02 |
ZA200607119B (en) | 2007-04-25 |
JP2007533660A (ja) | 2007-11-22 |
US20070173638A1 (en) | 2007-07-26 |
WO2005082937A3 (en) | 2005-11-17 |
IL177541A (en) | 2014-09-30 |
PL1718675T3 (pl) | 2013-09-30 |
ES2407380T3 (es) | 2013-06-12 |
IL177541A0 (en) | 2006-12-10 |
BRPI0508096B8 (pt) | 2021-05-25 |
UA87836C2 (ru) | 2009-08-25 |
JP5042817B2 (ja) | 2012-10-03 |
ES2407380T5 (es) | 2017-07-07 |
CN1922207B (zh) | 2012-06-06 |
RU2337109C2 (ru) | 2008-10-27 |
WO2005082937A2 (en) | 2005-09-09 |
BRPI0508096A (pt) | 2007-07-17 |
PT1718675E (pt) | 2013-05-21 |
CA2557229A1 (en) | 2005-09-09 |
AU2005217148A1 (en) | 2005-09-09 |
KR101206788B1 (ko) | 2012-11-30 |
EP1718675B1 (en) | 2013-04-10 |
CA2557229C (en) | 2012-07-10 |
KR20060131920A (ko) | 2006-12-20 |
US7553938B2 (en) | 2009-06-30 |
AU2005217148B2 (en) | 2011-09-08 |
EP2277915A1 (en) | 2011-01-26 |
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