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) | EP1718675B2 (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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JP2010510963A (ja) * | 2006-06-14 | 2010-04-08 | グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー | セラミックヒドロキシアパタイトを使用する抗体の精製方法 |
EP1958626B1 (en) | 2007-02-13 | 2014-07-23 | Ajinomoto Co., Inc. | Method for inactivating viruses by addition of slightly acidic arginine |
WO2009118331A1 (en) * | 2008-03-28 | 2009-10-01 | Research Foundation For Medical Devices | Method of viral inactivation of biological fluids by solvent/detergent-treatment |
AR076607A1 (es) | 2009-05-27 | 2011-06-22 | Baxter Int | Composicion acuosa. metodo para producir una preparacion altamente concentrada de inmunoglobulina de uso subcutaneo |
US20130116413A1 (en) * | 2009-12-29 | 2013-05-09 | Dr. Reddy's Laboratories, Inc. | Purification of 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 |
TW201221641A (en) * | 2010-10-11 | 2012-06-01 | Abbott Lab | Processes for purification of proteins |
US8809510B2 (en) | 2010-10-13 | 2014-08-19 | Octapharma Ag | Method for purification of complement factor H |
CN103561758B (zh) * | 2011-02-04 | 2017-06-16 | 奥克塔法马股份有限公司 | 通过沉降灭活/去除凝血因子的方法 |
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 |
CN107551269A (zh) | 2012-02-29 | 2018-01-09 | 百深公司 | 周围神经的IgG刺激髓鞘再生 |
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 |
PT2864346T (pt) * | 2012-06-21 | 2018-12-12 | Synthon Biopharmaceuticals Bv | Método de purificação de um anticorpo |
AU2013205138B2 (en) * | 2012-08-09 | 2015-06-25 | Grifols, S.A. | Caprylate Viral Deactivation |
WO2014133459A1 (en) * | 2013-02-28 | 2014-09-04 | Agency For Science, Technology And Research | Chromatographic purification of antibodies from chromatin-deficient cell culture harvests |
RU2768003C2 (ru) | 2013-03-08 | 2022-03-22 | Джензим Корпорейшн | Интегрированное непрерывное производство терапевтических белковых лекарственных веществ |
WO2014141150A1 (en) * | 2013-03-15 | 2014-09-18 | Glaxosmithkline Intellectual Property (No.2) Limited | Methods for purifying antibodies |
JP6373376B2 (ja) | 2013-11-15 | 2018-08-15 | ノバルティス アーゲー | 残留細胞培養不純物の除去 |
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 |
SG11201607098SA (en) * | 2014-02-27 | 2016-09-29 | Agency Science Tech & Res | Antibody purification process |
EP3118210B1 (en) * | 2014-03-11 | 2019-11-13 | Green Cross Holdings Corporation | Method for purifying immunoglobulin |
EP3137186B1 (en) * | 2014-04-30 | 2021-01-27 | Novo Nordisk A/S | Methods for the purification of proteins using caprylic acid |
US10207225B2 (en) | 2014-06-16 | 2019-02-19 | Emd Millipore Corporation | Single-pass filtration systems and processes |
US10550148B2 (en) | 2014-06-16 | 2020-02-04 | Emd Millipore Corporation | Methods for increasing the capacity of flow-through processes |
CN110756051B (zh) | 2014-06-25 | 2022-11-04 | Emd 密理博公司 | 过滤器元件、切向流过滤系统、产生进料筛网的方法 |
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 |
KR102079585B1 (ko) | 2014-08-29 | 2020-02-21 | 이엠디 밀리포어 코포레이션 | 잔류물의 재순환을 이용한 싱글 패스 접선 유동 여과 시스템 및 접선 유동 여과 시스템 |
ES2721311T3 (es) | 2015-08-31 | 2019-07-30 | Inst Grifols S A | Procedimiento de preparación de inmunoglobulinas |
ES2770674T3 (es) | 2016-06-10 | 2020-07-02 | Octapharma Ag | Composición de inmunoglobulinas de alta concentración para aplicaciones farmacéuticas |
IT201600079328A1 (it) * | 2016-07-28 | 2018-01-28 | Altergon Sa | Metodo migliorato per la decontaminazione di materiale biologico mediante partizione e inattivazione |
WO2018047080A1 (en) | 2016-09-07 | 2018-03-15 | Glaxosmithkline Intellectual Property Development Limited | 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 |
BR112021003420A2 (pt) | 2018-08-31 | 2021-05-18 | Genzyme Corporation | resina cromatográfica estéril e uso da mesma em processos de manufatura |
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 |
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 |
AU2021414086A1 (en) * | 2020-12-28 | 2023-08-03 | Plasma Technologies, Llc | Systems and Methods for Process Scale Isolation of Immunoglobulin G |
CN117529497A (zh) * | 2021-05-26 | 2024-02-06 | 瑞士杰特贝林生物制品有限公司 | 通过连续提取分馏血浆 |
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 |
---|---|---|---|---|
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 |
DE69637181T2 (de) | 1995-07-14 | 2008-04-17 | Caf - Dcf Cvba - Scrl | Vorrichtung zur inaktivierung von viralen verunreinigungen in blutprodukten |
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 |
DK2272870T3 (da) * | 1998-06-09 | 2013-08-05 | Csl Behring Ag | Fremgangsmåde til fremstilling af immunoglobuliner med henblik på intravenøs indgivelse og andre immunoglobulin-lignende produkter. |
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 EP EP05716804.9A patent/EP1718675B2/en active Active
- 2005-02-25 US US10/590,900 patent/US7553938B2/en active Active
- 2005-02-25 EP EP10179436A patent/EP2277915A1/en not_active Ceased
- 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 DK DK05716804.9T patent/DK1718675T3/da active
- 2005-02-25 BR BRPI0508096A patent/BRPI0508096B8/pt active IP Right Grant
- 2005-02-25 JP JP2007500224A patent/JP5042817B2/ja not_active Expired - Fee Related
- 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 PL PL05716804T patent/PL1718675T3/pl unknown
- 2005-02-25 ES ES05716804.9T patent/ES2407380T5/es active Active
- 2005-02-25 UA UAA200610282A patent/UA87836C2/ru unknown
- 2005-02-25 RU RU2006134285/13A patent/RU2337109C2/ru 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 |
---|---|
CA2557229A1 (en) | 2005-09-09 |
BRPI0508096A (pt) | 2007-07-17 |
CN1922207B (zh) | 2012-06-06 |
DK1718675T3 (da) | 2013-07-15 |
BRPI0508096B8 (pt) | 2021-05-25 |
US20070173638A1 (en) | 2007-07-26 |
KR20060131920A (ko) | 2006-12-20 |
US7553938B2 (en) | 2009-06-30 |
RU2337109C2 (ru) | 2008-10-27 |
WO2005082937A3 (en) | 2005-11-17 |
ES2407380T5 (es) | 2017-07-07 |
IL177541A (en) | 2014-09-30 |
PT1718675E (pt) | 2013-05-21 |
CN1922207A (zh) | 2007-02-28 |
JP5042817B2 (ja) | 2012-10-03 |
KR101206788B1 (ko) | 2012-11-30 |
WO2005082937A2 (en) | 2005-09-09 |
AU2005217148B2 (en) | 2011-09-08 |
BRPI0508096B1 (pt) | 2019-04-02 |
RU2006134285A (ru) | 2008-04-10 |
JP2007533660A (ja) | 2007-11-22 |
ES2407380T3 (es) | 2013-06-12 |
PL1718675T3 (pl) | 2013-09-30 |
ZA200607119B (en) | 2007-04-25 |
AU2005217148A1 (en) | 2005-09-09 |
UA87836C2 (ru) | 2009-08-25 |
IL177541A0 (en) | 2006-12-10 |
EP1718675A2 (en) | 2006-11-08 |
EP1718675B2 (en) | 2017-01-25 |
CA2557229C (en) | 2012-07-10 |
EP1718675B1 (en) | 2013-04-10 |
EP2277915A1 (en) | 2011-01-26 |
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