ES2184594B1 - Procedimiento para la produccion de gammaglobulina g humana inactivada de virus. - Google Patents

Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.

Info

Publication number
ES2184594B1
ES2184594B1 ES200100101A ES200100101A ES2184594B1 ES 2184594 B1 ES2184594 B1 ES 2184594B1 ES 200100101 A ES200100101 A ES 200100101A ES 200100101 A ES200100101 A ES 200100101A ES 2184594 B1 ES2184594 B1 ES 2184594B1
Authority
ES
Spain
Prior art keywords
peg
content
virus
procedure
production
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 - Fee Related
Application number
ES200100101A
Other languages
English (en)
Other versions
ES2184594A1 (es
Inventor
Debart Pere Ristol
Gimenez Francisco Rabaneda
Hernandez M Teresa Lopez
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Probitas Pharma SA
Original Assignee
Probitas Pharma SA
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Probitas Pharma SA filed Critical Probitas Pharma SA
Priority to ES200100101A priority Critical patent/ES2184594B1/es
Priority to HU0200103A priority patent/HU228252B1/hu
Priority to SK58-2002A priority patent/SK287633B6/sk
Priority to ES02380009T priority patent/ES2295308T3/es
Priority to CZ20020131A priority patent/CZ300413B6/cs
Priority to EP02380009A priority patent/EP1225180B1/en
Priority to PT02380009T priority patent/PT1225180E/pt
Priority to AT02380009T priority patent/ATE382631T1/de
Priority to DE60224310T priority patent/DE60224310T2/de
Priority to ARP020100114A priority patent/AR032242A1/es
Priority to UY27126A priority patent/UY27126A1/es
Priority to JP2002009029A priority patent/JP4070468B2/ja
Priority to US10/052,324 priority patent/US6875848B2/en
Priority to MXPA02000639A priority patent/MXPA02000639A/es
Priority to HK03100521.5A priority patent/HK1048324B/en
Publication of ES2184594A1 publication Critical patent/ES2184594A1/es
Application granted granted Critical
Publication of ES2184594B1 publication Critical patent/ES2184594B1/es
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Procedimiento para la producción de gammaglobulina G humana inactivada de virus. Se efectúa la extracción de la gammaglobulina de una fracción aislada por fraccionamiento con etanol en presencia de un carbohidrato, y después de reducir el contenido de contaminantes con PEG, se aplica a una columna de resinas de intercambio aniónico obteniéndose un efluente cuyo contenido de PEG es posteriormente reducido por ultrafiltración y se concentra para llevar a cabo de forma secuencial un eventual tratamiento a pH ácido y al menos una de las siguientes etapas de inactivación vírica, consistentes en una pasteurización y un tratamiento con solvente-detergente, siendo después el producto precipitado y lavado con PEG para eliminar los eventuales reactivos químicos de inactivación vírica y luego, por solubilización y cambio de pH, los contaminantes proteicos, y finalmente purificado por ultrafiltración para reducir el volumen y el contenido de PEG, efectuando luego una eventual filtración de virus y posterior concentración hasta el valor de proteína del 5% ó 10%.
ES200100101A 2001-01-17 2001-01-17 Procedimiento para la produccion de gammaglobulina g humana inactivada de virus. Expired - Fee Related ES2184594B1 (es)

Priority Applications (15)

Application Number Priority Date Filing Date Title
ES200100101A ES2184594B1 (es) 2001-01-17 2001-01-17 Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
HU0200103A HU228252B1 (en) 2001-01-17 2002-01-10 Process for the production of virus-inactivated human gammaglobulin g
DE60224310T DE60224310T2 (de) 2001-01-17 2002-01-11 Verfahren zur Herstellung von virusinaktiviertem humanem Gammaglobulin G
ES02380009T ES2295308T3 (es) 2001-01-17 2002-01-11 Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
CZ20020131A CZ300413B6 (cs) 2001-01-17 2002-01-11 Zpusob výroby humánního gama-globulinu G a viry inaktivovaný humánní gama-globulin G
EP02380009A EP1225180B1 (en) 2001-01-17 2002-01-11 Process for the production of virus-inactivated human gammaglobulin G
PT02380009T PT1225180E (pt) 2001-01-17 2002-01-11 Processo relativo a produção de gamaglobulina g humana com vírus inactivado
AT02380009T ATE382631T1 (de) 2001-01-17 2002-01-11 Verfahren zur herstellung von virusinaktiviertem humanem gammaglobulin g
SK58-2002A SK287633B6 (sk) 2001-01-17 2002-01-11 Spôsob výroby humánneho gamaglobulínu G a humánny gamaglobulín G s inaktivovanými vírusmi
ARP020100114A AR032242A1 (es) 2001-01-17 2002-01-15 Procedimiento para la produccion de gamma globulina g humana inactivada de virus
UY27126A UY27126A1 (es) 2001-01-17 2002-01-16 Procedimiento para la producción de gammaglobulina g humana inactiva de virus
JP2002009029A JP4070468B2 (ja) 2001-01-17 2002-01-17 ウイルス不活性化ヒトγグロブリンＧを生成するための方法
US10/052,324 US6875848B2 (en) 2001-01-17 2002-01-17 Process for the production of virus-inactivated human gammaglobulin G
MXPA02000639A MXPA02000639A (es) 2001-01-17 2002-01-17 Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
HK03100521.5A HK1048324B (en) 2001-01-17 2003-01-21 Process for the production of virus-inactivated human gammaglobulin g

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ES200100101A ES2184594B1 (es) 2001-01-17 2001-01-17 Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.

Publications (2)

Publication Number Publication Date
ES2184594A1 ES2184594A1 (es) 2003-04-01
ES2184594B1 true ES2184594B1 (es) 2004-01-01

Family

ID=8496419

Family Applications (2)

Application Number Title Priority Date Filing Date
ES200100101A Expired - Fee Related ES2184594B1 (es) 2001-01-17 2001-01-17 Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
ES02380009T Expired - Lifetime ES2295308T3 (es) 2001-01-17 2002-01-11 Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.

Family Applications After (1)

Application Number Title Priority Date Filing Date
ES02380009T Expired - Lifetime ES2295308T3 (es) 2001-01-17 2002-01-11 Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.

Country Status (14)

Country Link
US (1) US6875848B2 (es)
EP (1) EP1225180B1 (es)
JP (1) JP4070468B2 (es)
AR (1) AR032242A1 (es)
AT (1) ATE382631T1 (es)
CZ (1) CZ300413B6 (es)
DE (1) DE60224310T2 (es)
ES (2) ES2184594B1 (es)
HK (1) HK1048324B (es)
HU (1) HU228252B1 (es)
MX (1) MXPA02000639A (es)
PT (1) PT1225180E (es)
SK (1) SK287633B6 (es)
UY (1) UY27126A1 (es)

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US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
ES2626268T3 (es) 2002-09-11 2017-07-24 Chugai Seiyaku Kabushiki Kaisha Método de purificación de proteínas
US20060051347A1 (en) 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
AU2005229674B2 (en) * 2004-11-18 2010-11-04 Kedrion Melville Inc. Low concentration solvent/detergent process of immuneglobulin with pre-treatment
WO2006138181A2 (en) 2005-06-14 2006-12-28 Amgen Inc. Self-buffering protein formulations
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
US7879332B2 (en) * 2005-09-01 2011-02-01 Plasma Technologies, Llc Ultra-high yield intravenous immune globulin preparation
JP2008094722A (ja) * 2006-10-05 2008-04-24 Benesis Corp 免疫グロブリン製剤の製造方法
WO2008100578A2 (en) * 2007-02-14 2008-08-21 Amgen Inc. Method of isolating antibodies by precipitation
TWI532498B (zh) 2008-03-17 2016-05-11 巴克斯特保健公司 供免疫球蛋白及玻尿酸酶之皮下投藥之用的組合及方法
AU2010292897B2 (en) 2009-08-06 2016-01-07 Genentech, Inc. Method to improve virus removal in protein purification
CN102655853B (zh) 2009-09-17 2015-07-29 巴克斯特卫生保健有限公司 透明质酸酶和免疫球蛋白的稳定的复合制剂及其使用方法
ES2648264T3 (es) * 2010-03-10 2017-12-29 F. Hoffmann-La Roche Ag Procedimiento para la purificación de soluciones de inmunoglobulinas
WO2013023362A1 (zh) * 2011-08-16 2013-02-21 深圳市卫武光明生物制品有限公司 静注巨细胞病毒人免疫球蛋白及其制备方法
ES2381828B1 (es) 2012-03-20 2012-11-16 Grifols, S.A. PROCEDIMIENTO PARA OBTENER UNA COMPOSICION DE IgG MEDIANTE TRATAMIENTO TERMICO
EP3119490B1 (en) 2014-03-21 2021-09-08 F. Hoffmann-La Roche AG In vitro prediction of in vivo half-life of antibodies
EP4234569A3 (en) 2014-04-15 2023-10-18 Boehringer Ingelheim International GmbH Method and use for continuously inactivating a virus during manufacture of a biological product
LT3154597T (lt) * 2014-06-12 2019-02-25 Biosyn Arzneimittel Gmbh Naujos kartos biologiniu požiuriu saugių klh produktų, skirtų vėžiui gydyti, gavimo būdai, skirti konjuguotų terapinių vakcinų ir kaip stimuliuojančių agentų pagerinimui
CA2951735C (en) 2014-06-12 2020-06-30 Biosyn Arzneimittel Gmbh Preparation methods for a novel generation of biological safe klh products used for cancer treatment, for the development of conjugated therapeutic vaccines and as challenging agents
JP6521351B2 (ja) 2014-10-14 2019-05-29 テックプロジェクトサービス株式会社 ウィルス不活化およびサンプリング装置
EP3215528B1 (en) 2014-11-06 2019-08-07 F.Hoffmann-La Roche Ag Fc-region variants with modified fcrn-binding and methods of use
TR201905974T4 (tr) 2015-08-31 2019-05-21 Inst Grifols S A İmmünoglobuli̇nleri̇n hazirlanmasi i̇çi̇n yöntem
JP6946313B2 (ja) 2016-02-03 2021-10-06 プラズマ テクノロジーズ エルエルシーＰｌａｓｍａ Ｔｅｃｈｎｏｌｏｇｉｅｓ， Ｌｌｃ 血液系物質からタンパク質を抽出する方法
SG11201807824UA (en) 2016-03-11 2018-10-30 Boehringer Ingelheim Int Methods for continuously inactivating a virus during manufacture of a protein
KR102372105B1 (ko) * 2016-09-26 2022-03-07 인스티투토 그리폴스, 에스.아. 면역글로블린의 제조방법
ES3064802T3 (en) 2016-10-21 2026-04-29 Amgen Inc Pharmaceutical formulations and methods of making the same
US10815270B1 (en) 2019-09-20 2020-10-27 Plasma Technologies, Llc Compositions and methods for high efficiency protein precipitation

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US4164495A (en) * 1976-04-06 1979-08-14 Nordisk Insulinlaboratorium Method of recovering immunoglobulin using a polyol and an alkanoic acid
US4374763A (en) * 1979-09-17 1983-02-22 Morishita Pharmaceutical Co., Ltd. Method for producing gamma-globulin for use in intravenous administration and method for producing a pharmaceutical preparation thereof
DE3382394D1 (de) * 1982-08-30 1991-10-02 Baxter Travenol Lab Verfahren zur herstellung von gamma-globulin enthaltenden zusammensetzungen.
US5234685A (en) * 1983-03-16 1993-08-10 Immuno Aktiengesellschaft Fur Chemisch-Medizinische Produkte Method of determining incompatibility-reaction-causing substances in blood products as well as a method of inactivating said incompatibility-reaction-causing substances
JP2547556B2 (ja) * 1987-02-06 1996-10-23 株式会社 ミドリ十字 ｒ−グロブリンの液状製剤
US5177194A (en) * 1990-02-01 1993-01-05 Baxter International, Inc. Process for purifying immune serum globulins
DE59309332D1 (de) * 1993-12-27 1999-03-04 Rotkreuzstiftung Zentratrallab 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
IL121900A (en) * 1997-10-07 2001-12-23 Omrix Biopharmaceuticals Ltd A method for the purification of immunoglobulins
ES2182202T5 (es) * 1997-10-23 2007-12-01 Mitsubishi Pharma Corporation Preparacion de inmunoglobulinas para inyeccion intravenosa apta para ser almacenada a temperatura ambiente.
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)
IL140155A (en) * 1998-06-09 2005-12-18 Statens Seruminstitut Process for producing immunoglobulins for intravenous administration and other immunoglobulin products
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Also Published As

Publication number Publication date
JP2003002896A (ja) 2003-01-08
US20020151688A1 (en) 2002-10-17
EP1225180A2 (en) 2002-07-24
ES2295308T3 (es) 2008-04-16
JP4070468B2 (ja) 2008-04-02
DE60224310D1 (de) 2008-02-14
HUP0200103A3 (en) 2004-10-28
ATE382631T1 (de) 2008-01-15
UY27126A1 (es) 2002-07-31
HK1048324B (en) 2008-02-22
PT1225180E (pt) 2008-03-18
SK582002A3 (en) 2002-10-08
HUP0200103A2 (hu) 2003-08-28
AR032242A1 (es) 2003-10-29
SK287633B6 (sk) 2011-04-05
DE60224310T2 (de) 2009-01-08
MXPA02000639A (es) 2004-11-01
HU0200103D0 (en) 2002-03-28
ES2184594A1 (es) 2003-04-01
HU228252B1 (en) 2013-02-28
HK1048324A1 (en) 2003-03-28
EP1225180B1 (en) 2008-01-02
CZ2002131A3 (cs) 2002-09-11
CZ300413B6 (cs) 2009-05-13
US6875848B2 (en) 2005-04-05
EP1225180A3 (en) 2004-01-28

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