ES2184594A1 - 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
ES2184594A1
ES2184594A1 ES200100101A ES200100101A ES2184594A1 ES 2184594 A1 ES2184594 A1 ES 2184594A1 ES 200100101 A ES200100101 A ES 200100101A ES 200100101 A ES200100101 A ES 200100101A ES 2184594 A1 ES2184594 A1 ES 2184594A1
Authority
ES
Spain
Prior art keywords
peg
content
ultrafiltration
contaminants
virus
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.)
Granted
Application number
ES200100101A
Other languages
English (en)
Other versions
ES2184594B1 (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 CZ20020131A priority patent/CZ300413B6/cs
Priority to ES02380009T priority patent/ES2295308T3/es
Priority to PT02380009T priority patent/PT1225180E/pt
Priority to AT02380009T priority patent/ATE382631T1/de
Priority to DE60224310T priority patent/DE60224310T2/de
Priority to EP02380009A priority patent/EP1225180B1/en
Priority to ARP020100114A priority patent/AR032242A1/es
Priority to UY27126A priority patent/UY27126A1/es
Priority to US10/052,324 priority patent/US6875848B2/en
Priority to MXPA02000639A priority patent/MXPA02000639A/es
Priority to JP2002009029A priority patent/JP4070468B2/ja
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)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biochemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Separation Using Semi-Permeable Membranes (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
EP02380009A EP1225180B1 (en) 2001-01-17 2002-01-11 Process for the production of virus-inactivated human gammaglobulin G
CZ20020131A CZ300413B6 (cs) 2001-01-17 2002-01-11 Zpusob výroby humánního gama-globulinu G a viry inaktivovaný humánní gama-globulin G
ES02380009T ES2295308T3 (es) 2001-01-17 2002-01-11 Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
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
DE60224310T DE60224310T2 (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
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.
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
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 true ES2184594A1 (es) 2003-04-01
ES2184594B1 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
ES2558303T3 (es) 2002-09-11 2016-02-03 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
MX2007015476A (es) 2005-06-14 2008-02-25 Amgen Inc Formulaciones de proteina autoamortiguadoras.
US7879332B2 (en) * 2005-09-01 2011-02-01 Plasma Technologies, Llc 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
US20070049732A1 (en) * 2005-09-01 2007-03-01 Zurlo Eugene J 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
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
MX346115B (es) 2009-08-06 2017-03-08 Genentech Inc * Metodo para mejorar la eliminación de virus en la purificacion proteica.
MX2012003282A (es) 2009-09-17 2012-04-30 Baxter Healthcare Sa Co-formulacion estable de hialuronidasa e inmunoglobulina, y metodos de su uso.
US9884904B2 (en) * 2010-03-10 2018-02-06 Hoffmann-La Roche Inc. Method for purifying polypeptide solutions
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
CN114225072B (zh) 2014-04-15 2024-01-02 勃林格殷格翰国际公司 在制造生物制品期间连续灭活病毒的方法、装置和系统
MY191616A (en) * 2014-06-12 2022-07-03 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
HUE043180T2 (hu) 2014-06-12 2019-08-28 Biosyn Arzneimittel Gmbh Rák kezelésére, konjugált terápiás vakcinák fejlesztésére és aktiválószerként alkalmazott biológiailag biztonságos KLH termékek új generációjának elõállítási eljárásai
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
RS59340B1 (sr) 2014-11-06 2019-10-31 Hoffmann La Roche Varijante fc regiona sa modifikovanim vezivanjem za fcrn i metode upotrebe
TR201905974T4 (tr) 2015-08-31 2019-05-21 Inst Grifols S A İmmünoglobuli̇nleri̇n hazirlanmasi i̇çi̇n yöntem
CA3012694A1 (en) 2016-02-03 2017-08-10 Plasma Technologies, Llc Methods for extracting proteins from a blood-based material
US11407981B2 (en) 2016-03-11 2022-08-09 Boehringer Ingelheim International Gmbh 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
AU2017345490B2 (en) 2016-10-21 2022-07-07 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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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4164495A (en) * 1976-04-06 1979-08-14 Nordisk Insulinlaboratorium Method of recovering immunoglobulin using a polyol and an alkanoic acid
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
WO1999064462A1 (en) * 1998-06-09 1999-12-16 Statens Serum Institut Process for producing immunoglobulins for intravenous administration and other immunoglobulin products

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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
EP0116571B2 (en) * 1982-08-30 1997-10-29 BAXTER INTERNATIONAL INC. (a Delaware corporation) Method for making gamma globulin-containing compositions
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
DK0659767T4 (da) * 1993-12-27 2003-02-10 Zlb Bioplasma Ag Fremgangsmåde til fremstilling af et koncentrat af anti-D-immunoglobulin G og et farmaceutisk præparat, som indeholder dette
US6124437A (en) * 1997-03-19 2000-09-26 Welfide Corporation Immunoglobulin preparation and preparation process thereof
IL121900A (en) * 1997-10-07 2001-12-23 Omrix Biopharmaceuticals Ltd A method for the purification of immunoglobulins
US6159471A (en) * 1997-10-23 2000-12-12 Yoshitomi Pharmaceutical Industries, Ltd. Room temperature storable immunoglobulin preparation for intravenous injection
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)
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Publication number Priority date Publication date Assignee Title
US4164495A (en) * 1976-04-06 1979-08-14 Nordisk Insulinlaboratorium Method of recovering immunoglobulin using a polyol and an alkanoic acid
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
WO1999064462A1 (en) * 1998-06-09 1999-12-16 Statens Serum Institut Process for producing immunoglobulins for intravenous administration and other immunoglobulin products

Also Published As

Publication number Publication date
HU228252B1 (en) 2013-02-28
ES2184594B1 (es) 2004-01-01
EP1225180A2 (en) 2002-07-24
UY27126A1 (es) 2002-07-31
HUP0200103A3 (en) 2004-10-28
US20020151688A1 (en) 2002-10-17
DE60224310T2 (de) 2009-01-08
SK582002A3 (en) 2002-10-08
HUP0200103A2 (hu) 2003-08-28
PT1225180E (pt) 2008-03-18
US6875848B2 (en) 2005-04-05
MXPA02000639A (es) 2004-11-01
CZ300413B6 (cs) 2009-05-13
AR032242A1 (es) 2003-10-29
DE60224310D1 (de) 2008-02-14
JP2003002896A (ja) 2003-01-08
EP1225180A3 (en) 2004-01-28
ES2295308T3 (es) 2008-04-16
CZ2002131A3 (cs) 2002-09-11
EP1225180B1 (en) 2008-01-02
JP4070468B2 (ja) 2008-04-02
HU0200103D0 (en) 2002-03-28
ATE382631T1 (de) 2008-01-15
HK1048324B (en) 2008-02-22
HK1048324A1 (en) 2003-03-28
SK287633B6 (sk) 2011-04-05

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