AR032242A1 - Procedimiento para la produccion de gamma globulina g humana inactivada de virus - Google Patents

Procedimiento para la produccion de gamma globulina g humana inactivada de virus

Info

Publication number
AR032242A1
AR032242A1 ARP020100114A ARP020100114A AR032242A1 AR 032242 A1 AR032242 A1 AR 032242A1 AR P020100114 A ARP020100114 A AR P020100114A AR P020100114 A ARP020100114 A AR P020100114A AR 032242 A1 AR032242 A1 AR 032242A1
Authority
AR
Argentina
Prior art keywords
peg
content
ultrafiltration
inactivada
globulina
Prior art date
Application number
ARP020100114A
Other languages
English (en)
Inventor
Debart Pere Ristol
Gimenez Francisco Rabaneda
Hernandez Maria Teresa Lopez
Original Assignee
Grifols 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 Grifols Sa filed Critical Grifols Sa
Publication of AR032242A1 publication Critical patent/AR032242A1/es

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

Se efectua la extraccion de la gammaglobulina de una fraccion 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 anionico obteniéndose un efluente cuyo contenido de PEG es posteriormente reducido por ultrafiltracion 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 inactividad vírica, consistentes en una pasteurizacion y un tratamiento con solvente-detergente, siendo después el producto precipitado y lavado con PEG para eliminar los eventualmente reactivos químicos de inactivacion vírica y luego, por solubilizacion y cambio de pH, los contaminantes proteicos, y finalmente purificado por ultrafiltracion para deducir el volumen y el contenido de PEG, efectuando luego una eventual filtracion de virus y posterior concentracion hasta el valor de proteína del 5% o 10%.
ARP020100114A 2001-01-17 2002-01-15 Procedimiento para la produccion de gamma globulina g humana inactivada de virus AR032242A1 (es)

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 (1)

Publication Number Publication Date
AR032242A1 true AR032242A1 (es) 2003-10-29

Family

ID=8496419

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP020100114A AR032242A1 (es) 2001-01-17 2002-01-15 Procedimiento para la produccion de gamma globulina 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

Family Cites Families (14)

* 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
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
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
US6441144B1 (en) * 1999-05-20 2002-08-27 Alpha Therapeutic Corporation Method for repairing dual virally inactivated immune globulin for intravenous administration

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
SK287633B6 (sk) 2011-04-05
DE60224310T2 (de) 2009-01-08
MXPA02000639A (es) 2004-11-01
ES2184594B1 (es) 2004-01-01
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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