MXPA02000639A - 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
MXPA02000639A
MXPA02000639A MXPA02000639A MXPA02000639A MXPA02000639A MX PA02000639 A MXPA02000639 A MX PA02000639A MX PA02000639 A MXPA02000639 A MX PA02000639A MX PA02000639 A MXPA02000639 A MX PA02000639A MX PA02000639 A MXPA02000639 A MX PA02000639A
Authority
MX
Mexico
Prior art keywords
peg
content
ultrafiltration
contaminants
virus
Prior art date
Application number
MXPA02000639A
Other languages
English (en)
Inventor
Hernandez Ma Teresa Lopez
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
Publication of MXPA02000639A publication Critical patent/MXPA02000639A/es

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
    • 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)
  • Investigating Or Analysing Biological Materials (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)

Abstract

Se efectua la extraccion de la gammaglobulina de una fraccion aislada por fraccionamiento con etanol en presencia de un carbohidrato, y despues de reducir el contenido de contaminantes con PEG, se aplica a una columna de resinas de intercambio anionico obteniendose 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 acido y al menos una de las siguientes etapas de inactivacion virica, consistentes en una pasteurizacion y un tratamiento con solvente-detergente, siendo despues el producto precipitado y lavado con PEG para eliminar los eventuales reactivos quimicos de inactivacion virica y luego, por solubilizacion y cambio de pH, los contaminantes proteicos, y finalmente purificado por ultrafiltracion para reducir el volumen y el contenido de PEG, efectuando luego una eventual filtracion de virus y posterior concentracion hasta el valor de proteina del 5% o 10%.
MXPA02000639A 2001-01-17 2002-01-17 Procedimiento para la produccion de gammaglobulina g humana inactivada de virus. MXPA02000639A (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
MXPA02000639A true MXPA02000639A (es) 2004-11-01

Family

ID=8496419

Family Applications (1)

Application Number Title Priority Date Filing Date
MXPA02000639A MXPA02000639A (es) 2001-01-17 2002-01-17 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
SI2261230T1 (sl) 2002-09-11 2017-08-31 Chugai Seiyaku Kabushiki Kaisha Postopek čiščenja proteinov
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
EP1909831A4 (en) 2005-06-14 2013-02-20 Amgen Inc PREPARATIONS OF SPONTANEOUS TAMPING PROTEINS
US20070049732A1 (en) * 2005-09-01 2007-03-01 Zurlo Eugene J Ultra-high yield intravenous immune globulin preparation
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
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
BR112012002574A2 (pt) 2009-08-06 2020-11-03 Genentech, Inc. método para aprimorar a remoção de vírus na purificação de proteínas
MX2012003282A (es) 2009-09-17 2012-04-30 Baxter Healthcare Sa Co-formulacion estable de hialuronidasa e inmunoglobulina, y metodos de su uso.
JP5814951B2 (ja) * 2010-03-10 2015-11-17 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ 免疫グロブリン溶液を精製するための方法
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
CN111632167B (zh) 2014-04-15 2021-12-28 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
ES2717683T3 (es) 2014-06-12 2019-06-24 Biosyn Arzneimittel Gmbh Métodos de preparación para una generación novedosa de productos de KLH biológicamente seguros usados para el tratamiento contra el cáncer, para el desarrollo de vacunas terapéuticas conjugadas y como agentes de exposición
US10221220B2 (en) 2014-06-12 2019-03-05 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
ES2749383T3 (es) 2014-11-06 2020-03-20 Hoffmann La Roche Variantes de la región Fc con unión al FcRn modificada y procedimientos de uso
PL3135687T3 (pl) 2015-08-31 2019-09-30 Instituto Grifols, S.A. Sposób wytwarzania immunoglobulin
WO2017136785A1 (en) 2016-02-03 2017-08-10 Plasma Technologies, Llc Methods for extracting proteins from a blood-based material
EP3426683A1 (en) 2016-03-11 2019-01-16 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
JP6884858B2 (ja) 2016-10-21 2021-06-09 アムジエン・インコーポレーテツド 医薬製剤及びその製造方法
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
ATE66616T1 (de) * 1982-08-30 1991-09-15 Baxter Int 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
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
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
PT911037E (pt) * 1997-10-23 2002-12-31 Mitsubishi Pharma Corp Preparacao de imunoglobulina armazenavel a temperatura ambiente para injeccao intravenosa
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)
DK2270044T3 (en) * 1998-06-09 2015-01-26 Csl Behring Ag Liquid immunoglobulin G (IgG) product
AU753468B2 (en) * 1998-06-09 2002-10-17 Csl Behring Ag Process for producing immunoglobulins for intravenous administration and other immunoglobulin products
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
SK582002A3 (en) 2002-10-08
EP1225180A2 (en) 2002-07-24
ATE382631T1 (de) 2008-01-15
HUP0200103A2 (hu) 2003-08-28
HUP0200103A3 (en) 2004-10-28
PT1225180E (pt) 2008-03-18
ES2184594B1 (es) 2004-01-01
SK287633B6 (sk) 2011-04-05
US6875848B2 (en) 2005-04-05
US20020151688A1 (en) 2002-10-17
JP2003002896A (ja) 2003-01-08
EP1225180B1 (en) 2008-01-02
HU0200103D0 (en) 2002-03-28
ES2295308T3 (es) 2008-04-16
CZ300413B6 (cs) 2009-05-13
HK1048324B (zh) 2008-02-22
CZ2002131A3 (cs) 2002-09-11
DE60224310D1 (de) 2008-02-14
ES2184594A1 (es) 2003-04-01
HK1048324A1 (en) 2003-03-28
JP4070468B2 (ja) 2008-04-02
HU228252B1 (en) 2013-02-28
AR032242A1 (es) 2003-10-29
UY27126A1 (es) 2002-07-31
DE60224310T2 (de) 2009-01-08
EP1225180A3 (en) 2004-01-28

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