HUP0200103A2 - Eljárás vírus-inaktivált humán gamma-globulin G előállítására - Google Patents

Eljárás vírus-inaktivált humán gamma-globulin G előállítására

Info

Publication number
HUP0200103A2
HUP0200103A2 HU0200103A HUP0200103A HUP0200103A2 HU P0200103 A2 HUP0200103 A2 HU P0200103A2 HU 0200103 A HU0200103 A HU 0200103A HU P0200103 A HUP0200103 A HU P0200103A HU P0200103 A2 HUP0200103 A2 HU P0200103A2
Authority
HU
Hungary
Prior art keywords
virus
followed
peg
production
inactivated human
Prior art date
Application number
HU0200103A
Other languages
English (en)
Inventor
Teresa López Hernández
Francisco Rabaneda Giménez
Pere Ristol Debart
Original Assignee
Probitas Pharma, S.A.
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, S.A. filed Critical Probitas Pharma, S.A.
Publication of HU0200103D0 publication Critical patent/HU0200103D0/hu
Publication of HUP0200103A2 publication Critical patent/HUP0200103A2/hu
Publication of HUP0200103A3 publication Critical patent/HUP0200103A3/hu
Publication of HU228252B1 publication Critical patent/HU228252B1/hu

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)
  • 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

A találmány tárgya eljárás vírus-inaktivált humán gamma-globulin Gelőállítására, amely szerint a gamma-globulint etanollal történőfrakcionálással elválasztott frakcióból extrahálják szénhidrátjelenlétében, majd PEG-gel csökkentik a szennyeződések mennyiségét,felviszik egy anioncserélő oszlopra, egy elfolyó folyadékot kapnak,amelynek PEG-tartalmát ezt követően ultraszűréssel csökkentik és afolyadékot betöményítik. Ezután egymást követően egy opcionáliskezelést végeznek savas pH-n, majd legalább egy vírus-inaktiválólépést, amely pasztőrözésből és oldószer/detergens eleggyel valókezelésből áll, ezután a terméket kicsapják és PEG-gel mossák, hogyeltávolítsák a kémiai vírus-inaktiváló reagenseket, majdszolubilizálással és a pH-t megváltoztatva a fehérje szennyeződéseketis, végül ultraszűréssel tisztítják, majd adott esetben vírusszűrésthajtanak végre és ezután 5% vagy 10% fehérje értékre valóbetöményítést végeznek. Ó
HU0200103A 2001-01-17 2002-01-10 Process for the production of virus-inactivated human gammaglobulin g HU228252B1 (en)

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 (4)

Publication Number Publication Date
HU0200103D0 HU0200103D0 (en) 2002-03-28
HUP0200103A2 true HUP0200103A2 (hu) 2003-08-28
HUP0200103A3 HUP0200103A3 (en) 2004-10-28
HU228252B1 HU228252B1 (en) 2013-02-28

Family

ID=8496419

Family Applications (1)

Application Number Title Priority Date Filing Date
HU0200103A HU228252B1 (en) 2001-01-17 2002-01-10 Process for the production of virus-inactivated human gammaglobulin g

Country Status (14)

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

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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
SI1561756T1 (sl) 2002-09-11 2016-02-29 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
EA012801B1 (ru) 2005-06-14 2009-12-30 Эмджен Инк. Самобуферирующиеся композиции белков
US7879332B2 (en) * 2005-09-01 2011-02-01 Plasma Technologies, Llc Ultra-high yield intravenous immune globulin preparation
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
JP2008094722A (ja) * 2006-10-05 2008-04-24 Benesis Corp 免疫グロブリン製剤の製造方法
US20080214795A1 (en) * 2007-02-14 2008-09-04 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
KR20190018041A (ko) 2009-08-06 2019-02-20 제넨테크, 인크. 단백질 정제 시의 바이러스 제거의 개선방법
PT2477603E (pt) 2009-09-17 2016-06-16 Baxalta Inc Co-formulação estável de hialuronidase e imunoglobulina e métodos para a sua utilização
EP2545066B1 (en) * 2010-03-10 2017-09-20 F. Hoffmann-La Roche AG Method for purifying immunoglobulin solutions
US20130172536A1 (en) * 2011-08-16 2013-07-04 Shenzhen Weiguang Biological Products Co.,Ltd. Intravenous Cytomegalovirus Human Immune Globulin and Manufacturing Method Thereof
ES2381828B1 (es) * 2012-03-20 2012-11-16 Grifols, S.A. PROCEDIMIENTO PARA OBTENER UNA COMPOSICION DE IgG MEDIANTE TRATAMIENTO TERMICO
DK3131589T3 (da) 2014-04-15 2023-08-07 Boehringer Ingelheim Int Fremgangsmåde og anvendelse til fortløbende inaktivering af en virus under tilvejebringelse af et biologisk produkt
PT3154597T (pt) * 2014-06-12 2019-05-08 Biosyn Arzneimittel Gmbh Métodos de preparação para uma nova geração de produtos biológicos de klh seguros utilizados para o tratamento de cancro, para o desenvolvimento de de vacinas conjugadas terapêuticas e como agentes competitivos
DK3154578T3 (en) 2014-06-12 2019-04-15 Biosyn Arzneimittel Gmbh Preparation Methods for a New Generation of Biologically Safe KLH Products Used for Cancer Treatment, for the Development of Conjugated Therapeutic Vaccines, and as Provocation Test Substances
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
PL3215528T3 (pl) 2014-11-06 2020-01-31 F.Hoffmann-La Roche Ag Warianty regionu Fc ze zmodyfikowanym wiązaniem FcRn i sposoby stosowania
TR201905974T4 (tr) 2015-08-31 2019-05-21 Inst Grifols S A İmmünoglobuli̇nleri̇n hazirlanmasi i̇çi̇n yöntem
WO2017136785A1 (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
EP3528787A4 (en) 2016-10-21 2020-05-06 Amgen Inc. PHARMACEUTICAL FORMULATIONS AND PROCESSES FOR THEIR PREPARATION
US10815270B1 (en) 2019-09-20 2020-10-27 Plasma Technologies, Llc Compositions and methods for high efficiency protein precipitation

Family Cites Families (14)

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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
WO1984000891A1 (en) * 1982-08-30 1984-03-15 Baxter Travenol Lab Method for making gamma globulin-containing compositions
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
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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
CN1149100C (zh) * 1997-10-23 2004-05-12 三菱制药株式会社 可室温贮存的免疫球蛋白静脉注射制剂
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
UY27126A1 (es) 2002-07-31
SK287633B6 (sk) 2011-04-05
US6875848B2 (en) 2005-04-05
EP1225180B1 (en) 2008-01-02
JP2003002896A (ja) 2003-01-08
ES2184594A1 (es) 2003-04-01
HU0200103D0 (en) 2002-03-28
CZ300413B6 (cs) 2009-05-13
ATE382631T1 (de) 2008-01-15
ES2295308T3 (es) 2008-04-16
AR032242A1 (es) 2003-10-29
HK1048324A1 (en) 2003-03-28
CZ2002131A3 (cs) 2002-09-11
ES2184594B1 (es) 2004-01-01
DE60224310D1 (de) 2008-02-14
JP4070468B2 (ja) 2008-04-02
EP1225180A2 (en) 2002-07-24
MXPA02000639A (es) 2004-11-01
HK1048324B (zh) 2008-02-22
US20020151688A1 (en) 2002-10-17
PT1225180E (pt) 2008-03-18
DE60224310T2 (de) 2009-01-08
SK582002A3 (en) 2002-10-08
HU228252B1 (en) 2013-02-28
EP1225180A3 (en) 2004-01-28
HUP0200103A3 (en) 2004-10-28

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Legal Events

Date Code Title Description
HC9A Change of name, address

Owner name: GRIFOLS, S.A., ES

Free format text: FORMER OWNER(S): PROBITAS PHARMA, S.A., ES; GRIFOLS, S.A., ES