AU2013201853B2 - Process for obtaining an lgG composition through heat treatment - Google Patents

Process for obtaining an lgG composition through heat treatment Download PDF

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Publication number
AU2013201853B2
AU2013201853B2 AU2013201853A AU2013201853A AU2013201853B2 AU 2013201853 B2 AU2013201853 B2 AU 2013201853B2 AU 2013201853 A AU2013201853 A AU 2013201853A AU 2013201853 A AU2013201853 A AU 2013201853A AU 2013201853 B2 AU2013201853 B2 AU 2013201853B2
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AU
Australia
Prior art keywords
igg
process according
solution
carried out
weight
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AU2013201853A
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AU2013201853A1 (en
Inventor
Salvador Grancha Gamon
Pere Ristol Debart
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Grifols SA
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Grifols SA
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Application filed by Grifols SA filed Critical Grifols SA
Publication of AU2013201853A1 publication Critical patent/AU2013201853A1/en
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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39516—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
    • A61K39/39525—Purification
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, 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
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/18—Ion-exchange chromatography
    • 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
    • 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

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Analytical Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Confectionery (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
AU2013201853A 2012-03-20 2013-03-19 Process for obtaining an lgG composition through heat treatment Active AU2013201853B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES201230413 2012-03-20
ES201230413A ES2381828B1 (es) 2012-03-20 2012-03-20 PROCEDIMIENTO PARA OBTENER UNA COMPOSICION DE IgG MEDIANTE TRATAMIENTO TERMICO

Publications (2)

Publication Number Publication Date
AU2013201853A1 AU2013201853A1 (en) 2013-10-10
AU2013201853B2 true AU2013201853B2 (en) 2014-07-03

Family

ID=46053016

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2013201853A Active AU2013201853B2 (en) 2012-03-20 2013-03-19 Process for obtaining an lgG composition through heat treatment

Country Status (21)

Country Link
US (1) US9200032B2 (enExample)
EP (1) EP2641912B1 (enExample)
JP (2) JP6048936B2 (enExample)
KR (1) KR101840064B1 (enExample)
CN (1) CN103319592B (enExample)
AR (1) AR090337A1 (enExample)
AU (1) AU2013201853B2 (enExample)
BR (1) BR102013006411A2 (enExample)
CA (1) CA2809513C (enExample)
CL (1) CL2013000688A1 (enExample)
ES (2) ES2381828B1 (enExample)
HU (1) HUE027915T2 (enExample)
IL (1) IL225197A (enExample)
MX (1) MX339268B (enExample)
MY (1) MY165024A (enExample)
PL (1) PL2641912T3 (enExample)
PT (1) PT2641912T (enExample)
RU (1) RU2636049C2 (enExample)
SG (1) SG193738A1 (enExample)
TW (1) TWI554283B (enExample)
UY (1) UY34679A (enExample)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2990033A1 (fr) * 2014-08-26 2016-03-02 Carlina Technologies Procédé de préparation de nanoprécipites de peptide ou protéine de faible poids moléculaire
PL3135687T3 (pl) * 2015-08-31 2019-09-30 Instituto Grifols, S.A. Sposób wytwarzania immunoglobulin
RU2708394C2 (ru) * 2016-09-26 2019-12-06 Институто Грифольс,С.А. Способ получения иммуноглобулинов
MA52204A (fr) * 2018-04-12 2021-02-17 Amgen Inc Procédés de préparation de compositions protéiques stables
CN112557643B (zh) * 2019-09-26 2023-04-14 菲鹏生物股份有限公司 变性IgG和类风湿因子免疫抗原及制备方法
CN112858671B (zh) * 2019-11-27 2022-12-27 菲鹏生物股份有限公司 制备类风湿因子检测试剂的方法、类风湿因子检测试剂、试剂盒和检测方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2091161A1 (es) * 1995-04-12 1996-10-16 Grifols Grupo Sa Procedimiento para la produccion de gammaglobulina intramascular inactivada por pasteurizacion.
WO1999064462A1 (en) * 1998-06-09 1999-12-16 Statens Serum Institut Process for producing immunoglobulins for intravenous administration and other immunoglobulin products
US6338849B1 (en) * 1998-06-25 2002-01-15 Chengdu Shuyang Pharmaceutical Factory Process of preparing immunoglobulin for intravenous injection by viruses double-sterilized without adding any protectant

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US514375A (en) 1894-02-06 miller
CA1064396A (en) 1975-02-18 1979-10-16 Myer L. Coval Fractional precipitation of gamma globulin with polyethylene glycol
US4165370A (en) 1976-05-21 1979-08-21 Coval M L Injectable gamma globulin
DE3176491D1 (en) 1980-03-05 1987-11-26 Miles Lab Pasteurized therapeutically active protein compositions
US4396608A (en) 1981-08-24 1983-08-02 Cutter Laboratories Intravenously injectable immune serum globulin
ES8206184A1 (es) 1981-10-29 1982-08-16 Green Cross Corp Un procedimiento para preparar una immunoglobulina adecuada para inyeccion intravenosa
US4540573A (en) 1983-07-14 1985-09-10 New York Blood Center, Inc. Undenatured virus-free biologically active protein derivatives
JPH0825902B2 (ja) 1985-02-21 1996-03-13 株式会社ミドリ十字 γ−グロブリンの加熱処理方法
JPH0662436B2 (ja) 1986-05-19 1994-08-17 株式会社ミドリ十字 静注用免疫グロブリン製剤の製造方法
CA1310267C (en) 1986-07-09 1992-11-17 Yutaka Hirao Process for heat treating chemically unmodified _-globulin
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
US4876241A (en) * 1987-05-22 1989-10-24 Armour Pharmaceutical Company Stabilization of biological and pharmaceutical products during thermal inactivation of viral and bacterial contaminants
AT403989B (de) * 1996-09-16 1998-07-27 Immuno Ag Verfahren zur herstellung eines plasmaprotein-hältigen arzneimittels
US5886154A (en) 1997-06-20 1999-03-23 Lebing; Wytold R. Chromatographic method for high yield purification and viral inactivation of antibodies
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)
ES2421736T3 (es) * 1998-06-09 2013-09-05 Csl Behring Ag Procedimiento para la preparación de inmunoglobulinas para administración intravenosa y otros productos inmunoglobulínicos
ES2184594B1 (es) 2001-01-17 2004-01-01 Probitas Pharma Sa Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
ATE468755T1 (de) * 2004-05-07 2010-06-15 Wisconsin Alumni Res Found Verfahren und zusammensetzungen mit molkeproteinisolaten
KR101226353B1 (ko) * 2007-06-01 2013-01-24 에프. 호프만-라 로슈 아게 면역글로불린 정제
US8796430B2 (en) * 2010-05-26 2014-08-05 Baxter International Inc. Method to produce an immunoglobulin preparation with improved yield

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2091161A1 (es) * 1995-04-12 1996-10-16 Grifols Grupo Sa Procedimiento para la produccion de gammaglobulina intramascular inactivada por pasteurizacion.
WO1999064462A1 (en) * 1998-06-09 1999-12-16 Statens Serum Institut Process for producing immunoglobulins for intravenous administration and other immunoglobulin products
US6338849B1 (en) * 1998-06-25 2002-01-15 Chengdu Shuyang Pharmaceutical Factory Process of preparing immunoglobulin for intravenous injection by viruses double-sterilized without adding any protectant

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
AGHAIE A ET AL, HUMAN ANTIBODIES, VOL 19, NO 1, 1 JAN 2010, PAGES 1-6 *
BUCHACHER ANDREA ET AL, BIOTECHNOLOGY JOURNAL, VOL 1, NO 2, 1 FEB 2006, PAGES 148-163 *
RADOSEVICH M ET AL, VOX SANGUINIS, VOL 98, NO 1, 1 JAN 2010, PAGES 12-28 *

Also Published As

Publication number Publication date
AU2013201853A1 (en) 2013-10-10
TW201343179A (zh) 2013-11-01
IL225197A0 (en) 2013-06-27
EP2641912B1 (en) 2016-06-15
SG193738A1 (en) 2013-10-30
MX339268B (es) 2016-05-18
MX2013002910A (es) 2013-09-19
KR101840064B1 (ko) 2018-03-19
UY34679A (es) 2013-10-31
ES2381828A1 (es) 2012-06-01
US20140113355A1 (en) 2014-04-24
TWI554283B (zh) 2016-10-21
AR090337A1 (es) 2014-11-05
JP6048936B2 (ja) 2016-12-21
IL225197A (en) 2017-06-29
HK1185625A1 (en) 2014-02-21
JP2016199586A (ja) 2016-12-01
CN103319592A (zh) 2013-09-25
PT2641912T (pt) 2016-08-12
CL2013000688A1 (es) 2014-02-28
CA2809513A1 (en) 2013-09-20
MY165024A (en) 2018-02-28
ES2381828B1 (es) 2012-11-16
US9200032B2 (en) 2015-12-01
BR102013006411A2 (pt) 2015-06-09
PL2641912T3 (pl) 2016-11-30
HUE027915T2 (en) 2016-11-28
KR20130106792A (ko) 2013-09-30
JP2013194054A (ja) 2013-09-30
RU2013112276A (ru) 2014-09-27
RU2636049C2 (ru) 2017-11-17
EP2641912A1 (en) 2013-09-25
ES2590045T3 (es) 2016-11-17
CN103319592B (zh) 2020-03-03
CA2809513C (en) 2016-09-27

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DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE NAME OF THE INVENTOR TO READ RISTOL DEBART, PERE AND GRANCHA GAMON, SALVADOR

FGA Letters patent sealed or granted (standard patent)