CN103319592B - 通过热处理获得IgG组合物的方法 - Google Patents

通过热处理获得IgG组合物的方法 Download PDF

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Publication number
CN103319592B
CN103319592B CN201310090730.0A CN201310090730A CN103319592B CN 103319592 B CN103319592 B CN 103319592B CN 201310090730 A CN201310090730 A CN 201310090730A CN 103319592 B CN103319592 B CN 103319592B
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China
Prior art keywords
igg
solution
concentration
protein
polymer
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Chinese (zh)
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CN103319592A (zh
Inventor
佩雷·里斯托尔德巴尔特
萨尔瓦多尔·格兰沙加蒙
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Grifols SA
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Grifols SA
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    • 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
    • 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
    • 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
    • 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

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  • 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)
CN201310090730.0A 2012-03-20 2013-03-20 通过热处理获得IgG组合物的方法 Active CN103319592B (zh)

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
CN103319592A CN103319592A (zh) 2013-09-25
CN103319592B true CN103319592B (zh) 2020-03-03

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ID=46053016

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CN201310090730.0A Active CN103319592B (zh) 2012-03-20 2013-03-20 通过热处理获得IgG组合物的方法

Country Status (21)

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

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
TR201905974T4 (tr) * 2015-08-31 2019-05-21 Inst Grifols S A İmmünoglobuli̇nleri̇n hazirlanmasi i̇çi̇n yöntem
RU2708394C2 (ru) * 2016-09-26 2019-12-06 Институто Грифольс,С.А. Способ получения иммуноглобулинов
KR102791798B1 (ko) * 2018-04-12 2025-04-07 암젠 인크 안정한 단백질 조성물의 제조 방법
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)

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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.
CN1201694A (zh) * 1998-06-25 1998-12-16 成都蜀阳制药厂 无保护剂双重病毒灭活制备静注免疫球蛋白工艺
CN1311797A (zh) * 1998-06-09 2001-09-05 斯塔滕斯血清研究所 生产用于静脉给药的免疫球蛋白和其他免疫球蛋白产品的方法

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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
EP0035204B2 (en) 1980-03-05 1991-05-22 Miles Inc. Pasteurized therapeutically active protein compositions
US4396608A (en) 1981-08-24 1983-08-02 Cutter Laboratories Intravenously injectable immune serum globulin
ES506679A0 (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)
DK2270044T3 (en) * 1998-06-09 2015-01-26 Csl Behring Ag Liquid immunoglobulin G (IgG) product
ES2184594B1 (es) 2001-01-17 2004-01-01 Probitas Pharma Sa Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
DE602005021485D1 (de) * 2004-05-07 2010-07-08 Wisconsin Alumni Res Found Verfahren und zusammensetzungen mit molkeproteinisolaten
BRPI0812288A2 (pt) * 2007-06-01 2014-11-25 Hoffmann La Roche Purificação de imunoglobulina.
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.
CN1311797A (zh) * 1998-06-09 2001-09-05 斯塔滕斯血清研究所 生产用于静脉给药的免疫球蛋白和其他免疫球蛋白产品的方法
CN1201694A (zh) * 1998-06-25 1998-12-16 成都蜀阳制药厂 无保护剂双重病毒灭活制备静注免疫球蛋白工艺

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
Preparation, purification and virus inactivation of intravenous immunoglobulin from human plasma;Aghaie A;《Hum Antibodies》;20100131;第19卷(第1期);1-6 *

Also Published As

Publication number Publication date
ES2590045T3 (es) 2016-11-17
KR101840064B1 (ko) 2018-03-19
UY34679A (es) 2013-10-31
US9200032B2 (en) 2015-12-01
MY165024A (en) 2018-02-28
AU2013201853A1 (en) 2013-10-10
SG193738A1 (en) 2013-10-30
PT2641912T (pt) 2016-08-12
CL2013000688A1 (es) 2014-02-28
US20140113355A1 (en) 2014-04-24
ES2381828A1 (es) 2012-06-01
AR090337A1 (es) 2014-11-05
ES2381828B1 (es) 2012-11-16
JP2013194054A (ja) 2013-09-30
RU2013112276A (ru) 2014-09-27
TW201343179A (zh) 2013-11-01
JP2016199586A (ja) 2016-12-01
BR102013006411A2 (pt) 2015-06-09
CA2809513A1 (en) 2013-09-20
KR20130106792A (ko) 2013-09-30
HK1185625A1 (en) 2014-02-21
MX339268B (es) 2016-05-18
MX2013002910A (es) 2013-09-19
JP6048936B2 (ja) 2016-12-21
IL225197A0 (en) 2013-06-27
PL2641912T3 (pl) 2016-11-30
TWI554283B (zh) 2016-10-21
CA2809513C (en) 2016-09-27
EP2641912A1 (en) 2013-09-25
AU2013201853B2 (en) 2014-07-03
HUE027915T2 (en) 2016-11-28
RU2636049C2 (ru) 2017-11-17
CN103319592A (zh) 2013-09-25
EP2641912B1 (en) 2016-06-15
IL225197A (en) 2017-06-29

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