TWI554283B - 經由熱處理獲得IgG組成物的方法 - Google Patents

經由熱處理獲得IgG組成物的方法 Download PDF

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Publication number
TWI554283B
TWI554283B TW102109161A TW102109161A TWI554283B TW I554283 B TWI554283 B TW I554283B TW 102109161 A TW102109161 A TW 102109161A TW 102109161 A TW102109161 A TW 102109161A TW I554283 B TWI554283 B TW I554283B
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Taiwan
Prior art keywords
solution
igg
diafiltration
carried out
concentration
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TW102109161A
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English (en)
Chinese (zh)
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TW201343179A (zh
Inventor
比瑞 瑞斯特戴伯特
沙瓦多 格蘭加蓋蒙
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蓋立復股份有限公司
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39516Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
    • A61K39/39525Purification
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins 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)
TW102109161A 2012-03-20 2013-03-15 經由熱處理獲得IgG組成物的方法 TWI554283B (zh)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
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
TW201343179A TW201343179A (zh) 2013-11-01
TWI554283B true TWI554283B (zh) 2016-10-21

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TW102109161A TWI554283B (zh) 2012-03-20 2013-03-15 經由熱處理獲得IgG組成物的方法

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
HUE042984T2 (hu) * 2015-08-31 2019-07-29 Inst Grifols S A Eljárás immunglobulinok elõállítására
RU2708394C2 (ru) * 2016-09-26 2019-12-06 Институто Грифольс,С.А. Способ получения иммуноглобулинов
IL277797B1 (en) * 2018-04-12 2024-11-01 Amgen Inc Methods for making stable protein compositions
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 (2)

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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
CN101679509A (zh) * 2007-06-01 2010-03-24 弗·哈夫曼-拉罗切有限公司 免疫球蛋白纯化

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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
ES2091161B1 (es) * 1995-04-12 1997-05-16 Grifols Grupo Sa Procedimiento para la produccion de gammaglobulina intramuscular inactivada por pasteurizacion.
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)
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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
CN101679509A (zh) * 2007-06-01 2010-03-24 弗·哈夫曼-拉罗切有限公司 免疫球蛋白纯化

Non-Patent Citations (1)

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Also Published As

Publication number Publication date
CA2809513A1 (en) 2013-09-20
EP2641912A1 (en) 2013-09-25
RU2013112276A (ru) 2014-09-27
JP2013194054A (ja) 2013-09-30
HK1185625A1 (en) 2014-02-21
MX2013002910A (es) 2013-09-19
SG193738A1 (en) 2013-10-30
US20140113355A1 (en) 2014-04-24
AU2013201853B2 (en) 2014-07-03
ES2381828B1 (es) 2012-11-16
EP2641912B1 (en) 2016-06-15
IL225197A (en) 2017-06-29
MY165024A (en) 2018-02-28
JP6048936B2 (ja) 2016-12-21
KR20130106792A (ko) 2013-09-30
PL2641912T3 (pl) 2016-11-30
CL2013000688A1 (es) 2014-02-28
CA2809513C (en) 2016-09-27
AU2013201853A1 (en) 2013-10-10
JP2016199586A (ja) 2016-12-01
ES2590045T3 (es) 2016-11-17
KR101840064B1 (ko) 2018-03-19
ES2381828A1 (es) 2012-06-01
CN103319592A (zh) 2013-09-25
TW201343179A (zh) 2013-11-01
BR102013006411A2 (pt) 2015-06-09
MX339268B (es) 2016-05-18
RU2636049C2 (ru) 2017-11-17
PT2641912T (pt) 2016-08-12
IL225197A0 (en) 2013-06-27
AR090337A1 (es) 2014-11-05
US9200032B2 (en) 2015-12-01
CN103319592B (zh) 2020-03-03
UY34679A (es) 2013-10-31
HUE027915T2 (en) 2016-11-28

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