CN102459331B - 生产用于皮下使用的高度浓缩的免疫球蛋白制品的方法 - Google Patents

生产用于皮下使用的高度浓缩的免疫球蛋白制品的方法 Download PDF

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Publication number
CN102459331B
CN102459331B CN201080032613.3A CN201080032613A CN102459331B CN 102459331 B CN102459331 B CN 102459331B CN 201080032613 A CN201080032613 A CN 201080032613A CN 102459331 B CN102459331 B CN 102459331B
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igg
ultrafiltration
diafiltration
storage
solution
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Chinese (zh)
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CN102459331A (zh
Inventor
W·特施纳
H·A·巴特维克
A·普列夫利亚科维奇
T·F·鲍尔
B·克尔布尔
H-P·施瓦茨
N·尼科利奇
G·珀尔斯勒
J·金德曼
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Takeda Pharmaceutical Co Ltd
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Baxter Healthcare SA
Baxter International Inc
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • B01D61/146—Ultrafiltration comprising multiple ultrafiltration steps
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • 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
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2315/00—Details relating to the membrane module operation
    • B01D2315/16—Diafiltration
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Water Supply & Treatment (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Dispersion Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
CN201080032613.3A 2009-05-27 2010-05-27 生产用于皮下使用的高度浓缩的免疫球蛋白制品的方法 Active CN102459331B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US18160609P 2009-05-27 2009-05-27
US61/181,606 2009-05-27
PCT/US2010/036430 WO2010138736A2 (en) 2009-05-27 2010-05-27 A method to produce a highly concentrated immunoglobulin preparation for subcutaneous use

Publications (2)

Publication Number Publication Date
CN102459331A CN102459331A (zh) 2012-05-16
CN102459331B true CN102459331B (zh) 2015-01-28

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Country Status (18)

Country Link
US (5) US8546548B2 (https=)
EP (3) EP2762492A3 (https=)
JP (1) JP5341252B2 (https=)
KR (1) KR101464032B1 (https=)
CN (1) CN102459331B (https=)
AR (1) AR076607A1 (https=)
AU (6) AU2010253830B2 (https=)
BR (1) BRPI1012082B1 (https=)
CA (1) CA2763138A1 (https=)
CL (2) CL2011002996A1 (https=)
CO (1) CO6480954A2 (https=)
EA (1) EA023382B1 (https=)
HK (1) HK1200843A1 (https=)
MX (1) MX2011012576A (https=)
MY (1) MY157239A (https=)
SG (1) SG176256A1 (https=)
TW (1) TWI445714B (https=)
WO (1) WO2010138736A2 (https=)

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MX2012003282A (es) 2009-09-17 2012-04-30 Baxter Healthcare Sa Co-formulacion estable de hialuronidasa e inmunoglobulina, y metodos de su uso.
US8796430B2 (en) 2010-05-26 2014-08-05 Baxter International Inc. Method to produce an immunoglobulin preparation with improved yield
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AU2010202125B1 (en) 2010-05-26 2010-09-02 Takeda Pharmaceutical Company Limited A method to produce an immunoglobulin preparation with improved yield
FR2962650B1 (fr) * 2010-07-19 2013-04-05 Lab Francais Du Fractionnement Composition d'immunoglobulines humaines concentrees
CA2810731A1 (en) 2010-09-17 2012-03-22 Baxter International Inc. Stabilization of immunoglobulins and other proteins through aqueous formulation with sodium chloride at weak acidic to neutral ph
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CN102532307B (zh) * 2012-02-22 2013-06-12 成都蓉生药业有限责任公司 一种制备人免疫球蛋白的方法
TWI629283B (zh) 2012-02-23 2018-07-11 巴克斯歐塔公司 來自血漿中的免疫球蛋白之ｉ-ｉｖ-１部分沉澱
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MX380902B (es) * 2013-11-15 2025-03-12 Genentech Inc Métodos para la inactivación viral usando detergentes ecológico.
CN108026507A (zh) * 2015-04-02 2018-05-11 K·黄 由组分vi制造afod静脉注射剂的方法
WO2016196070A1 (en) 2015-06-03 2016-12-08 Children's Hospital Medical Center Compositions and methods for treating neonatal biliary atresia
US11186858B1 (en) 2016-03-15 2021-11-30 Fresenius Kabi Deutschland Gmbh Methods for increasing biosimilarity
EP3275897A1 (en) * 2016-07-27 2018-01-31 Biotest AG Process for preparing immunoglobulin compositions
US10259865B2 (en) 2017-03-15 2019-04-16 Adma Biologics, Inc. Anti-pneumococcal hyperimmune globulin for the treatment and prevention of pneumococcal infection
MX2020004151A (es) 2017-10-30 2020-08-13 Takeda Pharmaceuticals Co Detergentes compatibles con el medio ambiente para la inactivacion de virus envueltos en lipidos.
FR3081328B1 (fr) * 2018-05-24 2021-01-01 Lab Francais Du Fractionnement Composition d'immunoglobulines humaines concentrees
KR102337683B1 (ko) * 2018-09-21 2021-12-13 주식회사 녹십자 고효율 항-tfpi 항체 조성물
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CN1157572A (zh) * 1994-09-08 1997-08-20 红十字基金会输血服务中央实验室 液态免疫球蛋白制剂
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
WO2005073252A1 (en) * 2004-01-30 2005-08-11 Suomen Punainen Risti Veripalvelu Process for the manufacture of virus safe immunoglobulin
CN101279246A (zh) * 2007-12-28 2008-10-08 华侨大学 一种嗜硫性磁性复合微球的制备方法和用此复合微球分离免疫球蛋白g的方法

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AU2010253830A1 (en) 2011-12-15
HK1200843A1 (en) 2015-08-14
SG176256A1 (en) 2012-01-30
KR101464032B1 (ko) 2014-11-27
US8546548B2 (en) 2013-10-01
AU2020204244B2 (en) 2022-08-18
BRPI1012082B1 (pt) 2022-08-16
EP3708581A1 (en) 2020-09-16
AR076607A1 (es) 2011-06-22
US20220153823A1 (en) 2022-05-19
US20100330071A1 (en) 2010-12-30
US11242380B2 (en) 2022-02-08
AU2010253830B2 (en) 2016-03-03
CL2013001673A1 (es) 2013-12-06
EP2762492A3 (en) 2015-03-18
US20160244512A1 (en) 2016-08-25
EP2762492A2 (en) 2014-08-06
MY157239A (en) 2016-05-13
AU2020204244A1 (en) 2020-07-16
CN102459331A (zh) 2012-05-16
US10125189B2 (en) 2018-11-13
EP2435474A2 (en) 2012-04-04
WO2010138736A3 (en) 2011-03-17
CO6480954A2 (es) 2012-07-16
EP3708581A3 (en) 2021-10-20
BRPI1012082A2 (pt) 2019-04-02
JP5341252B2 (ja) 2013-11-13
EA201171481A1 (ru) 2012-07-30
WO2010138736A2 (en) 2010-12-02
JP2012528190A (ja) 2012-11-12
AU2024203600A1 (en) 2024-06-20
EA023382B1 (ru) 2016-05-31
MX2011012576A (es) 2012-05-08
AU2018200548B2 (en) 2020-04-02
AU2022228125A1 (en) 2022-09-29
CA2763138A1 (en) 2010-12-02
AU2016203542B2 (en) 2018-02-15
AU2016203542A1 (en) 2016-06-16
KR20140014403A (ko) 2014-02-06
TWI445714B (zh) 2014-07-21
AU2022228125B2 (en) 2024-02-29
TW201107344A (en) 2011-03-01
US20190085064A1 (en) 2019-03-21
CL2011002996A1 (es) 2012-10-19
US9175068B2 (en) 2015-11-03
AU2018200548A1 (en) 2018-02-15
US20140030252A1 (en) 2014-01-30

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