JP5341252B2 - 皮下使用の高濃度免疫グロブリン製剤を生成する方法 - Google Patents

皮下使用の高濃度免疫グロブリン製剤を生成する方法 Download PDF

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Publication number
JP5341252B2
JP5341252B2 JP2012513260A JP2012513260A JP5341252B2 JP 5341252 B2 JP5341252 B2 JP 5341252B2 JP 2012513260 A JP2012513260 A JP 2012513260A JP 2012513260 A JP2012513260 A JP 2012513260A JP 5341252 B2 JP5341252 B2 JP 5341252B2
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Prior art keywords
igg
ultrafiltration
ultrafiltration membrane
volume
diafiltration
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Japanese (ja)
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JP2012528190A (ja
JP2012528190A5 (https=
Inventor
ヴォルフガング テシュナー，
ハラルト アルノー ブターヴェク，
アズラ プリエリヤコヴィチ，
テレーザ フリーデリケ バウアー，
ベルンハルト ケールブル，
ハンス−ペーター シュヴァルツ，
ネボイサ ニコリッチ，
ゲルハルト ペルスラー，
ヨハナ キンデーマン，
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Baxter Healthcare SA
Baxter International Inc
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Baxter Healthcare SA
Baxter International Inc
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Publication of JP2012528190A5 publication Critical patent/JP2012528190A5/ja
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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

Landscapes

  • 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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Dispersion Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
JP2012513260A 2009-05-27 2010-05-27 皮下使用の高濃度免疫グロブリン製剤を生成する方法 Active JP5341252B2 (ja)

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 (3)

Publication Number Publication Date
JP2012528190A JP2012528190A (ja) 2012-11-12
JP2012528190A5 JP2012528190A5 (https=) 2013-07-11
JP5341252B2 true JP5341252B2 (ja) 2013-11-13

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Country Link
US (5) US8546548B2 (https=)
EP (3) EP3708581A3 (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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Also Published As

Publication number Publication date
US8546548B2 (en) 2013-10-01
SG176256A1 (en) 2012-01-30
US9175068B2 (en) 2015-11-03
TW201107344A (en) 2011-03-01
KR20140014403A (ko) 2014-02-06
MX2011012576A (es) 2012-05-08
JP2012528190A (ja) 2012-11-12
US20190085064A1 (en) 2019-03-21
HK1200843A1 (en) 2015-08-14
US20220153823A1 (en) 2022-05-19
EP2762492A2 (en) 2014-08-06
AU2024203600A1 (en) 2024-06-20
EA023382B1 (ru) 2016-05-31
WO2010138736A3 (en) 2011-03-17
EA201171481A1 (ru) 2012-07-30
CL2013001673A1 (es) 2013-12-06
AU2016203542B2 (en) 2018-02-15
EP2435474A2 (en) 2012-04-04
AU2020204244B2 (en) 2022-08-18
AU2010253830A1 (en) 2011-12-15
EP3708581A3 (en) 2021-10-20
CA2763138A1 (en) 2010-12-02
CL2011002996A1 (es) 2012-10-19
AU2010253830B2 (en) 2016-03-03
CO6480954A2 (es) 2012-07-16
AU2020204244A1 (en) 2020-07-16
US10125189B2 (en) 2018-11-13
AU2016203542A1 (en) 2016-06-16
CN102459331B (zh) 2015-01-28
AU2022228125B2 (en) 2024-02-29
EP2762492A3 (en) 2015-03-18
BRPI1012082A2 (pt) 2019-04-02
US20160244512A1 (en) 2016-08-25
WO2010138736A2 (en) 2010-12-02
MY157239A (en) 2016-05-13
US20100330071A1 (en) 2010-12-30
AU2018200548A1 (en) 2018-02-15
US20140030252A1 (en) 2014-01-30
TWI445714B (zh) 2014-07-21
CN102459331A (zh) 2012-05-16
KR101464032B1 (ko) 2014-11-27
BRPI1012082B1 (pt) 2022-08-16
AU2022228125A1 (en) 2022-09-29
US11242380B2 (en) 2022-02-08
AR076607A1 (es) 2011-06-22
EP3708581A1 (en) 2020-09-16
AU2018200548B2 (en) 2020-04-02

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