KR101464032B1 - 피하 사용을 위한 고 농축 면역글로불린 제제의 제조 방법 - Google Patents

피하 사용을 위한 고 농축 면역글로불린 제제의 제조 방법 Download PDF

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KR101464032B1
KR101464032B1 KR1020117030990A KR20117030990A KR101464032B1 KR 101464032 B1 KR101464032 B1 KR 101464032B1 KR 1020117030990 A KR1020117030990 A KR 1020117030990A KR 20117030990 A KR20117030990 A KR 20117030990A KR 101464032 B1 KR101464032 B1 KR 101464032B1
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igg
ultrafiltration
ultrafiltration membrane
filtration system
concentrate
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KR20140014403A (ko
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볼프강 테쉬너
하랄트 아르노 부터벡
아즈라 플리에블리야코빅
테레자 프리데리케 바우어
베른하르트 쾰블
한스-페터 슈바르츠
네보이자 니콜릭
게르하르트 ?슬러
요한나 킨더만
Original Assignee
백스터 인터내셔널 인코포레이티드
박스터 헬쓰케어 에스에이
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Application filed by 백스터 인터내셔널 인코포레이티드, 박스터 헬쓰케어 에스에이 filed Critical 백스터 인터내셔널 인코포레이티드
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Assigned to 박스앨타 게엠베하, 박스알타 인코퍼레이티드 reassignment 박스앨타 게엠베하 권리의 전부이전등록 Assignors: 박스터 헬쓰케어 에스에이, 백스터 인터내셔널 인코포레이티드
Assigned to 다케다 야쿠힌 고교 가부시키가이샤 reassignment 다케다 야쿠힌 고교 가부시키가이샤 권리의 전부이전등록 Assignors: 박스알타 인코퍼레이티드, 박스앨타 게엠베하
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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
    • 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
    • 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)
  • 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)
KR1020117030990A 2009-05-27 2010-05-27 피하 사용을 위한 고 농축 면역글로불린 제제의 제조 방법 Active KR101464032B1 (ko)

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
KR20140014403A KR20140014403A (ko) 2014-02-06
KR101464032B1 true KR101464032B1 (ko) 2014-11-27

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KR1020117030990A Active KR101464032B1 (ko) 2009-05-27 2010-05-27 피하 사용을 위한 고 농축 면역글로불린 제제의 제조 방법

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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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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
JP5341252B2 (ja) 2013-11-13
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
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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