EA023382B1 - Способ получения высококонцентрированного препарата иммуноглобулина для подкожного применения - Google Patents

Способ получения высококонцентрированного препарата иммуноглобулина для подкожного применения Download PDF

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Publication number
EA023382B1
EA023382B1 EA201171481A EA201171481A EA023382B1 EA 023382 B1 EA023382 B1 EA 023382B1 EA 201171481 A EA201171481 A EA 201171481A EA 201171481 A EA201171481 A EA 201171481A EA 023382 B1 EA023382 B1 EA 023382B1
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EA
Eurasian Patent Office
Prior art keywords
ultrafiltration
membrane
diafiltration
ultrafiltration membrane
obtaining
Prior art date
Application number
EA201171481A
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English (en)
Russian (ru)
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EA201171481A1 (ru
Inventor
Вольфганг Тешнер
Харальд Арно Буттервек
Азра Плевляковиц
Тереза Фридерике Бауэр
Бернхард Кельбль
Ханс-Петер Шварц
Небойса Николич
Герхард Пельслер
Йоханна Киндерманн
Original Assignee
Бакстер Интернэшнл Инк.
Бакстер Хелткэр С.А.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42335649&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA023382(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Бакстер Интернэшнл Инк., Бакстер Хелткэр С.А. filed Critical Бакстер Интернэшнл Инк.
Publication of EA201171481A1 publication Critical patent/EA201171481A1/ru
Publication of EA023382B1 publication Critical patent/EA023382B1/ru

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    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • 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
    • A61P37/04Immunostimulants
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D61/00Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14Ultrafiltration; Microfiltration
    • B01D61/145Ultrafiltration
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D61/00Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14Ultrafiltration; Microfiltration
    • B01D61/145Ultrafiltration
    • B01D61/146Ultrafiltration comprising multiple ultrafiltration steps
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2315/00Details relating to the membrane module operation
    • B01D2315/16Diafiltration
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/10Immunoglobulins specific features characterized by their source of isolation or production
    • 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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  • 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)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dispersion Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
EA201171481A 2009-05-27 2010-05-27 Способ получения высококонцентрированного препарата иммуноглобулина для подкожного применения EA023382B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US18160609P 2009-05-27 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
EA201171481A1 EA201171481A1 (ru) 2012-07-30
EA023382B1 true EA023382B1 (ru) 2016-05-31

Family

ID=42335649

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201171481A EA023382B1 (ru) 2009-05-27 2010-05-27 Способ получения высококонцентрированного препарата иммуноглобулина для подкожного применения

Country Status (18)

Country Link
US (5) US8546548B2 (enExample)
EP (3) EP2435474A2 (enExample)
JP (1) JP5341252B2 (enExample)
KR (1) KR101464032B1 (enExample)
CN (1) CN102459331B (enExample)
AR (1) AR076607A1 (enExample)
AU (6) AU2010253830B2 (enExample)
BR (1) BRPI1012082B1 (enExample)
CA (1) CA2763138A1 (enExample)
CL (2) CL2011002996A1 (enExample)
CO (1) CO6480954A2 (enExample)
EA (1) EA023382B1 (enExample)
HK (1) HK1200843A1 (enExample)
MX (1) MX2011012576A (enExample)
MY (1) MY157239A (enExample)
SG (1) SG176256A1 (enExample)
TW (1) TWI445714B (enExample)
WO (1) WO2010138736A2 (enExample)

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US9084743B2 (en) * 2009-09-17 2015-07-21 Baxter International Inc. Stable co-formulation of hyaluronidase and immunoglobulin, and methods of use thereof
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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
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SG11201400233TA (en) * 2011-08-26 2014-08-28 Baxter Int Method for reducing the thromboembolic potential of a plasma-derived immunoglobulin composition
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CA2986957A1 (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
CA3080656A1 (en) 2017-10-30 2019-05-09 Baxalta GmbH Environmentally compatible detergents for inactivation of lipid-enveloped viruses
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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Also Published As

Publication number Publication date
US8546548B2 (en) 2013-10-01
AU2018200548A1 (en) 2018-02-15
AU2010253830A1 (en) 2011-12-15
AU2022228125B2 (en) 2024-02-29
KR101464032B1 (ko) 2014-11-27
CN102459331B (zh) 2015-01-28
HK1200843A1 (en) 2015-08-14
WO2010138736A2 (en) 2010-12-02
CN102459331A (zh) 2012-05-16
US20160244512A1 (en) 2016-08-25
WO2010138736A3 (en) 2011-03-17
EP3708581A3 (en) 2021-10-20
EP2762492A2 (en) 2014-08-06
AR076607A1 (es) 2011-06-22
CL2011002996A1 (es) 2012-10-19
AU2018200548B2 (en) 2020-04-02
EP3708581A1 (en) 2020-09-16
EP2762492A3 (en) 2015-03-18
AU2016203542A1 (en) 2016-06-16
CL2013001673A1 (es) 2013-12-06
US11242380B2 (en) 2022-02-08
TWI445714B (zh) 2014-07-21
US20100330071A1 (en) 2010-12-30
MX2011012576A (es) 2012-05-08
MY157239A (en) 2016-05-13
AU2020204244A1 (en) 2020-07-16
BRPI1012082B1 (pt) 2022-08-16
EP2435474A2 (en) 2012-04-04
BRPI1012082A2 (pt) 2019-04-02
AU2022228125A1 (en) 2022-09-29
CA2763138A1 (en) 2010-12-02
AU2016203542B2 (en) 2018-02-15
JP2012528190A (ja) 2012-11-12
US20140030252A1 (en) 2014-01-30
US10125189B2 (en) 2018-11-13
SG176256A1 (en) 2012-01-30
US20220153823A1 (en) 2022-05-19
KR20140014403A (ko) 2014-02-06
JP5341252B2 (ja) 2013-11-13
TW201107344A (en) 2011-03-01
AU2020204244B2 (en) 2022-08-18
US9175068B2 (en) 2015-11-03
US20190085064A1 (en) 2019-03-21
CO6480954A2 (es) 2012-07-16
AU2010253830B2 (en) 2016-03-03
AU2024203600A1 (en) 2024-06-20
EA201171481A1 (ru) 2012-07-30

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