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AR076607A1 - Composicion acuosa. metodo para producir una preparacion altamente concentrada de inmunoglobulina de uso subcutaneo - Google Patents

Composicion acuosa. metodo para producir una preparacion altamente concentrada de inmunoglobulina de uso subcutaneo

Info

Publication number
AR076607A1
AR076607A1 ARP100101845A ARP100101845A AR076607A1 AR 076607 A1 AR076607 A1 AR 076607A1 AR P100101845 A ARP100101845 A AR P100101845A AR P100101845 A ARP100101845 A AR P100101845A AR 076607 A1 AR076607 A1 AR 076607A1
Authority
AR
Argentina
Prior art keywords
composition
producing
lgg
highly concentrated
concentrated preparation
Prior art date
Application number
ARP100101845A
Other languages
English (en)
Inventor
Wolfgang Teschner
Theresa Friederike Bauer
Bernhard Koelbl
Hans-Peter Schwarz
Azra Pljevljakovic
Nebojsa Nikiloc
Gerhard Polsler
Harald Arno Butterweck
Johanna Kindermann
Original Assignee
Baxter Int
Baxter Healthcare Sa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
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=AR076607(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Baxter Int, Baxter Healthcare Sa filed Critical Baxter Int
Publication of AR076607A1 publication Critical patent/AR076607A1/es

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], 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)
  • 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)

Abstract

Reivindicacion 1: Una composicion acuosa caracterizada porque comprende más de aproximadamente 180 gramos de proteínas por litro de la composicion, donde al menos 95% de las proteínas son lgG. Reivindicacion 2: La composicion de la reivindicacion 1, caracterizada porque se produce con un proceso que da como resultado un producto apropiado para la administracion subcutánea e intravenosa, y que puede tratarse a una temperatura elevada en el recipiente final para inactivar los virus, independientemente del ajuste de la concentracion de proteínas en un rango de entre 10 y 22%. Reivindicacion 3: La composicion de la reivindicacion 1, caracterizada porque la lgG es lgG humana. Reivindicacion 19: Un método para tratar un paciente que sufre una inmunodeficiencia, una enfermedad autoinmune o una infeccion aguda, caracterizado porque comprende administrarle al paciente una cantidad eficaz de la composicion de cualquiera de las reivindicaciones 1 - 6 y 17 - 18.
ARP100101845A 2009-05-27 2010-05-27 Composicion acuosa. metodo para producir una preparacion altamente concentrada de inmunoglobulina de uso subcutaneo AR076607A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US18160609P 2009-05-27 2009-05-27

Publications (1)

Publication Number Publication Date
AR076607A1 true AR076607A1 (es) 2011-06-22

Family

ID=42335649

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP100101845A AR076607A1 (es) 2009-05-27 2010-05-27 Composicion acuosa. metodo para producir una preparacion altamente concentrada de inmunoglobulina de uso subcutaneo

Country Status (18)

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

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Also Published As

Publication number Publication date
US20100330071A1 (en) 2010-12-30
BRPI1012082B1 (pt) 2022-08-16
CN102459331B (zh) 2015-01-28
TWI445714B (zh) 2014-07-21
AU2020204244A1 (en) 2020-07-16
AU2016203542A1 (en) 2016-06-16
MX2011012576A (es) 2012-05-08
EP2762492A3 (en) 2015-03-18
US10125189B2 (en) 2018-11-13
US20140030252A1 (en) 2014-01-30
CO6480954A2 (es) 2012-07-16
BRPI1012082A2 (pt) 2019-04-02
MY157239A (en) 2016-05-13
AU2020204244B2 (en) 2022-08-18
US9175068B2 (en) 2015-11-03
US20160244512A1 (en) 2016-08-25
EP2435474A2 (en) 2012-04-04
SG176256A1 (en) 2012-01-30
EP3708581A1 (en) 2020-09-16
EA023382B1 (ru) 2016-05-31
US20190085064A1 (en) 2019-03-21
AU2022228125A1 (en) 2022-09-29
AU2010253830A1 (en) 2011-12-15
AU2024203600A1 (en) 2024-06-20
AU2018200548A1 (en) 2018-02-15
CN102459331A (zh) 2012-05-16
KR20140014403A (ko) 2014-02-06
US11242380B2 (en) 2022-02-08
CA2763138A1 (en) 2010-12-02
CL2013001673A1 (es) 2013-12-06
WO2010138736A3 (en) 2011-03-17
AU2018200548B2 (en) 2020-04-02
EP3708581A3 (en) 2021-10-20
CL2011002996A1 (es) 2012-10-19
TW201107344A (en) 2011-03-01
AU2016203542B2 (en) 2018-02-15
EP2762492A2 (en) 2014-08-06
AU2022228125B2 (en) 2024-02-29
HK1200843A1 (en) 2015-08-14
JP2012528190A (ja) 2012-11-12
WO2010138736A2 (en) 2010-12-02
KR101464032B1 (ko) 2014-11-27
US8546548B2 (en) 2013-10-01
AU2010253830B2 (en) 2016-03-03
EA201171481A1 (ru) 2012-07-30
US20220153823A1 (en) 2022-05-19
JP5341252B2 (ja) 2013-11-13

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