DK2270044T3 - Flydende immunglobulin G (IgG) produkt - Google Patents

Flydende immunglobulin G (IgG) produkt Download PDF

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Publication number
DK2270044T3
DK2270044T3 DK10011725.8T DK10011725T DK2270044T3 DK 2270044 T3 DK2270044 T3 DK 2270044T3 DK 10011725 T DK10011725 T DK 10011725T DK 2270044 T3 DK2270044 T3 DK 2270044T3
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DK
Denmark
Prior art keywords
igg
product
virus
immunoglobulin
iga
Prior art date
Application number
DK10011725.8T
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English (en)
Inventor
Inga Laursen
Børge Teisner
Original Assignee
Csl Behring Ag
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
Application filed by Csl Behring Ag filed Critical Csl Behring Ag
Priority claimed from EP04077620A external-priority patent/EP1493751A1/en
Application granted granted Critical
Publication of DK2270044T3 publication Critical patent/DK2270044T3/da

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    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Claims (14)

1. Flydende immunglobulin G (IgG) produkt udvundet af rå plasma eller af en rå plasmaproteinfraktion, med følgende egenskaber: a) en renhed på mere end 95%, b) et indhold af IgG monomere og dimere på mindst 95%, og c) et indhold af I g A på mindre end 6 mg IgA/l, hvori koncentrationen af IgG er 1 - 20 vægt-%.
2. IgG-produkt ifølge krav 1, hvori renheden er mindst 97%.
3. IgG-produkt ifølge krav 2, hvori renheden er mindst 98%.
4. IgG-produkt ifølge ethvert af de foregående krav, hvori indholdet af IgG monomere og dimere er mindst 97%.
5. IgG-produkt ifølge krav 4, hvori indholdet af IgG monomere og dimere er mindst 98%.
6. IgG-produkt ifølge ethvert af de foregående krav, hvori indholdet af IgA er mindre end 4 mg IgA/l.
7. IgG-produkt ifølge krav 6, hvori indholdet af IgA er mindre end 3 mg IgA/l.
8. IgG-produkt ifølge krav 7, hvori indholdet af IgA er mindre end 2 mg IgA/l.
9. IgG-produkt ifølge ethvert af de foregående krav, og som ikke indeholder albumin som stabilisator.
10. IgG-produkt ifølge ethvert af de foregående krav, og som ikke omfatter non-ionisk afspændingsmiddel, PEG eller albumin som stabilisator.
11. IgG-produkt ifølge ethvert af de foregående krav, hvori pH er i området 5,1 -5, 7.
12. IgG-produkt ifølge ethvert af de foregående krav, hvori koncentrationen af IgG er 5 eller 10 vægt-%.
13. IgG-produkt ifølge ethvert af krav 1 til 11, hvori koncentrationen af IgG er 12, 14, 16, 18 eller 20 vægt-%.
14. IgG-produkt ifølge ethvert af de foregående krav, og som indeholder mindre end 1,5% polymere og aggregater.
DK10011725.8T 1998-06-09 1999-06-09 Flydende immunglobulin G (IgG) produkt DK2270044T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP98201909 1998-06-09
US10205598P 1998-09-28 1998-09-28
EP04077620A EP1493751A1 (en) 1998-06-09 1999-06-09 Process for producing immunoglobulins for intravenous administration and other immunoglobulin products

Publications (1)

Publication Number Publication Date
DK2270044T3 true DK2270044T3 (da) 2015-01-26

Family

ID=44193921

Family Applications (2)

Application Number Title Priority Date Filing Date
DK10011725.8T DK2270044T3 (da) 1998-06-09 1999-06-09 Flydende immunglobulin G (IgG) produkt
DK10184829.9T DK2272870T3 (da) 1998-06-09 1999-06-09 Fremgangsmåde til fremstilling af immunoglobuliner med henblik på intravenøs indgivelse og andre immunoglobulin-lignende produkter.

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK10184829.9T DK2272870T3 (da) 1998-06-09 1999-06-09 Fremgangsmåde til fremstilling af immunoglobuliner med henblik på intravenøs indgivelse og andre immunoglobulin-lignende produkter.

Country Status (4)

Country Link
US (2) US6281336B1 (da)
JP (1) JP4685238B2 (da)
DK (2) DK2270044T3 (da)
ES (2) ES2421736T3 (da)

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Also Published As

Publication number Publication date
US6281336B1 (en) 2001-08-28
US7138120B2 (en) 2006-11-21
JP2002517516A (ja) 2002-06-18
DK2272870T3 (da) 2013-08-05
JP4685238B2 (ja) 2011-05-18
ES2421736T3 (es) 2013-09-05
US20010051708A1 (en) 2001-12-13
ES2527915T3 (es) 2015-02-02

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