DE06025470T1 - Reinigung von Polysaccharid-Protein-Konjugat Impfstoffen durch Ultrafiltration mit Ammoniumsulfat-Lösungen - Google Patents

Reinigung von Polysaccharid-Protein-Konjugat Impfstoffen durch Ultrafiltration mit Ammoniumsulfat-Lösungen Download PDF

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Publication number
DE06025470T1
DE06025470T1 DE06025470T DE06025470T DE06025470T1 DE 06025470 T1 DE06025470 T1 DE 06025470T1 DE 06025470 T DE06025470 T DE 06025470T DE 06025470 T DE06025470 T DE 06025470T DE 06025470 T1 DE06025470 T1 DE 06025470T1
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Prior art keywords
polysaccharide
protein
ammonium sulfate
mixture
membrane
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DE06025470T
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Ronald P. Stroudsburg McMaster
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Sanofi Pasteur Ltd
Sanofi Pasteur Inc
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Connaught Laboratories Ltd
Connaught Laboratories Inc
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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
    • A61K39/02Bacterial antigens
    • A61K39/095Neisseria
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/385Haptens or antigens, bound to carriers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031Proteins
    • A61K2039/6037Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/25Chemistry: analytical and immunological testing including sample preparation
    • Y10T436/25375Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

Verfahren zur Entfernung von ungebundenem Polysaccharid von Protein-Polysaccharid-Konjugat-Vakzinen in einem Gemisch von Protein-Polysaccharid-Konjugat und ungebundenem Polysaccharid, wobei das Verfahren ein Zusetzen von sättigenden Mengen an Ammoniumsulfat zu dem Gemisch umfasst, gefolgt von Filtration des Gemisches durch eine semipermeable Membran.

Claims (12)

  1. Verfahren zur Entfernung von ungebundenem Polysaccharid von Protein-Polysaccharid-Konjugat-Vakzinen in einem Gemisch von Protein-Polysaccharid-Konjugat und ungebundenem Polysaccharid, wobei das Verfahren ein Zusetzen von sättigenden Mengen an Ammoniumsulfat zu dem Gemisch umfasst, gefolgt von Filtration des Gemisches durch eine semipermeable Membran.
  2. Verfahren nach Anspruch 1, wobei die semipermeable Membran hydrophob ist.
  3. Verfahren nach Anspruch 2, wobei die hydrophobe Membran aus Polyethersulfon zusammengesetzt ist.
  4. Verfahren nach Anspruch 3, wobei die Polyethersulfonmembran einen Molekulargewichtsausschluss von 30.000 aufweist.
  5. Verfahren nach Anspruch 1, wobei die semipermeable Membran hydrophil ist.
  6. Verfahren nach Anspruch 5, wobei die hydrophile Membran aus regenerierter Zellulose zusammengesetzt ist.
  7. Verfahren nach Anspruch 6, wobei die regenerierte Zellulose einen Molekulargewichtsausschluss von 30.000 aufweist.
  8. Verfahren nach Anspruch 1, wobei das Ammoniumsulfat bei 20 bis 60% Sättigung vorhanden ist.
  9. Verfahren nach Anspruch 1, wobei das Protein Diphtherietoxoid ist.
  10. Verfahren nach Anspruch 1, wobei das Polysaccharid kapsuläres Polysaccharid aus Bakterien ist, ausgewählt aus der Gruppe bestehend aus Streptococcus pneumoniae-Serotypen 1, 3, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F und Neisseria meningitidis-Serogruppen A, C, W-135 und Y.
  11. Aufgereinigte Polysaccharid-Protein-Konjugat-Vakzine, hergestellt durch das Verfahren gemäß einem der Ansprüche 1 bis 10.
  12. Aufgereinigte Polysaccharid-Protein-Konjugat-Vakzine gemäß Anspruch 11, die weniger als 1% an ungebundenem Polysaccharid nach Gewicht enthält.
DE06025470T 1998-12-29 1999-12-16 Reinigung von Polysaccharid-Protein-Konjugat Impfstoffen durch Ultrafiltration mit Ammoniumsulfat-Lösungen Pending DE06025470T1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US221728 1994-04-01
US09/221,728 US6146902A (en) 1998-12-29 1998-12-29 Purification of polysaccharide-protein conjugate vaccines by ultrafiltration with ammonium sulfate solutions

Publications (1)

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DE06025470T1 true DE06025470T1 (de) 2007-08-02

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Family Applications (3)

Application Number Title Priority Date Filing Date
DE69934434T Expired - Lifetime DE69934434T2 (de) 1998-12-29 1999-12-16 Reinigung von polysaccharid-protein-konjugat impfstoffen durch ultrafiltration mit ammoniumsulfat-lösungen
DE69943169T Expired - Lifetime DE69943169D1 (de) 1998-12-29 1999-12-16 Reinigung von Polysaccharid-Protein-Konjugat Impfstoffen durch Ultrafiltration mit Ammoniumsulfat-Lösungen
DE06025470T Pending DE06025470T1 (de) 1998-12-29 1999-12-16 Reinigung von Polysaccharid-Protein-Konjugat Impfstoffen durch Ultrafiltration mit Ammoniumsulfat-Lösungen

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DE69934434T Expired - Lifetime DE69934434T2 (de) 1998-12-29 1999-12-16 Reinigung von polysaccharid-protein-konjugat impfstoffen durch ultrafiltration mit ammoniumsulfat-lösungen
DE69943169T Expired - Lifetime DE69943169D1 (de) 1998-12-29 1999-12-16 Reinigung von Polysaccharid-Protein-Konjugat Impfstoffen durch Ultrafiltration mit Ammoniumsulfat-Lösungen

Country Status (12)

Country Link
US (1) US6146902A (de)
EP (3) EP1762245B1 (de)
AT (2) ATE496633T1 (de)
AU (1) AU2367500A (de)
CA (2) CA2358022C (de)
CY (3) CY1105985T1 (de)
DE (3) DE69934434T2 (de)
DK (2) DK1762245T3 (de)
ES (2) ES2278551T3 (de)
HK (1) HK1106999A1 (de)
PT (2) PT1762245E (de)
WO (1) WO2000038711A2 (de)

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CY2200152T2 (el) 2010-07-28
DE69943169D1 (de) 2011-03-10
CY1111375T1 (el) 2015-08-05
EP1140156B1 (de) 2006-12-13
ES2277462T3 (es) 2007-07-01
EP1762245A2 (de) 2007-03-14
DE69934434D1 (de) 2007-01-25
WO2000038711A3 (en) 2000-10-19
DE69934434T2 (de) 2008-01-03
EP2292261A1 (de) 2011-03-09
WO2000038711A2 (en) 2000-07-06
EP1762245B1 (de) 2011-01-26
CA2358022A1 (en) 2000-07-06
AU2367500A (en) 2000-07-31
CA2358022C (en) 2008-03-11
CY1105985T1 (el) 2011-04-06
DK1762245T3 (da) 2011-04-04
ES2278551T3 (es) 2011-04-11
ES2278551T1 (es) 2007-08-16
CA2621097A1 (en) 2000-07-06
ATE496633T1 (de) 2011-02-15
DK1140156T3 (da) 2007-03-26
PT1140156E (pt) 2007-02-28
EP1140156A2 (de) 2001-10-10
US6146902A (en) 2000-11-14
HK1106999A1 (en) 2008-03-28
EP1762245A3 (de) 2007-04-25
PT1762245E (pt) 2011-05-02
ATE347906T1 (de) 2007-01-15

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