DK2131857T3 - Fremgangsmåde til fremstilling af en immunologisk aktiv adjuvansbundet tørret vaccinesammensætning - Google Patents

Fremgangsmåde til fremstilling af en immunologisk aktiv adjuvansbundet tørret vaccinesammensætning Download PDF

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DK2131857T3
DK2131857T3 DK08732401.8T DK08732401T DK2131857T3 DK 2131857 T3 DK2131857 T3 DK 2131857T3 DK 08732401 T DK08732401 T DK 08732401T DK 2131857 T3 DK2131857 T3 DK 2131857T3
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adjuvant
samples
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DK08732401.8T
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Theodore W Randolph
Amber Clausi
John F Carpenter
Daniel K Schwartz
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Univ Colorado Regents
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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
    • A61K39/02—Bacterial antigens
    • A61K39/08—Clostridium, e.g. Clostridium tetani
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61P31/04—Antibacterial agents
    • 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
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • 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
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • 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
    • A61K2039/62—Medicinal preparations containing antigens or antibodies characterised by the link between antigen and carrier
    • A61K2039/622—Medicinal preparations containing antigens or antibodies characterised by the link between antigen and carrier non-covalent binding
    • Y—GENERAL 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
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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

Claims (11)

1. Fremgangsmåde til fremstilling af en immunologisk aktiv adjuvansbundet tørret vaccinesammensætning, hvilken fremgangsmåde omfatter: a) at kombinere mindst en aluminiumsaltadjuvans, mindst et succinatbuffer-system, mindst et glasdannende middel, som består af trehalose og mindst et antigen, der er valgt fra gruppen bestående af Clostridium botulinum-neurotoksinprotein type A, type B, type C, type D, type E, type F og type G til dannelse af en flydende vaccineformulering; b) at lyofilisere den flydende vaccineformulering, hvor lyofiliseringen omfatter trinnene med: i) at fryse den flydende vaccineformulering til dannelse af en frossen vaccineformulering; og ii) at tørre den frosne vaccineformulering til dannelse af en tørret vaccine sammensætning; hvor sammensætningen kan udløse en immunreaktion hos et individ:
2. Fremgangsmåde ifølge krav 1, hvor aluminiumsaltadjuvansen vælges fra gruppen bestående af aluminiumhydroxid, aluminiumphosphat og aluminiumsulfat.
3. Fremgangsmåde ifølge krav 2, hvor aluminiumsaltadjuvansen er aluminiumhydroxid.
4. Fremgangsmåde ifølge krav 1, hvor trehalosen forekommer i en vægt til volumen-koncentration på fra 5% til 20% i den flydende vaccineformulering.
5. Fremgangsmåde ifølge krav 4, hvor trehalosen forekommer i en vægt til volumen-koncentration på fra 7% til 15% i den flydende vaccineformulering.
6. Fremgangsmåde ifølge krav 1, hvor antigenet vælges fra gruppen bestående af rekombinant Clostridium botulinum-neurotoksinprotein type A (SEQ ID NO: 3), type B (SEQ ID NO: 4), type C (SEQ ID NO: 2), type E (SEQ ID NO: 1) og type F (SEQ ID NO: 5).
7. Fremgangsmåde ifølge krav 1, hvor frysetrinnet omfatter en af bakkefrys-ning, hyldefrysning, spray-frysning, skalfrysning og nedsænkning i flydende nitrogen.
8. Fremgangsmåde ifølge krav 7, hvor frysetrinnet omfatter sprøjtefrysning.
9. Anvendelse af en adjuvanssammensætning i en adjuvansbundet frysetørret vaccinesammensætning, hvor adjuvanssammensætningen omfatter: a) en aluminiumsaltadjuvans, b) det glasdannende middel trehalose og c) et buffersalt, der er valgt blandt en eller flere fra gruppen bestående af na-triumsuccinat og kaliumsuccinat.
10. Anvendelse ifølge krav 9, hvor aluminiumsaltadjuvansen er valgt blandt aluminiumhydroxid og aluminiumphosphat.
11. Fremgangsmåde til styring af partikelstørrelsen i en frossen vaccineformulering, hvilken fremgangsmåde omfatter: a) at blande mindst en adjuvans, det glasdannende middel trehalose, der forekommer i en vægt til volumen-koncentration på fra 7% til 15%, og mindst et antigen, der er valgt fra gruppen bestående af Clostridium botulinum-neurotoksinprotein type A, type B, type C, type D, type E, type F og type G eller gruppen bestående af rekombinant Clostridium botulinum-neurotoksinprotein type A (SEQ ID NO: 3), type B (SEQ ID NO: 4), type C (SEQ ID NO: 2), type E (SEQ ID NO: 1) og type F (SEQ ID NO: 5) i et succi-natbuffersystem til dannelse af en flydende vaccineformulering; b) at lyofilisere den flydende vaccineformulering, hvor lyofiliseringen omfatter trinnene med: i) at afkøle den flydende vaccineformulering til en frossen tilstand til dannelse af en frossen vaccineformulering; og ii) at tørre den frosne vaccineformulering til dannelse af en tørret vaccine sammensætning; hvor den gennemsnitlige partikeldiameter af den omdannede vaccinesammensætning efter optøning og fortynding med et vandigt fortyndingsmiddel til dannelse af en omdannet vaccinesammensætning er mindre end 10 mikrometer, hvor den gennemsnitlige partikeldiameter af den omdannede vaccinesammensætning er en funktion af trehalosekoncentration, og adjuvansen er aluminiumhydroxid.
DK08732401.8T 2007-03-22 2008-03-18 Fremgangsmåde til fremstilling af en immunologisk aktiv adjuvansbundet tørret vaccinesammensætning DK2131857T3 (da)

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US89642907P 2007-03-22 2007-03-22
PCT/US2008/057355 WO2008118691A2 (en) 2007-03-22 2008-03-18 Method of preparing an immunologically-active adjuvant-bound dried vaccine composition

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US (2) US8444991B2 (da)
EP (2) EP2131857B1 (da)
AU (1) AU2008231072B2 (da)
CA (1) CA2681567C (da)
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HK (1) HK1206247A1 (da)
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US8444991B2 (en) 2013-05-21
US8808710B2 (en) 2014-08-19
US20100158951A1 (en) 2010-06-24
EP2829282A1 (en) 2015-01-28
CA2681567A1 (en) 2008-10-02
AU2008231072A1 (en) 2008-10-02
US20130315966A1 (en) 2013-11-28
EP2829282B1 (en) 2017-10-25
WO2008118691A2 (en) 2008-10-02
EP2131857A4 (en) 2011-07-20
EP2131857B1 (en) 2015-07-29
WO2008118691A3 (en) 2008-12-18
DK2829282T3 (da) 2018-01-02
HK1206247A1 (en) 2016-01-08
EP2131857A2 (en) 2009-12-16
CA2681567C (en) 2016-07-19
AU2008231072B2 (en) 2013-08-01

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