DK2829282T3 - 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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Publication number
DK2829282T3
DK2829282T3 DK14182864.0T DK14182864T DK2829282T3 DK 2829282 T3 DK2829282 T3 DK 2829282T3 DK 14182864 T DK14182864 T DK 14182864T DK 2829282 T3 DK2829282 T3 DK 2829282T3
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asn
samples
lys
adjuvant
ser
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DK14182864.0T
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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)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Claims (8)

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 bestående af trehalose og et rekom-binant antigen, hvor antigenet er udvalgt eller stammer fra gruppen bestående af toksiner og vira, til dannelse af en flydende vaccineformulering; b. at lyofilisere den flydende vaccineformulering, hvor lyofiliseringen omfatter trinnene med: 1. at fryse den flydende vaccineformulering til dannelse af en frossen vaccineformulering; og ii. at tørre den frosne vaccineformulering til dannelse af en tørret vaccinesammensætning; 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 trehalose forekommer i en vægt til volumen-koncentration på fra 5 % til 20 % i den flydende vaccineformulering.
5. Fremgangsmåde ifølge krav 1, hvor trehalose forekommer i en vægt til volumen-koncentration på fra 7 % til 15 % i den flydende vaccineformulering.
6. Fremgangsmåde ifølge krav 1, hvor frysetrinnet omfatter en af bakkefrys-ning, hyldefrysning, spray-frysning, skalfrysning og nedsænkning i flydende nitrogen.
7. Fremgangsmåde ifølge krav 6, hvor frysetrinnet omfatter spray-frysning.
8. Fremgangsmåde til styring af partikelstørrelsen i en frossen vaccineformulering, hvilken fremgangsmåde omfatter: a. at blande mindst en adjuvans, hvor adjuvansen er aluminiumhydroxid, et glasdannende middel trehalose, der forekommer i en vægt til volumenkoncentration på fra 7 % til 15 %, og mindst et antigen, hvor antigenet er udvalgt eller stammer fra gruppen bestående af toksiner og vira i et succinatbuf-fersystem, til dannelse af en flydende vaccineformulering; og 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 ved spray-frysning; og ii. at tørre den frosne vaccineformulering til dannelse af en tørret vaccinesammensætning; hvor den gennemsnitlige partikeldiameter af den rekonstituerede vaccinesammensætning efter optøning og fortynding af den tørrede vaccinesammensætning med et vandigt fortyndingsmiddel til dannelse af en rekonstitueret vaccinesammensætning er mindre end 10 mikrometer, hvor den gennemsnitlige partikeldiameter af den rekonstituerede vaccinesammensætning er en funktion af trehalosekoncentration.
DK14182864.0T 2007-03-22 2008-03-18 Fremgangsmåde til fremstilling af en immunologisk aktiv adjuvansbundet tørret vaccinesammensætning DK2829282T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US89642907P 2007-03-22 2007-03-22
EP08732401.8A EP2131857B1 (en) 2007-03-22 2008-03-18 Method of preparing an immunologically-active adjuvant-bound dried vaccine composition

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DK2829282T3 true DK2829282T3 (da) 2018-01-02

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DK14182864.0T DK2829282T3 (da) 2007-03-22 2008-03-18 Fremgangsmåde til fremstilling af en immunologisk aktiv adjuvansbundet tørret vaccinesammensætning

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US (2) US8444991B2 (da)
EP (2) EP2829282B1 (da)
AU (1) AU2008231072B2 (da)
CA (1) CA2681567C (da)
DK (2) DK2131857T3 (da)
HK (1) HK1206247A1 (da)
WO (1) WO2008118691A2 (da)

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EP2131857B1 (en) 2015-07-29
AU2008231072B2 (en) 2013-08-01
EP2131857A4 (en) 2011-07-20
US8444991B2 (en) 2013-05-21
HK1206247A1 (en) 2016-01-08
AU2008231072A1 (en) 2008-10-02
WO2008118691A2 (en) 2008-10-02
EP2829282A1 (en) 2015-01-28
US20130315966A1 (en) 2013-11-28
EP2131857A2 (en) 2009-12-16
US8808710B2 (en) 2014-08-19
CA2681567C (en) 2016-07-19
WO2008118691A3 (en) 2008-12-18
US20100158951A1 (en) 2010-06-24
EP2829282B1 (en) 2017-10-25
CA2681567A1 (en) 2008-10-02
DK2131857T3 (da) 2015-09-14

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