DK2099485T3 - Alfavirus- og alfavirusreplikonpartikelformuleringer samt tilhørende fremgangsmåder - Google Patents

Alfavirus- og alfavirusreplikonpartikelformuleringer samt tilhørende fremgangsmåder Download PDF

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DK2099485T3
DK2099485T3 DK07844849.5T DK07844849T DK2099485T3 DK 2099485 T3 DK2099485 T3 DK 2099485T3 DK 07844849 T DK07844849 T DK 07844849T DK 2099485 T3 DK2099485 T3 DK 2099485T3
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virus
alphavirus
protein
formulations
vol
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DK07844849.5T
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English (en)
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Roberto A Depaz
Todd L Talarico
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Alphavax Inc
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    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525Virus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525Virus
    • A61K2039/5256Virus expressing foreign proteins
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011Details
    • C12N2770/36011Togaviridae
    • C12N2770/36111Alphavirus, e.g. Sindbis virus, VEE, EEE, WEE, Semliki
    • C12N2770/36134Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011Details
    • C12N2770/36011Togaviridae
    • C12N2770/36111Alphavirus, e.g. Sindbis virus, VEE, EEE, WEE, Semliki
    • C12N2770/36151Methods of production or purification of viral material

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Genetics & Genomics (AREA)
  • Epidemiology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Mycology (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Claims (9)

1. Fremgangsmåde til fremstilling af en tørret sammensætning med rehydrerings- og lagerstabilitet, hvilken fremgangsmåde omfatter følgende trin: (a) at fremstille en vandig opløsning eller dispersion omfattende venezuelansk hesteencephalitisvirus (VEE) eller replikonpartikler deraf; et salt, hvor saltet er natriumsulfat i en ionstyrke fra 50 mM til 400 mM; eller hvor saltet er natriumchlorid i en ionstyrke fra 100 mM til 500 mM; en surfaktant, hvor surfaktanten er humant serumalbumin; sukrose; og eventuelt, et blødgøringsmiddel omfattende glycerol og/eller et fyldemiddel, hvor fyl-demidlet er hydroxyethylstivelse, dextran, mannitol, glycin, Ficoll eller polyvinylpyr-rolidon; at holde opløsningen eller dispersionen ved en pH-værdi på 7 til 9 forud for tørring; og at pufre opløsningen eller dispersionen med borsyre og et farmaceutisk acceptabelt salt af tetraborat forud for tørring, og b) at tørre den vandige dispersion til opnåelse af en sammensætning, hvor VEE eller replikonpartikler deraf er dispergeret i en amorf glasagtig matrix omfattende surfaktanten og sukrosen og, eventuelt, blødgøringsmidlet og/eller fyldemidlet.
2. Fremgangsmåde ifølge krav 1, hvor den vandige opløsning eller dispersion yderligere omfatter blødgøringsmidlet.
3. Fremgangsmåde ifølge krav 1 eller 2, hvor den vandige opløsning eller dispersion yderligere omfatter fyldemidlet.
4. Fremgangsmåde ifølge krav 1, hvor det humane serumalbumin fremstilles rekom-binant.
5. Fremgangsmåde ifølge krav 1, hvor restfugtindholdet i den tørrede sammensætning er fra 0,5 % til 10 %; hvor restfugtindholdet eventuelt er fra 2 til 7 %; og hvor restfugtindholdet eventuelt er fra 3 til 5 %.
6. Fremgangsmåde ifølge krav 1, hvor sammensætningen omfatter blødgøringsmidlet, og mængden af glycerol i den vandige opløsning eller dispersion er fra 0,05 % til 2 %.
7. Fremgangsmåde ifølge krav 1, hvor sammensætningen omfatter blødgøringsmidlet, og blødgøringsmidlet yderligere omfatter polypropylenglykol.
8. Fremgangsmåde ifølge krav 1, hvor den vandige opløsning eller dispersion omfatter 10 mM natriumphosphat, 4 % sukrose, 0,1 % humant serumalbumin, 100 mM natriumsulfat og 0,25 % glycerol.
9. Tørret sammensætning omfattende (1) venezuelansk hesteencephalitisvirus (VEE) eller replikonpartikler deraf, (2) et salt, hvor saltet er udvalgt blandt natriumsulfat og natriumchlorid, (3) en surfaktant, hvor surfaktanten er humant serumalbumin, og (4) sukrose, og, eventuelt, (5) et blødgøringsmiddel omfattende glycerol og/eller et fyldemiddel, hvor fyldemidlet er hydroxyethylstivelse, dextran, mannitol, glycin, Ficoll eller polyvinylpyr-rolidon; og hvor den tørrede sammensætning kan opnås ved fremgangsmåden ifølge et hvilket som helst af kravene 1 til 8.
DK07844849.5T 2006-11-03 2007-11-02 Alfavirus- og alfavirusreplikonpartikelformuleringer samt tilhørende fremgangsmåder DK2099485T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US86436606P 2006-11-03 2006-11-03
PCT/US2007/083537 WO2008058035A1 (en) 2006-11-03 2007-11-02 Alphavirus and alphavirus replicon particle formulations and methods

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DK2099485T3 true DK2099485T3 (da) 2018-05-22

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US (2) US20090047255A1 (da)
EP (1) EP2099485B1 (da)
AU (1) AU2007317347B2 (da)
CA (1) CA2668417A1 (da)
DK (1) DK2099485T3 (da)
ES (1) ES2673823T3 (da)
IL (1) IL198364A (da)
NZ (1) NZ576563A (da)
WO (1) WO2008058035A1 (da)
ZA (1) ZA200903791B (da)

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Also Published As

Publication number Publication date
EP2099485A1 (en) 2009-09-16
EP2099485B1 (en) 2018-03-21
US9187729B2 (en) 2015-11-17
WO2008058035A1 (en) 2008-05-15
ES2673823T3 (es) 2018-06-25
AU2007317347B2 (en) 2014-02-06
IL198364A0 (en) 2011-08-01
CA2668417A1 (en) 2008-05-15
ZA200903791B (en) 2010-03-31
US20110182941A1 (en) 2011-07-28
US20090047255A1 (en) 2009-02-19
AU2007317347A1 (en) 2008-05-15
NZ576563A (en) 2012-09-28
IL198364A (en) 2017-11-30

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