DK2709657T3 - Termostabile vaccine sammensætninger og fremgangsmåder til fremstilling deraf - Google Patents

Termostabile vaccine sammensætninger og fremgangsmåder til fremstilling deraf Download PDF

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Publication number
DK2709657T3
DK2709657T3 DK12786638.2T DK12786638T DK2709657T3 DK 2709657 T3 DK2709657 T3 DK 2709657T3 DK 12786638 T DK12786638 T DK 12786638T DK 2709657 T3 DK2709657 T3 DK 2709657T3
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Denmark
Prior art keywords
vaccine
adjuvant
freezing
aluminum
dried
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DK12786638.2T
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English (en)
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Kimberly Hassett
Pradyot Nandi
Robert Brey
John Carpenter
Theodore Randolph
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Soligenix Inc
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
    • 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
    • A61K39/07—Bacillus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • A61K2039/55572—Lipopolysaccharides; Lipid A; Monophosphoryl lipid A
    • 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
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/572—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 cytotoxic response
    • 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
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response

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

Claims (5)

1. Fremgangsmåde til fremstilling af en immunologisk aktiv adjuvansbundet tørret vaccinesammensætning, hvilken fremgangsmåde omfatter: (a) at tilvejebringe aluminiumhydroxid som aluminiumsaltadjuvans i en koncentration på 1 mg/ml, mindst et buffersystem indeholdende mindst et flygtigt salt ved 10 mM og ved pH 6 udvalgt fra gruppen bestående af ammoniumacetat, ammoniumformat, ammoniumcarbonat, ammoniumbicarbonat, mindst et glasdannende middel bestående af trehalose i en vægt-til-volumen-koncentra-tion på fra ca. 5 % til ca. 15 % og mindst et antigen bestående af ricintoksin og mindst en TLR-4 agonist som en immunologisk aktiv co-adjuvans udvalgt fra gruppen bestående af lipid A, lipid A-derivater, monophosphoryl lipid A; (b) at kombinere (a) sammen til dannelse af en flydende vaccineformulering; (c) at lyofilisere den flydende vaccineformulering i (b), hvor lyofilisering omfatter trinnene: i) at fryse den flydende vaccineformulering til dannelse af en frossen vaccineformulering, hvor frysetrinnet omfatter et blandt bakkefrysning, hyldefrysning, spray-frysning og skalfrysning og anvender en forafkølet bakke til påbegyndelse af frysetrinnet; og (d) at tørre den frosne vaccineformulering i (c) til dannelse af en tørret vaccinesammensætning, hvor den tørrede vaccinesammensætning kan fremkalde en immunreaktion hos et individ, hvor immunreaktionen udviklet hos individet kan være humoral immunitet og/eller celle-medieret immunitet, som er specifik for antigenet.
2. Fremgangsmåde ifølge krav 1, hvor den tørrede vaccinesammensætning rekonstitueres med et vandigt fortyndingsmiddel til dannelse afen rekonstitueret vaccinesammensætning.
3. Fremgangsmåde ifølge krav 1, hvor vaccinesammensætningen indeholder en gennemsnitlig partikeldiameter på mindre end 100 mikrometer.
4. Fremgangsmåde ifølge krav 1, hvor den flydende vaccineformulering først fremstilles som en hypertonisk blanding før frysning og dernæst justeres til isotoniske niveauer efter fortynding af den tørrede vaccinesammensætning med et vandigt fortyndingsmiddel.
5. Vaccinesammensætning omfattende: (a) aluminiumhydroxid som aluminiumsaltadjuvans i en koncentration på 1 mg/ml og mindst en TLR-4 agonist som en immunologisk aktiv co-adjuvans udvalgt fra gruppen bestående af lipid A, lipid A-derivater, monophosphoryl lipid A; (b) mindst et buffermiddel, hvor det mindst ene buffermiddel omfatter et flygtigt salt ved 10mM og pH 6 udvalgt fra gruppen bestående af ammoniumacetat, ammoniumformat, ammoniumcarbonat, ammoniumbicarbonat; (c) mindst et glasdannende middel bestående af trehalose i en vægt-til-volu-men-koncentration på fra ca. 5 % til ca. 15 % og (d) mindst et antigen bestående af ricintoksin, hvor sammensætningen er lyo-filiseret til dannelse af en tørret vaccinesammensætning, og yderligere hvor den tørrede vaccinesammensætning kan fremkalde en immunreaktion hos et individ.
DK12786638.2T 2011-05-17 2012-05-17 Termostabile vaccine sammensætninger og fremgangsmåder til fremstilling deraf DK2709657T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161487206P 2011-05-17 2011-05-17
PCT/US2012/038457 WO2012158978A1 (en) 2011-05-17 2012-05-17 Thermostable vaccine compositions and methods of preparing same

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DK2709657T3 true DK2709657T3 (da) 2019-01-14

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EP (2) EP3449938A1 (da)
JP (2) JP6110845B2 (da)
KR (2) KR102374576B1 (da)
CN (2) CN107625958A (da)
AU (4) AU2012255132B2 (da)
CA (1) CA2836273C (da)
DK (1) DK2709657T3 (da)
IL (1) IL229419B (da)
WO (1) WO2012158978A1 (da)

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KR20140106389A (ko) 2014-09-03
AU2023237223A1 (en) 2023-10-26
EP2709657B1 (en) 2018-10-24
AU2012255132B2 (en) 2017-05-25
AU2020200335A1 (en) 2020-02-06
EP2709657A1 (en) 2014-03-26
IL229419B (en) 2018-12-31
CA2836273A1 (en) 2012-11-22
JP2014516967A (ja) 2014-07-17
KR102374576B1 (ko) 2022-03-15
KR20200089690A (ko) 2020-07-27
JP6110845B2 (ja) 2017-04-05
EP3449938A1 (en) 2019-03-06
CN103781491A (zh) 2014-05-07
NZ618319A (en) 2015-11-27
CA2836273C (en) 2019-01-15
EP2709657A4 (en) 2015-02-18
AU2012255132A1 (en) 2013-12-19
AU2017218989B2 (en) 2019-10-31
IL229419A0 (en) 2014-01-30
JP2017081928A (ja) 2017-05-18
WO2012158978A1 (en) 2012-11-22
CN107625958A (zh) 2018-01-26
AU2017218989A1 (en) 2017-09-07

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