AU2017305498B2 - Compositions and methods for stabilizing flaviviruses with improved formulations - Google Patents

Compositions and methods for stabilizing flaviviruses with improved formulations Download PDF

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AU2017305498B2
AU2017305498B2 AU2017305498A AU2017305498A AU2017305498B2 AU 2017305498 B2 AU2017305498 B2 AU 2017305498B2 AU 2017305498 A AU2017305498 A AU 2017305498A AU 2017305498 A AU2017305498 A AU 2017305498A AU 2017305498 B2 AU2017305498 B2 AU 2017305498B2
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composition
dengue
trehalose
virus
sucrose
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AU2017305498A1 (en
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Steven Michael Erb
Jill Ann LIVENGOOD
Linda Marie Strange
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Takeda Vaccines Inc
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Takeda Vaccines Inc
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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
    • A61K39/12—Viral antigens
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • 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
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5254—Virus avirulent or attenuated
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55516—Proteins; Peptides
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/24011—Flaviviridae
    • C12N2770/24034—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/24011—Flaviviridae
    • C12N2770/24111—Flavivirus, e.g. yellow fever virus, dengue, JEV
    • C12N2770/24134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • 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)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
AU2017305498A 2016-08-03 2017-08-03 Compositions and methods for stabilizing flaviviruses with improved formulations Active AU2017305498B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2023203715A AU2023203715A1 (en) 2016-08-03 2023-06-14 Compositions And Methods For Stabilizing Flaviviruses With Improved Formulations

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662370611P 2016-08-03 2016-08-03
US62/370,611 2016-08-03
PCT/US2017/045375 WO2018027075A1 (en) 2016-08-03 2017-08-03 Compositions and methods for stabilizing flaviviruses with improved formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2023203715A Division AU2023203715A1 (en) 2016-08-03 2023-06-14 Compositions And Methods For Stabilizing Flaviviruses With Improved Formulations

Publications (2)

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AU2017305498A1 AU2017305498A1 (en) 2019-01-24
AU2017305498B2 true AU2017305498B2 (en) 2023-03-30

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AU2017305498A Active AU2017305498B2 (en) 2016-08-03 2017-08-03 Compositions and methods for stabilizing flaviviruses with improved formulations
AU2023203715A Pending AU2023203715A1 (en) 2016-08-03 2023-06-14 Compositions And Methods For Stabilizing Flaviviruses With Improved Formulations

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Country Status (13)

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US (3) US10835597B2 (OSRAM)
EP (1) EP3493839A1 (OSRAM)
JP (2) JP7280179B2 (OSRAM)
KR (2) KR20230132887A (OSRAM)
CN (1) CN109789200A (OSRAM)
AU (2) AU2017305498B2 (OSRAM)
CA (1) CA3030343A1 (OSRAM)
CO (1) CO2019001448A2 (OSRAM)
MX (2) MX2019001473A (OSRAM)
PH (1) PH12019500003A1 (OSRAM)
SG (2) SG11201811831SA (OSRAM)
TW (2) TW202309276A (OSRAM)
WO (1) WO2018027075A1 (OSRAM)

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CN104984357B (zh) * 2015-06-02 2018-01-30 长春百克生物科技股份公司 不含明胶的疫苗保护剂组合物及流感减毒活疫苗
GEAP202315128A (en) * 2016-12-23 2023-02-10 Serum Institute Of India Pvt Ltd Improved methods for enhancing antibody productivity in mammalian cell culture and minimizing aggregation during downstream, formulation processes and stable antibody formulations obtained thereof
US20200390877A1 (en) 2017-12-07 2020-12-17 Merck Sharp & Dohme Corp. Formulations of dengue virus vaccine compositions
US11738075B2 (en) 2018-03-20 2023-08-29 National Research Council Of Canada Method for lyophilizing live vaccine strains of Francisella tularensis
KR102649069B1 (ko) 2018-05-31 2024-03-19 주식회사 엑소코바이오 줄기세포 유래의 엑소좀을 유효성분으로 포함하는 안면 홍조 개선용 조성물
WO2020027466A1 (ko) 2018-07-28 2020-02-06 주식회사 엑소코바이오 엑소좀의 동결건조 방법
KR102163806B1 (ko) 2018-07-30 2020-10-07 주식회사 엑소코바이오 줄기세포 유래의 엑소좀을 유효성분으로 포함하는 피지분비 감소용 조성물
US11464815B2 (en) * 2018-09-05 2022-10-11 Takeda Vaccines, Inc. Dengue vaccine unit dose and administration thereof
AU2019393877A1 (en) * 2018-12-05 2021-06-17 Seres Therapeutics, Inc. Compositions for stabilizing bacteria and uses thereof
MX2022001742A (es) 2019-08-16 2022-04-07 Takeda Vaccines Inc Metodos para prevenir el dengue y la hepatitis a.
EP4110381A1 (en) * 2020-02-27 2023-01-04 Takeda Vaccines, Inc. Method for removing host cell dna from virus preparation
CN115023135B (zh) * 2020-02-28 2024-04-19 台湾粒线体应用技术股份有限公司 线粒体的冷冻保存剂与使用其的线粒体冷冻保存方法
CN113549653B (zh) * 2020-04-23 2024-03-22 上海赛比曼生物科技有限公司 用于慢病毒载体长期存贮的组合试剂
CN111588859B (zh) * 2020-06-02 2021-09-03 成都可恩生物科技有限公司 一种冻干保护剂及其应用和冻干苗及其制备方法
CN112501024A (zh) * 2020-12-03 2021-03-16 英科新创(苏州)生物科技有限公司 一种体外诊断试剂盒通用型质控品保存液
EP4012025A1 (en) * 2020-12-10 2022-06-15 Univerzita Palackého v Olomouci Transport medium for samples containing nucleic acids and/or proteins
CN113730592B (zh) * 2021-09-03 2023-12-19 吉林正业生物制品股份有限公司 一种鸭坦布苏病毒病活疫苗冻干保护剂及制备方法和应用
WO2023158989A1 (en) * 2022-02-15 2023-08-24 Takeda Vaccines, Inc. Dengue vaccine batch mixing process
AU2023365824A1 (en) * 2022-10-18 2025-06-05 Takeda Vaccines, Inc. Dengue vaccine formulation
WO2025027616A1 (en) * 2023-08-01 2025-02-06 Serum Institute Of India Private Limited Freeze-dried viral vaccine compositions and method of manufacturing thereof
WO2025072259A1 (en) 2023-09-25 2025-04-03 Takeda Vaccines, Inc. Coadministration of tetravalent dengue vaccine with hpv vaccine
WO2025122946A1 (en) * 2023-12-07 2025-06-12 Rovin Richard A Zika viruses and uses thereof

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WO2005066333A1 (en) * 2003-12-30 2005-07-21 Aventis Pasteur, Inc. Stabilizing compositions for recombinant viruses
WO2010003670A1 (en) * 2008-07-09 2010-01-14 Sanofi Pasteur Stabilizer and vaccine composition comprising one or more live attenuated flaviviruses
WO2017179017A1 (en) * 2016-04-13 2017-10-19 Takeda Vaccines, Inc. Compositions and methods of vaccination against dengue virus in children and young adults

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SI2144998T1 (sl) * 2007-04-06 2017-05-31 Takeda Vaccines, Inc. Postopki in sestavki za žive atenuirane viruse
CN104984357B (zh) * 2015-06-02 2018-01-30 长春百克生物科技股份公司 不含明胶的疫苗保护剂组合物及流感减毒活疫苗

Patent Citations (3)

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WO2005066333A1 (en) * 2003-12-30 2005-07-21 Aventis Pasteur, Inc. Stabilizing compositions for recombinant viruses
WO2010003670A1 (en) * 2008-07-09 2010-01-14 Sanofi Pasteur Stabilizer and vaccine composition comprising one or more live attenuated flaviviruses
WO2017179017A1 (en) * 2016-04-13 2017-10-19 Takeda Vaccines, Inc. Compositions and methods of vaccination against dengue virus in children and young adults

Also Published As

Publication number Publication date
WO2018027075A1 (en) 2018-02-08
JP2019524771A (ja) 2019-09-05
US10835597B2 (en) 2020-11-17
US11701421B2 (en) 2023-07-18
SG11201811831SA (en) 2019-01-30
KR20230132887A (ko) 2023-09-18
JP7280179B2 (ja) 2023-05-23
MX2019001473A (es) 2019-09-23
PH12019500003A1 (en) 2019-10-14
TWI766876B (zh) 2022-06-11
TW202309276A (zh) 2023-03-01
SG10201913040SA (en) 2020-03-30
CA3030343A1 (en) 2018-02-08
US20230263880A1 (en) 2023-08-24
AU2017305498A1 (en) 2019-01-24
JP2023052624A (ja) 2023-04-11
TW201807191A (zh) 2018-03-01
KR20190034598A (ko) 2019-04-02
CN109789200A (zh) 2019-05-21
KR102576789B1 (ko) 2023-09-12
MX2022010907A (es) 2022-10-07
US20210121558A1 (en) 2021-04-29
AU2023203715A1 (en) 2023-07-06
CO2019001448A2 (es) 2019-04-30
EP3493839A1 (en) 2019-06-12
BR112019001299A2 (pt) 2019-04-30
US20190184004A1 (en) 2019-06-20

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