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

Compositions and methods for stabilizing flaviviruses with improved formulations Download PDF

Info

Publication number
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
Authority
AU
Australia
Prior art keywords
composition
dengue
trehalose
virus
sucrose
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
AU2017305498A
Other languages
English (en)
Other versions
AU2017305498A1 (en
Inventor
Steven Michael Erb
Jill Ann LIVENGOOD
Linda Marie Strange
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Takeda Vaccines Inc
Original Assignee
Takeda Vaccines Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Takeda Vaccines Inc filed Critical Takeda Vaccines Inc
Publication of AU2017305498A1 publication Critical patent/AU2017305498A1/en
Application granted granted Critical
Publication of AU2017305498B2 publication Critical patent/AU2017305498B2/en
Priority to AU2023203715A priority Critical patent/AU2023203715A1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • 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
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525Virus
    • A61K2039/5254Virus avirulent or attenuated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505Inorganic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55516Proteins; Peptides
    • 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
    • C12N2770/24011Flaviviridae
    • C12N2770/24034Use 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
    • C12N2770/24011Flaviviridae
    • C12N2770/24111Flavivirus, e.g. yellow fever virus, dengue, JEV
    • C12N2770/24134Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • YGENERAL 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
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)

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

Family

ID=59593235

Family Applications (2)

Application Number Title Priority Date Filing Date
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

Family Applications After (1)

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

Country Status (13)

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

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CR20190291A (es) * 2016-12-23 2019-11-05 Serum Institute Of India Pvt Ltd Métodos mejorados para estimular la productividad de anticuerpos en el cultivo de células de mamiferos y reducir la agregación durante los procesos de formulación post-tratamiento (downstream) y formulaciones de anticuerpos estables obtenidas a partir de los mismos
WO2019112921A1 (en) 2017-12-07 2019-06-13 Merck Sharp & Dohme Corp. Formulations of dengue virus vaccine compositions
CA3094404A1 (en) * 2018-03-20 2019-09-26 National Research Council Of Canada A method for lyophilizing live vaccine strains of francisella tularensis
KR102646145B1 (ko) 2018-05-31 2024-03-11 주식회사 엑소코바이오 줄기세포 유래의 엑소좀을 유효성분으로 포함하는 모공 축소용 조성물
KR102058961B1 (ko) 2018-07-28 2019-12-24 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
KR20210100662A (ko) * 2018-12-05 2021-08-17 세레스 테라퓨틱스, 인코포레이티드 박테리아를 안정화시키는 조성물 그리고 이의 용도
BR112022001476A2 (pt) 2019-08-16 2023-10-03 Takeda Vaccines Inc Uso de uma vacina contra hepatite a e uma composição de vacina contra dengue ou uma dose unitária de uma composição de vacina contra dengue, combinação de vacina e kit
BR112022015710A2 (pt) * 2020-02-27 2022-09-27 Takeda Vaccines Inc Método para remover dna de célula hospedeira a partir da preparação de vírus
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
EP4356925B1 (en) * 2022-10-18 2025-09-10 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

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2009004862A (es) * 2006-11-07 2009-07-17 Sanofi Pasteur Biologics Co Estabilizacion de vacunas por liofilizacion.
WO2009014774A1 (en) * 2007-04-06 2009-01-29 Inviragen, Inc. Methods and compositions for live attenuated viruses
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)

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

Similar Documents

Publication Publication Date Title
US20230263880A1 (en) Compositions and methods for stabilizing flaviviruses with improved formulations
US9827303B2 (en) Methods and compositions for stabilizing dried biological materials
Patel et al. Combined semi-empirical screening and design of experiments (DOE) approach to identify candidate formulations of a lyophilized live attenuated tetravalent viral vaccine candidate
HUE026885T2 (en) Stabilize virus fragments
US10806781B2 (en) Compositions and methods for live, attenuated alphavirus formulations
US20200306361A1 (en) Compositions and methods for stabilizing alphaviruses with improved formulations
BR112019001299B1 (pt) Composições, usos, métodos e kits para estabilizar flavivírus com formulações aprimoradas
HK1220358B (en) Compositions and methods for live, attenuated alphavirus formulations

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)