KR20220098370A - 감소된 입자 크기를 가지는 바이러스 백신을 제조하기 위한 조성물 및 방법 - Google Patents

감소된 입자 크기를 가지는 바이러스 백신을 제조하기 위한 조성물 및 방법 Download PDF

Info

Publication number
KR20220098370A
KR20220098370A KR1020227018894A KR20227018894A KR20220098370A KR 20220098370 A KR20220098370 A KR 20220098370A KR 1020227018894 A KR1020227018894 A KR 1020227018894A KR 20227018894 A KR20227018894 A KR 20227018894A KR 20220098370 A KR20220098370 A KR 20220098370A
Authority
KR
South Korea
Prior art keywords
ionic surfactant
viral particles
sub
virions
viral
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.)
Pending
Application number
KR1020227018894A
Other languages
English (en)
Korean (ko)
Inventor
크리스토퍼 대드
매튜 스미스
데브라 리디아드
Original Assignee
세퀴러스 유케이 리미티드
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 세퀴러스 유케이 리미티드 filed Critical 세퀴러스 유케이 리미티드
Publication of KR20220098370A publication Critical patent/KR20220098370A/ko
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/145—Orthomyxoviridae, e.g. influenza virus
    • 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
    • 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
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
    • 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
    • C12N7/04—Inactivation or attenuation; Producing viral sub-units
    • 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
    • C12N7/04—Inactivation or attenuation; Producing viral sub-units
    • C12N7/06—Inactivation or attenuation by chemical treatment
    • 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
    • A61K2039/5252—Virus inactivated (killed)
    • 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
    • A61K2039/5258—Virus-like particles
    • 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
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • 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
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16111—Influenzavirus A, i.e. influenza A virus
    • 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
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16111—Influenzavirus A, i.e. influenza A virus
    • C12N2760/16134—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
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16111—Influenzavirus A, i.e. influenza A virus
    • C12N2760/16151—Methods of production or purification of viral material
    • 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
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16211—Influenzavirus B, i.e. influenza B virus
    • 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
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16211—Influenzavirus B, i.e. influenza B virus
    • C12N2760/16234—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
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16211—Influenzavirus B, i.e. influenza B virus
    • C12N2760/16251—Methods of production or purification of viral material

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Virology (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pulmonology (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
KR1020227018894A 2019-11-07 2020-11-06 감소된 입자 크기를 가지는 바이러스 백신을 제조하기 위한 조성물 및 방법 Pending KR20220098370A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962931909P 2019-11-07 2019-11-07
US62/931,909 2019-11-07
PCT/IB2020/000961 WO2021090067A2 (en) 2019-11-07 2020-11-06 Compositions and methods for producing a viral vaccine with reduced particle size

Publications (1)

Publication Number Publication Date
KR20220098370A true KR20220098370A (ko) 2022-07-12

Family

ID=74104121

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020227018894A Pending KR20220098370A (ko) 2019-11-07 2020-11-06 감소된 입자 크기를 가지는 바이러스 백신을 제조하기 위한 조성물 및 방법

Country Status (11)

Country Link
US (1) US20230220356A1 (https=)
EP (1) EP4054630A2 (https=)
JP (2) JP2023500873A (https=)
KR (1) KR20220098370A (https=)
CN (1) CN114929270A (https=)
AU (1) AU2020380604A1 (https=)
BR (1) BR112022008711A2 (https=)
CL (2) CL2022001176A1 (https=)
IL (1) IL292699A (https=)
MX (1) MX2022005513A (https=)
WO (1) WO2021090067A2 (https=)

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4064232A (en) * 1974-01-14 1977-12-20 Sandoz Ltd. Process for isolating the immunogenic components of influenza viruses
TW570803B (en) * 1997-04-09 2004-01-11 Duphar Int Res Influenza vaccine
PL355287A1 (en) 1999-09-24 2004-04-05 Smithkline Beecham Biologicals S.A. Intranasal influenza virus vaccine
GB0024089D0 (en) 2000-10-02 2000-11-15 Smithkline Beecham Biolog Novel compounds
CA2438960A1 (en) * 2001-02-23 2002-09-06 Glaxosmithkline Biologicals S.A. Influenza vaccine formulations for intradermal delivery
EP2281573A3 (en) 2001-02-23 2011-12-07 GlaxoSmithKline Biologicals s.a. Influenza vaccine formulations for intradermal delivery
ES2525518T3 (es) * 2005-11-01 2014-12-26 Novartis Vaccines And Diagnostics Gmbh Vacunas virales derivadas de células con niveles reducidos de ADN celular residual
CA2628152C (en) 2005-11-04 2016-02-02 Novartis Vaccines And Diagnostics S.R.L. Adjuvanted vaccines with non-virion antigens prepared from influenza viruses grown in cell culture
PE20090146A1 (es) * 2007-04-20 2009-03-23 Glaxosmithkline Biolog Sa Composicion inmunogenica contra el virus influenza
JP5518041B2 (ja) * 2008-03-18 2014-06-11 ノバルティス アーゲー インフルエンザウイルスワクチン抗原の調製における改良
CA2797059A1 (en) 2010-05-03 2011-11-10 Glaxosmithkline Biologicals S.A. Novel method
US9426989B2 (en) 2010-05-06 2016-08-30 Novartis Ag Organic peroxide compounds for microorganism inactivation
CN103370072B (zh) * 2010-12-15 2016-02-03 巴克斯特国际公司 使用改进的溶剂-清洁剂方法进行病毒灭活
CN102690334A (zh) * 2011-03-21 2012-09-26 王一丁 一种病毒类疫苗的纯化方法
CN103827296B (zh) * 2011-07-20 2016-11-16 雅培生物学有限责任公司 用于产生病毒抗原和疫苗的方法
WO2013173256A2 (en) * 2012-05-16 2013-11-21 Kj Biosciences, Llc New and improved influenza vaccines
JP7403733B2 (ja) * 2017-09-04 2023-12-25 国立感染症研究所長 インフルエンザｈａスプリットワクチンの製造方法
WO2019045090A1 (ja) * 2017-09-04 2019-03-07 公益財団法人ヒューマンサイエンス振興財団 インフルエンザｈａスプリットワクチンの製造方法
CA3107409A1 (en) * 2018-07-23 2020-01-30 Japan As Represented By Director General Of National Institute Of Infectious Diseases Composition containing influenza vaccine
EA202192398A1 (ru) * 2019-03-04 2021-11-23 Джэпэн Эз Репризентид Баи Директор Дженерал Оф Нэшнл Инститьют Оф Инфекшес Дизизис Способ приготовления сплит-вакцины против гриппа на основе гемагглютинина

Also Published As

Publication number Publication date
WO2021090067A3 (en) 2021-06-10
EP4054630A2 (en) 2022-09-14
BR112022008711A2 (pt) 2022-07-19
US20230220356A1 (en) 2023-07-13
CL2022001176A1 (es) 2023-01-20
MX2022005513A (es) 2022-06-08
CN114929270A (zh) 2022-08-19
JP2025092571A (ja) 2025-06-19
JP2023500873A (ja) 2023-01-11
IL292699A (en) 2022-07-01
CL2025002531A1 (es) 2025-12-19
WO2021090067A2 (en) 2021-05-14
AU2020380604A1 (en) 2022-06-09

Similar Documents

Publication Publication Date Title
AU2012286098B2 (en) Process for producing viral antigen and vaccines
CA2197683C (en) Method for preparing an influenza virus, antigens obtained and applications thereof
JP6275641B2 (ja) ウイルス抗原およびワクチンの製造方法
CN107567496B (zh) 有关病毒的无菌纯化方法
JP6385559B2 (ja) 細胞培養体からのポリオウイルスの精製プロセス
US4206014A (en) Process for removing detergents from virus-antigen suspensions
AU2004249802B2 (en) Improvements in virus production
CN105612250A (zh) 经处理的滤器
KR20220098370A (ko) 감소된 입자 크기를 가지는 바이러스 백신을 제조하기 위한 조성물 및 방법
EP3234113B1 (en) A method for a large scale virus purification
JP2016528905A (ja) 細胞培養中でのウイルスの大規模製造
JP2016508720A (ja) ウイルス様粒子の放出方法
US20090042273A1 (en) Recovery of virus from cell culture using hypertonic salt solution
CN100398642C (zh) 病毒生产的改进
Weigel Development of chromatography-based purification processes for cell culture-derived influenza virus particles
JP2025167597A (ja) ウイルスクリアランス性能の決定方法
CN120192936A (zh) 一种高剂量流感病毒裂解疫苗原液的制备方法
Aiyedebinu Circumvention of bottlenecks in the manufacture of influenza subunit vaccines using aqueous two-phase systems
AU2007221746A1 (en) Improvements in virus production
WO2010079081A1 (en) Methods for recovering a virus or a viral antigen produced by cell culture
HK1194763A (en) Process for producing viral antigen and vaccines

Legal Events

Date Code Title Description
PA0105 International application

St.27 status event code: A-0-1-A10-A15-nap-PA0105

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PA0201 Request for examination

St.27 status event code: A-1-2-D10-D11-exm-PA0201

D13 Search requested

Free format text: ST27 STATUS EVENT CODE: A-1-2-D10-D13-SRH-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

D13-X000 Search requested

St.27 status event code: A-1-2-D10-D13-srh-X000

D21 Rejection of application intended

Free format text: ST27 STATUS EVENT CODE: A-1-2-D10-D21-EXM-PE0902 (AS PROVIDED BY THE NATIONAL OFFICE)

PE0902 Notice of grounds for rejection

St.27 status event code: A-1-2-D10-D21-exm-PE0902