US20110014230A1 - preparation of influenza virus vaccine antigens - Google Patents

preparation of influenza virus vaccine antigens Download PDF

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Publication number
US20110014230A1
US20110014230A1 US12/933,379 US93337909A US2011014230A1 US 20110014230 A1 US20110014230 A1 US 20110014230A1 US 93337909 A US93337909 A US 93337909A US 2011014230 A1 US2011014230 A1 US 2011014230A1
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United States
Prior art keywords
influenza
virions
detergent
virus
vaccine
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Abandoned
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US12/933,379
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English (en)
Inventor
Christoph Haussmann
Frank Hauschild
Bjorn Jobst
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Novartis AG
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Novartis AG
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41091288&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20110014230(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis AG filed Critical Novartis AG
Priority to US12/933,379 priority Critical patent/US20110014230A1/en
Assigned to NOVARTIS VACCINES AND DIAGNOSTICS GMBH reassignment NOVARTIS VACCINES AND DIAGNOSTICS GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HAUSCHILD, FRANK, HAUSSMANN, CHRISTOPH, JOBST, BJORN
Assigned to NOVARTIS AG reassignment NOVARTIS AG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: NOVARTIS VACCINES AND DIAGNOSTICS GMBH
Publication of US20110014230A1 publication Critical patent/US20110014230A1/en
Assigned to NOVARTIS AG reassignment NOVARTIS AG CORRECTIVE ASSIGNMENT TO CORRECT THE TYPO IN THE PRIORITY FROM 61069898 TO 61069868 PREVIOUSLY RECORDED ON REEL 025346 FRAME 0690. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT OF NOVARTIS VACCINES AND DIAGNOSTICS GMBH TO NOVARTIS AG. Assignors: NOVARTIS VACCINES AND DIAGNOSTICS GMBH
Assigned to NOVARTIS AG reassignment NOVARTIS AG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: NOVARTIS VACCINES AND DIAGNOSTICS SRL
Abandoned legal-status Critical Current

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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
    • A61K39/145—Orthomyxoviridae, e.g. influenza virus
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • 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
    • A61K2039/5252—Virus inactivated (killed)
    • 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
    • C12N2760/16034—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
    • C12N2760/16051—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
    • C12N2760/16111—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
    • C12N2760/16161—Methods of inactivation or attenuation
    • C12N2760/16163—Methods of inactivation or attenuation by chemical treatment

Definitions

  • influenza virions are maintained before, during and after splitting in a Tris buffer.
  • the virions are maintained before, during and after splitting in a phosphate buffer. This buffer change has been associated with a >20-fold increase in antigen yield, in particular with a H5 subtype influenza A virus.
  • the virus harvest prior to the capture step is subjected to an ultra-/diafiltration step into a low conductivity buffer.
  • This initial step can result in up to a 10-fold increase of antigen yield depending on the influenza virus strain, and is particularly useful for virions that do not bind to the capture agent.
  • the invention protects against a strain that is capable of human-to-human transmission, and so the strain's genome will usually include at least one RNA segment that originated in a mammalian (e.g. in a human) influenza virus. It may include NS segment that originated in an avian influenza virus.
  • Treatment with ⁇ -propiolactone is particularly useful, as disclosed in reference 68.
  • the ⁇ -propiolactone may be present in a phosphate buffer.
  • a process of the invention for disrupting influenza virions can be used as part of an overall process for preparing a split virus vaccine or for preparing a purified surface antigen vaccine.
  • a hemagglutinin-containing antigen preparation will be obtained from a virus by a process in which influenza virions are disrupted by a process as described herein.
  • the hemagglutinin-containing antigen preparation will then be used to prepare the vaccine, also as described herein.
  • Preferred adjuvants for use with the invention are oil-in-water emulsions, which have been found to be particularly suitable for use in adjuvanting influenza virus vaccines.
  • Various such emulsions are known, and they typically include at least one oil and at least one surfactant, with the oil(s) and surfactant(s) being biodegradable (metabolisable) and biocompatible.
  • the oil droplets in the emulsion are generally less than 5 ⁇ m in diameter, and ideally have a sub-micron diameter, with these small sizes being achieved with a microfluidiser to provide stable emulsions. Droplets with a size less than 220 nm are preferred as they can be subjected to filter sterilization.
  • composition includes a tocopherol
  • any of the ⁇ , ⁇ , ⁇ , ⁇ , ⁇ or ⁇ tocopherols can be used, but ⁇ -tocopherols are preferred.
  • the tocopherol can take several forms e.g. different salts and/or isomers. Salts include organic salts, such as succinate, acetate, nicotinate, etc. D- ⁇ -tocopherol and DL- ⁇ -tocopherol can both be used.
  • Tocopherols are advantageously included in vaccines for use in elderly patients (e.g. aged 60 years or older) because vitamin E has been reported to have a positive effect on the immune response in this patient group [169].

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Virology (AREA)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Molecular Biology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
US12/933,379 2008-03-18 2009-03-18 preparation of influenza virus vaccine antigens Abandoned US20110014230A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US12/933,379 US20110014230A1 (en) 2008-03-18 2009-03-18 preparation of influenza virus vaccine antigens

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US6986808P 2008-03-18 2008-03-18
US12/933,379 US20110014230A1 (en) 2008-03-18 2009-03-18 preparation of influenza virus vaccine antigens
PCT/IB2009/005122 WO2009115917A2 (en) 2008-03-18 2009-03-18 Improvements in preparation of influenza virus vaccine antigens

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2009/005122 A-371-Of-International WO2009115917A2 (en) 2008-03-18 2009-03-18 Improvements in preparation of influenza virus vaccine antigens

Related Child Applications (1)

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US14/961,778 Continuation US10946088B2 (en) 2008-03-18 2015-12-07 Preparation of influenza virus vaccine antigens

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US20110014230A1 true US20110014230A1 (en) 2011-01-20

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Family Applications (3)

Application Number Title Priority Date Filing Date
US12/933,379 Abandoned US20110014230A1 (en) 2008-03-18 2009-03-18 preparation of influenza virus vaccine antigens
US14/961,778 Active US10946088B2 (en) 2008-03-18 2015-12-07 Preparation of influenza virus vaccine antigens
US17/151,840 Pending US20210205438A1 (en) 2008-03-18 2021-01-19 Preparation of influenza virus vaccine antigens

Family Applications After (2)

Application Number Title Priority Date Filing Date
US14/961,778 Active US10946088B2 (en) 2008-03-18 2015-12-07 Preparation of influenza virus vaccine antigens
US17/151,840 Pending US20210205438A1 (en) 2008-03-18 2021-01-19 Preparation of influenza virus vaccine antigens

Country Status (11)

Country Link
US (3) US20110014230A1 (ja)
EP (3) EP3459563A1 (ja)
JP (1) JP5518041B2 (ja)
KR (1) KR20100135766A (ja)
CN (1) CN101998990B (ja)
AU (1) AU2009227674C1 (ja)
CA (1) CA2718430A1 (ja)
EA (1) EA201071086A1 (ja)
ES (1) ES2535101T3 (ja)
NZ (1) NZ587798A (ja)
WO (1) WO2009115917A2 (ja)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110200635A1 (en) * 2008-06-12 2011-08-18 Novartis Ag Combined influenza vaccines for seasonal and pandemic protection
US9821051B1 (en) * 2010-10-28 2017-11-21 Seqirus UK Limited Reducing hospitalization in elderly influenza vaccine recipients
US10144917B2 (en) 2014-08-29 2018-12-04 Calixar Method for preparing a vaccine antigen, resulting vaccine antigen and uses
RU2741003C1 (ru) * 2020-03-27 2021-01-22 Евгений Дмитриевич Некрасов Способ производства четырехвалентной субъединичной вакцины против гриппа без адъювантов

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US11707520B2 (en) * 2005-11-03 2023-07-25 Seqirus UK Limited Adjuvanted vaccines with non-virion antigens prepared from influenza viruses grown in cell culture
GB0918830D0 (en) 2009-10-27 2009-12-09 Glaxosmithkline Biolog Niederl Process
SG184804A1 (en) 2010-04-30 2012-11-29 Temasek Life Sciences Lab Ltd Universal vaccine against h5n1 lineages
ES2653197T3 (es) * 2011-07-20 2018-02-06 Bgp Products B.V. Procedimiento para producir antígeno ortomixoviral y vacunas
JP6136236B2 (ja) * 2012-12-19 2017-05-31 東ソー株式会社 組換えタンパク質の精製方法
RU2710239C1 (ru) * 2019-06-14 2019-12-25 Федеральное государственное унитарное предприятие "Санкт-Петербургский научно-исследовательский институт вакцин и сывороток и предприятие по производству бактерийных препаратов" Федерального медико-биологического агентства Способ получения антигена или антигенов для производства противогриппозной вакцины и вакцина на его основе
JP2023500873A (ja) * 2019-11-07 2023-01-11 セキラス ユーケー リミテッド 低減した粒度を有するウイルスワクチンを生成するための組成物および方法

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