DK2134360T3 - Oprensning af viruslignende partikel - Google Patents

Oprensning af viruslignende partikel Download PDF

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Publication number
DK2134360T3
DK2134360T3 DK08782762.2T DK08782762T DK2134360T3 DK 2134360 T3 DK2134360 T3 DK 2134360T3 DK 08782762 T DK08782762 T DK 08782762T DK 2134360 T3 DK2134360 T3 DK 2134360T3
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DK
Denmark
Prior art keywords
vlps
chromatography
chromatographic
vlp
norovirus
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DK08782762.2T
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English (en)
Inventor
Thomas S Vedvick
Bryan Steadman
Charles Richardson
Thomas R Foubert
Charles R Petrie
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Takeda Vaccines Inc
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Application filed by Takeda Vaccines Inc filed Critical Takeda Vaccines Inc
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Publication of DK2134360T3 publication Critical patent/DK2134360T3/da

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    • 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
    • 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
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/18—Ion-exchange chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from 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
    • 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
    • C12N7/02—Recovery or purification
    • 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
    • C12N2770/16011—Caliciviridae
    • C12N2770/16023—Virus like particles [VLP]
    • 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
    • C12N2770/16011—Caliciviridae
    • C12N2770/16034—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
    • 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
    • C12N2770/16011—Caliciviridae
    • C12N2770/16051—Methods of production or purification of viral material

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Analytical Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (13)

1. Fremgangsmåde til oprensning af Calicivirus-viruslignende partikler (VLP'-er) under anvendelse af en flertrinskromatografi-fremgangsmåde, hvor der i flertrinskromatografi-fremgangsmåden anvendes mere end et kromatografimateriale, og hvor et trin i fremgangsmåden omfatter at bringe en VLP-holdig opløsning i kontakt med en methyl-hydrofob interaktions-(HIC)-resin, hvor flertrinskromatografi-fremgangsmåden oprenser VLP'erne til mere end ca. 70 %.
2. Fremgangsmåde ifølge krav 1, hvor ionstyrken af den VLP-holdige opløsning justeres til at forårsage retention af VLP'er, idet de kontaminerende materialer passerer gennem det methyl-hydrofobe interaktionsmateriale.
3. Fremgangsmåde ifølge krav 2, hvor ionstyrken justeres ved tilsætning af ammoniumsulfat.
4. Fremgangsmåde ifølge krav 1, hvor VLP'erne oprenses til mere end ca. 90 %.
5. Fremgangsmåde ifølge krav 1, hvor Calicivirus-VLP'erne er Norovirus-VLP'er.
6. Fremgangsmåde ifølge krav 5, hvor Norovirus-VLP'erne er Norovirus ge-nogruppe l-VLP'er eller Norovirus genogruppe ll-VLP'er.
7. Fremgangsmåde ifølge krav 1, hvor flertrinsfremgangsmåden omfatter et trin med kationbytningskromatografi efterfulgt af trinnet med methyl-FIIC.
8. Fremgangsmåde ifølge krav 7, hvor VLP'erne er Norovirus genogruppe ll-VLP'er.
9. Fremgangsmåde ifølge krav 8, hvor Norovirus genogruppe Il-virussen er en Houston-virus.
10. Fremgangsmåde ifølge krav 1, hvor multitrinsfremgangsmåden udføres på cellelysat eller kultursupernatant produceret under anvendelse af rekom-binante metodologier.
11. Fremgangsmåde ifølge krav 10, hvor VLP'erne produceres i bakterieceller, insektceller, gærceller eller pattedyrsceller.
12. Fremgangsmåde ifølge krav 11, hvor kontaminantniveauet af værtscelle-DNA-indhold er lavere end 1 %.
13. Fremgangsmåde ifølge krav 11, hvor kontaminantniveauet af værtscelle-proteinindhold er lavere end 5 %.
DK08782762.2T 2007-03-14 2008-03-14 Oprensning af viruslignende partikel DK2134360T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US90682107P 2007-03-14 2007-03-14
PCT/US2008/057072 WO2008113011A2 (en) 2007-03-14 2008-03-14 Virus like particle purification

Publications (1)

Publication Number Publication Date
DK2134360T3 true DK2134360T3 (da) 2016-02-22

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Country Status (13)

Country Link
US (4) US8481693B2 (da)
EP (1) EP2134360B1 (da)
JP (4) JP5284290B2 (da)
KR (3) KR101576219B1 (da)
AU (1) AU2008224877B2 (da)
CA (1) CA2683977C (da)
DK (1) DK2134360T3 (da)
ES (1) ES2559421T3 (da)
HK (1) HK1138795A1 (da)
HU (1) HUE028605T2 (da)
PL (1) PL2134360T3 (da)
SG (2) SG179488A1 (da)
WO (1) WO2008113011A2 (da)

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Publication number Publication date
SG179488A1 (en) 2012-04-27
US20100150961A1 (en) 2010-06-17
KR20100015562A (ko) 2010-02-12
EP2134360A2 (en) 2009-12-23
PL2134360T3 (pl) 2016-05-31
JP2013176392A (ja) 2013-09-09
JP2019068846A (ja) 2019-05-09
WO2008113011A2 (en) 2008-09-18
CA2683977C (en) 2017-04-25
US20190282686A1 (en) 2019-09-19
US10172930B2 (en) 2019-01-08
KR101576219B1 (ko) 2015-12-10
WO2008113011A3 (en) 2008-12-24
KR20170001720A (ko) 2017-01-04
US10792353B2 (en) 2020-10-06
US8481693B2 (en) 2013-07-09
ES2559421T3 (es) 2016-02-12
US20130344107A1 (en) 2013-12-26
JP2010530734A (ja) 2010-09-16
KR20150098681A (ko) 2015-08-28
HK1138795A1 (zh) 2010-09-03
HUE028605T2 (en) 2016-12-28
AU2008224877A1 (en) 2008-09-18
EP2134360A4 (en) 2011-08-24
AU2008224877B2 (en) 2013-07-11
JP5284290B2 (ja) 2013-09-11
CA2683977A1 (en) 2008-09-18
JP2017086090A (ja) 2017-05-25
SG10201701988TA (en) 2017-04-27
US20160317645A1 (en) 2016-11-03
EP2134360B1 (en) 2015-11-18
US9359410B2 (en) 2016-06-07

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