HUE028605T2 - Vírusszerû részecskék tisztítása - Google Patents

Vírusszerû részecskék tisztítása Download PDF

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Publication number
HUE028605T2
HUE028605T2 HUE08782762A HUE08782762A HUE028605T2 HU E028605 T2 HUE028605 T2 HU E028605T2 HU E08782762 A HUE08782762 A HU E08782762A HU E08782762 A HUE08782762 A HU E08782762A HU E028605 T2 HUE028605 T2 HU E028605T2
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HU
Hungary
Prior art keywords
vlps
chromatographic
vlp
chromatography
norovirus
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HUE08782762A
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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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Publication of HUE028605T2 publication Critical patent/HUE028605T2/hu

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    • 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
    • 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
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from 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
    • 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
    • C12N7/02Recovery or purification
    • 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
    • C12N2770/16011Caliciviridae
    • C12N2770/16023Virus like particles [VLP]
    • 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
    • C12N2770/16011Caliciviridae
    • C12N2770/16034Use 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
    • C12N2770/16011Caliciviridae
    • C12N2770/16051Methods 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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Gastroenterology & Hepatology (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 (6)

  1. VlRUSSZERŰ részecskék tisztítása Szabadalmi igénypontok
    1, Eprás Calidvirus ví rosszéra részecskék {Y'LP-k} tisztítására többlépéses kromatográfiás eljárás alkalmazásával, ahol a többlépéses kromatográfiás eljárás egynél több kromatográfiás anyagot alkalmaz, és ahol az eljárás egy lépése során érinikeztetönk egy ViP-tartalmö oldatot egy mefikhldrcfób kölcsön hatásos (NIC) gyantával, ahol a többlépéses kromatográfiás eljárás körülbelül ?0%-ná! nagyobb tisztaságra megtisztítja a VLF-ket
  2. 2, Az 1. igénypont szerinti eljárás, amelynél a VLP-tartálmü oldat ionerősségét úgy állítjuk be, hogy a VIP-k retencióját eredményezze és a szennyezöanyagok átfolyását a metibhidroföb kölcsönhatásös anyagon. 3, A 2, igénypont szerinti eljárás, amelynél az lonerosséget ammónlum-szulfát hozzáadásával állítjuk be.
  3. 4, Az 1, igénypont szerinti eprás, amelynél a VtP-ket körülbelül 90%~nát nagyobb tisztaságra tisztítjuk meg.
  4. 5, Az 1 igénypont szerinti eljárás, amelynél a Calidvirus VLP-k Norovirus YLP-k, $< Az 5. igénypont szerinti eljárás, amelynél a Korovirus VLP~k az I, vagy II. genoosopobba tartozó Nomvirus VLP-k,
  5. 7, Az 1, Igénypont szerinti eljárás, amelynél a többlépéses kromatográfiás eljárás tartalmaz egy kationcserés kromatográfiás lépést, amelyet követi a rneÜÍ-HIC 8. A 7, igénypont szerinti eljárás, amelynél a Vt.P~k II,. genoosoportba tartozó Norovirus VLP-k. H A 8, igénypont szerinti epirás, amelynél a íh genocsoportba tartozó Norovirus egy Houston-vlrus.
  6. 10, Az 1, igénypont szerinti eljárás, amelynél a többlépéses eljárást rekombináns módszerek alkalmazásával előállított sejtlizátymon vagy tenyészeí-fetylészón 11, A 10. igénypont szerinti eljárás, amelynél a VtP-kei bakteriális sejtekben, rovarsejtekben, élesztősejtekben vagy emíöseredető sejtekben termeltetjük. 12, A 11, igénypont szerinti eljárás, amelynél a gazdasejt DNSéarfalmában 1 linói kisebb a szennyezők szintje, 13, A 11 igénypont szerinti eljárás, amelynél a gazdasejt fehérjetartalmában Síinél kisebb a szennyezők szintje.
HUE08782762A 2007-03-14 2008-03-14 Vírusszerû részecskék tisztítása HUE028605T2 (hu)

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US90682107P 2007-03-14 2007-03-14

Publications (1)

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HUE028605T2 true HUE028605T2 (hu) 2016-12-28

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US (4) US8481693B2 (hu)
EP (1) EP2134360B1 (hu)
JP (4) JP5284290B2 (hu)
KR (3) KR20150098681A (hu)
AU (1) AU2008224877B2 (hu)
CA (1) CA2683977C (hu)
DK (1) DK2134360T3 (hu)
ES (1) ES2559421T3 (hu)
HK (1) HK1138795A1 (hu)
HU (1) HUE028605T2 (hu)
PL (1) PL2134360T3 (hu)
SG (2) SG10201701988TA (hu)
WO (1) WO2008113011A2 (hu)

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US20160317645A1 (en) 2016-11-03
JP2013176392A (ja) 2013-09-09
US20190282686A1 (en) 2019-09-19
AU2008224877B2 (en) 2013-07-11
ES2559421T3 (es) 2016-02-12
CA2683977A1 (en) 2008-09-18
JP2017086090A (ja) 2017-05-25
KR20100015562A (ko) 2010-02-12
US10172930B2 (en) 2019-01-08
WO2008113011A3 (en) 2008-12-24
SG10201701988TA (en) 2017-04-27
JP5284290B2 (ja) 2013-09-11
SG179488A1 (en) 2012-04-27
EP2134360B1 (en) 2015-11-18
DK2134360T3 (en) 2016-02-22
EP2134360A2 (en) 2009-12-23
US20100150961A1 (en) 2010-06-17
WO2008113011A2 (en) 2008-09-18
US20130344107A1 (en) 2013-12-26
HK1138795A1 (zh) 2010-09-03
US8481693B2 (en) 2013-07-09
US10792353B2 (en) 2020-10-06
KR20150098681A (ko) 2015-08-28
US9359410B2 (en) 2016-06-07
JP2010530734A (ja) 2010-09-16
EP2134360A4 (en) 2011-08-24
AU2008224877A1 (en) 2008-09-18
PL2134360T3 (pl) 2016-05-31
KR101576219B1 (ko) 2015-12-10
CA2683977C (en) 2017-04-25
KR20170001720A (ko) 2017-01-04
JP2019068846A (ja) 2019-05-09

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