DK2099485T3 - Alfavirus- og alfavirusreplikonpartikelformuleringer samt tilhørende fremgangsmåder - Google Patents
Alfavirus- og alfavirusreplikonpartikelformuleringer samt tilhørende fremgangsmåder Download PDFInfo
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Classifications
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- 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
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K39/12—Viral antigens
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- 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
- A61K9/19—Particulate 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
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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
- A61P31/14—Antivirals for RNA viruses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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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
- A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
- A61K2039/525—Virus
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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
- A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
- A61K2039/525—Virus
- A61K2039/5256—Virus expressing foreign proteins
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- 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
- C12N2770/36011—Togaviridae
- C12N2770/36111—Alphavirus, e.g. Sindbis virus, VEE, EEE, WEE, Semliki
- C12N2770/36134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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- 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
- C12N2770/36011—Togaviridae
- C12N2770/36111—Alphavirus, e.g. Sindbis virus, VEE, EEE, WEE, Semliki
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Claims (9)
1. Fremgangsmåde til fremstilling af en tørret sammensætning med rehydrerings- og lagerstabilitet, hvilken fremgangsmåde omfatter følgende trin: (a) at fremstille en vandig opløsning eller dispersion omfattende venezuelansk hesteencephalitisvirus (VEE) eller replikonpartikler deraf; et salt, hvor saltet er natriumsulfat i en ionstyrke fra 50 mM til 400 mM; eller hvor saltet er natriumchlorid i en ionstyrke fra 100 mM til 500 mM; en surfaktant, hvor surfaktanten er humant serumalbumin; sukrose; og eventuelt, et blødgøringsmiddel omfattende glycerol og/eller et fyldemiddel, hvor fyl-demidlet er hydroxyethylstivelse, dextran, mannitol, glycin, Ficoll eller polyvinylpyr-rolidon; at holde opløsningen eller dispersionen ved en pH-værdi på 7 til 9 forud for tørring; og at pufre opløsningen eller dispersionen med borsyre og et farmaceutisk acceptabelt salt af tetraborat forud for tørring, og b) at tørre den vandige dispersion til opnåelse af en sammensætning, hvor VEE eller replikonpartikler deraf er dispergeret i en amorf glasagtig matrix omfattende surfaktanten og sukrosen og, eventuelt, blødgøringsmidlet og/eller fyldemidlet.
2. Fremgangsmåde ifølge krav 1, hvor den vandige opløsning eller dispersion yderligere omfatter blødgøringsmidlet.
3. Fremgangsmåde ifølge krav 1 eller 2, hvor den vandige opløsning eller dispersion yderligere omfatter fyldemidlet.
4. Fremgangsmåde ifølge krav 1, hvor det humane serumalbumin fremstilles rekom-binant.
5. Fremgangsmåde ifølge krav 1, hvor restfugtindholdet i den tørrede sammensætning er fra 0,5 % til 10 %; hvor restfugtindholdet eventuelt er fra 2 til 7 %; og hvor restfugtindholdet eventuelt er fra 3 til 5 %.
6. Fremgangsmåde ifølge krav 1, hvor sammensætningen omfatter blødgøringsmidlet, og mængden af glycerol i den vandige opløsning eller dispersion er fra 0,05 % til 2 %.
7. Fremgangsmåde ifølge krav 1, hvor sammensætningen omfatter blødgøringsmidlet, og blødgøringsmidlet yderligere omfatter polypropylenglykol.
8. Fremgangsmåde ifølge krav 1, hvor den vandige opløsning eller dispersion omfatter 10 mM natriumphosphat, 4 % sukrose, 0,1 % humant serumalbumin, 100 mM natriumsulfat og 0,25 % glycerol.
9. Tørret sammensætning omfattende (1) venezuelansk hesteencephalitisvirus (VEE) eller replikonpartikler deraf, (2) et salt, hvor saltet er udvalgt blandt natriumsulfat og natriumchlorid, (3) en surfaktant, hvor surfaktanten er humant serumalbumin, og (4) sukrose, og, eventuelt, (5) et blødgøringsmiddel omfattende glycerol og/eller et fyldemiddel, hvor fyldemidlet er hydroxyethylstivelse, dextran, mannitol, glycin, Ficoll eller polyvinylpyr-rolidon; og hvor den tørrede sammensætning kan opnås ved fremgangsmåden ifølge et hvilket som helst af kravene 1 til 8.
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| AU2010234362B2 (en) | 2009-04-08 | 2015-11-26 | Alphavax, Inc. | Alphavirus replicon particles expressing TRP2 |
| CA2795050C (en) | 2010-03-31 | 2018-05-22 | Stabilitech Ltd. | Method for preserving alum adjuvants and alum-adjuvanted vaccines |
| WO2011121301A1 (en) | 2010-03-31 | 2011-10-06 | Stabilitech Ltd | Excipients for stabilising viral particles, polypeptides or biological material |
| ES2757591T3 (es) * | 2010-03-31 | 2020-04-29 | Stabilitech Biopharma Ltd | Estabilización de partículas virales |
| MX349294B (es) | 2010-12-02 | 2017-07-21 | Oncolytics Biotech Inc | Formulaciones virales liofilizadas. |
| EP2646051A4 (en) | 2010-12-02 | 2014-05-28 | Oncolytics Biotech Inc | FORMULATIONS OF LIQUID VIRUSES |
| GB201117233D0 (en) | 2011-10-05 | 2011-11-16 | Stabilitech Ltd | Stabilisation of polypeptides |
| US11576958B2 (en) | 2013-02-07 | 2023-02-14 | Children's Medical Center Corporation | Protein antigens that provide protection against pneumococcal colonization and/or disease |
| AP2015008733A0 (en) * | 2013-03-14 | 2015-09-30 | Takeda Vaccines Inc | Compositions and methods for live, attenuated alphavirus formulations |
| KR101398764B1 (ko) | 2013-08-29 | 2014-05-27 | 강릉원주대학교산학협력단 | 입자의 이동에 의해 분석물질을 검출하는 장치 및 방법 |
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| US5185440A (en) * | 1989-06-20 | 1993-02-09 | North Carolina State University | cDNA clone coding for Venezuelan equine encephalitis virus and attenuating mutations thereof |
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-
2007
- 2007-11-02 DK DK07844849.5T patent/DK2099485T3/da active
- 2007-11-02 AU AU2007317347A patent/AU2007317347B2/en active Active
- 2007-11-02 US US11/934,702 patent/US20090047255A1/en not_active Abandoned
- 2007-11-02 NZ NZ57656307A patent/NZ576563A/xx unknown
- 2007-11-02 WO PCT/US2007/083537 patent/WO2008058035A1/en not_active Ceased
- 2007-11-02 CA CA 2668417 patent/CA2668417A1/en not_active Abandoned
- 2007-11-02 ES ES07844849.5T patent/ES2673823T3/es active Active
- 2007-11-02 EP EP07844849.5A patent/EP2099485B1/en active Active
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2009
- 2009-04-23 IL IL198364A patent/IL198364A/en active IP Right Grant
- 2009-06-01 ZA ZA200903791A patent/ZA200903791B/xx unknown
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2011
- 2011-01-24 US US13/012,714 patent/US9187729B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| EP2099485A1 (en) | 2009-09-16 |
| EP2099485B1 (en) | 2018-03-21 |
| US9187729B2 (en) | 2015-11-17 |
| WO2008058035A1 (en) | 2008-05-15 |
| ES2673823T3 (es) | 2018-06-25 |
| AU2007317347B2 (en) | 2014-02-06 |
| IL198364A0 (en) | 2011-08-01 |
| CA2668417A1 (en) | 2008-05-15 |
| ZA200903791B (en) | 2010-03-31 |
| US20110182941A1 (en) | 2011-07-28 |
| US20090047255A1 (en) | 2009-02-19 |
| AU2007317347A1 (en) | 2008-05-15 |
| NZ576563A (en) | 2012-09-28 |
| IL198364A (en) | 2017-11-30 |
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