DK1556477T3 - Fremgangsmåde til tørring - Google Patents
Fremgangsmåde til tørring Download PDFInfo
- Publication number
- DK1556477T3 DK1556477T3 DK03779829.5T DK03779829T DK1556477T3 DK 1556477 T3 DK1556477 T3 DK 1556477T3 DK 03779829 T DK03779829 T DK 03779829T DK 1556477 T3 DK1556477 T3 DK 1556477T3
- Authority
- DK
- Denmark
- Prior art keywords
- viscous liquid
- sample
- vaccine
- active element
- highly viscous
- Prior art date
Links
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
- C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
- C12N1/04—Preserving or maintaining viable microorganisms
-
- 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
- A61K39/125—Picornaviridae, e.g. calicivirus
- A61K39/13—Poliovirus
-
- 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
- A61K39/295—Polyvalent viral antigens; Mixtures of viral and bacterial antigens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
-
- 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
- A61P31/04—Antibacterial agents
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
-
- 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
- C12N2770/32011—Picornaviridae
- C12N2770/32611—Poliovirus
- C12N2770/32634—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Virology (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Wood Science & Technology (AREA)
- Genetics & Genomics (AREA)
- Biotechnology (AREA)
- Zoology (AREA)
- Biomedical Technology (AREA)
- Biochemistry (AREA)
- General Engineering & Computer Science (AREA)
- Tropical Medicine & Parasitology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicinal Preparation (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Sampling And Sample Adjustment (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (28)
1. Fremgangsmåde til konservering af et virksomt element, hvilken fremgangsmåde omfatter følgende trin: a) at fremstille en konserveringsprøve ved at opløse/opslæmme et virksomt element i en opløsning af et stabiliseringsmiddel; b) at underkaste konserveringsprøven temperaturforhold over 0 °C og trykforhold under 30 mbar, således at konserveringsprøven taber opløsningsmiddel ved fordampning, uden frysnings- eller bobledannelsesforbundet skumdannelse, til dannelse af en viskøs væske, hvor det virksomme element omfatter et biologisk system udvalgt fra gruppen bestående af vira, virusbestanddele og viruslignende partikler.
2. Fremgangsmåde ifølge krav 1, yderligere omfattende følgende trin: c) yderligere at underkaste konserveringsprøven sådanne temperatur- og trykforhold, at den viskøse væske tørrer til dannelse af en højviskøs væske, hvor den højviskøse væske har et opløsningsmiddelindhold på eller under 15 °/o efter vægt.
3. Fremgangsmåde ifølge krav 1 eller 2, hvor trykket sænkes til 20 mbar eller derunder under trin b).
4. Fremgangsmåde ifølge krav 1-3, hvor temperaturen uden for konserveringsprøven er mellem 5 °C og 37 °C under trin b).
5. Fremgangsmåde ifølge krav 2-4, hvor temperaturen uden for konserveringsprøven er mellem 5 °C og 37 °C under trin c).
6. Fremgangsmåde ifølge krav 2-5, hvor temperaturen uden for konserveringsprøven er højere under trin c), end den er i trin b).
7. Fremgangsmåde ifølge krav 6, hvor temperaturen uden for konserveringsprøven hæves til over 20 °C under trin c).
8. Fremgangsmåde ifølge krav 2-7, hvor trykket sænkes i trin c) sammenlignet med trykket under trin b).
9. Fremgangsmåde ifølge krav 8, hvor trykket sænkes til 1 mbar eller derunder under trin c).
10. Fremgangsmåde ifølge krav 1-9, hvor trin b) fuldendes på under 4 timer.
11. Fremgangsmåde ifølge krav 2-10, hvor trinnene b) og c) fuldendes på under 12 timer.
12. Fremgangsmåde ifølge krav 1-11, hvor stabiliseringsmidlet omfatter en glasdannende polyol udvalgt fra gruppen bestående af glukose, maltulose, iso-maltulose, laktulose, sukrose, maltose, laktose, sorbitol, iso-maltose, maltitol, laktitol, palatinit, trehalose, raffi-nose, stachyose, melezitose og dextran.
13. Fremgangsmåde ifølge krav 12, hvor stabiliseringsmidlet er sukrose.
14. Fremgangsmåde ifølge krav 12-13, hvor koncentrationen af stabiliseringsmidlet er under 15 %.
15. Fremgangsmåde ifølge krav 1-14, hvor konserveringsprøven omfatter phenolrød.
16. Fremgangsmåde ifølge kravene 1-15, hvor konserveringsprøven tørres i en beholder med en indre opløsningsmiddelafvisende overflade.
17. Fremgangsmåde ifølge et hvilket som helst af kravene 1-16, hvor det virksomme element omfatter IPV (inaktiveret poliovirus).
18. Fremgangsmåde ifølge kravene 1-17, hvor det virksomme element omfatter en vaccine.
19. Højviskøs væske omfattende et virksomt element, hvor det virksomme elements antigenicitet eller aktivitet er bevaret, opnåelig ved fremgangsmåden ifølge kravene 1-18, hvor den højviskøse væske har et opløsningsmiddelindhold på eller under 15 % efter vægt, og hvor det virksomme element omfatter et biologisk system udvalgt fra gruppen bestående af vira, virusbestanddele og viruslignende partikler.
20. Højviskøs væske ifølge krav 19 omfattende en glasdannende polyol udvalgt fra gruppen bestående af glukose, maltulose, iso-maltulose, laktulose, sukrose, maltose, lak-tose, sorbitol, iso-maltose, maltitol, laktitol, palatinit, trehalose, raffinose, stachyose, mele-zitose og dextran.
21. Højviskøs væske ifølge krav 20, hvor den glasdannende polyol er sukrose.
22. Højviskøs væske ifølge krav 19-21, hvor det virksomme element omfatter en vaccine.
23. Højviskøs væske ifølge krav 19-22, opbevaret i en beholder med en indre opløsningsmiddelafvisende overflade.
24. Immunogen sammensætning eller vaccine omfattende den højviskøse væske ifølge krav 19-22 og en farmaceutisk acceptabel excipiens.
25. Fremgangsmåde til fremstilling af en vaccine omfattende trinnet at rekonstituere den højviskøse væske ifølge krav 19-22 i en vandig opløsning.
26. Fremgangsmåde ifølge krav 25, hvor den vandige opløsning omfatter difteri-antigen, stivkrampe-antigen og kighoste-antigener (acellulære eller hele celler).
27. Fremgangsmåde ifølge krav 26, hvor DTP-vaccinen i det mindste til dels har aluminiumhydroxid som hjælpestof.
28. Sæt omfattende den højviskøse væske ifølge kravene 19-22 opbevaret i en første beholder og en flydende vaccinebestanddel i en anden beholder.
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB0225543A GB0225543D0 (en) | 2002-11-01 | 2002-11-01 | Immunogenic composition |
| GB0225532A GB0225532D0 (en) | 2002-11-01 | 2002-11-01 | Drying process |
| GBGB0225520.6A GB0225520D0 (en) | 2002-11-01 | 2002-11-01 | Drying process |
| GB0317380A GB0317380D0 (en) | 2003-07-24 | 2003-07-24 | Drying method |
| GB0317381A GB0317381D0 (en) | 2003-07-24 | 2003-07-24 | Drying method |
| GB0317371A GB0317371D0 (en) | 2003-07-24 | 2003-07-24 | Immunogenic composition |
| PCT/EP2003/012191 WO2004039417A2 (en) | 2002-11-01 | 2003-10-30 | Drying process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK1556477T3 true DK1556477T3 (da) | 2017-10-23 |
Family
ID=32234471
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK03779829.5T DK1556477T3 (da) | 2002-11-01 | 2003-10-30 | Fremgangsmåde til tørring |
| DK11180306.0T DK2395073T3 (da) | 2002-11-01 | 2003-10-30 | Fremgangsmåde til tørring. |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK11180306.0T DK2395073T3 (da) | 2002-11-01 | 2003-10-30 | Fremgangsmåde til tørring. |
Country Status (28)
| Country | Link |
|---|---|
| US (3) | US8409587B2 (da) |
| EP (3) | EP1575612B1 (da) |
| JP (2) | JP4579156B2 (da) |
| KR (2) | KR101058978B1 (da) |
| AR (2) | AR041880A1 (da) |
| AT (1) | ATE352316T1 (da) |
| AU (2) | AU2003278166B2 (da) |
| BR (1) | BR0315767A (da) |
| CA (2) | CA2503871C (da) |
| CY (2) | CY1119362T1 (da) |
| DE (1) | DE60311526T2 (da) |
| DK (2) | DK1556477T3 (da) |
| ES (3) | ES2645924T3 (da) |
| HK (1) | HK1085380A1 (da) |
| HU (1) | HUE034801T2 (da) |
| IL (2) | IL168052A (da) |
| IS (2) | IS3028B (da) |
| LT (2) | LT1556477T (da) |
| MA (2) | MA27551A1 (da) |
| MX (3) | MXPA05004528A (da) |
| MY (2) | MY132859A (da) |
| NO (3) | NO20052010L (da) |
| NZ (2) | NZ539613A (da) |
| PL (2) | PL213647B1 (da) |
| PT (2) | PT1556477T (da) |
| SI (2) | SI2395073T1 (da) |
| TW (2) | TWI332843B (da) |
| WO (2) | WO2004039417A2 (da) |
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| BR0315767A (pt) * | 2002-11-01 | 2005-09-06 | Glaxosmithkline Biolog Sa | Composição imunogência, método para fabricar uma vacina, kit, vacina, recipiente com uma superfìcie interna repelente à água, e, método para preservar uma composição que compreende ipv e um agente estabilizador |
| NZ550119A (en) * | 2004-04-08 | 2009-10-30 | Biomatrica Inc | Method for storing biological material in a dissolvable matrix |
| US20060099567A1 (en) * | 2004-04-08 | 2006-05-11 | Biomatrica, Inc. | Integration of sample storage and sample management for life science |
| US20080176209A1 (en) * | 2004-04-08 | 2008-07-24 | Biomatrica, Inc. | Integration of sample storage and sample management for life science |
| GB0409795D0 (en) | 2004-04-30 | 2004-06-09 | Glaxosmithkline Biolog Sa | Drying method |
| TWI398272B (zh) * | 2005-03-08 | 2013-06-11 | Intervet Int Bv | 化學定義的安定劑 |
| GB0505518D0 (en) * | 2005-03-17 | 2005-04-27 | Chiron Srl | Combination vaccines with whole cell pertussis antigen |
| PT1896065E (pt) | 2005-06-27 | 2011-08-31 | Glaxosmithkline Biolog Sa | Processo para a preparação de vacinas |
| US8968721B2 (en) | 2005-12-28 | 2015-03-03 | Advanced Bionutrition Corporation | Delivery vehicle for probiotic bacteria comprising a dry matrix of polysaccharides, saccharides and polyols in a glass form and methods of making same |
| EP1973406B1 (en) | 2005-12-28 | 2014-03-12 | Advanced Bionutrition Corporation | A delivery vehicle for probiotic bacteria comprising a dry matrix of polysaccharides, saccharides and polyols in a glass form |
| WO2008028957A2 (en) * | 2006-09-07 | 2008-03-13 | Glaxosmithkline Biologicals S.A. | Vaccine |
| CA2673120C (en) | 2006-12-18 | 2012-08-07 | Advanced Bionutrition Corporation | A dry food product containing live probiotic |
| EA201490303A1 (ru) | 2007-05-02 | 2014-05-30 | Глаксосмитклайн Байолоджикалс С.А. | Вакцина |
| BRPI0811161A2 (pt) * | 2007-05-18 | 2014-10-07 | Medimmune Llc | Conservação de materiais bioativos por espuma liofilizada. |
| GB0711683D0 (en) * | 2007-06-16 | 2007-07-25 | Enigma Diagnostics Ltd | Compositions |
| WO2008155529A1 (en) * | 2007-06-16 | 2008-12-24 | Enigma Diagnostics Limited | Compositions |
| CN101801343A (zh) * | 2007-07-26 | 2010-08-11 | 圣诺菲·帕斯图尔有限公司 | 抗原佐剂组合物及其方法 |
| GB0822633D0 (en) * | 2008-12-11 | 2009-01-21 | Novartis Ag | Formulation |
| ES2908047T3 (es) | 2009-03-27 | 2022-04-27 | Intervet Int Bv | Vacunas en micropartículas para la vacunación oral o nasal y el refuerzo de animales incluidos los peces |
| NZ597053A (en) | 2009-05-26 | 2014-02-28 | Advanced Bionutrition Corp | Stable dry powder composition comprising biologically active microorganisms and/or bioactive materials and methods of making |
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| EP2529004B1 (en) | 2010-01-28 | 2017-06-07 | Advanced Bionutrition Corporation | Dry glassy composition comprising a bioactive material |
| US9504750B2 (en) | 2010-01-28 | 2016-11-29 | Advanced Bionutrition Corporation | Stabilizing composition for biological materials |
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| BR112013005049A2 (pt) | 2010-09-02 | 2016-05-31 | Sanofi Pasteur | estabilizador para a preparação de uma composição vacina da pólio seca injetável |
| JP6034798B2 (ja) | 2010-12-02 | 2016-11-30 | オンコリティクス バイオテク，インコーポレーテッド | 液体ウイルス製剤 |
| TW201233803A (en) | 2010-12-02 | 2012-08-16 | Oncolytics Biotech Inc | Lyophilized viral formulations |
| US20120222979A1 (en) | 2011-03-04 | 2012-09-06 | Elwha LLC, a limited liability company of the State of Delaware | Glassy compositions |
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