DK2395073T3 - Fremgangsmåde til tørring. - Google Patents
Fremgangsmåde til tørring. Download PDFInfo
- Publication number
- DK2395073T3 DK2395073T3 DK11180306.0T DK11180306T DK2395073T3 DK 2395073 T3 DK2395073 T3 DK 2395073T3 DK 11180306 T DK11180306 T DK 11180306T DK 2395073 T3 DK2395073 T3 DK 2395073T3
- Authority
- DK
- Denmark
- Prior art keywords
- viscous liquid
- vaccine
- highly viscous
- sample
- ipv
- 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
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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
-
- 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
- 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)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Microbiology (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Mycology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (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)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Sampling And Sample Adjustment (AREA)
Claims (9)
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 mellem 5 °C og 37 °C og trykforhold under 20 mbar, således at konserveringsprøven taber opløsningsmiddel ved fordampning, uden frysnings- eller bobledannelsesforbundet skumdannelse, til dannelse af en viskøs væske, hvor en viskøs væske er produktet af den primære opløsningsmiddelfjernelsesfase; c) yderligere at underkaste konserveringsprøven temperaturforhold mellem 5 °C og 37 °C og sådanne trykforhold, at den viskøse væske tørrer til dannelse af en højviskøs væske, hvor trykket er reduceret i trin c) i sammenligning med trykket under trin b), 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, raffinose, stachyose, melezitose og dextran, hvor koncentrationen af det anvendte stabiliseringsmiddel er mellem 5 % og 50 % vægt/volumen, hvor den højviskøse væske har et opløsningsmiddelindhold på eller under 15 % efter vægt, og hvor det virksomme element omfatter en vaccine omfattende en virus.
2. Fremgangsmåde ifølge krav 1, hvor koncentrationen af stabiliseringsmidlet er på under 15 %.
3. Fremgangsmåde ifølge krav 1 eller krav 2, hvor det virksomme element omfatter IPV (inaktiveret poliovirus).
4. Højviskøs væske omfattende et aktivt element, hvor antigeniciteten eller aktiviteten af det virksomme element er bevaret, opnåelig ved fremgangsmåden ifølge kravene 1-3, hvor den højviskøse væske har et opløsningsmiddelindhold på eller under 15 % efter vægt, og hvor det virksomme element omfatter en vaccine omfattende en virus.
5. Immunogen sammensætning eller vaccine omfattende den højviskøse væske ifølge krav 4 og en farmaceutisk acceptabel excipiens.
6. Fremgangsmåde til fremstilling af en vaccine, hvilken fremgangsmåde omfatter trinnet at rekonstituere den højviskøse væske ifølge krav 4 i en vandig opløsning.
7. Fremgangsmåde ifølge krav 6, hvor den vandige opløsning omfatter difteri-antigen, stivkrampe-antigen og kighoste-antigener (acellulære eller hele celler).
8. Fremgangsmåde ifølge krav 7, hvor DTP-vaccinen i det mindste delvist har aluminiumhydroxid som adjuvans.
9. Sæt omfattende den højviskøse væske ifølge krav 4 opbevaret i en første beholder og en flydende vaccinebestanddel i en anden beholder.
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0225532A GB0225532D0 (en) | 2002-11-01 | 2002-11-01 | Drying process |
GB0225543A GB0225543D0 (en) | 2002-11-01 | 2002-11-01 | Immunogenic composition |
GBGB0225520.6A GB0225520D0 (en) | 2002-11-01 | 2002-11-01 | Drying process |
GB0317371A GB0317371D0 (en) | 2003-07-24 | 2003-07-24 | Immunogenic composition |
GB0317381A GB0317381D0 (en) | 2003-07-24 | 2003-07-24 | Drying method |
GB0317380A GB0317380D0 (en) | 2003-07-24 | 2003-07-24 | Drying method |
EP03779829.5A EP1556477B1 (en) | 2002-11-01 | 2003-10-30 | Drying process |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2395073T3 true DK2395073T3 (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 Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK03779829.5T DK1556477T3 (da) | 2002-11-01 | 2003-10-30 | Fremgangsmåde til tørring |
Country Status (28)
Country | Link |
---|---|
US (3) | US7927858B2 (da) |
EP (3) | EP2395073B1 (da) |
JP (2) | JP2006504801A (da) |
KR (2) | KR101130948B1 (da) |
AR (2) | AR041881A1 (da) |
AT (1) | ATE352316T1 (da) |
AU (2) | AU2003278166B2 (da) |
BR (1) | BR0315767A (da) |
CA (2) | CA2503946C (da) |
CY (2) | CY1119362T1 (da) |
DE (1) | DE60311526T2 (da) |
DK (2) | DK1556477T3 (da) |
ES (3) | ES2649048T3 (da) |
HK (1) | HK1085380A1 (da) |
HU (1) | HUE034801T2 (da) |
IL (2) | IL168054A (da) |
IS (2) | IS3028B (da) |
LT (2) | LT1556477T (da) |
MA (2) | MA27644A1 (da) |
MX (3) | MXPA05004675A (da) |
MY (2) | MY132859A (da) |
NO (3) | NO20052010L (da) |
NZ (2) | NZ539706A (da) |
PL (2) | PL215237B1 (da) |
PT (2) | PT1556477T (da) |
SI (2) | SI2395073T1 (da) |
TW (2) | TW200501981A (da) |
WO (2) | WO2004039399A1 (da) |
Families Citing this family (47)
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ES2649048T3 (es) * | 2002-11-01 | 2018-01-09 | Glaxosmithkline Biologicals S.A. | Procedimiento de secado |
US20080176209A1 (en) * | 2004-04-08 | 2008-07-24 | Biomatrica, Inc. | Integration of sample storage and sample management for life science |
US20060099567A1 (en) * | 2004-04-08 | 2006-05-11 | Biomatrica, Inc. | Integration of sample storage and sample management for life science |
JP4896006B2 (ja) * | 2004-04-08 | 2012-03-14 | バイオマトリカ, インコーポレイテッド | ライフサイエンスのためのサンプル保存とサンプル管理との統合 |
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 |
NZ564606A (en) | 2005-06-27 | 2010-10-29 | Glaxosmithkline Biolog Sa | Immunogenic composition comprising atleast two N. meningitidis capsular polysaccharides conjugated through a linker protein |
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 |
ES2470340T3 (es) * | 2005-12-28 | 2014-06-23 | Advanced Bionutrition Corporation | Vehículo de administración para bacterias probi�ticas que comprende una matriz seca de polisac�ridos, sac�ridos y polioles en forma vítrea |
AU2007293672B2 (en) * | 2006-09-07 | 2013-06-27 | Glaxosmithkline Biologicals S.A. | Vaccine |
CA2673120C (en) * | 2006-12-18 | 2012-08-07 | Advanced Bionutrition Corporation | A dry food product containing live probiotic |
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EP2529004B1 (en) | 2010-01-28 | 2017-06-07 | Advanced Bionutrition Corporation | Dry glassy composition comprising a bioactive material |
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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 |
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