DK2829282T3 - Fremgangsmåde til fremstilling af en immunologisk aktiv adjuvansbundet tørret vaccinesammensætning - Google Patents
Fremgangsmåde til fremstilling af en immunologisk aktiv adjuvansbundet tørret vaccinesammensætning Download PDFInfo
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- DK2829282T3 DK2829282T3 DK14182864.0T DK14182864T DK2829282T3 DK 2829282 T3 DK2829282 T3 DK 2829282T3 DK 14182864 T DK14182864 T DK 14182864T DK 2829282 T3 DK2829282 T3 DK 2829282T3
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- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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Claims (8)
1. Fremgangsmåde til fremstilling af en immunologisk aktiv adjuvansbundet tørret vaccinesammensætning, hvilken fremgangsmåde omfatter: a. at kombinere mindst en aluminiumsaltadjuvans, mindst et succinatbuffer-system, mindst et glasdannende middel bestående af trehalose og et rekom-binant antigen, hvor antigenet er udvalgt eller stammer fra gruppen bestående af toksiner og vira, til dannelse af en flydende vaccineformulering; b. at lyofilisere den flydende vaccineformulering, hvor lyofiliseringen omfatter trinnene med: 1. at fryse den flydende vaccineformulering til dannelse af en frossen vaccineformulering; og ii. at tørre den frosne vaccineformulering til dannelse af en tørret vaccinesammensætning; hvor sammensætningen kan udløse en immunreaktion hos et individ.
2. Fremgangsmåde ifølge krav 1, hvor aluminiumsaltadjuvansen vælges fra gruppen bestående af aluminiumhydroxid, aluminiumphosphat og aluminiumsulfat.
3. Fremgangsmåde ifølge krav 2, hvor aluminiumsaltadjuvansen er aluminiumhydroxid.
4. Fremgangsmåde ifølge krav 1, hvor trehalose forekommer i en vægt til volumen-koncentration på fra 5 % til 20 % i den flydende vaccineformulering.
5. Fremgangsmåde ifølge krav 1, hvor trehalose forekommer i en vægt til volumen-koncentration på fra 7 % til 15 % i den flydende vaccineformulering.
6. Fremgangsmåde ifølge krav 1, hvor frysetrinnet omfatter en af bakkefrys-ning, hyldefrysning, spray-frysning, skalfrysning og nedsænkning i flydende nitrogen.
7. Fremgangsmåde ifølge krav 6, hvor frysetrinnet omfatter spray-frysning.
8. Fremgangsmåde til styring af partikelstørrelsen i en frossen vaccineformulering, hvilken fremgangsmåde omfatter: a. at blande mindst en adjuvans, hvor adjuvansen er aluminiumhydroxid, et glasdannende middel trehalose, der forekommer i en vægt til volumenkoncentration på fra 7 % til 15 %, og mindst et antigen, hvor antigenet er udvalgt eller stammer fra gruppen bestående af toksiner og vira i et succinatbuf-fersystem, til dannelse af en flydende vaccineformulering; og b. at lyofilisere den flydende vaccineformulering, hvor lyofiliseringen omfatter trinnene med: i. at afkøle den flydende vaccineformulering til en frossen tilstand til dannelse af en frossen vaccineformulering ved spray-frysning; og ii. at tørre den frosne vaccineformulering til dannelse af en tørret vaccinesammensætning; hvor den gennemsnitlige partikeldiameter af den rekonstituerede vaccinesammensætning efter optøning og fortynding af den tørrede vaccinesammensætning med et vandigt fortyndingsmiddel til dannelse af en rekonstitueret vaccinesammensætning er mindre end 10 mikrometer, hvor den gennemsnitlige partikeldiameter af den rekonstituerede vaccinesammensætning er en funktion af trehalosekoncentration.
Applications Claiming Priority (2)
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| US89642907P | 2007-03-22 | 2007-03-22 | |
| EP08732401.8A EP2131857B1 (en) | 2007-03-22 | 2008-03-18 | Method of preparing an immunologically-active adjuvant-bound dried vaccine composition |
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| DK08732401.8T DK2131857T3 (da) | 2007-03-22 | 2008-03-18 | Fremgangsmåde til fremstilling af en immunologisk aktiv adjuvansbundet tørret vaccinesammensætning |
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| DK08732401.8T DK2131857T3 (da) | 2007-03-22 | 2008-03-18 | Fremgangsmåde til fremstilling af en immunologisk aktiv adjuvansbundet tørret vaccinesammensætning |
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| US (2) | US8444991B2 (da) |
| EP (2) | EP2829282B1 (da) |
| AU (1) | AU2008231072B2 (da) |
| CA (1) | CA2681567C (da) |
| DK (2) | DK2829282T3 (da) |
| WO (1) | WO2008118691A2 (da) |
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Also Published As
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| EP2131857A2 (en) | 2009-12-16 |
| AU2008231072A1 (en) | 2008-10-02 |
| US8444991B2 (en) | 2013-05-21 |
| EP2829282A1 (en) | 2015-01-28 |
| DK2131857T3 (da) | 2015-09-14 |
| CA2681567C (en) | 2016-07-19 |
| CA2681567A1 (en) | 2008-10-02 |
| AU2008231072B2 (en) | 2013-08-01 |
| US20100158951A1 (en) | 2010-06-24 |
| EP2131857B1 (en) | 2015-07-29 |
| WO2008118691A3 (en) | 2008-12-18 |
| EP2829282B1 (en) | 2017-10-25 |
| WO2008118691A2 (en) | 2008-10-02 |
| EP2131857A4 (en) | 2011-07-20 |
| US8808710B2 (en) | 2014-08-19 |
| US20130315966A1 (en) | 2013-11-28 |
| HK1206247A1 (en) | 2016-01-08 |
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