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DK2351578T3 - Fremgangsmåde til fremstilling af vacciner - Google Patents

Fremgangsmåde til fremstilling af vacciner Download PDF

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Publication number
DK2351578T3
DK2351578T3 DK10179820.5T DK10179820T DK2351578T3 DK 2351578 T3 DK2351578 T3 DK 2351578T3 DK 10179820 T DK10179820 T DK 10179820T DK 2351578 T3 DK2351578 T3 DK 2351578T3
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Denmark
Prior art keywords
saccharide
minutes
protein carrier
amino
carbodiimide
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DK10179820.5T
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English (en)
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Ralph Leon Biemans
Pierre Duvivier
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Glaxosmithkline Biologicals Sa
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Priority claimed from GBGB0513071.1A external-priority patent/GB0513071D0/en
Priority claimed from GBGB0513069.5A external-priority patent/GB0513069D0/en
Priority claimed from GB0515556A external-priority patent/GB0515556D0/en
Priority claimed from GB0524204A external-priority patent/GB0524204D0/en
Priority claimed from GB0526041A external-priority patent/GB0526041D0/en
Priority claimed from GB0526040A external-priority patent/GB0526040D0/en
Application filed by Glaxosmithkline Biologicals Sa filed Critical Glaxosmithkline Biologicals Sa
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Claims (11)

1. Fremgangsmåde til at konjugere et sakkarid til et proteinbærestof ved anvendelse af carbodiimidkondensationskemi, hvor sakkaridet omfatter (for eksempel som del af dens gentagelsesenhed) eller er derivatiseret til at omfatte, amino- og/eller carboxylgrupper og hvor proteinbærestoffet omfatter eller er derivatiseret til at omfatte, amino- og/eller carboxylgrupper, omfattende trinnene af: I) - hvis proteinbærestoffet omfatter både amino- og carboxylgrupper og sakkaridet omfatter enten amino- eller carboxylgrupper: a) at blande sakkaridet og en afmålt portion af carbodiimid nødvendig til at lave kon-jugeringen og b) at tilsætte den afmålte portion af proteinbærestoffet nødvendig, i løbet af en periode på 5 minutter til 6 timer, hvor mindst én fjerdedel af den afmålte portion tilsættes i løbet af den første halvdel af perioden og mindst én fjerdedel af den afmålte portion i løbet af den anden halvdel af perioden; II) - hvis sakkaridet omfatter både amino- og carboxylgrupper og proteinbærestoffet omfatter enten amino- eller carboxylgrupper: a) at blande protein bærestoffet og en afmålt portion af carbodiimid nødvendig til at lave konjugeringen og b) at tilsætte den afmålte portion af sakkaridet nødvendig, i løbet af en periode på 1 minut til 6 timer, hvor mindst én fjerdedel af den afmålte portion tilsættes i løbet af den første halvdel af perioden og mindst én fjerdedel af den afmålte portion i løbet af den anden halvdel af perioden; III) - hvis sakkaridet omfatter både amino- og carboxylgrupper og protein bærestoffet omfatter både amino- og carboxylgrupper: a) at blande proteinbærestoffet og sakkarid og b) at tilsætte den afmålte portion af carbodiimid nødvendig til at lave konjugeringen i løbet af en periode af 1 minut til 6 timer, hvor mindst én fjerdedel af den afmålte portion tilsættes i løbet af den første halvdel af perioden og mindst én fjerdedel af den afmålte portion i løbet af den anden halvdel af perioden; og hvor: den afmålte portion af carbodiimid er 0,01 til 3 mg carbodiimid / mg sakkarid; sakkaridet foreligger ved en endelig koncentration af 0,5-50 mg/ml i trin b); proteinbærestoffet foreligger ved en endelig koncentration af 1-50 mg/ml i trin b); det indledende forhold af proteinbærestof til sakkarid er 4:1 til 1:1 (vægt/vægt); reaktions-pH'en i trin b) er fastholdt ved pH 4,5-6,5, eller pH 4,5-7,5 hvis en forbindelse foreligger i trin b), som holder reaktionsmellemproduktet stabilt; temperaturen af reaktionen i trin b) er fastholdt ved 4-37°C.
2. Fremgangsmåde ifølge krav 1, hvor i trin b) perioden er 1 minut til 4 timer, 2 minutter til 3 timer, 3 minutter til 2 timer, 4 til 60 minutter, 5 til 50 minutter, 6 til 40 minutter, 7 til 30 minutter eller 8 til 20 minutter.
3. Fremgangsmåde ifølge krav 1 eller 2, hvor carbodiimid er EDAC (l-ethyl-3-(3-dimethyl-aminopropyl)carbodiimid).
4. Fremgangsmåde ifølge kravene 1-3, hvor sakkaridet og/eller proteinbærestoffet er derivatiseret til at omfatte amino- eller carboxylgrupper.
5. Fremgangsmåde ifølge kravene 1-4, omfattende et efterfølgende trin c), hvor sak-karid-proteinkonjugatet er oprenset i en størrelseskromatografikolonne.
6. Fremgangsmåde ifølge kravene 1-5, omfattende et efterfølgende trin d), hvor sak-karid-proteinkonjugatet er sterilt filtreret.
7. Fremgangsmåde ifølge kravene 1-6, hvor sakkaridet er et bakteriekapselsakkarid, for eksempel afledt fra en bakterie valgt blandt en liste bestående af: N. meningitidis-sero-gruppe A, B, C, W135 eller Y, Streptococcus pneumoniae-serotyper 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F eller 33F, Gruppe B Streptococcus-gruppe la, Ib, II, III, IV, V, VI, eller VII, Staphylococcus aureus-type 5, Staphylococcus aureus-type 8, Salmonella typhi (Vi saccharid), Vibrio cholerae, eller H. in-fluenzae-type b.
8. Fremgangsmåde ifølge kravene 1-6, hvor sakkaridet er en bakteriel lipooligosakka-rid eller lipopolysakkarid, for eksempel afledt fra en bakterie valgt blandt en liste bestående af: N. meningitidis, H. influenzae, E. coli, Salmonella eller M. catarrhalis.
9. Fremgangsmåde ifølge kravene 1-8, hvor proteinbærestoffet omfatter én eller flere T-hjælpeepitoper.
10. Fremgangsmåde ifølge kravene 1-9, hvor proteinbærestoffet er valgt fra gruppen bestående af: TT, DT, CRM197, fragment C af TT, protein D af H. influenzae, pneumococcal PhtD og pneumococcal Pneumolysin.
11. Sakkarid-proteinbærestofkonjugat, der kan tilvejebringes ved fremgangsmåden ifølge kravene 1-10, hvor sakkaridet er et bakteriekapselsakkarid, for eksempel afledt fra en bakterie valgt blandt en liste bestående af: N. meningitidis-serogruppe A, B, C, W135 eller Y, Streptococcus pneumoniae-serotyper 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F eller 33F, Gruppe B Streptococcus-gruppe la, Ib, II, III, IV, V, VI, eller VII, Staphylococcus aureus-type 5, Staphylococcus aureus-type 8, Salmonella typhi (Vi saccharid), Vibrio cholerae eller, hvor sakkaridet er et bakteriel lipooli-gosakkarid eller lipopolysakkaride, for eksempel afledt fra en bakterie valgt blandt en liste bestående af: N. meningitidis, H. influenzae, E. coli, Salmonella eller M. catarrhalis.
DK10179820.5T 2005-06-27 2006-06-23 Fremgangsmåde til fremstilling af vacciner DK2351578T3 (da)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
GBGB0513071.1A GB0513071D0 (en) 2005-06-27 2005-06-27 Immunogenic composition
GBGB0513069.5A GB0513069D0 (en) 2005-06-27 2005-06-27 Immunogenic composition
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