DK2436700T3 - Afkortet oprensningsfremgangsmåde til fremstilling af streptococcus pneumoniae-kapselpolysaccharider - Google Patents

Afkortet oprensningsfremgangsmåde til fremstilling af streptococcus pneumoniae-kapselpolysaccharider Download PDF

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DK2436700T3
DK2436700T3 DK11194173.8T DK11194173T DK2436700T3 DK 2436700 T3 DK2436700 T3 DK 2436700T3 DK 11194173 T DK11194173 T DK 11194173T DK 2436700 T3 DK2436700 T3 DK 2436700T3
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protein
solution
retentate
polysaccharide
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DK2436700T5 (da
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Yonghui Yuan
Mark Ruppen
Wei-Qiang Sun
Ling Chu
John Simpson
James Patch
Charbonneau Pamela Fink
Justin K Moran
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Wyeth Llc
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/09Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A61K39/092Streptococcus
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/646Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • C07ORGANIC CHEMISTRY
    • C07HSUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H1/00Processes for the preparation of sugar derivatives
    • C07H1/06Separation; Purification
    • C07H1/08Separation; Purification from natural products
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    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08BPOLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0003General processes for their isolation or fractionation, e.g. purification or extraction from biomass
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    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12PFERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P19/00Preparation of compounds containing saccharide radicals
    • C12P19/04Polysaccharides, i.e. compounds containing more than five saccharide radicals attached to each other by glycosidic bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6087Polysaccharides; Lipopolysaccharides [LPS]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/62Medicinal preparations containing antigens or antibodies characterised by the link between antigen and carrier
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08BPOLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof

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Claims (21)

1. Fremgangsmåde til fremstilling af oprensede kapselpolysaccharider ud fra et Streptococcus pneumoniae-ce\\e\ysat, hvilken fremgangsmåde omfatter trinnene: (a) at tilvejebringe en fermenteringssuppe omfattende bakterieceller, der producerer en udvalgt Streptococcus pneumoniae-serotype-, (b) at lysere bakteriecellerne fra trin (a) med et lytisk middel, hvorved der fremstilles et cellelysat omfattende celledebris, opløselige proteiner, nukleinsyrer og polysaccharider; (c) at klare cellelysatet fra trin (b) under anvendelse af centrifugering eller filtrering til fjernelse af celledebris, hvorved der fremstilles et klaret cellelysat; (d) at ultrafiltrere og diafiltrere det klarede cellelysat fra trin (c) til fjernelse af urenheder med lav molekylvægt og øgning af polysaccharidkoncentrationen, hvorved der fremstilles et retentat; (e) at sænke pH-værdien af retentatet fra trin (d) til mindre end 4,5 under anvendelse af en organisk syre eller en mineralsyre til udfældning af protein og nukleinsyrer, hvorved der dannes en forsuret retentatopløsning; (f) at fastholde den forsurede retentatopløsning dannet i trin (e) i et tidsrum, der er tilstrækkeligt til at muliggøre, at udfældningsproduktet bundfælder sig, efterfulgt af filtrering eller centrifugering af den forsurede retentatopløsning, hvorved der fremstilles en polysaccharidopløsning; (g) at filtrere den klarede polysaccharidopløsning fra trin (f) gennem et aktiveret kulfilter; (h) at ultrafiltrere og diafiltrere den filtrerede opløsning fremstillet ved trin (g), hvorved der fremstilles en koncentreret oprenset polysaccharidopløsning; og (i) at filtrere den koncentrerede oprensede polysaccharidopløsning fremstillet ved trin (h) under anvendelse af et sterilt filter; hvorved der fremstilles oprensede kapselpolysaccharider i form af en opløsning.
2. Fremgangsmåde ifølge krav 1, hvor den valgte Streptococcus pneumoniae-serotype udvælges fra gruppen bestående af 1,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19Fog 23F.
3. Fremgangsmåde ifølge krav 1, omfattende trinnene: (a) at tilvejebringe en fermenteringssuppe omfattende bakterieceller, der producerer Streptococcus pneumoniae-serotype 1,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F eller 23F; (b) at lysere bakteriecellerne fra trin (a) med et lytisk middel, hvorved der fremstilles et cellelysat omfattende celledebris, opløselige proteiner, nukleinsyrer og polysaccharider; (c) at klare cellelysatet fra trin (b) under anvendelse af centrifugering eller filtrering til fjernelse af celledebris, hvorved der fremstilles et klaret cellelysat; (d) at ultrafiltrere og diafiltrere det klarede cellelysat fra trin (c) ved rumtemperatur ved neutral pH i saltfri medier til fjernelse af urenheder med lav molekylvægt og øgning af polysaccharidkoncentrationen, hvorved der fremstilles et saltfrit retentat; (e) at sænke pH-værdien af det saltfri retentat fra trin (d) til mindre end 4,5 under anvendelse af en organisk syre eller en mineralsyre til udfældning af protein og nukleinsyrer, hvorved der dannes en forsuret retentatopløsning; (f) at fastholde den forsurede retentatopløsning dannet i trin (e) i mindst 2 timer ved rumtemperatur til muliggørelse af, at udfældningsproduktet bundfælder sig, efterfulgt af filtrering eller centrifugering af den forsurede retentatopløsning, hvorved der fremstilles en polysaccharidopløsning; (g) at filtrere den klarede polysaccharidopløsning fra trin (f) gennem et aktiveret kulfilter; (h) at ultrafiltrere og diafiltrere den filtrerede opløsning fremstillet ved trin (g), hvorved der fremstilles en koncentreret oprenset polysaccharidopløsning; og (i) at filtrere den koncentrerede oprensede polysaccharidopløsning fremstillet ved trin (h) under anvendelse af et sterilt filter; hvorved der fremstilles oprensede kapselpolysaccharider omfattende serotype 1,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F eller 23F i form af en opløsning.
4. Fremgangsmåde ifølge krav 1,2 eller 3, hvor pH-værdien fra trin (e) sænkes til ca. 3,5.
5. Fremgangsmåde ifølge krav 1,2, 3 eller 4, hvor diafiltreringen i trin (h) omfatter en pH-justering til mellem ca. 5,5 til ca. 7,5, fortrinsvis hvor diafiltreringen i trin (h) omfatter en pH-justering til mellem ca. 7,0 til ca. 7,5, endnu mere foretrukket hvor diafiltreringen i trin (h) omfatter en pH-justering til ca. 7,4.
6. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 5, hvor trin (e) fjerner mindst 98 % af protein fra retentatet fra trin (d).
7. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 6, hvor trin (g) fjerner mindst 90 % af proteinet fra den klarede polysaccharidopløsning fra trin (f)·
8. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 7, hvor det aktiverede kulfilter i trin (g) omfatter træbaseret phosphorsyreaktiveret kul.
9. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 8, hvor trin (f) omfatter at fastholde den forsurede retentatopløsning dannet i trin (e) i mindst 2 timer.
10. Fremgangsmåde ifølge krav 1, omfattende trinnene: (a) at tilvejebringe en fermenteringssuppe omfattende bakterieceller, der producerer Streptococcus pneumoniae-serotype 19A; (b) at lysere bakteriecellerne fra trin (a) med et lytisk middel, hvorved der fremstilles et cellelysat omfattende celledebris, opløselige proteiner, nukleinsyrer og polysaccharider; (c) at klare cellelysatet fra trin (b) under anvendelse af centrifugering eller filtrering til fjernelse af celledebris, hvorved der fremstilles et klaret cellelysat; (d) at ultrafiltrere og diafiltrere det klarede cellelysat fra trin (c) ved ca. 4 °C ved en pH-værdi på ca. 6 i natriumphosphatbuffer til fjernelse af urenheder med lav molekylvægt og øgning af polysaccharidkoncentrationen, hvorved der fremstilles et retentat; (e) at sænke pH-værdien af retentatet fra trin (d) til mindre end 4,5 under anvendelse af en organisk syre eller en mineralsyre til udfældning af protein og nukleinsyrer, hvorved der dannes en forsuret retentatopløsning; (f) at fastholde den forsurede retentatopløsning dannet i trin (e) i mindst 2 timer ved ca. 4 °C til muliggørelse af, at udfældningsproduktet bundfælder sig, efterfulgt af filtrering eller centrifugering af den forsurede retentatopløsning, hvorved der fremstilles en polysaccharidopløsning; (g) at justere pH-værdien af den klarede polysaccharidopløsning fra trin (f) til ca. 6, hvorved der fremstilles en pH-justeret klaret polysaccharidopløsning; (h) at filtrere den pH-justerede klarede polysaccharidopløsning fra trin (g) gennem et aktiveret kulfilter; (i) at ultrafiltrere og diafiltrere den filtrerede opløsning fremstillet ved trin (h), hvorved der fremstilles en koncentreret oprenset polysaccharidopløsning; og (j) at filtrere den koncentrerede oprensede polysaccharidopløsning fremstillet ved trin (i) under anvendelse af et sterilt filter; hvorved der fremstilles oprensede kapselpolysaccharider omfattende serotype 19A i form af en opløsning.
11. Fremgangsmåde ifølge krav 10, hvor pH-værdien fra trin (e) sænkestil ca. 3,5.
12. Fremgangsmåde ifølge krav 10 eller 11, hvor diafiltreringen i trin (i) omfatter en pH-justering til mellem ca. 5,5 til ca. 7,5, fortrinsvis hvor diafiltreringen i trin (i) omfatter en pH-justering til mellem ca. 7,0 til ca. 7,5, endnu mere foretrukket hvor diafiltreringen i trin (i) omfatter en pH-justering til ca. 7,4.
13. fremgangsmåde ifølge et hvilket som helst af kravene 10 til 12, hvor trin (e) fjerner mindst 98 % af protein fra retentatet i trin (d).
14. Fremgangsmåde ifølge et hvilket som helst af kravene 10 til 13, hvor trin (h) fjerner mindst 90 % af proteinet fra den pH-justerede klarede polysaccharidopløsning fra trin (g).
15. Fremgangsmåde ifølge et hvilket som helst af kravene 10 til 13, hvor det aktiverede kulfilter i trin (h) omfatter træbaseret phosphorsyreaktiveret kul.
16. Fremgangsmåde ifølge et hvilket som helst af kravene 10 til 15, hvor natri-umphosphatbufferen i trin (d) er 25 mM natriumphosphat.
17. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 16, hvor det lytiske middel i trin (b) er deoxycholatnatrium.
18. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 16, hvor det lytiske middel i trin (b) er et lytisk middel af ikke-animalsk oprindelse, fortrinsvis hvor det lytiske middel af ikke-animalsk oprindelse er udvalgt fra gruppen bestående af: decansulfonsyre, tert-octylphenoxy-poly(oxyethylen)ethanoler, oc-tylphenolethylenoxidkondensater, N-lauryl-sarcosinnatrium (NLS), laurylimi-nodipropionat, natriumdodecylsulfat, chenodeoxycholat, hyodeoxycholat, gly-codeoxycholat, taurodeoxycholat, taurochenodeoxycholat og cholat, endnu mere foretrukket hvor det lytiske middel af ikke-animalsk oprindelse er N-lauryl-sarcosinnatrium.
19. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 18, hvor mineralsyren er udvalgt fra gruppen bestående af saltsyre, salpetersyre, phosphor-syre og svovlsyre.
20. Fremgangsmåde til fremstilling af en pneumokokvaccine, som omfatter at fremstille oprensede kapselpolysaccharider fra et Streptococcus pneumoniae-cellelysat ved en fremgangsmåde ifølge et hvilket som helst af kravene 1 til 19 og at anvende de oprensede kapselpolysaccharider til fremstilling af en pneumokokvaccine.
21. Fremgangsmåde ifølge krav 20, hvor pneumokokvaccinen indeholder po-lysaccharid konjugeret med en proteinbærer.
DK11194173.8T 2007-03-23 2008-03-20 Afkortet oprensningsfremgangsmåde til fremstilling af streptococcus pneumoniae-kapselpolysaccharider DK2436700T5 (da)

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US89661607P 2007-03-23 2007-03-23
EP08732592.4A EP2129693B1 (en) 2007-03-23 2008-03-20 Shortened purification process for the production of capsular streptococcus pneumoniae polysaccharides

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DK18177128.8T DK3406635T3 (da) 2007-03-23 2008-03-20 Afkortet oprensningsmetode til fremstilling af Streptococcus Pneumoniae-kapselpolysaccharider
DK11194173.8T DK2436700T5 (da) 2007-03-23 2008-03-20 Afkortet oprensningsfremgangsmåde til fremstilling af streptococcus pneumoniae-kapselpolysaccharider

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