DK2010219T3 - Formuleringer, som stabiliserer og forhindrer præcipitation af immunogene sammensætninger - Google Patents

Formuleringer, som stabiliserer og forhindrer præcipitation af immunogene sammensætninger Download PDF

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DK2010219T3
DK2010219T3 DK07760907.1T DK07760907T DK2010219T3 DK 2010219 T3 DK2010219 T3 DK 2010219T3 DK 07760907 T DK07760907 T DK 07760907T DK 2010219 T3 DK2010219 T3 DK 2010219T3
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polysaccharide
formulation
polypeptide
crm
serotype
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Lakshmi Khandke
Ying Chen
Hanyoung Han
Robert Chancey Seid Jr
Zhaowei Jin
Jee Loon Look
Ronald Malone
Xudong Yang
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Wyeth Llc
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    • A61K47/64—Drug-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
    • A61K47/646—Drug-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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Claims (31)

1. Formulering, som stabiliserer et polysaccharid-proteinkonjugat, hvilken formulering omfatter (i) en pH-bufret saltopløsning, hvor bufferen har en pKa på 3,5 til 7,5, (ii) polysorbat 80 ved en endelig koncentration på 0,01 % til 0,05 % polysorbat 80 vægt/volumen af formuleringen og (iii) et eller flere po-lysaccharid-proteinkonjugater, hvor polysaccharid-proteinkonjugatet omfatter et eller flere pneumokokpolysaccharider.
2. Formulering ifølge krav 1, hvor den pFI-bufrede saltopløsning har en pH på 5.5 til 7,5.
3. Formulering ifølge et af kravene 1 til 2, hvor bufferen er phosphat, succinat, histidin eller citrat.
4. Formulering ifølge et af kravene 1 til 3, hvor bufferen er succinat ved en endelig koncentration på 1 mM til 10 mM og pH 5,8 til 6,0.
5. Formulering ifølge krav 4, hvor den endelige koncentration af succinatbufferen er 5 mM.
6. Formulering ifølge et af kravene 1 til 5, hvor saltet i den pH-bufrede saltopløsning omfatter magnesiumchlorid, kaliumchlorid, natriumchlorid eller en kombination deraf.
7. Formulering ifølge krav 6, hvor saltet i den pH-bufrede saltopløsning er natriumchlorid.
8. Formulering ifølge krav 3, hvor den pH-bufrede saltopløsning har en pH på 5.5 til 7,5, hvor bufferen er histidin, og hvor saltet i den pH-bufrede saltopløsning er natriumchlorid.
9. Formulering ifølge et af kravene 1 til 8, hvor den endelige koncentration af polysorbatet 80 i formuleringen er 0,01 % polysorbat 80 vægt/volumen af formuleringen.
10. Formulering ifølge et af kravene 1 til 8, hvor den endelige koncentration af polysorbatet 80 i formuleringen er 0,05 % polysorbat 80 vægt/volumen af formuleringen.
11. Formulering ifølge et af kravene 1 til 10, yderligere omfattende et eller flere meningokokpolysaccharider, et eller flere antigene meningokokproteiner eller en kombination deraf.
12. Formulering ifølge et af kravene 1 til 10, yderligere omfattende et eller flere streptokokpolysaccharider, eller flere antigene streptokokproteiner eller en kombination deraf.
13. Formulering ifølge et af kravene 1 til 12, hvor det ene eller flere pneumo-kokpolysaccharider omfatter et S. pneu/77on/ae-serotype-4-polysaccharid, et S. pneumoniae-serotype-6B-polysaccharid, et S. pneu/77on/ae-serotype-9V-polysaccharid, et S. pneumon/ae-serotype-14-polysaccharid, et S. pneumo-niae-serotype-18C-polysaccharid, et S. pneumoniae-serotype-19F-polysaccharid, et S. pneumoniae-serotype-23F-polysaccharid, et S. pneumoniae-serotype-1-polysaccharid, et S. pneu-/770/7/ae-serotype-3-polysaccharid, et S. pneumoniae serotype-5-polysaccharid, et S. pneu/77on/ae-serotype-6A-polysaccharid, et S. pneumo-n/ae-serotype-7F-polysaccharidad, et S. pneumoniae-serotype-19A-polysaccharid.
14. Formulering ifølge et af kravene 1 til 12, hvor polysaccharid-proteinkonjugatformuleringen er et 7-valent pneumokokkonjugat-(7vPnC)-formulering, omfattende et S. pneumoniae-serotype-4-polysaccharid konjugeret til et CFtM-197-polypeptid, et S. pnei/mon/ae-serotype-6B-polysaccharid konjugeret til et CRM-i97-polypeptid, et S. pneumoniae-serotype-9V-polysaccharid konjugeret til et CRM-i97-polypeptid, et S. pneumoniae-serotype-14-polysaccharid konjugeret til et CRM-i97-polypeptid, et S. pneu-moniae-serotype-18C-polysaccharid konjugeret til et CRM-i97-polypeptid, et S. pneu/7)on/ae-serotype-19F-polysaccharid konjugeret til et CRM-i97-polypeptid og et S. pneumoniae-serotype-23F-polysaccharid konjugeret til et CRM-197-polypeptid.
15. Formulering ifølge et af kravene 1 til 12, hvor polysaccharid-protein- konjugatformuleringen er et 13-valent pneumokokkonjugat-(13vPnC)-formulering, omfattende et S. pneumoniae-serotype-4-polysaccharid konjugeret til et CRM-197-polypeptid, et S. pneumoniae-serotype-6B- polysaccharid konjugeret til et CRM-i97-polypeptid, et S. pneu/77on/åe-serotype-9V- polysaccharid konjugeret til et CRM-197-polypeptid, et S. pneumoniae-serotype- 14-polysaccharid konjugeret til et CRM-i97-polypeptid, et S. pneu-/77on/ae-serotype-18C-polysaccharid konjugeret til et CRM-i97-polypeptid, et S. pneumoniae-serotype- 19F-polysaccharid konjugeret til et CRM-i97-polypeptid, et S. pneu/77on/åe-serotype-23F-polysaccharid konjugeret til et CRM -197-polypeptid, et S. pneumoniae-serotype- 1-polysaccharid konjugeret til et CRM-197-polypeptid, et S. pneu/77on/ae-serotype-3-polysaccharid konjugeret til et CRM-i97-polypeptid, et S. pneumoniae-serotype- 5-polysaccharid konjugeret til et CRMi97-polypeptid, et S. pneumoniae-serotype-6A- polysaccharid konjugeret til et CRM-i97-polypeptid, et S. pneumoniae-serotype- 7F-polysaccharid konjugeret til et CRM-i97-polypeptid og et S. pneumoniae- serotype-19A-polysaccharid konjugeret til et CRM-197-polypeptid.
16. Formulering ifølge et af kravene 1 til 15, hvor formuleringen endvidere omfatter en eller flere adjuvanser.
17. Formulering ifølge krav 16, hvor adjuvansen er et aluminumsalt.
18. Formulering ifølge krav 17, hvor aluminumsaltet er aluminumhydroxid, aluminumphosphat eller aluminumsulfat.
19. Formulering ifølge krav 16, hvor adjuvansen er aluminumphosphat.
20. Formulering ifølge krav 1, omfattende (i) en pH-bufret saltopløsning, hvor bufferen er succinat ved en endelig koncentration på 1 mM til 10 mM og pH 5,8 til 6,0, (ii) polysorbat 80 ved en endelig koncentration på 0,01 % til 0,05 % polysor-bat 80 vægt/volumen af formuleringen og (iii) et 13-valent pneumokok-konjugat-(13vPnC)-formulering, omfattende et S. pneumoniae-serotype-4- polysaccharid konjugeret til et CRM-i97-polypeptid, et S. pneumon/ae-serotype-6B-polysaccharid konjugeret til et CRM-197-polypeptid, et S. pnei//77on/ae-serotype-9V-polysaccharid konjugeret til et CRM-197-polypeptid, et S. pneumoniae-serotype-14-polysaccharid konjugeret til et CRMi97-polypeptid, et S. pneumoniae-serotype-18C-polysaccharid konjugeret til et CRM-197-polypeptid, et S. pneumoniae- serotype-19F-polysaccharid konjugeret til et CRM-197-polypeptid, et S. pneumoniae-serotype-23F-polysaccharid konjugeret til et CRM-i97-polypeptid, et S. pneu-moniae-serotype-1-polysaccharid konjugeret til et CRM-197-polypeptid, et S. pneL//77on/ae-serotype-3-polysaccharid konjugeret til et CRM-i97-polypeptid, et S. pneumoniae-serotype 5-polysaccharid konjugeret til et CRM-197-polypeptid, et S. pnei//77o/7/ae-serotype-6A-polysaccharid konjugeret til et CRM-197-polypeptid, et S. pneumoniae-serotype-7F-polysaccharid konjugeret til et CRMi97-polypeptid og et S. pnei/mon/ae-serotype-19A-polysaccharid konjugeret til et CRM-197-polypeptid.
21. Formulering ifølge krav 20, hvor bufferen er succinat ved en endelig koncentration på 5 mM.
22. Formulering ifølge krav 21, hvor saltet i den pH-bufrede saltopløsning omfatter natriumchlorid.
23. Formulering ifølge krav 22, hvor formuleringen endvidere omfatter en ad-juvans, og hvor adjuvansen er aluminiumphosphat.
24. Formulering ifølge et af kravene 1 til 23, hvor polysaccharid-proteinkonjugatformuleringen er indeholdt i et beholdermiddel udvalgt fra en eller flere af gruppen bestående af et hætteglas, en hætteglasprop, et hætte-glaslåg, et glaslåg, et gummilåg, et plastlåg, en sprøjte, en sprøjteprop, et sprøjtestempel, en kolbe, et bæger, en målecylinder, en fermentor, en bioreaktor, tubing, et rør, en pose, en glasbeholder, en ampul, en kassette og en engangspen.
25. Formulering ifølge krav 24, hvor beholderen er silikoniseret.
26. Beholdermiddel, som er fyldt med formuleringen ifølge et af kravene 1 til 23.
27. Beholdermiddel ifølge krav 26 udvalgt fra gruppen bestående, af kolber, bægre, målecylindere, fermentorer, bioreaktorer, tubings, rør, poser, glasbeholdere, hætteglas, ampuler, sprøjter.
28. Beholdermiddel ifølge krav 27, hvor beholderen er fremstillet af glas, metaller eller polymerer.
29. Beholdermiddel ifølge krav 27, hvor beholderen er en sprøjte.
30. Beholdermiddel ifølge krav 27, hvor beholderen er en glassprøjte.
31. Formulering ifølge et af kravene 27 til 30, hvor beholdermidlet er silikoni-seret.
DK07760907.1T 2006-04-26 2007-04-19 Formuleringer, som stabiliserer og forhindrer præcipitation af immunogene sammensætninger DK2010219T3 (da)

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PCT/US2007/066959 WO2007127665A2 (en) 2006-04-26 2007-04-19 Novel formulations which stabilize and inhibit precipitation of immunogenic compositions

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DK13186453.0T DK2679244T3 (da) 2006-04-26 2007-04-19 Formuleringer, som stabiliserer og hæmmer udfældning af immunogene sammensætninger
DK13186454.8T DK2679245T3 (da) 2006-04-26 2007-04-19 Formuleringer, der stabiliserer og hæmmer udfældning af immunogene sammensætninger
DK13185292.3T DK2676679T4 (da) 2006-04-26 2007-04-19 Anvendelse af formuleringer til at stabilisere og inhibere udfældning af immunogene sammensætninger
DK07760907.1T DK2010219T3 (da) 2006-04-26 2007-04-19 Formuleringer, som stabiliserer og forhindrer præcipitation af immunogene sammensætninger

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DK13185292.3T DK2676679T4 (da) 2006-04-26 2007-04-19 Anvendelse af formuleringer til at stabilisere og inhibere udfældning af immunogene sammensætninger

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