DK2654784T3 - Stabile immunogene sammensætninger af staphylococcus aureus-antigener - Google Patents

Stabile immunogene sammensætninger af staphylococcus aureus-antigener Download PDF

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Publication number
DK2654784T3
DK2654784T3 DK11804822.2T DK11804822T DK2654784T3 DK 2654784 T3 DK2654784 T3 DK 2654784T3 DK 11804822 T DK11804822 T DK 11804822T DK 2654784 T3 DK2654784 T3 DK 2654784T3
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clfa
immunogenic composition
protein
lyophilized
crm
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DK11804822.2T
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English (en)
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Lakshmi Khandke
Akihisa Nonoyama
Tamara Shafer Hodge
Sandeep Nema
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Wyeth Llc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/085Staphylococcus
    • AHUMAN NECESSITIES
    • 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
    • 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
    • A61K2039/6031Proteins
    • A61K2039/6037Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)

Claims (17)

1. Lyofiliseret immunogen sammensætning omfattende: (a) et isoleret Staphylococcus afreus-sammenklumpningsfaktor A (ClfA)-polypeptid, (b) et isoleret Staphylococcus aareus-MntC-polypeptid, (c) et kapselpolysaccharid type 5 (CP5)-CRMi97-konjugat, (d) et kapselpolysaccharid type 8 (CP8)-CRMi97-konjugat, (e) en buffer med en pKa på 6,0 ± 0,6 og (f) et fyldemiddel, hvor ClfA-polypeptidet omfatter et N1-, N2- og N3-domæne.
2. Lyofiliseret immunogen sammensætning ifølge krav 1, hvor sammensætningen yderligere omfatter en isoleret Staphylococcus aureus-sammenklumpningsfaktor B (ClfB).
3. Lyofiliseret immunogen sammensætning ifølge et hvilket som helst af kravene 1-2, hvor det fibrinogen-bindende domæne af ClfA-polypeptidet udviser reduceret binding til fibrinogen, på grund af at det har en aminosyresubstitu-tion ved en eller flere af Tyr 338, Tyr 256, Pro 336, Lys 389, Ala 254 og Ile 387.
4. Lyofiliseret immunogen sammensætning ifølge krav 3, hvor aminosyre-substitutionen ved en eller flere af Tyr 338, Tyr 256, Pro 336, Lys 389, Ala 254 og Ile 387 er til Ala eller Ser.
5. Lyofiliseret immunogen sammensætning ifølge krav 4, hvor Tyr 338 er substitueret til Ala.
6. Lyofiliseret immunogen sammensætning ifølge et hvilket som helst af kravene 1-5, som omfatter vand med mindre end 3 vægtprocent af den samlede vægt af den immunogene sammensætning (% w/w), hvor ClfA-polypeptidet er mellem 0,09% ± 0,027% og 0,85% ± 0,26% w/w, CP5-CRMi97-konjugatet er mellem 0,04% ± 0,013% og 0,42 ± 0,13% w/w, CP8-CRMi97-konjugatet er mellem 0,04% ± 0,013% og 0,42 ± 0,13% w/w, og bufferen er på 2,54% ± 0,76% w/w.
7. Lyofiliseret immunogen sammensætning ifølge et hvilket som helst af kravene 1-6, hvor bufferen omfatter histidin med pH 6,0 ± 0,6.
8. Lyofiliseret immunogen sammensætning ifølge et hvilket som helst af kravene 1-7, hvor fyldemidlet er udvalgt fra gruppen bestående af saccharose, trehalose, mannitol, glycin og sorbitol.
9. Lyofiliseret immunogen sammensætning ifølge krav 8, hvor fyldemidlet er saccharose.
10. Lyofiliseret immunogen sammensætning ifølge krav 9, hvor fyldemidlet er saccharose med 96% ± 0,060% w/w.
11. Lyofiliseret immunogen sammensætning ifølge et hvilket som helst af kravene 1-10, yderligere omfattende et overfladeaktivt stof.
12. Lyofiliseret immunogen sammensætning ifølge krav 11, hvor det overfladeaktive stof er udvalgt fra gruppen bestående af en poloxamer, en polyoxy-ethylenalkylether og en polyoxyethylensorbitanfedtsyreester.
13. Lyofiliseret immunogen sammensætning ifølge krav 12, hvor polyoxy-ethylensorbitanfedtsyreesteren er polysorbat 80.
14. Lyofiliseret immunogen sammensætning ifølge krav 13, hvor polysorbat 80 er på 0,01 % ± 0,005% w/v.
15. Lyofiliseret immunogen sammensætning ifølge et hvilket som helst af kravene 1-14, hvor sammensætningen yderligere omfatter en adjuvans.
16. Lyofiliseret immunogen sammensætning ifølge krav 15, hvor adjuvansen er et saponin.
17. Fremgangsmåde til fremstilling af en immunogen sammensætning, omfattende trinnene: (a) at kombinere i en vandig opløsning: (i) et ClfA- polypeptid, hvor ClfA-polypeptidet omfatter et N1-, N2- og N3-domæne, (ii) et CP5-CRM 197-konjugat, (iii) et CP8-CRMi97-konjugat, (iv) et MntC-polypeptid, (v) en buffer med en pKa på 6,0 ± 0,6 og (vi) et fyldemiddel; og (b) at lyofili-sere kombinationen fra trin (a) til dannelse af en kage omfattende mindre end 3 vægtprocent vand.
DK11804822.2T 2010-12-22 2011-12-21 Stabile immunogene sammensætninger af staphylococcus aureus-antigener DK2654784T3 (da)

Applications Claiming Priority (2)

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US201061426476P 2010-12-22 2010-12-22
PCT/IB2011/055883 WO2012085872A2 (en) 2010-12-22 2011-12-21 Stable immunogenic compositions of staphylococcus aureus antigens

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EP (2) EP2654784B1 (da)
JP (1) JP6097478B2 (da)
KR (2) KR20130114210A (da)
CN (1) CN103826656B (da)
AU (1) AU2011346535B2 (da)
BR (1) BR112013016153A2 (da)
CA (1) CA2819120C (da)
DK (2) DK3150222T3 (da)
ES (2) ES2614815T3 (da)
HU (2) HUE047263T2 (da)
IL (1) IL226793B (da)
MX (1) MX350170B (da)
PL (2) PL3150222T3 (da)
PT (2) PT2654784T (da)
RU (1) RU2570730C2 (da)
SI (2) SI2654784T1 (da)
WO (1) WO2012085872A2 (da)

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KR102058961B1 (ko) * 2018-07-28 2019-12-24 주식회사 엑소코바이오 엑소좀의 동결건조 방법
KR102163806B1 (ko) 2018-07-30 2020-10-07 주식회사 엑소코바이오 줄기세포 유래의 엑소좀을 유효성분으로 포함하는 피지분비 감소용 조성물
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BR112013016153A2 (pt) 2017-07-11
KR101808398B1 (ko) 2017-12-12
CN103826656B (zh) 2015-08-26
HK1197370A1 (en) 2015-01-16
MX350170B (es) 2017-08-28
RU2013128277A (ru) 2015-01-27
EP3150222B1 (en) 2019-11-27
CN103826656A (zh) 2014-05-28
SI3150222T1 (sl) 2020-02-28
WO2012085872A3 (en) 2012-08-30
HUE047263T2 (hu) 2020-04-28
WO2012085872A2 (en) 2012-06-28
MX2013006960A (es) 2013-07-15
RU2570730C2 (ru) 2015-12-10
JP6097478B2 (ja) 2017-03-15
EP2654784A2 (en) 2013-10-30
CA2819120A1 (en) 2012-06-28
CA2819120C (en) 2016-07-05
ES2769425T3 (es) 2020-06-25
IL226793B (en) 2019-02-28
ES2614815T3 (es) 2017-06-02
JP2012136518A (ja) 2012-07-19
US20130259896A1 (en) 2013-10-03
PL3150222T3 (pl) 2020-05-18
EP3150222A1 (en) 2017-04-05
AU2011346535B2 (en) 2015-09-24
KR20150129071A (ko) 2015-11-18
PL2654784T3 (pl) 2017-08-31
HUE033072T2 (hu) 2017-11-28
DK3150222T3 (da) 2020-01-27
SI2654784T1 (sl) 2017-01-31
PT3150222T (pt) 2020-02-03
KR20130114210A (ko) 2013-10-16
AU2011346535A1 (en) 2013-06-13
PT2654784T (pt) 2017-02-13
EP2654784B1 (en) 2016-12-07

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