HRP20170457T1 - Postupak proizvodnje cjepiva - Google Patents

Postupak proizvodnje cjepiva Download PDF

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HRP20170457T1
HRP20170457T1 HRP20170457TT HRP20170457T HRP20170457T1 HR P20170457 T1 HRP20170457 T1 HR P20170457T1 HR P20170457T T HRP20170457T T HR P20170457TT HR P20170457 T HRP20170457 T HR P20170457T HR P20170457 T1 HRP20170457 T1 HR P20170457T1
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saccharide
aliquot
protein carrier
period
amino
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HRP20170457TT
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Ralph Leon Biemans
Pierre Duvivier
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Glaxosmithkline Biologicals S.A.
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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 S.A. filed Critical Glaxosmithkline Biologicals S.A.
Publication of HRP20170457T1 publication Critical patent/HRP20170457T1/hr

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Claims (11)

1. Postupak konjugiranja saharida s proteinskin nosačem karbodiimidnim kondenziranjem, gdje saharid sadrži (primjerice kao dio svoje repetitivne jedinice), ili je tako deriviran da sadrži, amino i/ili karboksilne skupine, te gdje proteinski nosač sadrži, ili je tako deriviran da sadrži, amino i/ili karboksilne skupine, naznačen time što se sastoji u koracima: I) – ako proteinski nosač sadrži i amino i karboksilne skupine i saharid sadrži bilo amino ili karboksilne skupine: a) miješanja saharida s alikvotom karbodiimida potrebnim za provođenje konjugiranja, i b) dodavanja alikvota proteinskog nosača potrebnog u periodu od 5 minuta do 6 sata, gdje se najmanje jednu četvrtinu alikvota dodaje tijekom prve polovine perioda, a najmanje jednu četvrtinu alikvota tijekom druge polovine perioda; II) – ako saharid sadrži i amino i karboksilne skupine i proteinski nosač sadrži bilo amino ili karboksilne skupine: a) miješanja proteinskog nosača s alikvotom karbodiimida potrebnim za provođenje konjugiranja, i b) dodavanja alikvota saharida potrebnog u periodu od 1 minute do 6 sata, gdje se najmanje jednu četvrtinu alikvota dodaje tijekom prve polovine perioda, a najmanje jednu četvrtinu alikvota tijekom druge polovine perioda; III) – ako saharid sadrži i amino i karboksilne skupine i proteinski nosač sadrži i amino i karboksilne skupine: a) miješanja proteinskog nosača sa saharidom, i b) dodavanja alikvota karbodiimida potrebnog za provođenje konjugiranja u periodu od 1 minute do 6 sata, gdje se tijekom prve polovine perioda dodaje najmanje jednu četvrtinu alikvota, a najmanje jednu četvrtinu alikvota tijekom druge polovine perioda; te što: alikvot karbodiimida je 0,01 do 3 mg karbodiimida/mg saharida; saharid je prisutan u konačnoj koncentraciji od 0,5-50 mg/ml u koraku b); proteinski nosač je prisutan u konačnoj koncentraciji od 1-50 mg/ml u koraku b); početni omjer između proteinskog nosača i saharida je 4:1 do 1:1 (tež./tež.); pH reakcije u koraku b) se održava na pH 4,5-6,5, ili pH 4,5-7,5 ako je prisutan u koraku b) spoj koji održava reakcijski međuprodukt stabilnim; temperaturu reakcije u koraku b) se održava na 4-37 °C.
2. Postupak u skladu s patentnim zahtjevom 1, naznačen time što je u koraku b) period 1 minute do 4 sata, 2 minute do 3 sata, 3 minute do 2 sata, 4 do 60 minuta, 5 do 50 minuta, 6 do 40 minuta, 7 do 30 minuta ili 8 do 20 minuta.
3. Postupak u skladu s patentnim zahtjevom 1 ili 2, naznačen time što je karbodiimid EDAC (1-etil-3-(3-dimetilaminopropil)karbodiimid).
4. Postupak u skladu s patentnim zahtjevima 1-3, naznačen time što je saharid i/ili proteinski nosač tako deriviran da sadrži amino ili karboksilne skupine.
5. Postupak u skladu s patentnim zahtjevima 1-4, naznačen time što uključuje naknadni korak c), u kojem se saharidno-proteinski konjugat pročisti na stupcu za kromatografiju s isključivošću na veličinu.
6. Postupak u skladu s patentnim zahtjevima 1-5, naznačen time što uključuje naknadni korak d), u kojem se saharidno-proteinski konjugat sterilno filtrira.
7. Postupak u skladu s patentnim zahtjevima 1-6, naznačen time što je saharid saharid iz bakterijske kapsule, primjerice dobiven iz bakterije koju se bira sa spiska kojeg čine: N. meningitidis seroskupina A, B, C, W135 ili Y, Streptococcus pneumoniae serotipovi 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F ili 33F, Group B Streptococcus skupina la, Ib, II, III, IV, V, VI ili VII, Staphilococcus aureus tip 5, Staphilococcus aureus tip 8, Salmonella typhi (saharid Vi), Vibrio cholerae, ili H. influenzae tip b.
8. Postupak u skladu s patentnim zahtjevima 1-6, naznačen time što je saharid bakterijski lipooligosaharid ili lipopolisaharid, primjerice dobiven iz bakterije koju se bira sa spiska kojeg čine: N. meningitidis, H. influenzae, E. coli, Salmonella ili M. catarrhalis.
9. Postupak u skladu s patentnim zahtjevima 1-8, naznačen time što proteinski nosač sadrži jedan ili više epitopa iz pomoćničkih T-stanica.
10. Postupak u skladu s patentnim zahtjevima 1-9, naznačen time što se proteinski nosač bira iz skupine koju čine: TT, DT, CRM197, fragment C od TT, protein D iz bakterije H. influenzae, pneumokokni PhtD, te pneumokokni pneumolizin.
11. Konjugat saharida s proteinskim nosačem, kojeg se može dobiti postupkom u skladu s patentnim zahtjevima 1-10, naznačen time što je saharid saharid iz bakterijske kapsule, primjerice dobiven iz bakterije koju se bira sa spiska kojeg čine: N. meningitidis seroskupina A, B, C, W135 ili Y, Streptococcus pneumoniae serotipovi 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F ili 33F, skupine Ia, Ib, II, III, IV, V, VI ili VII iz skupine B streptokoka, Staphilococcus aureus tip 5, Staphilococcus aureus tip 8, Salmonella typhi (saharid Vi), Vibrio cholerae, ili što je saharid bakterijski lipooligosaharid ili lipopolisaharid, primjerice dobiven iz bakterije koju se bira sa spiska kojeg čine: N. meningitidis, H. influenzae, E. coli, Salmonella ili M. catarrhalis.
HRP20170457TT 2005-06-27 2017-03-20 Postupak proizvodnje cjepiva HRP20170457T1 (hr)

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
GB0515556A GB0515556D0 (en) 2005-07-28 2005-07-28 Immunogenic composition
GB0524204A GB0524204D0 (en) 2005-11-28 2005-11-28 Immunogenic composition
GB0526041A GB0526041D0 (en) 2005-12-21 2005-12-21 Immunogenic composition
GB0526040A GB0526040D0 (en) 2005-12-21 2005-12-21 Immunogenic composition
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US9931397B2 (en) 2018-04-03
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CY1111827T1 (el) 2015-10-07
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JP2008543907A (ja) 2008-12-04
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US20080193476A1 (en) 2008-08-14
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BRPI0612670B8 (pt) 2021-05-25
JP2013107913A (ja) 2013-06-06
KR20080025184A (ko) 2008-03-19
SI1896061T1 (sl) 2019-10-30
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AU2010203115B2 (en) 2012-03-15
AP2436A (en) 2012-08-31
UA95237C2 (uk) 2011-07-25
US20200000911A1 (en) 2020-01-02
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EP1896065B2 (en) 2014-09-03
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US20170065714A1 (en) 2017-03-09
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