HRP20170457T1 - Postupak proizvodnje cjepiva - Google Patents
Postupak proizvodnje cjepiva Download PDFInfo
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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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- Croatia
- Prior art keywords
- saccharide
- aliquot
- protein carrier
- period
- amino
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- 238000000034 method Methods 0.000 title claims 12
- 238000004519 manufacturing process Methods 0.000 title 1
- 229960005486 vaccine Drugs 0.000 title 1
- 150000001720 carbohydrates Chemical class 0.000 claims 21
- 108090000623 proteins and genes Proteins 0.000 claims 13
- 102000004169 proteins and genes Human genes 0.000 claims 13
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 claims 9
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 claims 9
- 150000001718 carbodiimides Chemical class 0.000 claims 7
- LMDZBCPBFSXMTL-UHFFFAOYSA-N 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide Chemical group CCN=C=NCCCN(C)C LMDZBCPBFSXMTL-UHFFFAOYSA-N 0.000 claims 4
- 241000894006 Bacteria Species 0.000 claims 4
- 241000606768 Haemophilus influenzae Species 0.000 claims 4
- 241000191967 Staphylococcus aureus Species 0.000 claims 4
- 230000001580 bacterial effect Effects 0.000 claims 4
- 230000021615 conjugation Effects 0.000 claims 3
- 241000588724 Escherichia coli Species 0.000 claims 2
- 241000588655 Moraxella catarrhalis Species 0.000 claims 2
- 241000588650 Neisseria meningitidis Species 0.000 claims 2
- 241001174901 Neisseria meningitidis alpha275 Species 0.000 claims 2
- 241000921898 Neisseria meningitidis serogroup A Species 0.000 claims 2
- 241000588677 Neisseria meningitidis serogroup B Species 0.000 claims 2
- 241000947238 Neisseria meningitidis serogroup C Species 0.000 claims 2
- 241001573069 Neisseria meningitidis serogroup Y Species 0.000 claims 2
- 241000607142 Salmonella Species 0.000 claims 2
- 241000293871 Salmonella enterica subsp. enterica serovar Typhi Species 0.000 claims 2
- 241000193998 Streptococcus pneumoniae Species 0.000 claims 2
- 241000607626 Vibrio cholerae Species 0.000 claims 2
- 239000002775 capsule Substances 0.000 claims 2
- 239000002158 endotoxin Substances 0.000 claims 2
- 229920006008 lipopolysaccharide Polymers 0.000 claims 2
- 229940031000 streptococcus pneumoniae Drugs 0.000 claims 2
- 229940118696 vibrio cholerae Drugs 0.000 claims 2
- 108010071134 CRM197 (non-toxic variant of diphtheria toxin) Proteins 0.000 claims 1
- 102100037840 Dehydrogenase/reductase SDR family member 2, mitochondrial Human genes 0.000 claims 1
- 101710183389 Pneumolysin Proteins 0.000 claims 1
- 101710188053 Protein D Proteins 0.000 claims 1
- 101710132893 Resolvase Proteins 0.000 claims 1
- 241000193990 Streptococcus sp. 'group B' Species 0.000 claims 1
- 239000007806 chemical reaction intermediate Substances 0.000 claims 1
- 238000004587 chromatography analysis Methods 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- 238000009833 condensation Methods 0.000 claims 1
- 230000005494 condensation Effects 0.000 claims 1
- 230000001268 conjugating effect Effects 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 210000002443 helper t lymphocyte Anatomy 0.000 claims 1
- 230000003252 repetitive effect Effects 0.000 claims 1
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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.
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HR20120102T HRP20120102T1 (hr) | 2005-06-27 | 2012-02-01 | Imunogeni pripravak |
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