HRP20170692T1 - Postupak za formuliranje cjepiva koje sadrži barem dva antigena koji se mogu adsorbirati na aluminijev oksihidroksid - Google Patents
Postupak za formuliranje cjepiva koje sadrži barem dva antigena koji se mogu adsorbirati na aluminijev oksihidroksid Download PDFInfo
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- HRP20170692T1 HRP20170692T1 HRP20170692TT HRP20170692T HRP20170692T1 HR P20170692 T1 HRP20170692 T1 HR P20170692T1 HR P20170692T T HRP20170692T T HR P20170692TT HR P20170692 T HRP20170692 T HR P20170692T HR P20170692 T1 HRP20170692 T1 HR P20170692T1
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- alooh
- hbsag
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- 239000000427 antigen Substances 0.000 title claims 30
- 102000036639 antigens Human genes 0.000 title claims 30
- 108091007433 antigens Proteins 0.000 title claims 30
- 238000000034 method Methods 0.000 title claims 13
- 229960005486 vaccine Drugs 0.000 title claims 8
- -1 aluminium oxyhydroxide Chemical compound 0.000 title claims 7
- 229910002706 AlOOH Inorganic materials 0.000 claims 20
- 238000002360 preparation method Methods 0.000 claims 15
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 7
- 239000000725 suspension Substances 0.000 claims 7
- 101710154643 Filamentous hemagglutinin Proteins 0.000 claims 5
- 206010043376 Tetanus Diseases 0.000 claims 5
- 208000002672 hepatitis B Diseases 0.000 claims 5
- 208000000474 Poliomyelitis Diseases 0.000 claims 4
- 201000005702 Pertussis Diseases 0.000 claims 3
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims 3
- 229910052782 aluminium Inorganic materials 0.000 claims 3
- 206010013023 diphtheria Diseases 0.000 claims 3
- 238000003756 stirring Methods 0.000 claims 3
- 102000016607 Diphtheria Toxin Human genes 0.000 claims 2
- 108010053187 Diphtheria Toxin Proteins 0.000 claims 2
- 241000991587 Enterovirus C Species 0.000 claims 2
- 241000606768 Haemophilus influenzae Species 0.000 claims 2
- 229910019142 PO4 Inorganic materials 0.000 claims 2
- 108010055044 Tetanus Toxin Proteins 0.000 claims 2
- 241000700605 Viruses Species 0.000 claims 2
- VXAUWWUXCIMFIM-UHFFFAOYSA-M aluminum;oxygen(2-);hydroxide Chemical compound [OH-].[O-2].[Al+3] VXAUWWUXCIMFIM-UHFFFAOYSA-M 0.000 claims 2
- 229940045808 haemophilus influenzae type b Drugs 0.000 claims 2
- 239000010452 phosphate Substances 0.000 claims 2
- 102000004169 proteins and genes Human genes 0.000 claims 2
- 108090000623 proteins and genes Proteins 0.000 claims 2
- 229940118376 tetanus toxin Drugs 0.000 claims 2
- 239000003053 toxin Substances 0.000 claims 2
- 231100000765 toxin Toxicity 0.000 claims 2
- 241000588832 Bordetella pertussis Species 0.000 claims 1
- 108010055425 Bordetella pertussis filamentous hemagglutinin adhesin Proteins 0.000 claims 1
- 102000014914 Carrier Proteins Human genes 0.000 claims 1
- 108010078791 Carrier Proteins Proteins 0.000 claims 1
- 150000004676 glycans Chemical class 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229920001282 polysaccharide Polymers 0.000 claims 1
- 239000005017 polysaccharide Substances 0.000 claims 1
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- A61K47/02—Inorganic compounds
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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/02—Bacterial antigens
- A61K39/05—Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella, Corynebacterium; Propionibacterium
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Claims (17)
1. Postupak za pripremanje kombinacije tekućeg cjepiva koji sadrži barem:
- aluminij oksid hidroksid (AlOOH),
- jedan površinski antigen hepatitisa B (HBsAg),
- jedan antigen Haemophilus influenzae tipa b (Hib) koji sadrži kapsularni polisaharid konjugiran na protein nosač,
u kojem se površinski antigen hepatitisa B čuva adsorbiran na AlOOH, dok se Hib antigen čuva ne-adsorbiran,
naznačen time da:
- se površinski antigen hepatitisa B adsorbira na AlOOH kako bi se dobilo AlOOH/HBsAg kompleks,
- navedeni AlOOH/HBsAg kompleks se miješa s Hib antigenom u prisutnosti kationskih aminokiselina u koncentraciji od barem 100 mg/l i fosfatnih iona u koncentraciji od 35 do 45 mMol/l.
2. Postupak prema zahtjevu 1, naznačen time da se HBsAg antigen adsorbira na aluminij miješanjem suspenzije AlOOH sa suspenzijom HBsAg uz miješanje tijekom barem 4 sata.
3. Postupak prema zahtjevu 1, naznačen time da se HBsAg antigen adsorbira na aluminij miješanjem suspenzije AlOOH sa suspenzijom HBsAg uz miješanje tijekom barem 12 sati.
4. Postupak prema zahtjevu 1, naznačen time da se HBsAg antigen adsorbira na aluminij miješanjem suspenzije AlOOH sa suspenzijom HBsAg uz miješanje tijekom barem između 20 i 24 sati.
5. Postupak prema jednom od prethodnih zahtjeva, naznačen time da se u navedeni AlOOH/HBsAg kompleks prije miješanja s Hib antigenom dodaju kationske aminokiseline.
6. Postupak u skladu s bilo kojim od zahtjeva 1 i 2, naznačen time da se u navedeni Hib antigen dodaju kationske aminokiseline prije miješanja s AlOOH/HBsAg kompleksom.
7. Postupak prema jednom od prethodnih zahtjeva, naznačen time da se u navedeni AlOOH/HBsAg kompleks dodaju fosfatni ioni prije miješanja s Hib antigenom.
8. Postupak prema jednom od prethodnih zahtjeva, naznačen time da se pH pripravka koji sadrži AlOOH/HBsAg kompleks podešava na 7.1 ± 0.1 prije miješanja s Hib antigenom.
9. Postupak prema zahtjevu 1, naznačen time da također sadrži:
- pripravljanje pripravka koji sadrži barem jedan antigen koji je odabran od antigena difterije, tetanusa, polio i hripavca, te također aluminij oksid hidroksid, te
- miješanje navedenog AlOOH/HBsAg kompleksa s navedenim pripravkom, prije provođenja miješanja s Hib antigenom.
10. Postupak prema zahtjevu 9, naznačen time da se sastoji se od pripravljanja navedenog pripravka dodavanjem svakog od antigena uzastopno u suspenziju aluminij oksid hidroksida i uz miješanje između svakog dodavanja antigena.
11. Postupak prema zahtjevu 1, naznačen time da:
- se HBsAg adsorbira na djelomičnu količinu AlOOH koja predstavlja jednu trećinu ukupnog AlOOH prisutnog u konačnom pripravku, tijekom perioda od 20 do 24 sata, kako bi nastao AlOOH/HBsAg kompleks,
- paralelno, slijedeći se uzastopno adsorbiraju na dodatnu količinu AlOOH: toksin difterije D, toksin tetanusa T, pročišćeni toksin Bordetella pertussis PTxd, koji je sam prethodno adsorbiran na AlOOH, te filamentozni hemaglutinin Bordetella pertussis FHA, koji je sam prethodno adsorbiran na A1OOH, zatim se u to dodaju fosfatni ioni, zatim se u to dodaje AlOOH/HBsAg kompleks,
- fosfatni ioni se ponovno dodaju u količini koja omogućava da se u konačnom pripravku postigne koncentracija od 40 mMol/l,
- barem jedna kationska aminokiselina se dodaje u količini koja omogućava da se u konačnom pripravku postigne koncentracija od barem 100 mg/l,
- pH se podešava na 7.1 ± 0.1,
- dodaju se polio antigeni u obliku inaktiviranog tipa 1 i/ili tipa 2 i/ili tipa 3 virusa,
- dodaje se Hib antigen,
- pH se podešava na 7.1 ± 0.1,
- dobiveni pripravak se raspoređuje u štrcaljke ili u bočice.
12. Postupak prema jednom od prethodnih zahtjeva, naznačen time da se u industrijskim razmjerima priprema barem 250 l pripravka cjepiva.
13. Pripravak cjepiva dobiven u skladu s postupkom prema bilo kojem od prethodnih zahtjeva, te je naznačen time da sadrži barem površinski antigen hepatitisa B (HBsAg) i Hib antigen koji sadrži poliribosilribitol fosfat konjugiran na protein tetanusa (PRP-T).
14. Pripravak cjepiva prema prethodnom zahtjevu, naznačen time da također sadrži antigene difterije, tetanusa, polio i hripavca.
15. Pripravak cjepiva u skladu s bilo kojim od zahtjeva 13 i 14, naznačen time da sadrži barem:
- površinski antigen hepatitisa B, HBsAg,
- antigen difterije u obliku toksina difterije D,
- antigen tetanusa u obliku toksina tetanusa T,
- antigene hripavca u obliku Pročišćenog Toksina (PTxd) i Filamentoznog Hemaglutinina (FHA),
- antigen Haemophilus influenzae tipa b, u obliku poliribosilribitol fosfata konjugiran na protein tetanusa (PRP-T),
- polio antigene u obliku inaktiviranih virusa koji su odabrani od tipova 1, 2 i 3.
16. Pripravak cjepiva prema zahtjevu 14, naznačen time da sadrži barem:
- od 10 do 30 µg HBsAg/ml;
- od 40 do 80 Lf D/ml;
- od 10 do 50 Lf T/ml;
- od 40 do 60 µg FHA /ml;
- od 40 do 60 µg PTxd/ml;
- od 2 do 60 µg PRP/ml u obliku PRP-T konjugata;
- od 1 do 2 mg AlOOH/ml;
- od 35 do 45 mMol/l fosfatnih iona ;
- od 100 do 1000 mg/l kationskih aminokiselina;
- tipove poliovirusa 1, 2 i 3 u inaktiviranom obliku, u odgovarajućoj količini 80, 16 i 64 DU/ml.
17. Pripravak cjepiva prema zahtjevu 16, naznačen time da sadrži barem:
- 20 µg/ml HBsAg,
- od 50 do 70 Lf /ml D,
- od 10 do 30 Lf /ml T,
- 50 µg/ml FHA,
- 50 µg/ml PTxd,
- od 20-24 µg/ml PRP u obliku PRP-T konjugata,
- 1.2 mg/ml A1OOH,
- od 38 do 42 mMol/l fosfatnih iona,
- od 400 do 800 mg/l kationskih aminokiselina,
- tipove poliovirusa 1, 2 i 3 u inaktiviranom obliku, u odgovarajućoj količini 80, 16 i 64 DU/ml.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR1250464A FR2985663B1 (fr) | 2012-01-17 | 2012-01-17 | Procede de formulation d'un vaccin contenant au moins deux antigenes susceptibles de s'adsorber sur de l'oxy hydroxyde d'aluminium |
PCT/FR2013/050106 WO2013107988A1 (fr) | 2012-01-17 | 2013-01-17 | Procédé de formulation d'un vaccin contenant au moins deux antigènes susceptibles de s'adsorber sur de l'oxyhydroxyde d'aluminium |
EP13704171.1A EP2804628B1 (fr) | 2012-01-17 | 2013-01-17 | Procédé de formulation d'un vaccin contenant au moins deux antigènes susceptibles de s'adsorber sur de l'oxyhydroxyde d'aluminium |
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Publication Number | Publication Date |
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HRP20170692T1 true HRP20170692T1 (hr) | 2017-07-14 |
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HRP20170692TT HRP20170692T1 (hr) | 2012-01-17 | 2017-05-10 | Postupak za formuliranje cjepiva koje sadrži barem dva antigena koji se mogu adsorbirati na aluminijev oksihidroksid |
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Country | Link |
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US (1) | US9358294B2 (hr) |
EP (1) | EP2804628B1 (hr) |
JP (2) | JP6199310B2 (hr) |
KR (1) | KR102019848B1 (hr) |
CN (1) | CN104039348B (hr) |
AP (1) | AP2014007848A0 (hr) |
AR (1) | AR089737A1 (hr) |
AU (1) | AU2013210927B2 (hr) |
BR (1) | BR112014017416B1 (hr) |
CA (1) | CA2861304C (hr) |
CR (1) | CR20140356A (hr) |
CY (1) | CY1119206T1 (hr) |
DK (1) | DK2804628T3 (hr) |
EA (1) | EA026058B1 (hr) |
ES (1) | ES2625011T3 (hr) |
FR (1) | FR2985663B1 (hr) |
GE (1) | GEP201706642B (hr) |
GT (1) | GT201400120A (hr) |
HK (1) | HK1204293A1 (hr) |
HR (1) | HRP20170692T1 (hr) |
HU (1) | HUE032539T2 (hr) |
IL (1) | IL233643A (hr) |
LT (1) | LT2804628T (hr) |
MX (1) | MX349411B (hr) |
NZ (1) | NZ627345A (hr) |
PE (1) | PE20141515A1 (hr) |
PH (1) | PH12014501546A1 (hr) |
PL (1) | PL2804628T3 (hr) |
PT (1) | PT2804628T (hr) |
RS (1) | RS55962B1 (hr) |
SI (1) | SI2804628T1 (hr) |
UA (1) | UA113000C2 (hr) |
WO (1) | WO2013107988A1 (hr) |
ZA (1) | ZA201405431B (hr) |
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CN106075428A (zh) * | 2015-07-01 | 2016-11-09 | 北京科兴中维生物技术有限公司 | 一种免疫原性组合物及其制备方法 |
WO2021176409A1 (en) | 2020-03-05 | 2021-09-10 | Sanofi Healthcare India Private Limited | Preservative combination for vaccine composition |
KR20230173114A (ko) | 2021-04-20 | 2023-12-26 | 케이엠 바이올로직스 가부시키가이샤 | 6종 혼합 액상 백신 조성물 |
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CZ283910B6 (cs) * | 1992-05-23 | 1998-07-15 | Smithkline Beecham Biologicals (S.A.) | Kombinovaný očkovací prostředek, způsob jeho výroby a použití fosforečnanu hlinitého jako pomocného prostředku |
US6790445B1 (en) * | 1997-02-06 | 2004-09-14 | Merck & Co., Inc. | Preservatives for vaccines |
ATE470434T1 (de) * | 1997-02-06 | 2010-06-15 | Merck Sharp & Dohme | Thimerosal-freie konservierungsmittel für impfstoffe |
AU4707097A (en) * | 1997-09-15 | 1999-04-05 | Pasteur Merieux Serums Et Vaccins | Multivalent vaccines |
WO2003009869A1 (en) * | 2001-07-26 | 2003-02-06 | Chiron Srl. | Vaccines comprising aluminium adjuvants and histidine |
GB0118249D0 (en) * | 2001-07-26 | 2001-09-19 | Chiron Spa | Histidine vaccines |
EP1414433B1 (en) | 2001-08-07 | 2006-04-12 | Laboratoires SMB SA | Improved pharmaceutical composition containing a ppar alpha agent and a process for preparing it |
FR2828406B1 (fr) | 2001-08-08 | 2005-06-24 | Aventis Pasteur | Composition vaccinale bivalente havi |
GB0610140D0 (en) * | 2006-05-22 | 2006-06-28 | Insense Ltd | Protein stability |
PE20100366A1 (es) * | 2008-10-24 | 2010-05-21 | Panacea Biotec Ltd | Novedosas composiciones de vacuna con tos ferina acelular asi como el metodo para su elaboracion |
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2012
- 2012-01-17 FR FR1250464A patent/FR2985663B1/fr active Active
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2013
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