HRP20171161T1 - Postupak konjugiranja bakterijskih polisaharida s proteinskim nosačima - Google Patents
Postupak konjugiranja bakterijskih polisaharida s proteinskim nosačima Download PDFInfo
- Publication number
- HRP20171161T1 HRP20171161T1 HRP20171161TT HRP20171161T HRP20171161T1 HR P20171161 T1 HRP20171161 T1 HR P20171161T1 HR P20171161T T HRP20171161T T HR P20171161TT HR P20171161 T HRP20171161 T HR P20171161T HR P20171161 T1 HRP20171161 T1 HR P20171161T1
- Authority
- HR
- Croatia
- Prior art keywords
- bacterial saccharide
- buffer
- saccharide
- kda
- conjugate
- Prior art date
Links
- 230000001580 bacterial effect Effects 0.000 title claims 17
- 238000000034 method Methods 0.000 title claims 15
- 230000021615 conjugation Effects 0.000 title claims 2
- 102000014914 Carrier Proteins Human genes 0.000 title 1
- 108010078791 Carrier Proteins Proteins 0.000 title 1
- 150000004676 glycans Chemical class 0.000 title 1
- 229920001282 polysaccharide Polymers 0.000 title 1
- 239000005017 polysaccharide Substances 0.000 title 1
- 150000001720 carbohydrates Chemical class 0.000 claims 17
- 239000000872 buffer Substances 0.000 claims 6
- 108090000623 proteins and genes Proteins 0.000 claims 5
- 102000004169 proteins and genes Human genes 0.000 claims 5
- 239000000427 antigen Substances 0.000 claims 4
- 102000036639 antigens Human genes 0.000 claims 4
- 108091007433 antigens Proteins 0.000 claims 4
- 241000894006 Bacteria Species 0.000 claims 3
- 239000003638 chemical reducing agent Substances 0.000 claims 3
- KHIWWQKSHDUIBK-UHFFFAOYSA-N periodic acid Chemical compound OI(=O)(=O)=O KHIWWQKSHDUIBK-UHFFFAOYSA-N 0.000 claims 3
- 101710183389 Pneumolysin Proteins 0.000 claims 2
- 229960000814 tetanus toxoid Drugs 0.000 claims 2
- 101100420868 Anuroctonus phaiodactylus phtx gene Proteins 0.000 claims 1
- BTBUEUYNUDRHOZ-UHFFFAOYSA-N Borate Chemical compound [O-]B([O-])[O-] BTBUEUYNUDRHOZ-UHFFFAOYSA-N 0.000 claims 1
- 108010071134 CRM197 (non-toxic variant of diphtheria toxin) Proteins 0.000 claims 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims 1
- 101710164918 Choline-binding protein Proteins 0.000 claims 1
- 102100037840 Dehydrogenase/reductase SDR family member 2, mitochondrial Human genes 0.000 claims 1
- 101710099976 Photosystem I P700 chlorophyll a apoprotein A1 Proteins 0.000 claims 1
- 101710188053 Protein D Proteins 0.000 claims 1
- 101710132893 Resolvase Proteins 0.000 claims 1
- 239000008351 acetate buffer Substances 0.000 claims 1
- 239000002671 adjuvant Substances 0.000 claims 1
- 125000003277 amino group Chemical group 0.000 claims 1
- 239000011230 binding agent Substances 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 125000000837 carbohydrate group Chemical group 0.000 claims 1
- 239000007979 citrate buffer Substances 0.000 claims 1
- 229960003983 diphtheria toxoid Drugs 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 230000004927 fusion Effects 0.000 claims 1
- 102000037865 fusion proteins Human genes 0.000 claims 1
- 108020001507 fusion proteins Proteins 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000008363 phosphate buffer Substances 0.000 claims 1
- 229920002704 polyhistidine Polymers 0.000 claims 1
- 230000001603 reducing effect Effects 0.000 claims 1
- BEOOHQFXGBMRKU-UHFFFAOYSA-N sodium cyanoborohydride Chemical compound [Na+].[B-]C#N BEOOHQFXGBMRKU-UHFFFAOYSA-N 0.000 claims 1
- -1 sodium triacetoxyborohydride Chemical compound 0.000 claims 1
- 239000012321 sodium triacetoxyborohydride Substances 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/61—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule the organic macromolecular compound being a polysaccharide or a derivative thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/02—Bacterial antigens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/02—Bacterial antigens
- A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
- A61K39/092—Streptococcus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
- 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
- A61K47/6415—Toxins or lectins, e.g. clostridial toxins or Pseudomonas exotoxins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
- A61K2039/6031—Proteins
- A61K2039/6037—Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/62—Medicinal preparations containing antigens or antibodies characterised by the link between antigen and carrier
Claims (14)
1. Postupak konjugiranja bakterijskog saharida, naznačen time što obuvaća korake
a) reakcija bakterijskog saharida s 0,001-0,7 molarnih ekvivalenata perjodata kako bi se dobio aktivirani bakterijski saharid;
b) miješanje aktiviranog bakterijskog saharida s proteinskim nosačem;
c) reakcija aktiviranog bakterijskog saharida i proteinskog nosača s reducensom kako bi se dobio konjugat;
ili
a) reakcija bakterijskog saharida s 0,001-0,7 molarnih ekvivalenata perjodata kako bi se dobio aktivirani bakterijski saharid;
b) miješanje aktiviranog bakterijskog saharida sa spojnicom;
2. c’) reakcija aktiviranog bakterijskog saharida sa spojnicom uz upotrebu reducensa kako bi se dobio kompleks bakterijski saharid-spojnica;
d) reakcija kompleksa bakterijski saharid-spojnica s proteinskim nosačem kako bi se dobio konjugat;
3. gdje se korak a) provodi u puferu koji ne sadrži aminsku skupinu, gdje je koncentracija pufera između 1 i 100 mM, te gdje je bakterijski saharid saharid 23F iz kapsule bakterije S. pneumoniae.
2. Postupak u skladu s patentnim zahtjevom 1, naznačen time što se pufer bira iz skupine koju čine fosfatni pufer, boratni pufer, acetatni pufer, karbonatni pufer i citratni pufer, gdje pufer može imati koncentraciju između 1 i 50 mM, 1 i 25 mM, 1 i 10 mM, 5 i 15 mM, 8 i 12 mM ili 10-50 mM, ili oko 10 mM.
3. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-2, naznačen time što je pH u koraku a) pH 3,5-8,0 5,0-7,0 ili pH 5,5-6,5, ili oko pH 6,0.
4. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-3, naznačen time što je prosječna molekulska težina bakterijskog saharida između 1 i 1100 kDa, 100 i 470 kDa, 200 i 300 kDa, 600 i 1100 kDa ili 800 i 1000 kDa nakon koraka a).
5. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-4, naznačen time što je prosječna molekulska težina saharida 23F između 100 i 470 kDa ili 200-300 kDa nakon koraka a).
6. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-5, naznačen time što se proteinski nosač bira iz skupine koju čine tetanusni toksoid, fragment C tetanusnog toksoida, difterijski toksoid, CRM197, pneumolizin, protein D, PhtD, PhtDE i N19.
7. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-6, naznačen time što reducens uključuje natrijev cijanoborohidrid ili natrijev triacetoksiborohidrid.
8. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-7, naznačen time što uključuje dodatni korak e) pročišćavanja konjugata.
9. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-8, naznačen time što uključuje dodatni korak miješanja konjugata s dodatnim antigensom, gdje dodatni antigeni može uključivati u najmanju ruku 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 ili 20 S. pneumoniae saharide, koji se biraju iz skupine koju čine 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F i 33F.
10. Postupak u skladu s patentnim zahtjevom 9, naznačen time što dodatni antigeni uključuju jedan ili više proteina iz bakterije S. pneumoniae, koji se biraju iz skupine koju čine obitelj polihistidinske trijade (PhtX), obitelj kolinski vežućeg proteina (CbpX), skraćeni CbpX, obitelj LytX, skraćeni LytX, kimerini proteini (ili fuzije) skraćeni CbpX-skraćeni LytX, pneumolizin (Ply), PspA, PsaA, Sp128, Sp101, Sp130, Sp125 i Sp133.
11. Postupak u skladu s patentnim zahtjevom 9 ili patentnim zahtjevom 10, naznačen time što dodatni antigeni uključuju saharide 1, 4, 5, 6B, 7F, 9V, 14, 18C i 19F iz bakterije S. pneumoniae.
12. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-11, naznačen time što se sastoji u koraku reakcije bakterijskog saharida s 0,1-0,5 molarnih ekvivalenata perjodata kako bi se dobio aktivirani bakterijski saharid.
13. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-12, naznačen time što smanjuje učinak smanjivanja na bakterijski saharid.
14. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-13, naznačen time što se konjugat pomiješa s adjuvansom ili farmaceutski prihvatljivom pomoćnom tvari.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB1003922.0A GB201003922D0 (en) | 2010-03-09 | 2010-03-09 | Conjugation process |
EP14181075.4A EP2815762B1 (en) | 2010-03-09 | 2011-03-07 | Conjugation process of bacterial polysaccharides to carrier proteins |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20171161T1 true HRP20171161T1 (hr) | 2017-10-06 |
Family
ID=42136725
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20150935TT HRP20150935T1 (en) | 2010-03-09 | 2015-09-07 | Conjugation process of bacterial polysaccharides to carrier proteins |
HRP20171161TT HRP20171161T1 (hr) | 2010-03-09 | 2017-07-28 | Postupak konjugiranja bakterijskih polisaharida s proteinskim nosačima |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20150935TT HRP20150935T1 (en) | 2010-03-09 | 2015-09-07 | Conjugation process of bacterial polysaccharides to carrier proteins |
Country Status (26)
Country | Link |
---|---|
US (3) | US8753645B2 (hr) |
EP (2) | EP2544708B1 (hr) |
JP (1) | JP5698770B2 (hr) |
KR (2) | KR20130038233A (hr) |
CN (1) | CN102883745A (hr) |
AU (1) | AU2011226160B2 (hr) |
BR (1) | BR112012022358B1 (hr) |
CA (1) | CA2791926C (hr) |
CY (2) | CY1116685T1 (hr) |
DK (2) | DK2544708T3 (hr) |
EA (1) | EA023059B1 (hr) |
ES (2) | ES2545221T3 (hr) |
GB (1) | GB201003922D0 (hr) |
HR (2) | HRP20150935T1 (hr) |
HU (2) | HUE027621T2 (hr) |
LT (1) | LT2815762T (hr) |
ME (1) | ME02204B (hr) |
MX (2) | MX2012010388A (hr) |
PL (2) | PL2815762T3 (hr) |
PT (2) | PT2815762T (hr) |
RS (1) | RS54188B1 (hr) |
SG (2) | SG183476A1 (hr) |
SI (2) | SI2815762T1 (hr) |
SM (1) | SMT201500211B (hr) |
WO (1) | WO2011110531A2 (hr) |
ZA (1) | ZA201206637B (hr) |
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BRPI0612669B8 (pt) | 2005-06-27 | 2021-05-25 | Glaxosmithkline Biologicals Sa | composição imunogênica, vacina, composição, e composição liofilizada |
GB201003922D0 (en) * | 2010-03-09 | 2010-04-21 | Glaxosmithkline Biolog Sa | Conjugation process |
PT3246044T (pt) | 2010-08-23 | 2021-02-15 | Wyeth Llc | Formulações estáveis de antigénios de rlp2086 de neisseria meningitidis |
MX362802B (es) | 2010-09-10 | 2019-02-13 | Wyeth Llc Star | Variantes no lipidadas de antigenos orf2086 de neisseria meningitidis. |
GB201103836D0 (en) * | 2011-03-07 | 2011-04-20 | Glaxosmithkline Biolog Sa | Conjugation process |
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