HRP20210242T1 - Stabilne formulacije antigena iz bakterije neisseria meningitidis rlp2086 - Google Patents
Stabilne formulacije antigena iz bakterije neisseria meningitidis rlp2086 Download PDFInfo
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- HRP20210242T1 HRP20210242T1 HRP20210242TT HRP20210242T HRP20210242T1 HR P20210242 T1 HRP20210242 T1 HR P20210242T1 HR P20210242T T HRP20210242T T HR P20210242TT HR P20210242 T HRP20210242 T HR P20210242T HR P20210242 T1 HRP20210242 T1 HR P20210242T1
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- Prior art keywords
- detergent
- protein
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- concentration
- molar ratio
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- 239000000203 mixture Substances 0.000 title claims 4
- 241000588650 Neisseria meningitidis Species 0.000 title 1
- 239000000427 antigen Substances 0.000 title 1
- 102000036639 antigens Human genes 0.000 title 1
- 108091007433 antigens Proteins 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims 22
- 239000003599 detergent Substances 0.000 claims 10
- 108090000623 proteins and genes Proteins 0.000 claims 8
- 102000004169 proteins and genes Human genes 0.000 claims 8
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims 4
- 229910052782 aluminium Inorganic materials 0.000 claims 4
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 4
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims 4
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 3
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 3
- 229920001184 polypeptide Polymers 0.000 claims 3
- 229920000053 polysorbate 80 Polymers 0.000 claims 3
- 229940068968 polysorbate 80 Drugs 0.000 claims 3
- 102000004196 processed proteins & peptides Human genes 0.000 claims 3
- 108090000765 processed proteins & peptides Proteins 0.000 claims 3
- 230000002163 immunogen Effects 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 229940037003 alum Drugs 0.000 claims 1
- 229910021502 aluminium hydroxide Inorganic materials 0.000 claims 1
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 claims 1
- 229910000329 aluminium sulfate Inorganic materials 0.000 claims 1
- DIZPMCHEQGEION-UHFFFAOYSA-H aluminium sulfate (anhydrous) Chemical compound [Al+3].[Al+3].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O DIZPMCHEQGEION-UHFFFAOYSA-H 0.000 claims 1
- 235000011128 aluminium sulphate Nutrition 0.000 claims 1
- 229910001679 gibbsite Inorganic materials 0.000 claims 1
- 229920001296 polysiloxane Polymers 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 230000000087 stabilizing effect Effects 0.000 claims 1
Classifications
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- 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
- A61K39/095—Neisseria
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
- C07K14/22—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Neisseriaceae (F)
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4172—Imidazole-alkanecarboxylic acids, e.g. histidine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/164—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56911—Bacteria
-
- 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
- A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
- A61K2039/55505—Inorganic adjuvants
-
- 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
- A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
- A61K2039/55511—Organic adjuvants
- A61K2039/55555—Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
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- General Health & Medical Sciences (AREA)
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- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Microbiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Mycology (AREA)
- Biochemistry (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- Inorganic Chemistry (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Tropical Medicine & Parasitology (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Food Science & Technology (AREA)
- Virology (AREA)
- Cell Biology (AREA)
- Biotechnology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
Claims (21)
1. Postupak stabiliziranja potentnosti polipeptida LP2086 (fHBP) iz potporodice B u imunogenom pripravku, naznačen time što se navedeni postupak sastoji u koraku (a) formuliranja polipeptida LP2086 (fHBP) iz potporodice B u pripravku, uz molarni omjer između detergenta i proteina između otprilike 0,5:1 i otprilike 10:1, gdje pripravak dodatno sadrži aluminij u koncentraciji između otprilike 0,1 mg/ml i otprilike 1 mg/ml.
2. Postupak u skladu s patentnim zahtjevom 1, naznačen time što se molarni omjer između detergenta i proteina kreće između otprilike 1:1 i otprilike 5:1.
3. Postupak u skladu s patentnim zahtjevom 2, naznačen time što se molarni omjer između detergenta i proteina kreće između otprilike 1,4:1 i otprilike 4,2:1.
4. Postupak u skladu s patentnim zahtjevom 2, naznačen time što je molarni omjer između detergenta i proteina otprilike 2,8:1.
5. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-4, naznačen time što je količina detergenta dovoljna za smanjivanje vezanja polipeptida na silikon u spremniku.
6. Postupak u skladu s patentnim zahtjevom 5, naznačen time što je spremnik štrcaljka ili bočica.
7. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-6, naznačen time što je detergent neionski detergent.
8. Postupak u skladu s patentnim zahtjevom 7, naznačen time što je detergent polisorbatni detergent.
9. Postupak u skladu s patentnim zahtjevom 8, naznačen time što je detergent polisorbat 80.
10. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-9, naznačen time što je koncentracija aluminija otprilike 0,5 mg/ml.
11. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-10, naznačen time što pripravak sadrži AlPO4, Al(OH)3, Al2(SO4)3 ili alaun.
12. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-11, naznačen time što pripravak dodatno sadrži histidin.
13. Postupak u skladu s patentnim zahtjevom 12, naznačen time što se koncentracija histidina kreće između otprilike 2 mM i otprilike 20 mM ili se kreće između otprilike 5 mM i otprilike 15 mM.
14. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-13, naznačen time što pripravak dodatno sadrži sukcinat.
15. Postupak u skladu s patentnim zahtjevom 14, naznačen time što se koncentracija sukcinata kreće između otprilike 2mM i otprilike 10 mM ili se kreće između otprilike 3 mM i otprilike 7 mM.
16. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-15, naznačen time što se pH kreće između otprilike 5,0 i otprilike 8,0 ili se kreće između otprilike 5,8 i 6,0.
17. Postupak u skladu s patentnim zahtjevom 16, naznačen time što je koncentracija histidina otprilike 10 mM, pH 6,0.
18. Postupak u skladu s patentnim zahtjevom 16, naznačen time što je koncentracija sukcinata otprilike 5 mM, pH 6,0.
19. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-18, naznačen time što dodatno uključuje korak (b) liofiliziranja imunogenog pripravka.
20. Postupak u skladu s patentnim zahtjevom 1, naznačen time što se protein iz potporodice B formulira u pripravku koji se uglavnom sastoji od polisorbata 80 i proteina u molarnom omjeru od otprilike 2,8:1, 0,5 mg/ml aluminija u obliku AlPO4, 10 mM histidina na pH 6,0, te 150 mM NaCl.
21. Postupak u skladu s patentnim zahtjevom 1, naznačen time što se protein iz potporodice B formulira u pripravku koji se uglavnom sastoji od polisorbata 80 i proteina u molarnom omjeru od otprilike 2,8:1, 0,5 mg/ml aluminija u obliku AlPO4, 5 mM sukcinata na pH 6,0, te 150 mM NaCl.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US37616010P | 2010-08-23 | 2010-08-23 | |
EP17172800.9A EP3246044B2 (en) | 2010-08-23 | 2011-08-22 | Stable formulations of neisseria meningitidis rlp2086 antigens |
Publications (2)
Publication Number | Publication Date |
---|---|
HRP20210242T1 true HRP20210242T1 (hr) | 2021-04-02 |
HRP20210242T4 HRP20210242T4 (hr) | 2024-05-10 |
Family
ID=44653380
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20210242TT HRP20210242T4 (hr) | 2010-08-23 | 2011-08-22 | Stabilne formulacije antigena iz bakterije neisseria meningitidis rlp2086 |
Country Status (23)
Country | Link |
---|---|
US (1) | US9556240B2 (hr) |
EP (3) | EP3246044B2 (hr) |
JP (1) | JP5945538B2 (hr) |
KR (2) | KR101817450B1 (hr) |
CN (3) | CN103189071A (hr) |
AR (1) | AR082529A1 (hr) |
AU (2) | AU2011294776B2 (hr) |
BR (1) | BR112013004236A2 (hr) |
CA (1) | CA2808975C (hr) |
DK (3) | DK2608805T3 (hr) |
ES (2) | ES2850973T3 (hr) |
FI (1) | FI3246044T4 (hr) |
HK (2) | HK1247083A1 (hr) |
HR (1) | HRP20210242T4 (hr) |
HU (3) | HUE034544T2 (hr) |
IL (1) | IL224626A (hr) |
MX (1) | MX350142B (hr) |
PL (2) | PL2608805T3 (hr) |
PT (2) | PT3246044T (hr) |
RU (1) | RU2580620C2 (hr) |
SI (2) | SI3246044T1 (hr) |
TW (1) | TW201221138A (hr) |
WO (1) | WO2012025873A2 (hr) |
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MX339524B (es) | 2001-10-11 | 2016-05-30 | Wyeth Corp | Composiciones inmunogenicas novedosas para la prevencion y tratamiento de enfermedad meningococica. |
ES2850973T3 (es) | 2010-08-23 | 2021-09-01 | Wyeth Llc | Formulaciones estables de antígenos rLP2086 de Neisseria meningitidis |
WO2012032489A1 (en) | 2010-09-10 | 2012-03-15 | Wyeth Llc | Non-lipidated variants of neisseria meningitidis orf2086 antigens |
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EP2823312B1 (en) * | 2012-03-08 | 2019-08-07 | GlaxoSmithKline Biologicals SA | In vitro potency assay for protein-based meningococcal vaccines |
NZ628449A (en) | 2012-03-09 | 2016-04-29 | Pfizer | Neisseria meningitidis compositions and methods thereof |
SA115360586B1 (ar) | 2012-03-09 | 2017-04-12 | فايزر انك | تركيبات لعلاج الالتهاب السحائي البكتيري وطرق لتحضيرها |
JP6446377B2 (ja) | 2013-03-08 | 2018-12-26 | ファイザー・インク | 免疫原性融合ポリペプチド |
CA2923129C (en) * | 2013-09-08 | 2020-06-09 | Pfizer Inc. | Neisseria meningitidis compositions and methods thereof |
US10365272B2 (en) * | 2014-07-25 | 2019-07-30 | Serum Institute Of India Private Limited | Highly sensitive immunoassay for rapid quantification of meningococcal capsular polysaccharide antigens |
BR112017017460A2 (pt) | 2015-02-19 | 2018-04-10 | Pfizer Inc. | composições de neisseria meningitidis e métodos das mesmas |
AR104847A1 (es) * | 2015-06-17 | 2017-08-16 | Lilly Co Eli | Formulación de anticuerpo anti-cgrp |
CN110234658B (zh) | 2017-01-31 | 2024-03-12 | 辉瑞大药厂 | 脑膜炎奈瑟菌组合物及其使用方法 |
WO2020165711A1 (en) | 2019-02-11 | 2020-08-20 | Pfizer Inc. | Neisseria meningitidiscompositions and methods thereof |
EP4034157A1 (en) | 2019-09-27 | 2022-08-03 | Pfizer Inc. | Neisseria meningitidis compositions and methods thereof |
WO2024030931A1 (en) * | 2022-08-03 | 2024-02-08 | Sanofi Pasteur Inc. | Adjuvanted immunogenic composition against neisseria meningitidis b |
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