CN102892409B - 用于保存铝盐佐剂和铝盐-佐剂化疫苗的方法 - Google Patents

用于保存铝盐佐剂和铝盐-佐剂化疫苗的方法 Download PDF

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Publication number
CN102892409B
CN102892409B CN201180014386.6A CN201180014386A CN102892409B CN 102892409 B CN102892409 B CN 102892409B CN 201180014386 A CN201180014386 A CN 201180014386A CN 102892409 B CN102892409 B CN 102892409B
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China
Prior art keywords
adjuvant
sucrose
concentration
drying
sugar
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Expired - Fee Related
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CN201180014386.6A
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English (en)
Chinese (zh)
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CN102892409A (zh
Inventor
杰弗里·德鲁
戴维·伍德华德
阿曼达·科尔泰恩
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Stabilitech Ltd
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Stabilitech Ltd
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Publication date
Priority claimed from GBGB1005518.4A external-priority patent/GB201005518D0/en
Priority claimed from GBGB1005522.6A external-priority patent/GB201005522D0/en
Application filed by Stabilitech Ltd filed Critical Stabilitech Ltd
Publication of CN102892409A publication Critical patent/CN102892409A/zh
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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
    • A61K31/095—Sulfur, selenium, or tellurium compounds, e.g. thiols
    • A61K31/10—Sulfides; Sulfoxides; Sulfones
    • 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
    • A61K31/13—Amines
    • A61K31/131—Amines acyclic
    • 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
    • A61K31/13—Amines
    • A61K31/14—Quaternary ammonium compounds, e.g. edrophonium, choline
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/08—Oxides; Hydroxides
    • 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
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
CN201180014386.6A 2010-03-31 2011-03-31 用于保存铝盐佐剂和铝盐-佐剂化疫苗的方法 Expired - Fee Related CN102892409B (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
GBGB1005518.4A GB201005518D0 (en) 2010-03-31 2010-03-31 Preservation of alum-adjuvanted vaccines
GB1005522.6 2010-03-31
GBGB1005522.6A GB201005522D0 (en) 2010-03-31 2010-03-31 Method for preserving alum-adjuvanted vaccines
GB1005518.4 2010-03-31
PCT/GB2011/000497 WO2011121305A2 (en) 2010-03-31 2011-03-31 Method for preserving alum adjuvants and alum-adjuvanted vaccines

Publications (2)

Publication Number Publication Date
CN102892409A CN102892409A (zh) 2013-01-23
CN102892409B true CN102892409B (zh) 2015-12-09

Family

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CN201180014386.6A Expired - Fee Related CN102892409B (zh) 2010-03-31 2011-03-31 用于保存铝盐佐剂和铝盐-佐剂化疫苗的方法

Country Status (13)

Country Link
US (1) US9101607B2 (OSRAM)
EP (1) EP2552410B1 (OSRAM)
JP (1) JP6023696B2 (OSRAM)
KR (1) KR101819250B1 (OSRAM)
CN (1) CN102892409B (OSRAM)
AU (1) AU2011234268B2 (OSRAM)
BR (1) BR112012025044A2 (OSRAM)
CA (1) CA2795050C (OSRAM)
DK (1) DK2552410T3 (OSRAM)
ES (1) ES2708989T3 (OSRAM)
GB (1) GB2499480A (OSRAM)
HU (1) HUE042330T2 (OSRAM)
WO (1) WO2011121305A2 (OSRAM)

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JP5869553B2 (ja) 2010-03-31 2016-02-24 スタビリテック リミテッド ウイルス粒子、ポリペプチド又は生体材料を安定化させる添加剤
JP5960120B2 (ja) 2010-03-31 2016-08-02 スタビリテック リミテッド ウイルス粒子の安定化
GB201117233D0 (en) 2011-10-05 2011-11-16 Stabilitech Ltd Stabilisation of polypeptides
GB201406569D0 (en) * 2014-04-11 2014-05-28 Stabilitech Ltd Vaccine compositions
US9588123B2 (en) * 2014-04-11 2017-03-07 Surmodics Ivd, Inc. Compositions and methods for in vitro diagnostic tests including zwitterionic solubilization reagent
GB2562241B (en) * 2017-05-08 2022-04-06 Stabilitech Biopharma Ltd Vaccine compositions
AR111760A1 (es) * 2017-05-19 2019-08-14 Novartis Ag Compuestos y composiciones para el tratamiento de tumores sólidos mediante administración intratumoral
CN113750228B (zh) * 2021-09-25 2024-02-20 大连理工大学 一种冷冻保护剂在铝佐剂中的应用

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Also Published As

Publication number Publication date
WO2011121305A2 (en) 2011-10-06
KR20130012956A (ko) 2013-02-05
AU2011234268A1 (en) 2012-09-27
WO2011121305A3 (en) 2011-11-24
JP2013523705A (ja) 2013-06-17
HUE042330T2 (hu) 2019-06-28
JP6023696B2 (ja) 2016-11-09
US20130156797A1 (en) 2013-06-20
AU2011234268B2 (en) 2015-07-02
GB2499480A (en) 2013-08-21
CA2795050A1 (en) 2011-10-06
CN102892409A (zh) 2013-01-23
KR101819250B1 (ko) 2018-01-16
BR112012025044A2 (pt) 2016-06-21
ES2708989T3 (es) 2019-04-12
US9101607B2 (en) 2015-08-11
DK2552410T3 (en) 2019-02-18
GB201216472D0 (en) 2012-10-31
EP2552410B1 (en) 2018-10-24
EP2552410A2 (en) 2013-02-06
CA2795050C (en) 2018-05-22

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