JP6253161B2 - 乾燥された生物学的材料を安定化するための方法及び組成物 - Google Patents

乾燥された生物学的材料を安定化するための方法及び組成物 Download PDF

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JP6253161B2
JP6253161B2 JP2014560879A JP2014560879A JP6253161B2 JP 6253161 B2 JP6253161 B2 JP 6253161B2 JP 2014560879 A JP2014560879 A JP 2014560879A JP 2014560879 A JP2014560879 A JP 2014560879A JP 6253161 B2 JP6253161 B2 JP 6253161B2
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formulation
solution
biodrug
drying
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JP2015509529A (ja
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ヘレーン クラーン，
ヘレーン クラーン，
ジャン‐ピエール アモリ，
ジャン‐ピエール アモリ，
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Nederlanden Staat
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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
    • A61K39/12—Viral antigens
    • A61K39/125—Picornaviridae, e.g. calicivirus
    • A61K39/13—Poliovirus
    • 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
    • A61K39/12—Viral antigens
    • 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
    • A61K47/16—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
    • A61K47/26—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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/32011—Picornaviridae
    • C12N2770/32611—Poliovirus
    • C12N2770/32634—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2014560879A 2012-03-05 2013-03-05 乾燥された生物学的材料を安定化するための方法及び組成物 Expired - Fee Related JP6253161B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201261606577P 2012-03-05 2012-03-05
EP12158086 2012-03-05
EP12158086.4 2012-03-05
US61/606,577 2012-03-05
PCT/NL2013/050139 WO2013133702A1 (en) 2012-03-05 2013-03-05 Methods and compositions for stabilizing dried biological materials

Publications (2)

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JP2015509529A JP2015509529A (ja) 2015-03-30
JP6253161B2 true JP6253161B2 (ja) 2017-12-27

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JP2014560879A Expired - Fee Related JP6253161B2 (ja) 2012-03-05 2013-03-05 乾燥された生物学的材料を安定化するための方法及び組成物

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US (2) US9827303B2 (enExample)
EP (1) EP2822540B1 (enExample)
JP (1) JP6253161B2 (enExample)
KR (1) KR102108876B1 (enExample)
CN (1) CN104271119B (enExample)
AU (1) AU2013228096B2 (enExample)
BR (1) BR112014020930A2 (enExample)
CA (1) CA2865551C (enExample)
IN (1) IN2014MN01714A (enExample)
WO (1) WO2013133702A1 (enExample)
ZA (1) ZA201407198B (enExample)

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CN104274827B (zh) * 2013-07-01 2020-07-14 上海贺普药业股份有限公司 贺普拉肽的制剂
WO2015097650A1 (en) 2013-12-23 2015-07-02 Theravectys Lyophilized lentiviral vector particles, compositions and methods
KR102389489B1 (ko) * 2016-06-16 2022-04-22 얀센 백신스 앤드 프리벤션 비.브이. Hiv 백신 제형
EP3586905B1 (en) * 2017-02-24 2023-07-26 Hisamitsu Pharmaceutical Co., Inc. Method for producing microneedle device
WO2018201154A1 (en) * 2017-04-28 2018-11-01 Universal Stabilization Technologies, Inc. Antigenic thermostable polio vaccines & related methods
AU2018301395B2 (en) * 2017-07-11 2024-11-14 Universal Stabilization Technologies, Inc. Method for Preserving Biological Materials
CN111166891B (zh) * 2018-11-13 2022-04-05 中国药科大学 甘露醇共晶辅料及其制备方法和用途
CN112111609A (zh) * 2020-10-29 2020-12-22 上海伯杰医疗科技有限公司 一种肠道病毒通用型核酸检测试剂盒
CN114748615A (zh) * 2022-04-29 2022-07-15 成都安永鼎业生物技术有限公司 一种治疗用重组卡介苗的冻干制剂及其制备方法和用途
CN115089864B (zh) * 2022-07-14 2023-12-29 复旦大学 一种使用冷冻干燥技术制备可溶性微针贴片的方法
CN116763914B (zh) * 2023-02-06 2024-02-23 广东永顺生物制药股份有限公司 猪瘟、高致病性猪繁殖与呼吸综合征二联耐热保护剂活疫苗及其制备方法
CN117482072A (zh) * 2023-11-17 2024-02-02 上海市浦东新区公利医院(第二军医大学附属公利医院) 山梨糖醇在制备治疗呼吸道合胞病毒所致疾病的药物中的应用

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FR2505657A1 (fr) * 1981-05-13 1982-11-19 Pasteur Institut Perfectionnements apportes aux agents de stabilisation de virus vivants pour la preparation de vaccins, et vaccins stabilises contenant lesdits agents de stabilisation
JPH0761955B2 (ja) * 1988-04-28 1995-07-05 国立予防衛生研究所長 凍結乾燥ａ型肝炎ワクチン
ATE377428T1 (de) * 1996-09-26 2007-11-15 Merck & Co Inc Rotavirus-impfstoff
US6210683B1 (en) * 1997-09-05 2001-04-03 Merck & Co., Inc. Stabilizers containing recombinant human serum albumin for live virus vaccines
EP2420247A1 (en) * 2000-03-07 2012-02-22 Merck Sharp & Dohme Corp. Adenovirus formulations
KR20030020294A (ko) * 2000-06-08 2003-03-08 파우더젝트 백신, 인코포레이티드 분말 조성물
GB0020089D0 (en) 2000-08-15 2000-10-04 Smithkline Beecham Biolog Vaccine Composition
FR2814957B1 (fr) * 2000-10-06 2002-12-20 Aventis Pasteur Composition vaccinale et procede de stabilisation
MXPA06006947A (es) * 2003-12-17 2007-01-26 Wyeth Corp Metodos para producir virus de almacenamiento estable y composiciones inmunogenicas de estos.
SI1699919T1 (sl) 2003-12-24 2017-07-31 De Staat der Nederlanden, Vertegenwoordigd Door de Minister Van Volksgezondheid, Welzijn Respiratorni sincicijski virus z genomsko pomanjkljivostjo komplementarno v trans
GB0503337D0 (en) * 2005-02-17 2005-03-23 Glaxosmithkline Biolog Sa Compositions
TWI398272B (zh) * 2005-03-08 2013-06-11 Intervet Int Bv 化學定義的安定劑
ES2776657T3 (es) * 2005-06-14 2020-07-31 Amgen Inc Formulaciones de proteínas autotamponantes
JP5891175B2 (ja) 2009-12-11 2016-03-22 バインド セラピューティックス インコーポレイテッド 治療用粒子の凍結乾燥に対する安定製剤

Also Published As

Publication number Publication date
US20180055924A1 (en) 2018-03-01
ZA201407198B (en) 2016-02-24
EP2822540A1 (en) 2015-01-14
KR102108876B1 (ko) 2020-05-12
AU2013228096B2 (en) 2017-07-13
IN2014MN01714A (enExample) 2015-05-29
EP2822540B1 (en) 2020-04-08
KR20150008848A (ko) 2015-01-23
US20150030629A1 (en) 2015-01-29
US9827303B2 (en) 2017-11-28
JP2015509529A (ja) 2015-03-30
CN104271119B (zh) 2018-07-10
BR112014020930A2 (pt) 2017-06-27
AU2013228096A1 (en) 2014-09-11
CA2865551A1 (en) 2013-09-12
CN104271119A (zh) 2015-01-07
WO2013133702A1 (en) 2013-09-12
US10335479B2 (en) 2019-07-02
CA2865551C (en) 2021-01-12

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