KR102108876B1 - 건조된 생물학적 물질을 안정화시키는 방법 및 조성물 - Google Patents

건조된 생물학적 물질을 안정화시키는 방법 및 조성물 Download PDF

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KR102108876B1
KR102108876B1 KR1020147024688A KR20147024688A KR102108876B1 KR 102108876 B1 KR102108876 B1 KR 102108876B1 KR 1020147024688 A KR1020147024688 A KR 1020147024688A KR 20147024688 A KR20147024688 A KR 20147024688A KR 102108876 B1 KR102108876 B1 KR 102108876B1
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biopharmaceutical
formulation
dried
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solution
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KR20150008848A (ko
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헬렌 크란
쟌 피에르 아모리
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드 슈타트 데르 네덜란덴, 베르테겐부어디그트 두어 드 미니스터 반 베이웨이에스, 미니스테리 반 폭스겐트존하이트, 벨지인 엔 스포츠
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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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
KR1020147024688A 2012-03-05 2013-03-05 건조된 생물학적 물질을 안정화시키는 방법 및 조성물 Expired - Fee Related KR102108876B1 (ko)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201261606577P 2012-03-05 2012-03-05
EP12158086.4 2012-03-05
US61/606,577 2012-03-05
EP12158086 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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KR20150008848A KR20150008848A (ko) 2015-01-23
KR102108876B1 true KR102108876B1 (ko) 2020-05-12

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

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
EP3087188A1 (en) 2013-12-23 2016-11-02 Theravectys Lyophilized lentiviral vector particles, compositions and methods
JP6595132B2 (ja) * 2016-06-16 2019-10-23 ヤンセン ファッシンズ アンド プリベンション ベーフェー Ｈｉｖワクチン製剤
KR102284550B1 (ko) * 2017-02-24 2021-07-30 히사미쓰 세이야꾸 가부시키가이샤 마이크로 니들 디바이스의 제조 방법
EP3615006A4 (en) * 2017-04-28 2020-12-30 Universal Stabilization Technologies, Inc. THERMOSTABLE ANTIGENIC POLIOMYELITIC VACCINES AND RELATED PROCESSES
BR112020000592A2 (pt) * 2017-07-11 2020-07-14 Universal Stabilization Technologies, Inc. método para conservar materiais biológicos
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

Citations (4)

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US4500512A (en) 1981-05-13 1985-02-19 Institut Pasteur Stabilizing agents for live viruses for preparing vaccines, and stabilized vaccines containing said stabilizing agents
WO1999012568A1 (en) * 1997-09-05 1999-03-18 Merck & Co., Inc. Stabilizers containing recombinant human serum albumin for live virus vaccines
JP2004506020A (ja) 2000-08-15 2004-02-26 グラクソスミスクライン　バイオロジカルズ　ソシエテ　アノニム 経口投与固形ワクチン
EP2322211A1 (en) 2005-02-17 2011-05-18 GlaxoSmithKline Biologicals S.A. Live attenuated rotavirus vaccine for oral administration

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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
EP0939648B1 (en) * 1996-09-26 2007-11-07 Merck & Co., Inc. Rotavirus vaccine formulations
EP2420247A1 (en) * 2000-03-07 2012-02-22 Merck Sharp & Dohme Corp. Adenovirus formulations
EP1289494A2 (en) * 2000-06-08 2003-03-12 Powderject Vaccines, Inc. Powder compositions
FR2814957B1 (fr) * 2000-10-06 2002-12-20 Aventis Pasteur Composition vaccinale et procede de stabilisation
EP1701738B1 (en) * 2003-12-17 2015-03-11 Wyeth LLC Method for producing storage stable RSV compositions
CN1922309B (zh) 2003-12-24 2011-07-13 由卫生福利和体育大臣代表的荷兰王国 具有反式互补的基因组缺陷的呼吸道合胞病毒
TWI398272B (zh) * 2005-03-08 2013-06-11 Intervet Int Bv 化學定義的安定劑
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US8357401B2 (en) * 2009-12-11 2013-01-22 Bind Biosciences, Inc. Stable formulations for lyophilizing therapeutic particles

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US4500512A (en) 1981-05-13 1985-02-19 Institut Pasteur Stabilizing agents for live viruses for preparing vaccines, and stabilized vaccines containing said stabilizing agents
WO1999012568A1 (en) * 1997-09-05 1999-03-18 Merck & Co., Inc. Stabilizers containing recombinant human serum albumin for live virus vaccines
JP2004506020A (ja) 2000-08-15 2004-02-26 グラクソスミスクライン　バイオロジカルズ　ソシエテ　アノニム 経口投与固形ワクチン
EP2322211A1 (en) 2005-02-17 2011-05-18 GlaxoSmithKline Biologicals S.A. Live attenuated rotavirus vaccine for oral administration

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Publication number Publication date
JP6253161B2 (ja) 2017-12-27
AU2013228096A1 (en) 2014-09-11
EP2822540B1 (en) 2020-04-08
US20180055924A1 (en) 2018-03-01
AU2013228096B2 (en) 2017-07-13
KR20150008848A (ko) 2015-01-23
US9827303B2 (en) 2017-11-28
EP2822540A1 (en) 2015-01-14
US10335479B2 (en) 2019-07-02
WO2013133702A1 (en) 2013-09-12
JP2015509529A (ja) 2015-03-30
CA2865551A1 (en) 2013-09-12
IN2014MN01714A (https=) 2015-05-29
BR112014020930A2 (pt) 2017-06-27
ZA201407198B (en) 2016-02-24
CN104271119B (zh) 2018-07-10
CN104271119A (zh) 2015-01-07
CA2865551C (en) 2021-01-12
US20150030629A1 (en) 2015-01-29

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