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
preparing
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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (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)
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 2012-03-05
US61/606,577 2012-03-05
EP12158086.4 2012-03-05
PCT/NL2013/050139 WO2013133702A1 (en) 2012-03-05 2013-03-05 Methods and compositions for stabilizing dried biological materials

Publications (2)

Publication Number Publication Date
KR20150008848A KR20150008848A (ko) 2015-01-23
KR102108876B1 true KR102108876B1 (ko) 2020-05-12

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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)

Families Citing this family (12)

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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
US10538785B2 (en) 2013-12-23 2020-01-21 Renaud Vaillant Lyophilized lentiviral vector particles, compositions and methods
BR112018075785A2 (pt) * 2016-06-16 2019-04-02 Janssen Vaccines & Prevention B.V. formulação de vacina para o hiv
WO2018155433A1 (ja) * 2017-02-24 2018-08-30 久光製薬株式会社 マイクロニードルデバイスの製造方法
WO2018201154A1 (en) * 2017-04-28 2018-11-01 Universal Stabilization Technologies, Inc. Antigenic thermostable polio vaccines & related methods
EP3655000A4 (en) * 2017-07-11 2021-07-14 Universal Stabilization Technologies, Inc. PROCESS FOR THE PRESERVATION OF BIOPHARMACEUTICALS
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
AU739916B2 (en) * 1996-09-26 2001-10-25 Merck Sharp & Dohme Corp. Rotavirus vaccine formulations
CA2399321C (en) * 2000-03-07 2013-04-30 Robert K. Evans Adenovirus formulations
BR0111494A (pt) * 2000-06-08 2004-01-13 Powderject Vaccines Inc Pó de livre escoamento formador de gel adequado para uso como uma vacina, processo para a preparação do mesmo, receptáculo de dosagem para uma seringa sem agulha, seringa sem agulha, composição de vacina, método para vacinação de um indivìduo, pó adequado para uso como uma vacina, e, processo para a preparação do mesmo
FR2814957B1 (fr) * 2000-10-06 2002-12-20 Aventis Pasteur Composition vaccinale et procede de stabilisation
CA2549197C (en) * 2003-12-17 2015-04-14 Wyeth Methods for producing storage stable viruses and immunogenic compositions thereof
AU2004303719B2 (en) 2003-12-24 2010-11-11 Intravacc B.V. A respiratory syncytial virus with a genomic deficiency complemented in trans
TWI398272B (zh) 2005-03-08 2013-06-11 Intervet Int Bv 化學定義的安定劑
JP2008543839A (ja) * 2005-06-14 2008-12-04 アムジェン インコーポレーテッド 自己緩衝タンパク質製剤
US8357401B2 (en) * 2009-12-11 2013-01-22 Bind Biosciences, Inc. Stable formulations for lyophilizing therapeutic particles

Patent Citations (4)

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

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