CN104271119B - 用于稳定干燥的生物材料的方法和组合物 - Google Patents

用于稳定干燥的生物材料的方法和组合物 Download PDF

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Publication number
CN104271119B
CN104271119B CN201380023800.9A CN201380023800A CN104271119B CN 104271119 B CN104271119 B CN 104271119B CN 201380023800 A CN201380023800 A CN 201380023800A CN 104271119 B CN104271119 B CN 104271119B
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China
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solution
drying
activity
dried
biopharmaceutical
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Expired - Fee Related
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CN201380023800.9A
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English (en)
Chinese (zh)
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CN104271119A (zh
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H·克兰
简-皮埃尔·阿莫瑞杰
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STAAT DER NEDERLANDEN VERT DOO
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STAAT DER NEDERLANDEN VERT DOO
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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)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • 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)
CN201380023800.9A 2012-03-05 2013-03-05 用于稳定干燥的生物材料的方法和组合物 Expired - Fee Related CN104271119B (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201261606577P 2012-03-05 2012-03-05
EP12158086.4 2012-03-05
EP12158086 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)

Publication Number Publication Date
CN104271119A CN104271119A (zh) 2015-01-07
CN104271119B true CN104271119B (zh) 2018-07-10

Family

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Family Applications (1)

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CN201380023800.9A Expired - Fee Related CN104271119B (zh) 2012-03-05 2013-03-05 用于稳定干燥的生物材料的方法和组合物

Country Status (11)

Country Link
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
WO2015097650A1 (en) 2013-12-23 2015-07-02 Theravectys Lyophilized lentiviral vector particles, compositions and methods
CN109219448B (zh) * 2016-06-16 2022-09-20 扬森疫苗与预防公司 Hiv疫苗配制品
EP3586905B1 (en) * 2017-02-24 2023-07-26 Hisamitsu Pharmaceutical Co., Inc. Method for producing microneedle device
EP3615006A4 (en) * 2017-04-28 2020-12-30 Universal Stabilization Technologies, Inc. THERMOSTABLE ANTIGENIC POLIOMYELITIC VACCINES AND RELATED PROCESSES
WO2019014338A1 (en) * 2017-07-11 2019-01-17 Universal Stabilization Technologies, Inc. METHOD FOR PRESERVING BIOPHARMACEUTICAL PRODUCTS
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 (2)

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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

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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
ES2294801T3 (es) * 1996-09-26 2008-04-01 MERCK & CO., INC. Formulaciones de vacunas contra rotavirus.
US20020041884A1 (en) * 2000-03-07 2002-04-11 Evans Robert K. Adenovirus formulations
WO2001093829A2 (en) * 2000-06-08 2001-12-13 Powderject Vaccines, Inc. Powder compositions
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
DK1701738T3 (en) * 2003-12-17 2015-03-30 Wyeth Llc Process for preparing storage-stable RSV compositions
EP1699919B1 (en) 2003-12-24 2017-01-11 De Staat der Nederlanden, Vertegenwoordigd Door de Minister Van Volksgezondheid, Welzijn en Sport A respiratory syncytial virus with a genomic deficiency complemented in 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
WO2006138181A2 (en) * 2005-06-14 2006-12-28 Amgen Inc. Self-buffering protein formulations
TR201906255T4 (tr) * 2009-12-11 2019-05-21 Pfizer Terapötik partiküllerin liyofilize edilmesine yönelik stabil formülasyonlar.

Patent Citations (2)

* Cited by examiner, † Cited by third party
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

Non-Patent Citations (1)

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heat stability of the lyophilized sabin poliovaccine;Hiroshi Shiomi,etal;《Jpn.J.Infect.Dis.》;20031231;70-72 *

Also Published As

Publication number Publication date
US20180055924A1 (en) 2018-03-01
US10335479B2 (en) 2019-07-02
KR20150008848A (ko) 2015-01-23
EP2822540B1 (en) 2020-04-08
CA2865551A1 (en) 2013-09-12
AU2013228096B2 (en) 2017-07-13
KR102108876B1 (ko) 2020-05-12
EP2822540A1 (en) 2015-01-14
JP2015509529A (ja) 2015-03-30
WO2013133702A1 (en) 2013-09-12
BR112014020930A2 (pt) 2017-06-27
ZA201407198B (en) 2016-02-24
CN104271119A (zh) 2015-01-07
IN2014MN01714A (enExample) 2015-05-29
JP6253161B2 (ja) 2017-12-27
AU2013228096A1 (en) 2014-09-11
US9827303B2 (en) 2017-11-28
US20150030629A1 (en) 2015-01-29
CA2865551C (en) 2021-01-12

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Granted publication date: 20180710