CN110430867B - 从水性混合物冷冻干燥的组合物及其制备方法 - Google Patents

从水性混合物冷冻干燥的组合物及其制备方法 Download PDF

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CN110430867B
CN110430867B CN201880021100.9A CN201880021100A CN110430867B CN 110430867 B CN110430867 B CN 110430867B CN 201880021100 A CN201880021100 A CN 201880021100A CN 110430867 B CN110430867 B CN 110430867B
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aqueous mixture
sorbitol
freeze
trehalose
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CN110430867A (zh
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E.布勒斯
O.德斯帕斯
D.纪尧姆
F.玛索
M.瓦塞勒
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GlaxoSmithKline Biologicals SA
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    • A—HUMAN NECESSITIES
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    • 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
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    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
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    • C12N15/86—Viral vectors
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
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    • C12N2710/10011—Adenoviridae
    • C12N2710/10111—Atadenovirus, e.g. ovine adenovirus D
    • C12N2710/10141—Use of virus, viral particle or viral elements as a vector
    • C12N2710/10143—Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector

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  • Inorganic Chemistry (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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CN201880021100.9A 2017-01-25 2018-01-25 从水性混合物冷冻干燥的组合物及其制备方法 Active CN110430867B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB1701239.4 2017-01-25
GBGB1701239.4A GB201701239D0 (en) 2017-01-25 2017-01-25 Novel formulation
PCT/IB2018/050453 WO2018138667A1 (en) 2017-01-25 2018-01-25 Novel formulation

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CN110430867A CN110430867A (zh) 2019-11-08
CN110430867B true CN110430867B (zh) 2023-04-07

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US (1) US11590243B2 (cg-RX-API-DMAC7.html)
EP (1) EP3573598A1 (cg-RX-API-DMAC7.html)
JP (1) JP7090089B2 (cg-RX-API-DMAC7.html)
CN (1) CN110430867B (cg-RX-API-DMAC7.html)
BE (1) BE1025187B1 (cg-RX-API-DMAC7.html)
BR (1) BR112019015245A2 (cg-RX-API-DMAC7.html)
CA (1) CA3050629A1 (cg-RX-API-DMAC7.html)
GB (1) GB201701239D0 (cg-RX-API-DMAC7.html)
MX (1) MX2019008798A (cg-RX-API-DMAC7.html)
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GB201513010D0 (en) * 2015-07-23 2015-09-09 Glaxosmithkline Biolog Sa Novel formulation
EP3587581A1 (en) * 2018-06-26 2020-01-01 GlaxoSmithKline Biologicals S.A. Formulations for simian adenoviral vectors having enhanced storage stability
BR112021025025A2 (pt) * 2019-06-11 2022-02-22 Glaxosmithkline Biologicals Sa Formulações de vacinas de mucosa
IL302332A (en) * 2020-10-29 2023-06-01 Flagship Pioneering Innovations V Inc Chicken anemia virus (cav)-based vectors
CN116829134A (zh) * 2020-11-16 2023-09-29 生物技术欧洲股份公司 包含rna的lnp组合物及其制备、储存和使用方法
US20230414516A1 (en) * 2020-11-16 2023-12-28 BioNTech SE Enhanced formulation stabilization and improved lyophilization processes
CN114903922B (zh) * 2021-02-09 2024-04-26 武汉博沃生物科技有限公司 包含腺病毒的医药配制品及其保存方法

Citations (8)

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US6258362B1 (en) * 1998-04-24 2001-07-10 Cantab Pharmaceuticals Research Ltd Stabilization of herpes virus preparations
JP2005523233A (ja) * 2001-06-22 2005-08-04 ザ・ウイスター・インステイテユート・オブ・アナトミー・アンド・バイオロジー 細胞障害性免疫応答を誘導する方法およびその方法において有用な組み換えサル・アデノウイルス組成物
CN101312742A (zh) * 2005-09-16 2008-11-26 梅瑞尔有限公司 用于冷冻干燥的疫苗的稳定剂
WO2010086189A2 (en) * 2009-02-02 2010-08-05 Okairòs Ag, Switzerland Simian adenovirus nucleic acid- and amino acid-sequences, vectors containing same, and uses thereof
CN102028954A (zh) * 2009-09-29 2011-04-27 成都康弘生物科技有限公司 一种重组腺病毒的制剂
CN102631672A (zh) * 2012-04-27 2012-08-15 天津百若克医药生物技术有限责任公司 一种冻干灭活乙型脑炎疫苗
CN105112428A (zh) * 2009-02-02 2015-12-02 葛兰素史密斯克莱生物公司 猿腺病毒核酸和氨基酸序列，包含其的载体及其用途
CN105636610A (zh) * 2013-09-27 2016-06-01 英特维特国际股份有限公司 室温稳定的疫苗的干燥制剂

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US7456009B2 (en) 2000-03-07 2008-11-25 Merck & Co., Inc. Adenovirus formulations
CA2993042A1 (en) 2004-01-23 2005-08-04 Msd Italia S.R.L. Chimpanzee adenovirus vaccine carriers
HRP20161606T1 (hr) 2007-03-02 2017-01-13 Glaxosmithkline Biologicals Sa Novi postupak i pripravci
TR201902214T4 (tr) 2010-04-16 2019-03-21 Glaxosmithkline Biologicals Sa Şempanze adenoviral vektörü-bazlı filovirüs aşıları.
WO2012089231A1 (en) 2010-12-30 2012-07-05 Okairòs Ag Paramyxovirus vaccines
IN2014DN03061A (cg-RX-API-DMAC7.html) 2011-10-05 2015-05-15 Genvec Inc
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US6258362B1 (en) * 1998-04-24 2001-07-10 Cantab Pharmaceuticals Research Ltd Stabilization of herpes virus preparations
JP2005523233A (ja) * 2001-06-22 2005-08-04 ザ・ウイスター・インステイテユート・オブ・アナトミー・アンド・バイオロジー 細胞障害性免疫応答を誘導する方法およびその方法において有用な組み換えサル・アデノウイルス組成物
CN101312742A (zh) * 2005-09-16 2008-11-26 梅瑞尔有限公司 用于冷冻干燥的疫苗的稳定剂
WO2010086189A2 (en) * 2009-02-02 2010-08-05 Okairòs Ag, Switzerland Simian adenovirus nucleic acid- and amino acid-sequences, vectors containing same, and uses thereof
CN105112428A (zh) * 2009-02-02 2015-12-02 葛兰素史密斯克莱生物公司 猿腺病毒核酸和氨基酸序列，包含其的载体及其用途
CN102028954A (zh) * 2009-09-29 2011-04-27 成都康弘生物科技有限公司 一种重组腺病毒的制剂
CN102631672A (zh) * 2012-04-27 2012-08-15 天津百若克医药生物技术有限责任公司 一种冻干灭活乙型脑炎疫苗
CN105636610A (zh) * 2013-09-27 2016-06-01 英特维特国际股份有限公司 室温稳定的疫苗的干燥制剂

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Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine T-g" in pharmaceutical lyophilization;James A.Searles等;《Journal of Pharmaceutical Sciences》;20010731;第90卷(第7期);摘要 *
Factors that influence stability of recombinant adenoviral preparations for human gene therapy;Maria A. Croyle等;《Pharmaceutical Development and Technology》;19980831;第3卷(第3期);第373-383页 *
冻干重组人三突变型低氧诱导因子-1α腺病毒的制备;陶宇等;《实用医学杂志》;20110210;第27卷(第03期);第369-371页 *

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MX2019008798A (es) 2019-09-11
BR112019015245A2 (pt) 2020-04-14
CA3050629A1 (en) 2018-08-02
BE1025187A1 (fr) 2018-11-27
JP7090089B2 (ja) 2022-06-23
BE1025187B1 (fr) 2018-12-03
US11590243B2 (en) 2023-02-28
CN110430867A (zh) 2019-11-08
JP2020506691A (ja) 2020-03-05
US20190365930A1 (en) 2019-12-05
EP3573598A1 (en) 2019-12-04
WO2018138667A1 (en) 2018-08-02
GB201701239D0 (en) 2017-03-08

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