KR102574849B1 - 아데노-연관 바이러스 제형 - Google Patents

아데노-연관 바이러스 제형 Download PDF

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Publication number
KR102574849B1
KR102574849B1 KR1020197015861A KR20197015861A KR102574849B1 KR 102574849 B1 KR102574849 B1 KR 102574849B1 KR 1020197015861 A KR1020197015861 A KR 1020197015861A KR 20197015861 A KR20197015861 A KR 20197015861A KR 102574849 B1 KR102574849 B1 KR 102574849B1
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pharmaceutical composition
aav
sodium chloride
certain embodiments
buffer
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KR20190080922A (ko
Inventor
크리스티앙 피들러
에바 프릿처
마인하르트 하슬라허
도미닉 미터그라드네거
탄버 타비쉬
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다케다 야쿠힌 고교 가부시키가이샤
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    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/76—Viruses; Subviral particles; Bacteriophages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • 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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • 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
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C12N15/86—Viral vectors

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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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Virology (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Plant Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
KR1020197015861A 2016-11-04 2017-11-03 아데노-연관 바이러스 제형 Active KR102574849B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662417750P 2016-11-04 2016-11-04
US62/417,750 2016-11-04
PCT/US2017/059971 WO2018128689A1 (en) 2016-11-04 2017-11-03 Adeno-associated virus formulations

Publications (2)

Publication Number Publication Date
KR20190080922A KR20190080922A (ko) 2019-07-08
KR102574849B1 true KR102574849B1 (ko) 2023-09-06

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KR1020197015861A Active KR102574849B1 (ko) 2016-11-04 2017-11-03 아데노-연관 바이러스 제형

Country Status (15)

Country Link
US (2) US11583563B2 (https=)
EP (2) EP4360652A3 (https=)
JP (3) JP7545210B2 (https=)
KR (1) KR102574849B1 (https=)
CN (1) CN110300591A (https=)
AU (1) AU2017391165B2 (https=)
BR (1) BR112019009113A2 (https=)
CA (1) CA3042689A1 (https=)
ES (1) ES2981519T3 (https=)
IL (1) IL266264B2 (https=)
MX (1) MX2019005088A (https=)
PL (1) PL3534922T3 (https=)
PT (1) PT3534922T (https=)
RU (1) RU2769196C2 (https=)
WO (1) WO2018128689A1 (https=)

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IL305149A (en) 2016-07-26 2023-10-01 Biomarin Pharm Inc Novel adeno-associated virus capsid proteins
BR112019009113A2 (pt) 2016-11-04 2019-07-16 Baxalta Incorporated formulações de vírus adenoassociado
JP2021505610A (ja) * 2017-12-05 2021-02-18 アプライド ジェネティック テクノロジーズ コーポレイション ウイルス粒子のための製剤最適化
TW202016314A (zh) 2018-05-09 2020-05-01 美商拜奧馬林製藥公司 治療苯丙酮尿症之方法
TW202005978A (zh) 2018-05-14 2020-02-01 美商拜奧馬林製藥公司 新穎肝靶向腺相關病毒載體
KR20210032984A (ko) * 2018-07-11 2021-03-25 박스알타 인코퍼레이티드 Aav 조성물
CN112770812A (zh) * 2018-07-24 2021-05-07 沃雅戈治疗公司 产生基因治疗制剂的系统和方法
SG11202107645RA (en) * 2019-01-18 2021-08-30 Voyager Therapeutics Inc Methods and systems for producing aav particles
TW202332458A (zh) * 2019-04-19 2023-08-16 美商銳進科斯生物股份有限公司 腺相關病毒載體調配物及方法
WO2021071835A1 (en) * 2019-10-07 2021-04-15 Regenxbio Inc. Adeno-associated virus vector pharmaceutical composition and methods
TW202144575A (zh) * 2020-04-03 2021-12-01 美商拜奧馬林製藥公司 使用ａａｖ及治療調配物之苯酮尿症治療
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
US20240307553A1 (en) * 2021-04-01 2024-09-19 Pfizer Inc. Pharmaceutical compositions containing adeno-associated viral vector
CN117836010A (zh) * 2021-06-21 2024-04-05 优尼科生物制药有限公司 改进的裂解程序
CR20240004A (es) * 2021-07-08 2024-06-11 Biocad Joint Stock Co Composición farmacéutica de virus no encapsulado
CN117980471A (zh) 2021-08-04 2024-05-03 武田药品工业株式会社 阳离子交换剂上的腺相关病毒分离
US20230090654A1 (en) * 2021-08-24 2023-03-23 Homology Medicines, Inc. Adeno-associated virus formulations
CN114949198B (zh) * 2022-06-02 2026-03-31 金宇保灵生物药品有限公司 一种禽类动物疫苗用油包水佐剂及其制备方法和应用
WO2023236964A1 (zh) * 2022-06-07 2023-12-14 成都弘基生物科技有限公司 腺相关病毒药物组合物及其用途
CN115337408A (zh) * 2022-09-16 2022-11-15 上海信致医药科技有限公司 腺相关病毒制剂
JP2025533988A (ja) * 2022-10-11 2025-10-09 メイラグティーエックス ユーケー アイアイ リミティド Ａａｖ遺伝子療法用の製剤
TW202426017A (zh) * 2022-11-24 2024-07-01 俄羅斯聯邦商拜奧卡德聯合股份公司 非包膜病毒的藥物組合物
WO2024138129A2 (en) * 2022-12-23 2024-06-27 Spark Therapeutics, Inc. Adeno-associated virus formulations
CN120000811A (zh) * 2023-11-15 2025-05-16 成都弘基生物科技有限公司 一种重组腺相关病毒药物组合物及其用途
WO2025114524A1 (en) * 2023-11-30 2025-06-05 Uniqure Biopharma B.V. Formulations for viral drug products

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US20040166122A1 (en) * 2000-03-07 2004-08-26 Evans Robert K. Adenovirus formulations
WO2009034127A1 (en) 2007-09-12 2009-03-19 INSERM (Institut National de la Santé et de la Recherche Médicale) Use of the cyp46a1 gene for the treatment of alzheimer's disease
US20120141528A1 (en) 2010-12-02 2012-06-07 Oncolytics Biotech Inc. Lyophilized viral formulations
WO2016154055A1 (en) * 2015-03-20 2016-09-29 Bluebird Bio, Inc. Vector formulations

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CN110300591A (zh) 2019-10-01
RU2769196C2 (ru) 2022-03-29
JP2019537578A (ja) 2019-12-26
RU2019116442A (ru) 2020-12-04
EP4360652A3 (en) 2024-06-26
US11583563B2 (en) 2023-02-21
PL3534922T3 (pl) 2024-08-19
WO2018128689A1 (en) 2018-07-12
KR20190080922A (ko) 2019-07-08
PT3534922T (pt) 2024-06-07
JP2024097059A (ja) 2024-07-17
US12257277B2 (en) 2025-03-25
AU2017391165A1 (en) 2019-05-23
EP3534922B1 (en) 2024-04-17
EP4360652A2 (en) 2024-05-01
RU2019116442A3 (https=) 2021-06-21
MX2019005088A (es) 2019-08-12
US20190255126A1 (en) 2019-08-22
IL266264A (en) 2019-06-30
JP2022137241A (ja) 2022-09-21
CA3042689A1 (en) 2018-07-12
ES2981519T3 (es) 2024-10-09
EP3534922A1 (en) 2019-09-11
JP7545210B2 (ja) 2024-09-04
IL266264B1 (en) 2023-07-01
US20230241139A1 (en) 2023-08-03
IL266264B2 (en) 2023-11-01
AU2017391165B2 (en) 2023-02-02
BR112019009113A2 (pt) 2019-07-16

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