PL3534922T3 - Preparaty wirusa związanego z adenowirusem - Google Patents

Preparaty wirusa związanego z adenowirusem

Info

Publication number
PL3534922T3
PL3534922T3 PL17866366.2T PL17866366T PL3534922T3 PL 3534922 T3 PL3534922 T3 PL 3534922T3 PL 17866366 T PL17866366 T PL 17866366T PL 3534922 T3 PL3534922 T3 PL 3534922T3
Authority
PL
Poland
Prior art keywords
adeno
associated virus
virus formulations
formulations
virus
Prior art date
Application number
PL17866366.2T
Other languages
English (en)
Polish (pl)
Inventor
Christian Fiedler
Eva FRITSCHER
Meinhard Hasslacher
Dominik MITTERGRADNEGGER
Tanvir TABISH
Original Assignee
Takeda Pharmaceutical Company Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Takeda Pharmaceutical Company Limited filed Critical Takeda Pharmaceutical Company Limited
Publication of PL3534922T3 publication Critical patent/PL3534922T3/pl

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66Microorganisms or materials therefrom
    • A61K35/76Viruses; Subviral particles; Bacteriophages
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C12N15/86Viral vectors

Landscapes

  • 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)
PL17866366.2T 2016-11-04 2017-11-03 Preparaty wirusa związanego z adenowirusem PL3534922T3 (pl)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
PL3534922T3 true PL3534922T3 (pl) 2024-08-19

Family

ID=62044945

Family Applications (1)

Application Number Title Priority Date Filing Date
PL17866366.2T PL3534922T3 (pl) 2016-11-04 2017-11-03 Preparaty wirusa związanego z adenowirusem

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=)

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8801338D0 (en) 1988-01-21 1988-02-17 Quadrant Bioresources Ltd Preservation of viruses
JPH053266A (ja) 1991-06-25 1993-01-08 Mitsubishi Electric Corp 半導体装置
JP2782982B2 (ja) 1991-06-26 1998-08-06 富士ゼロックス株式会社 プリンタ装置
EP0728195A1 (en) * 1993-10-12 1996-08-28 Chiron Corporation Methods for preserving recombinant viruses
CA2718347A1 (en) * 1996-09-05 1998-03-12 The Regents Of The University Of California Gene therapy for congestive heart failure
PT1061955E (pt) 1998-03-13 2005-08-31 Wyeth Corp Composicao de polinucleotido, metodo de preparacao e sua utilizacao
DK1133316T3 (da) * 1998-11-16 2009-05-25 Introgen Therapeutics Inc Adenovirus-formulering til genterapi
US6759050B1 (en) * 1998-12-03 2004-07-06 Avigen, Inc. Excipients for use in adeno-associated virus pharmaceutical formulations, and pharmaceutical formulations made therewith
JP5118798B2 (ja) * 2000-03-07 2013-01-16 メルク・シャープ・エンド・ドーム・コーポレイション アデノウイルス製剤
CA2469623C (en) * 2001-12-12 2012-05-29 F H Faulding & Co Limited Composition for the preservation of viruses
US20030153065A1 (en) * 2002-01-14 2003-08-14 Genvec, Inc. Composition and method for maintaining non-enveloped viral vectors
BRPI0511764B8 (pt) 2004-06-01 2021-05-25 Avigen Inc método de prevenção de agregação de vírions de vírus adeno-associado recombinante (raav) em uma preparação purificada de virions raav
EP2187898B8 (en) 2007-09-12 2016-09-14 INSERM (Institut National de la Santé et de la Recherche Médicale) Use of viral vectors carrying the cyp46a1 gene for the treatment of alzheimer's disease
CA2722238C (en) * 2008-04-22 2017-11-28 Life Sciences Research Partners Vzw Liver-specific nucleic acid regulatory elements and methods and use thereof
PL4218797T3 (pl) 2009-09-21 2025-02-10 Takeda Pharmaceutical Company Limited Stabilizowane płynne i liofilizowane preparaty adamts13
IT1405793B1 (it) * 2010-10-15 2014-01-24 Univ Ferrara Molecola di u1snrna umano modificato, gene codificante per la molecola di u1snrna umano modificato, vettore di espressione includente il gene, e loro uso in terapia genica
MX349294B (es) * 2010-12-02 2017-07-21 Oncolytics Biotech Inc Formulaciones virales liofilizadas.
WO2013036961A1 (en) 2011-09-09 2013-03-14 Api Genesis Llc A pain relief composition, comprising a trpv1 selective agonist, and manufacture and uses thereof
US10093947B2 (en) 2012-02-28 2018-10-09 Cornell University AAV-directed persistent expression of an anti-nicotine antibody gene for smoking cessation
US9254332B2 (en) 2013-03-15 2016-02-09 Arecor Limited Stable aqueous formulations of adenovirus vectors
WO2015040234A1 (en) 2013-09-23 2015-03-26 Crucell Holland B.V. Adenovirus formulations
GB201403684D0 (en) 2014-03-03 2014-04-16 King S College London Vector
WO2016004319A1 (en) 2014-07-02 2016-01-07 University Of Florida Research Foundation, Inc. Compositions and methods for purifying recombinant adeno-associated virus
CN104450747B (zh) * 2014-09-23 2018-02-09 武汉纽福斯生物科技有限公司 用于治疗Leber遗传性视神经病变的重组腺相关病毒‑NADH脱氢酶亚单位4基因全长以及药剂
WO2016154055A1 (en) * 2015-03-20 2016-09-29 Bluebird Bio, Inc. Vector formulations
EA202190827A1 (ru) 2015-11-13 2021-11-30 Баксалта Инкорпорейтед Вирусные векторы, кодирующие рекомбинантные варианты fviii с повышенной экспрессией для генной терапии гемофилии a
BR112019009113A2 (pt) 2016-11-04 2019-07-16 Baxalta Incorporated formulações de vírus adenoassociado

Also Published As

Publication number Publication date
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
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
KR102574849B1 (ko) 2023-09-06
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

Similar Documents

Publication Publication Date Title
IL266264A (en) Adeno-associated virus formulations
IL279154B (en) Adenovirus-related vector
IL273541A (en) formulations
IL273282A (en) Niraprib formulations
IL269630A (en) Niraprib formulations
IL266162A (en) Adeno-associated virus purification methods
IL269621A (en) Niraparib formulations
IL257551B (en) Clinical formulations
GB201401707D0 (en) Adeno-associated viral vectors
SG10201607915YA (en) Cleaning formulations
IL265609A (en) New formulations
SG11201707787SA (en) Cleaning formulations
GB201607918D0 (en) Novel formulations
PL3316856T3 (pl) Zmieszane formulacje
TR201503831A2 (tr) Antimipertansif kombinasyon formülasyonları
GB201805338D0 (en) Cosmetic formulations
GB201504482D0 (en) Novel formulations
IL268195A (en) Solid fosmetpantothenate formulations
GB201621277D0 (en) Formulations
GB201618110D0 (en) Formulations
GB201616366D0 (en) Formulations
GB201615754D0 (en) Formulations
GB201714461D0 (en) Formulations
GB201617866D0 (en) Novel formulations
GB201616509D0 (en) Novel formulations