BR112019009113A2 - formulações de vírus adenoassociado - Google Patents
formulações de vírus adenoassociadoInfo
- Publication number
- BR112019009113A2 BR112019009113A2 BR112019009113-0A BR112019009113A BR112019009113A2 BR 112019009113 A2 BR112019009113 A2 BR 112019009113A2 BR 112019009113 A BR112019009113 A BR 112019009113A BR 112019009113 A2 BR112019009113 A2 BR 112019009113A2
- Authority
- BR
- Brazil
- Prior art keywords
- adeno
- aav
- methods
- pharmaceutical compositions
- associated virus
- Prior art date
Links
Classifications
-
- 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
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)
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 (1)
| Publication Number | Publication Date |
|---|---|
| BR112019009113A2 true BR112019009113A2 (pt) | 2019-07-16 |
Family
ID=62044945
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112019009113-0A BR112019009113A2 (pt) | 2016-11-04 | 2017-11-03 | formulações de vírus adenoassociado |
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)
| 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)
| 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 |
-
2017
- 2017-11-03 BR BR112019009113-0A patent/BR112019009113A2/pt unknown
- 2017-11-03 EP EP24160547.6A patent/EP4360652A3/en active Pending
- 2017-11-03 US US16/347,107 patent/US11583563B2/en active Active
- 2017-11-03 IL IL266264A patent/IL266264B2/en unknown
- 2017-11-03 EP EP17866366.2A patent/EP3534922B1/en active Active
- 2017-11-03 PT PT178663662T patent/PT3534922T/pt unknown
- 2017-11-03 KR KR1020197015861A patent/KR102574849B1/ko active Active
- 2017-11-03 WO PCT/US2017/059971 patent/WO2018128689A1/en not_active Ceased
- 2017-11-03 PL PL17866366.2T patent/PL3534922T3/pl unknown
- 2017-11-03 RU RU2019116442A patent/RU2769196C2/ru active
- 2017-11-03 JP JP2019522442A patent/JP7545210B2/ja active Active
- 2017-11-03 CN CN201780082175.3A patent/CN110300591A/zh active Pending
- 2017-11-03 ES ES17866366T patent/ES2981519T3/es active Active
- 2017-11-03 CA CA3042689A patent/CA3042689A1/en active Pending
- 2017-11-03 AU AU2017391165A patent/AU2017391165B2/en active Active
- 2017-11-03 MX MX2019005088A patent/MX2019005088A/es unknown
-
2022
- 2022-07-15 JP JP2022113804A patent/JP2022137241A/ja active Pending
-
2023
- 2023-01-13 US US18/096,853 patent/US12257277B2/en active Active
-
2024
- 2024-04-26 JP JP2024072113A patent/JP2024097059A/ja not_active Abandoned
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 |
| 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 |
| 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 |
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