CA3042689A1 - Adeno-associated virus formulations - Google Patents
Adeno-associated virus formulations Download PDFInfo
- Publication number
- CA3042689A1 CA3042689A1 CA3042689A CA3042689A CA3042689A1 CA 3042689 A1 CA3042689 A1 CA 3042689A1 CA 3042689 A CA3042689 A CA 3042689A CA 3042689 A CA3042689 A CA 3042689A CA 3042689 A1 CA3042689 A1 CA 3042689A1
- Authority
- CA
- Canada
- Prior art keywords
- pharmaceutical composition
- aav
- buffer
- months
- sodium chloride
- Prior art date
- Legal status (The legal status 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 status listed.)
- Pending
Links
Classifications
-
- 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
- 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
- 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 |
|---|---|
| CA3042689A1 true CA3042689A1 (en) | 2018-07-12 |
Family
ID=62044945
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA3042689A Pending CA3042689A1 (en) | 2016-11-04 | 2017-11-03 | Adeno-associated virus formulations |
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 |
| 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 |
|---|---|---|
| US12257277B2 (en) | Adeno-associated virus formulations | |
| US12553062B2 (en) | AAV compositions | |
| JP7150804B2 (ja) | プラミノーゲンを含む医薬組成物及びその使用 | |
| ES2962373T3 (es) | Uso de aminoácidos como compuestos estabilizadores en composiciones farmacéuticas que contienen altas concentraciones de agentes terapéuticos basados en proteínas | |
| JP2024059878A (ja) | 高濃度のタンパク質ベースの治療剤を含有する医薬組成物中の非晶質安定化化合物としてのアミノ酸と糖との最適比 | |
| BR112012008000B1 (pt) | Composição vacinal e processo de preparação da mesma | |
| CN102302463B (zh) | 注射用兰索拉唑冻干粉针剂及制备方法 | |
| CN103118663A (zh) | 卡泊芬净组合物 | |
| WO2017104778A1 (ja) | 抗ヒトｔｓｌｐ受容体抗体含有医薬組成物 | |
| US9801859B2 (en) | Bendamustine formulations | |
| ES2749474T3 (es) | Agente farmacéutico estable y liofilizado que contiene nocatiacina | |
| AU2014301324A1 (en) | Stable intravenous formulation | |
| HK40013519A (en) | Adeno-associated virus formulations | |
| HK40013519B (en) | Adeno-associated virus formulations | |
| IL324857A (en) | Adeno-associated virus formulations | |
| BR112019007858B1 (pt) | Composições farmacêuticas, métodos relacionados, kit, recipiente de dose única e uso | |
| BRPI9715268B1 (pt) | preparações farmacêuticas liofilizadas estáveis de anticorpos monoclonais ou policlonais, bem como processo para sua produção |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20220830 |
|
| MFA | Maintenance fee for application paid |
Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 7TH ANNIV.) - STANDARD Year of fee payment: 7 |
|
| U00 | Fee paid |
Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED Effective date: 20241104 |
|
| U11 | Full renewal or maintenance fee paid |
Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT DETERMINED COMPLIANT Effective date: 20241104 Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL Effective date: 20241104 |
|
| D15 | Examination report completed |
Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D15-D126 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXAMINER'S REPORT Effective date: 20250120 |
|
| P11 | Amendment of application requested |
Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT RECEIVED - RESPONSE TO EXAMINER'S REQUISITION Effective date: 20250512 |
|
| W00 | Other event occurred |
Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT Effective date: 20250513 |
|
| P11 | Amendment of application requested |
Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT DETERMINED COMPLIANT Effective date: 20250516 |
|
| P13 | Application amended |
Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P13-X000 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPLICATION AMENDED Effective date: 20250516 |
|
| MFA | Maintenance fee for application paid |
Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 8TH ANNIV.) - STANDARD Year of fee payment: 8 |
|
| U00 | Fee paid |
Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED Effective date: 20251022 |
|
| U11 | Full renewal or maintenance fee paid |
Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL Effective date: 20251022 |
|
| D15 | Examination report completed |
Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D15-D126 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXAMINER'S REPORT Effective date: 20260414 |