JP6853245B2 - 安定なタンパク質組成物 - Google Patents

安定なタンパク質組成物 Download PDF

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Publication number
JP6853245B2
JP6853245B2 JP2018519460A JP2018519460A JP6853245B2 JP 6853245 B2 JP6853245 B2 JP 6853245B2 JP 2018519460 A JP2018519460 A JP 2018519460A JP 2018519460 A JP2018519460 A JP 2018519460A JP 6853245 B2 JP6853245 B2 JP 6853245B2
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JP
Japan
Prior art keywords
protein
biphasic
peg
aflibercept
liquid phase
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.)
Active
Application number
JP2018519460A
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English (en)
Japanese (ja)
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JP2018538243A (ja
JP2018538243A5 (enExample
Inventor
ハンター チェン
ハンター チェン
エリカ シュレジンジャー
エリカ シュレジンジャー
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals Inc
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.)
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Publication date
Application filed by Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Publication of JP2018538243A publication Critical patent/JP2018538243A/ja
Publication of JP2018538243A5 publication Critical patent/JP2018538243A5/ja
Priority to JP2021038817A priority Critical patent/JP7179112B2/ja
Application granted granted Critical
Publication of JP6853245B2 publication Critical patent/JP6853245B2/ja
Priority to JP2022182235A priority patent/JP7547438B2/ja
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Anticipated expiration legal-status Critical

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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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts, ocular implants
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L71/00—Compositions of polyethers obtained by reactions forming an ether link in the main chain; Compositions of derivatives of such polymers
    • C08L71/08—Polyethers derived from hydroxy compounds or from their metallic derivatives
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2203/00—Applications
    • C08L2203/02—Applications for biomedical use

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Polymers & Plastics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Peptides Or Proteins (AREA)
JP2018519460A 2015-10-16 2016-10-14 安定なタンパク質組成物 Active JP6853245B2 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2021038817A JP7179112B2 (ja) 2015-10-16 2021-03-11 安定なタンパク質組成物
JP2022182235A JP7547438B2 (ja) 2015-10-16 2022-11-15 安定なタンパク質組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562242412P 2015-10-16 2015-10-16
US62/242,412 2015-10-16
PCT/US2016/057019 WO2017066554A1 (en) 2015-10-16 2016-10-14 Stable protein compositions

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2021038817A Division JP7179112B2 (ja) 2015-10-16 2021-03-11 安定なタンパク質組成物

Publications (3)

Publication Number Publication Date
JP2018538243A JP2018538243A (ja) 2018-12-27
JP2018538243A5 JP2018538243A5 (enExample) 2019-07-25
JP6853245B2 true JP6853245B2 (ja) 2021-03-31

Family

ID=57209897

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2018519460A Active JP6853245B2 (ja) 2015-10-16 2016-10-14 安定なタンパク質組成物
JP2021038817A Active JP7179112B2 (ja) 2015-10-16 2021-03-11 安定なタンパク質組成物
JP2022182235A Active JP7547438B2 (ja) 2015-10-16 2022-11-15 安定なタンパク質組成物

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2021038817A Active JP7179112B2 (ja) 2015-10-16 2021-03-11 安定なタンパク質組成物
JP2022182235A Active JP7547438B2 (ja) 2015-10-16 2022-11-15 安定なタンパク質組成物

Country Status (13)

Country Link
US (1) US20180289623A1 (enExample)
EP (1) EP3362041A1 (enExample)
JP (3) JP6853245B2 (enExample)
KR (1) KR102731879B1 (enExample)
CN (2) CN113827704B (enExample)
AU (2) AU2016340072B2 (enExample)
CA (1) CA3001346A1 (enExample)
EA (1) EA036623B1 (enExample)
IL (2) IL258570B2 (enExample)
MX (2) MX390837B (enExample)
MY (2) MY199546A (enExample)
WO (1) WO2017066554A1 (enExample)
ZA (1) ZA201802460B (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2909777T3 (es) 2011-11-18 2022-05-10 Regeneron Pharma Formulación de liberación prolongada que comprende micropartículas para su uso en el humor vítreo del ojo para tratar trastornos oculares vasculares
IL258570B2 (en) * 2015-10-16 2024-07-01 Regeneron Pharma Stable protein preparations
US12156900B2 (en) 2017-11-17 2024-12-03 Amgen Inc. VEGFR-Fc fusion protein formulations
PT4364724T (pt) 2018-05-10 2025-12-16 Regeneron Pharma Formulações contendo uma proteína de fusão do recetor do vegf de concentração elevada
US20220054586A1 (en) * 2018-09-10 2022-02-24 Samsung Bioepis Co., Ltd. Liquid composition comprising protein
CN112294760B (zh) * 2019-07-26 2025-12-12 宁波新致生物科技有限公司 一种液体制剂及其应用
WO2025235973A1 (en) * 2024-05-09 2025-11-13 Deep Brain Bci Corporation Implantable medical devices for delivering therapeutics and brain-computer interface systems

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3756512B2 (ja) * 1992-09-21 2006-03-15 ファルマシア・アンド・アップジョン・カンパニー・エルエルシー 徐放性タンパク質製剤
US6004549A (en) * 1994-12-14 1999-12-21 Schering Corporation Crystalline protein controlled release compositions
RU2357750C2 (ru) * 2002-12-31 2009-06-10 Элтус Фармасьютикалз Инк. Кристаллы человеческого гормона роста и способы их получения
CA2530113C (en) * 2003-06-26 2013-08-13 Control Delivery Systems, Inc. Bioerodible sustained release drug delivery systems
CA2588449A1 (en) * 2004-11-24 2006-06-01 Therakine Corporation An implant for intraocular drug delivery
CN104434770A (zh) 2006-06-16 2015-03-25 瑞泽恩制药公司 适合玻璃体内施用的vegf拮抗剂的制剂
WO2008109886A1 (en) 2007-03-08 2008-09-12 The Regents Of The University Of California Topographically engineered structures and methods for using the same in regenerative medicine applications
EP3000434A1 (en) 2007-03-16 2016-03-30 The Regents Of The University Of California Nanostructure surface coated medical implants and methods of using the same
SG173167A1 (en) * 2009-01-29 2011-08-29 Forsight Labs Llc Posterior segment drug delivery
US8623395B2 (en) * 2010-01-29 2014-01-07 Forsight Vision4, Inc. Implantable therapeutic device
CN101559041B (zh) * 2009-05-19 2014-01-15 中国科学院过程工程研究所 粒径均一的多肽药物缓释微球或微囊制剂及制备方法
US8417452B2 (en) 2009-08-19 2013-04-09 General Motors Llc System for providing information to an operator of a vehicle
EP2600812B1 (en) * 2010-08-05 2021-09-22 ForSight Vision4, Inc. Apparatus to treat an eye
HUE054113T2 (hu) 2010-08-05 2021-08-30 Forsight Vision4 Inc Injekciós készülék gyógyszerbejuttatáshoz
WO2012142318A1 (en) 2011-04-14 2012-10-18 The Regents Of The University Of California Multilayer thin film drug delivery device and methods of making and using the same
BR112014029760A2 (pt) 2012-05-30 2017-06-27 Univ California dispositivos de distribuição de agente bioativo e métodos para fazer e usar os mesmos
US9463177B2 (en) 2012-09-10 2016-10-11 The Regents Of The University Of California Compounds and methods for modulating vascular injury
EP3929218A1 (en) * 2014-07-14 2021-12-29 Amgen, Inc Crystalline antibody formulations
KR101808234B1 (ko) 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
IL258570B2 (en) 2015-10-16 2024-07-01 Regeneron Pharma Stable protein preparations

Also Published As

Publication number Publication date
MX2018004695A (es) 2019-03-14
BR112018007507A2 (pt) 2018-10-23
JP2018538243A (ja) 2018-12-27
JP7179112B2 (ja) 2022-11-28
CA3001346A1 (en) 2017-04-20
AU2016340072B2 (en) 2021-10-28
MX2022003376A (es) 2022-04-12
KR102731879B1 (ko) 2024-11-20
JP7547438B2 (ja) 2024-09-09
IL258570B1 (en) 2024-03-01
AU2022200475B2 (en) 2023-09-14
JP2021098742A (ja) 2021-07-01
WO2017066554A1 (en) 2017-04-20
EA201890979A1 (ru) 2018-10-31
CN113827704A (zh) 2021-12-24
ZA201802460B (en) 2024-09-25
MY193964A (en) 2022-11-03
US20180289623A1 (en) 2018-10-11
IL258570A (en) 2018-05-31
IL310557A (en) 2024-03-01
EA036623B1 (ru) 2020-12-01
IL258570B2 (en) 2024-07-01
KR20180063311A (ko) 2018-06-11
JP2023025046A (ja) 2023-02-21
AU2016340072A1 (en) 2018-05-10
CN108348462B (zh) 2021-10-15
MX390837B (es) 2025-03-21
CN113827704B (zh) 2024-07-12
EP3362041A1 (en) 2018-08-22
MY199546A (en) 2023-11-06
AU2022200475A1 (en) 2022-02-17
CN108348462A (zh) 2018-07-31

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