AU2016340072B2 - Stable protein compositions - Google Patents

Stable protein compositions Download PDF

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Publication number
AU2016340072B2
AU2016340072B2 AU2016340072A AU2016340072A AU2016340072B2 AU 2016340072 B2 AU2016340072 B2 AU 2016340072B2 AU 2016340072 A AU2016340072 A AU 2016340072A AU 2016340072 A AU2016340072 A AU 2016340072A AU 2016340072 B2 AU2016340072 B2 AU 2016340072B2
Authority
AU
Australia
Prior art keywords
protein
peg
biphasic
liquid phase
concentration
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
AU2016340072A
Other languages
English (en)
Other versions
AU2016340072A1 (en
Inventor
Hunter Chen
Erica SCHLESINGER
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
Original Assignee
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.)
Filing date
Publication date
Application filed by Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Publication of AU2016340072A1 publication Critical patent/AU2016340072A1/en
Application granted granted Critical
Publication of AU2016340072B2 publication Critical patent/AU2016340072B2/en
Priority to AU2022200475A priority Critical patent/AU2022200475B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K9/0048Eye, e.g. artificial tears
    • A61K9/0051Ocular inserts, ocular implants
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular 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
    • 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
    • A61K9/141Intimate 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
    • A61K9/146Intimate 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
    • 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
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L71/00Compositions of polyethers obtained by reactions forming an ether link in the main chain; Compositions of derivatives of such polymers
    • C08L71/08Polyethers derived from hydroxy compounds or from their metallic derivatives
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2203/00Applications
    • C08L2203/02Applications 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)
AU2016340072A 2015-10-16 2016-10-14 Stable protein compositions Active AU2016340072B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2022200475A AU2022200475B2 (en) 2015-10-16 2022-01-25 Stable protein compositions

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
AU2022200475A Division AU2022200475B2 (en) 2015-10-16 2022-01-25 Stable protein compositions

Publications (2)

Publication Number Publication Date
AU2016340072A1 AU2016340072A1 (en) 2018-05-10
AU2016340072B2 true AU2016340072B2 (en) 2021-10-28

Family

ID=57209897

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2016340072A Active AU2016340072B2 (en) 2015-10-16 2016-10-14 Stable protein compositions
AU2022200475A Active AU2022200475B2 (en) 2015-10-16 2022-01-25 Stable protein compositions

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2022200475A Active AU2022200475B2 (en) 2015-10-16 2022-01-25 Stable protein compositions

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

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140363482A1 (en) * 2003-06-26 2014-12-11 Psivida Us, Inc. Bioerodible Sustained Release Drug Delivery Systems

Family Cites Families (19)

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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
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

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140363482A1 (en) * 2003-06-26 2014-12-11 Psivida Us, Inc. Bioerodible Sustained Release Drug Delivery Systems

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
JP6853245B2 (ja) 2021-03-31
CA3001346A1 (en) 2017-04-20
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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