CN116867481A - 包含Fc结构域的工程化蛋白质构建体的水性组合物 - Google Patents

包含Fc结构域的工程化蛋白质构建体的水性组合物 Download PDF

Info

Publication number
CN116867481A
CN116867481A CN202280015385.1A CN202280015385A CN116867481A CN 116867481 A CN116867481 A CN 116867481A CN 202280015385 A CN202280015385 A CN 202280015385A CN 116867481 A CN116867481 A CN 116867481A
Authority
CN
China
Prior art keywords
composition according
aqueous solution
solution composition
composition
engineered protein
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
Application number
CN202280015385.1A
Other languages
English (en)
Chinese (zh)
Inventor
J·耶热克
D·格林
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.)
Arecor Ltd
Original Assignee
Arecor Ltd
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 Arecor Ltd filed Critical Arecor Ltd
Publication of CN116867481A publication Critical patent/CN116867481A/zh
Pending legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70503—Immunoglobulin superfamily
    • C07K14/70521—CD28, CD152
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/08—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
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/605—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CN202280015385.1A 2021-02-17 2022-02-17 包含Fc结构域的工程化蛋白质构建体的水性组合物 Pending CN116867481A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163150510P 2021-02-17 2021-02-17
US63/150,510 2021-02-17
PCT/GB2022/050424 WO2022175663A1 (en) 2021-02-17 2022-02-17 Aqueous composition of an engineered protein construct comprising an fc domain

Publications (1)

Publication Number Publication Date
CN116867481A true CN116867481A (zh) 2023-10-10

Family

ID=80595297

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202280015385.1A Pending CN116867481A (zh) 2021-02-17 2022-02-17 包含Fc结构域的工程化蛋白质构建体的水性组合物

Country Status (10)

Country Link
US (1) US20240166718A1 (cg-RX-API-DMAC10.html)
EP (1) EP4294371A1 (cg-RX-API-DMAC10.html)
JP (1) JP2024507347A (cg-RX-API-DMAC10.html)
KR (1) KR20230146579A (cg-RX-API-DMAC10.html)
CN (1) CN116867481A (cg-RX-API-DMAC10.html)
AU (1) AU2022223669A1 (cg-RX-API-DMAC10.html)
CA (1) CA3208945A1 (cg-RX-API-DMAC10.html)
IL (1) IL305010A (cg-RX-API-DMAC10.html)
MX (1) MX2023009614A (cg-RX-API-DMAC10.html)
WO (1) WO2022175663A1 (cg-RX-API-DMAC10.html)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130209465A1 (en) * 2010-07-30 2013-08-15 Arecor Ltd. Stabilized Aqueous Antibody Compositions
US20190298801A1 (en) * 2016-11-21 2019-10-03 Just Biotherapeutics, Inc. Aflibercept formulations and uses thereof
US20190343918A1 (en) * 2018-05-10 2019-11-14 Regeneron Pharmaceuticals, Inc. High concentration vegf receptor fusion protein containing formulations
US20200023061A1 (en) * 2017-02-24 2020-01-23 Arecor Limited Stabilized antibody solutions
US20200069799A1 (en) * 2018-08-28 2020-03-05 Arecor Limited Stabilized antibody protein solutions
US20200338164A1 (en) * 2017-11-17 2020-10-29 Amgen Inc. Vegfr-fc fusion protein formulations

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008543839A (ja) 2005-06-14 2008-12-04 アムジェン インコーポレーテッド 自己緩衝タンパク質製剤
KR20080071192A (ko) * 2005-11-22 2008-08-01 와이어쓰 면역글로불린 융합 단백질 제형
GB0700523D0 (en) 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins
US8420081B2 (en) 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
AU2012326170B2 (en) 2011-10-18 2016-12-22 Coherus Biosciences, Inc. Etanercept formulations stabilized with metal ions
WO2014011629A1 (en) 2012-07-09 2014-01-16 Coherus Biosciences, Inc. Stable aqueous formulations of etanercept
US20200255496A1 (en) * 2017-09-18 2020-08-13 Amgen Inc. Vegfr-fc fusion protein formulations

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130209465A1 (en) * 2010-07-30 2013-08-15 Arecor Ltd. Stabilized Aqueous Antibody Compositions
US20190298801A1 (en) * 2016-11-21 2019-10-03 Just Biotherapeutics, Inc. Aflibercept formulations and uses thereof
US20200023061A1 (en) * 2017-02-24 2020-01-23 Arecor Limited Stabilized antibody solutions
US20200338164A1 (en) * 2017-11-17 2020-10-29 Amgen Inc. Vegfr-fc fusion protein formulations
US20190343918A1 (en) * 2018-05-10 2019-11-14 Regeneron Pharmaceuticals, Inc. High concentration vegf receptor fusion protein containing formulations
US20200069799A1 (en) * 2018-08-28 2020-03-05 Arecor Limited Stabilized antibody protein solutions

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
孟胜男: "药剂学", vol. 1, 30 September 2011, 上海科学技术出版社, pages: 327 - 328 *

Also Published As

Publication number Publication date
KR20230146579A (ko) 2023-10-19
MX2023009614A (es) 2023-08-24
JP2024507347A (ja) 2024-02-19
EP4294371A1 (en) 2023-12-27
IL305010A (en) 2023-10-01
AU2022223669A1 (en) 2023-08-03
WO2022175663A1 (en) 2022-08-25
US20240166718A1 (en) 2024-05-23
AU2022223669A9 (en) 2025-03-13
CA3208945A1 (en) 2022-08-25

Similar Documents

Publication Publication Date Title
EP2568960B1 (en) Liquid formulation of polypeptides containing an fc domain of an immunoglobulin
CN110559435B (zh) 包含离子性液体的液体蛋白质制剂
RU2614257C2 (ru) СТАБИЛЬНЫЕ ЖИДКИЕ ФАРМАЦЕВТИЧЕСКИЕ ПРЕПАРАТЫ СЛИТОГО БЕЛКА TNFR:Fc
EP3452075B1 (en) Ophthalmic pharmaceutical composition
US20150329628A1 (en) Liquid formulations for an anti-tnf alpha antibody
ES2974895T3 (es) Formulación líquida que comprende un compuesto neutralizante de GM-CSF
AU2019407063B2 (en) Protein solution formulation containing high concentration of an anti-VEGF antibody
JP2020500195A (ja) アフリベルセプト製剤及びその使用
CN104010657A (zh) 氯化钠稳定的依那西普制剂
JP2023011601A (ja) ミオスタチンに結合するフィブロネクチンベースの足場ドメインタンパク質の安定製剤
US20260077016A1 (en) Novel composition comprising antibodies
CN121927035A (zh) 一种药用glp-1r抗体融合蛋白的稳定溶液制剂
JP2025020122A (ja) 安定化Ｆｃ融合タンパク質溶液
JP2024507347A (ja) Ｆｃドメインを含む操作されたタンパク質コンストラクトの水性組成物
CN117279624A (zh) 用于提高工程化二聚体蛋白稳定性的水溶液组合物
CA3239182A1 (en) Stable antibody preparation
CN118119377A (zh) 制剂
EA040788B1 (ru) Жидкая композиция, содержащая соединение, нейтрализующее gm-csf
HK1176009A (en) Liquid formulations for long-acting erythropoietin conjugate

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination