JP2024507347A - 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 - Google Patents

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 Download PDF

Info

Publication number
JP2024507347A
JP2024507347A JP2023549058A JP2023549058A JP2024507347A JP 2024507347 A JP2024507347 A JP 2024507347A JP 2023549058 A JP2023549058 A JP 2023549058A JP 2023549058 A JP2023549058 A JP 2023549058A JP 2024507347 A JP2024507347 A JP 2024507347A
Authority
JP
Japan
Prior art keywords
acid
aqueous composition
composition according
composition
aqueous
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
JP2023549058A
Other languages
English (en)
Japanese (ja)
Other versions
JP2024507347A5 (https=
Inventor
ジェゼク ジャン
ジェリング デビッド
Original Assignee
アレコル リミテッド
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 アレコル リミテッド filed Critical アレコル リミテッド
Publication of JP2024507347A publication Critical patent/JP2024507347A/ja
Publication of JP2024507347A5 publication Critical patent/JP2024507347A5/ja
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)
JP2023549058A 2021-02-17 2022-02-17 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 Pending JP2024507347A (ja)

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 (2)

Publication Number Publication Date
JP2024507347A true JP2024507347A (ja) 2024-02-19
JP2024507347A5 JP2024507347A5 (https=) 2025-02-19

Family

ID=80595297

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023549058A Pending JP2024507347A (ja) 2021-02-17 2022-02-17 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

Country Status (10)

Country Link
US (1) US20240166718A1 (https=)
EP (1) EP4294371A1 (https=)
JP (1) JP2024507347A (https=)
KR (1) KR20230146579A (https=)
CN (1) CN116867481A (https=)
AU (1) AU2022223669A1 (https=)
CA (1) CA3208945A1 (https=)
IL (1) IL305010A (https=)
MX (1) MX2023009614A (https=)
WO (1) WO2022175663A1 (https=)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009516692A (ja) * 2005-11-22 2009-04-23 ワイス 免疫グロブリン融合タンパク質製剤
WO2019217927A1 (en) * 2018-05-10 2019-11-14 Regeneron Pharmaceuticals, Inc. High concentration vegf receptor fusion protein containing formulations
JP2020500195A (ja) * 2016-11-21 2020-01-09 ジャスト バイオセラピューティックス，インコーポレイテッド アフリベルセプト製剤及びその使用
JP2020508331A (ja) * 2017-02-24 2020-03-19 アレコル リミテッド 安定化された抗体溶液
US20200255496A1 (en) * 2017-09-18 2020-08-13 Amgen Inc. Vegfr-fc fusion protein formulations
JP2021503485A (ja) * 2017-11-17 2021-02-12 アムジエン・インコーポレーテツド ＶＥＧＦＲ−Ｆｃ融合タンパク質製剤

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0611901A2 (pt) 2005-06-14 2012-08-28 Amgen, Inc composição, liofilizado, kit, e, processo para preparar uma composição
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
EP2598167B1 (en) * 2010-07-30 2015-04-01 Arecor Limited Stabilized aqueous antibody compositions
BR112014009146A8 (pt) 2011-10-18 2017-06-20 Coherus Biosciences Inc formulações de etanercepte estabilizadas com aminoácidos
HK1209343A1 (en) 2012-07-09 2016-04-01 Coherus Biosciences, Inc. Etanercept formulations exhibiting marked reduction in sub-visible particles
US20200069799A1 (en) * 2018-08-28 2020-03-05 Arecor Limited Stabilized antibody protein solutions

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009516692A (ja) * 2005-11-22 2009-04-23 ワイス 免疫グロブリン融合タンパク質製剤
JP2020500195A (ja) * 2016-11-21 2020-01-09 ジャスト バイオセラピューティックス，インコーポレイテッド アフリベルセプト製剤及びその使用
JP2020508331A (ja) * 2017-02-24 2020-03-19 アレコル リミテッド 安定化された抗体溶液
US20200255496A1 (en) * 2017-09-18 2020-08-13 Amgen Inc. Vegfr-fc fusion protein formulations
JP2021503485A (ja) * 2017-11-17 2021-02-12 アムジエン・インコーポレーテツド ＶＥＧＦＲ−Ｆｃ融合タンパク質製剤
WO2019217927A1 (en) * 2018-05-10 2019-11-14 Regeneron Pharmaceuticals, Inc. High concentration vegf receptor fusion protein containing formulations

Also Published As

Publication number Publication date
AU2022223669A1 (en) 2023-08-03
CN116867481A (zh) 2023-10-10
MX2023009614A (es) 2023-08-24
IL305010A (en) 2023-10-01
WO2022175663A1 (en) 2022-08-25
AU2022223669A9 (en) 2025-03-13
KR20230146579A (ko) 2023-10-19
CA3208945A1 (en) 2022-08-25
US20240166718A1 (en) 2024-05-23
EP4294371A1 (en) 2023-12-27

Similar Documents

Publication Publication Date Title
EP2568960B1 (en) Liquid formulation of polypeptides containing an fc domain of an immunoglobulin
CN103998060B (zh) 使用糖与多元醇的结合物稳定的依那西普制剂
US9844594B2 (en) Liquid formulations for an anti-TNF α antibody
CN104224705B (zh) 稳定化的液体和冻干的adamts13制剂
EP3532029B1 (en) Liquid pharmaceutical composition
JP7220664B2 (ja) 液体医薬組成物
JP7357540B2 (ja) 液体医薬組成物
TW201733618A (zh) 含有抗人類ｔｓｌｐ受體抗體之醫藥組成物
KR20190071760A (ko) 약학적 제형 및 그의 제조 방법
US20260077016A1 (en) Novel composition comprising antibodies
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
HK40104639A (zh) 用於提高工程化二聚体蛋白稳定性的水溶液组合物
HK1200720B (en) Etanercept formulations stabilized with combinations of sugars and polyols

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250207

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20250207

RD13 Notification of appointment of power of sub attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7433

Effective date: 20250827

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20260128

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20260203

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20260402