JP7869227B2 - タンパク質液状製剤及びその製造方法 - Google Patents

タンパク質液状製剤及びその製造方法

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Publication number
JP7869227B2
JP7869227B2 JP2023545327A JP2023545327A JP7869227B2 JP 7869227 B2 JP7869227 B2 JP 7869227B2 JP 2023545327 A JP2023545327 A JP 2023545327A JP 2023545327 A JP2023545327 A JP 2023545327A JP 7869227 B2 JP7869227 B2 JP 7869227B2
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Prior art keywords
efrapegrastim
liquid formulation
concentration
polysorbate
liquid
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Japanese (ja)
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JP2024505211A (ja
JP2024505211A5 (enExample
Inventor
キュ リム、ヒョン
ユン キム、サン
ヒ ホン、スン
Original Assignee
ハンミ ファーマシューティカルズ カンパニー リミテッド
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    • 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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/193—Colony stimulating factors [CSF]
    • 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
    • A61K47/12—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
    • A61K47/26—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
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • 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
    • A61K9/08—Solutions
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
JP2023545327A 2021-01-27 2022-01-26 タンパク質液状製剤及びその製造方法 Active JP7869227B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR1020210011802A KR102375269B1 (ko) 2021-01-27 2021-01-27 단백질 액상 제제 및 이의 제조방법
KR10-2021-0011802 2021-01-27
PCT/KR2022/001406 WO2022164204A1 (en) 2021-01-27 2022-01-26 Liquid formulation of protein and methods of preparing the same

Publications (3)

Publication Number Publication Date
JP2024505211A JP2024505211A (ja) 2024-02-05
JP2024505211A5 JP2024505211A5 (enExample) 2026-04-14
JP7869227B2 true JP7869227B2 (ja) 2026-06-02

Family

ID=80936291

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JP2023545327A Active JP7869227B2 (ja) 2021-01-27 2022-01-26 タンパク質液状製剤及びその製造方法

Country Status (12)

Country Link
US (1) US20240082355A1 (enExample)
EP (1) EP4284340A4 (enExample)
JP (1) JP7869227B2 (enExample)
KR (1) KR102375269B1 (enExample)
CN (1) CN116782882A (enExample)
AR (1) AR124700A1 (enExample)
AU (1) AU2022213961A1 (enExample)
CA (1) CA3206349A1 (enExample)
IL (1) IL304528A (enExample)
MX (1) MX2023008804A (enExample)
TW (1) TWI924776B (enExample)
WO (1) WO2022164204A1 (enExample)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11267858B2 (en) 2019-05-31 2022-03-08 Spectrum Pharmaceuticals, Inc. Methods of treatment using G-CSF protein complex
US11684655B2 (en) 2019-05-31 2023-06-27 Spectrum Pharmaceuticals, Inc. Methods of treating neutorpenia using G-CSF protein complex

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010536929A (ja) 2007-08-27 2010-12-02 バイオジェネリクス アクチェンゲゼルシャフト Ｇ−ｃｓｆ結合体の液体調製物
JP2012515221A (ja) 2009-01-16 2012-07-05 テバ ファーマシューティカル インダストリーズ リミテッド 組換えヒトアルブミン−ヒト顆粒球コロニー刺激因子融合タンパク質の安定な製剤
JP2013517324A (ja) 2010-01-19 2013-05-16 ハンミ サイエンス カンパニー リミテッド 持続型顆粒球コロニー刺激因子結合体の液剤
JP2013522252A (ja) 2010-03-17 2013-06-13 バイオジェネリックス ゲーエムベーハー 生物学的活性型組換えヒトｇ−ｃｓｆを得るための方法
WO2020243755A1 (en) 2019-05-31 2020-12-03 Spectrum Pharmaceuticals, Inc. Methods of treatment using g-csf protein complex

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100356140B1 (ko) * 1999-07-08 2002-10-19 한미약품공업 주식회사 인간 과립구 콜로니 자극인자 변이체 및 이의 생산 방법
US8420081B2 (en) * 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
SI2849723T1 (sl) * 2012-05-18 2018-09-28 Genentech, Inc. Formulacije z visoko koncentracijo monoklonskih protiteles
US11173208B2 (en) * 2014-05-07 2021-11-16 Takeda Gmbh Liquid formulation comprising GM-CSF neutralizing compound
WO2019147615A1 (en) * 2018-01-24 2019-08-01 Beyondspring Pharmaceuticals, Inc. Composition and method for reducing thrombocytopenia via the administration of plinabulin
BR112020015758A2 (pt) * 2018-02-01 2020-12-08 Beyondspring Pharmaceuticals, Inc. Composição e método para reduzir neutropenia induzida por quimioterapia através da administração de plinabulina e agente de g-csf
US11684655B2 (en) * 2019-05-31 2023-06-27 Spectrum Pharmaceuticals, Inc. Methods of treating neutorpenia using G-CSF protein complex

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010536929A (ja) 2007-08-27 2010-12-02 バイオジェネリクス アクチェンゲゼルシャフト Ｇ−ｃｓｆ結合体の液体調製物
JP2012515221A (ja) 2009-01-16 2012-07-05 テバ ファーマシューティカル インダストリーズ リミテッド 組換えヒトアルブミン−ヒト顆粒球コロニー刺激因子融合タンパク質の安定な製剤
JP2013517324A (ja) 2010-01-19 2013-05-16 ハンミ サイエンス カンパニー リミテッド 持続型顆粒球コロニー刺激因子結合体の液剤
JP2013522252A (ja) 2010-03-17 2013-06-13 バイオジェネリックス ゲーエムベーハー 生物学的活性型組換えヒトｇ−ｃｓｆを得るための方法
WO2020243755A1 (en) 2019-05-31 2020-12-03 Spectrum Pharmaceuticals, Inc. Methods of treatment using g-csf protein complex

Also Published As

Publication number Publication date
TW202231295A (zh) 2022-08-16
AR124700A1 (es) 2023-04-26
KR102375269B1 (ko) 2022-03-17
EP4284340A4 (en) 2024-12-11
WO2022164204A1 (en) 2022-08-04
AU2022213961A1 (en) 2023-08-10
TWI924776B (zh) 2026-05-11
AU2022213961A9 (en) 2025-01-16
US20240082355A1 (en) 2024-03-14
IL304528A (en) 2023-09-01
JP2024505211A (ja) 2024-02-05
MX2023008804A (es) 2023-08-04
EP4284340A1 (en) 2023-12-06
CA3206349A1 (en) 2022-08-04
CN116782882A (zh) 2023-09-19

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