CA3206349A1 - Liquid formulation of protein and methods of preparing the same - Google Patents

Liquid formulation of protein and methods of preparing the same Download PDF

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Publication number
CA3206349A1
CA3206349A1 CA3206349A CA3206349A CA3206349A1 CA 3206349 A1 CA3206349 A1 CA 3206349A1 CA 3206349 A CA3206349 A CA 3206349A CA 3206349 A CA3206349 A CA 3206349A CA 3206349 A1 CA3206349 A1 CA 3206349A1
Authority
CA
Canada
Prior art keywords
formulation
liquid
eflapegrastim
polysorbate
liquid formulation
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
CA3206349A
Other languages
English (en)
French (fr)
Inventor
Hyung Kyu Lim
Sang Yun Kim
Sung Hee Hong
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.)
Hanmi Pharmaceutical Co Ltd
Original Assignee
Hanmi Pharmaceutical Co 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 Hanmi Pharmaceutical Co Ltd filed Critical Hanmi Pharmaceutical Co Ltd
Publication of CA3206349A1 publication Critical patent/CA3206349A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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)
CA3206349A 2021-01-27 2022-01-26 Liquid formulation of protein and methods of preparing the same Pending CA3206349A1 (en)

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 (1)

Publication Number Publication Date
CA3206349A1 true CA3206349A1 (en) 2022-08-04

Family

ID=80936291

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3206349A Pending CA3206349A1 (en) 2021-01-27 2022-01-26 Liquid formulation of protein and methods of preparing the same

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

Family Cites Families (12)

* 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
US8546328B2 (en) 2007-08-27 2013-10-01 Biogenerix Ag Liquid formulation of G-CSF conjugate
US8420081B2 (en) * 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
BRPI1004940A2 (pt) 2009-01-16 2018-06-19 Teva Pharma composição farmacêutica
PT2525787T (pt) * 2010-01-19 2017-12-18 Hanmi Science Co Ltd Formulações líquidas para conjugado de g-csf de longa ação
BR112012022518A2 (pt) 2010-03-17 2020-10-13 Biogenerix Gmbh método para obtenção de g- csf recombinante humano biologicamente ativo
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
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

Also Published As

Publication number Publication date
TW202231295A (zh) 2022-08-16
AR124700A1 (es) 2023-04-26
KR102375269B1 (ko) 2022-03-17
JP7869227B2 (ja) 2026-06-02
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
CN116782882A (zh) 2023-09-19

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