MA50239A - Procédé de formulation pharmaceutique lyophilisée d'une protéine thérapeutique - Google Patents

Procédé de formulation pharmaceutique lyophilisée d'une protéine thérapeutique

Info

Publication number
MA50239A
MA50239A MA050239A MA50239A MA50239A MA 50239 A MA50239 A MA 50239A MA 050239 A MA050239 A MA 050239A MA 50239 A MA50239 A MA 50239A MA 50239 A MA50239 A MA 50239A
Authority
MA
Morocco
Prior art keywords
pharmaceutical formulation
therapeutic protein
formulation process
lyophilized pharmaceutical
lyophilized
Prior art date
Application number
MA050239A
Other languages
English (en)
Inventor
Clea Talley
Original Assignee
Amgen 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=63686145&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MA50239(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of MA50239A publication Critical patent/MA50239A/fr

Links

Classifications

    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • 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
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/196Thrombopoietin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/524Thrombopoietin, i.e. C-MPL ligand
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • C07K16/2848Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily against integrin beta3-subunit-containing molecules, e.g. CD41, CD51, CD61
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies

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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Inorganic Chemistry (AREA)
  • Toxicology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Oncology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
MA050239A 2017-09-15 2018-09-10 Procédé de formulation pharmaceutique lyophilisée d'une protéine thérapeutique MA50239A (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201762559420P 2017-09-15 2017-09-15

Publications (1)

Publication Number Publication Date
MA50239A true MA50239A (fr) 2020-07-22

Family

ID=63686145

Family Applications (1)

Application Number Title Priority Date Filing Date
MA050239A MA50239A (fr) 2017-09-15 2018-09-10 Procédé de formulation pharmaceutique lyophilisée d'une protéine thérapeutique

Country Status (22)

Country Link
US (2) US12251474B2 (fr)
EP (1) EP3681483B1 (fr)
JP (3) JP2020534255A (fr)
KR (2) KR20250093620A (fr)
CN (1) CN111148510A (fr)
AU (2) AU2018334502A1 (fr)
CA (1) CA3072600A1 (fr)
CL (1) CL2020000625A1 (fr)
CY (1) CY1125794T1 (fr)
DK (1) DK3681483T3 (fr)
EA (1) EA202090731A1 (fr)
ES (1) ES2925232T3 (fr)
HU (1) HUE059339T2 (fr)
IL (2) IL272513B2 (fr)
LT (1) LT3681483T (fr)
MA (1) MA50239A (fr)
MX (1) MX2020002896A (fr)
PL (1) PL3681483T3 (fr)
PT (1) PT3681483T (fr)
SG (1) SG11202001449VA (fr)
SI (1) SI3681483T1 (fr)
WO (1) WO2019055357A1 (fr)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA202090731A1 (ru) * 2017-09-15 2020-06-11 Эмджен Инк. Способ получения лиофилизированного фармацевтического состава на основе терапевтического белка
DK4364724T3 (da) 2018-05-10 2025-12-22 Regeneron Pharma Formuleringer med høj koncentration af VEGF-receptorfusionsprotein
CN119264211A (zh) 2018-08-27 2025-01-07 瑞泽恩制药公司 拉曼光谱在下游纯化中的应用
CN111595658B (zh) * 2020-06-06 2023-11-14 宾傲 一种提取细胞中蛋白的裂解液及其制备方法
US11583521B2 (en) * 2020-07-01 2023-02-21 Jubilant Pharma Holdings Inc. Long-acting injection dosage form of beta 3 adrenoreceptor agonists
CN114681592A (zh) * 2020-12-31 2022-07-01 天境生物科技(杭州)有限公司 包含可溶性gp130二聚体的制剂和使用方法
CN113087782B (zh) * 2021-04-09 2021-12-14 北京美联泰科生物技术有限公司 一种中枢神经特异性蛋白的冻干方法
EP4346778A1 (fr) * 2021-06-01 2024-04-10 Amgen Inc. Procédé accéléré de fabrication de formulations de protéines lyophilisées
MX2024010846A (es) * 2022-03-24 2024-09-11 Richter Gedeon Nyrt Metodo para la preparacion de biofarmacos.
CN115932239B (zh) * 2022-12-22 2024-02-20 广州市进德生物科技有限公司 一种氧化低密度脂蛋白保护剂、测定氧化低密度脂蛋白的检测试剂盒及其应用

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GB8308235D0 (en) 1983-03-25 1983-05-05 Celltech Ltd Polypeptides
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
JPS6147500A (ja) 1984-08-15 1986-03-07 Res Dev Corp Of Japan キメラモノクロ−ナル抗体及びその製造法
EP0173494A3 (fr) 1984-08-27 1987-11-25 The Board Of Trustees Of The Leland Stanford Junior University Récepteurs chimériques par liaison et expression de l'ADN
GB8422238D0 (en) 1984-09-03 1984-10-10 Neuberger M S Chimeric proteins
US4751180A (en) 1985-03-28 1988-06-14 Chiron Corporation Expression using fused genes providing for protein product
US4935233A (en) 1985-12-02 1990-06-19 G. D. Searle And Company Covalently linked polypeptide cell modulators
US4946778A (en) 1987-09-21 1990-08-07 Genex Corporation Single polypeptide chain binding molecules
ATE243754T1 (de) 1987-05-21 2003-07-15 Micromet Ag Multifunktionelle proteine mit vorbestimmter zielsetzung
US5997856A (en) * 1988-10-05 1999-12-07 Chiron Corporation Method and compositions for solubilization and stabilization of polypeptides, especially proteins
DE69120146T2 (de) 1990-01-12 1996-12-12 Cell Genesys Inc Erzeugung xenogener antikörper
US7112324B1 (en) 1998-04-21 2006-09-26 Micromet Ag CD 19×CD3 specific polypeptides and uses thereof
JP2005508992A (ja) 2001-11-09 2005-04-07 セントカー・インコーポレーテツド 凍結乾燥されたモノクローナル抗体組成物
WO2004039337A2 (fr) 2002-10-31 2004-05-13 Protein Design Labs, Inc. Formulations pharmaceutiques liquides stables d'anticorps ayant tendance a l'isomerisation
BRPI0611901A2 (pt) 2005-06-14 2012-08-28 Amgen, Inc composição, liofilizado, kit, e, processo para preparar uma composição
WO2007074880A1 (fr) * 2005-12-28 2007-07-05 Chugai Seiyaku Kabushiki Kaisha Préparation stabilisatrice contenant des anticorps
US9283260B2 (en) 2006-04-21 2016-03-15 Amgen Inc. Lyophilized therapeutic peptibody formulations
AU2008255016B2 (en) 2007-05-15 2013-05-09 Stryker Corporation Concentrated protein preparations of bone morphogenetic proteins and methods of use thereof
US9345661B2 (en) 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
EP3974453A3 (fr) 2010-11-16 2022-08-03 Amgen Inc. Agents et procédés pour traiter les maladies en corrélation avec l'expression bcma
US9347077B2 (en) 2011-07-08 2016-05-24 University Of Florida Research Foundation, Incorporated Over-expression of a putative oxidoreductase (UcpA) for increasing furfural or 5-hydroxymethylfurfural tolerance
AR089434A1 (es) * 2011-12-23 2014-08-20 Genentech Inc Procedimiento para preparar formulaciones con alta concentracion de proteinas
US9872906B2 (en) * 2013-03-15 2018-01-23 Merck Sharp & Dohme Corp. Ceftolozane antibiotic compositions
US10017441B2 (en) 2013-05-02 2018-07-10 The University Of North Carolina At Chapel Hill Direct anti-markovnikov addition of acids to alkenes
ES3002132T3 (en) * 2014-03-29 2025-03-06 Intas Pharmaceuticals Ltd Lyophilized pharmaceutical composition of fc-peptide fusion protein
JOP20170017B1 (ar) * 2016-01-25 2021-08-17 Amgen Res Munich Gmbh تركيب صيدلي يتضمن تركيبات جسم مضاد ثنائي الاختصاص
EA202090731A1 (ru) * 2017-09-15 2020-06-11 Эмджен Инк. Способ получения лиофилизированного фармацевтического состава на основе терапевтического белка

Also Published As

Publication number Publication date
KR20250093620A (ko) 2025-06-24
JP2025024067A (ja) 2025-02-19
ES2925232T3 (es) 2022-10-14
SI3681483T1 (sl) 2022-10-28
SG11202001449VA (en) 2020-03-30
AU2024266756A1 (en) 2024-12-12
WO2019055357A1 (fr) 2019-03-21
JP2023126930A (ja) 2023-09-12
MX2020002896A (es) 2020-07-22
LT3681483T (lt) 2022-09-12
CY1125794T1 (el) 2026-02-25
CL2020000625A1 (es) 2020-08-21
JP2020534255A (ja) 2020-11-26
CA3072600A1 (fr) 2019-03-21
IL272513B (en) 2022-12-01
DK3681483T3 (da) 2022-08-29
HUE059339T2 (hu) 2022-11-28
US20190083402A1 (en) 2019-03-21
EP3681483A1 (fr) 2020-07-22
IL272513B2 (en) 2023-04-01
IL297824A (en) 2023-01-01
KR20200054251A (ko) 2020-05-19
IL272513A (en) 2020-03-31
EP3681483B1 (fr) 2022-05-18
US12251474B2 (en) 2025-03-18
PT3681483T (pt) 2022-08-22
US20210369616A1 (en) 2021-12-02
PL3681483T3 (pl) 2022-09-26
AU2018334502A1 (en) 2020-03-12
EA202090731A1 (ru) 2020-06-11
CN111148510A (zh) 2020-05-12
BR112020004902A2 (pt) 2020-09-15

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