LT3681483T - Terapinio baltymo farmacinės formos liofilizavimo būdas - Google Patents

Terapinio baltymo farmacinės formos liofilizavimo būdas

Info

Publication number
LT3681483T
LT3681483T LTEPPCT/US2018/050305T LTUS2018050305T LT3681483T LT 3681483 T LT3681483 T LT 3681483T LT US2018050305 T LTUS2018050305 T LT US2018050305T LT 3681483 T LT3681483 T LT 3681483T
Authority
LT
Lithuania
Prior art keywords
therapeutic protein
pharmaceutical form
lyophilizing pharmaceutical
lyophilizing
therapeutic
Prior art date
Application number
LTEPPCT/US2018/050305T
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=LT3681483(T) "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 LT3681483T publication Critical patent/LT3681483T/lt

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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • A61K38/196—Thrombopoietin
    • 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
    • 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
    • A61K47/16—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
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/524—Thrombopoietin, i.e. C-MPL ligand
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [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
    • C07K16/2809—Immunoglobulins [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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839—Immunoglobulins [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
    • C07K16/2848—Immunoglobulins [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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878—Immunoglobulins [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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • 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
    • A61K2039/505—Medicinal 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (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)
LTEPPCT/US2018/050305T 2017-09-15 2018-09-10 Terapinio baltymo farmacinės formos liofilizavimo būdas LT3681483T (lt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762559420P 2017-09-15 2017-09-15
PCT/US2018/050305 WO2019055357A1 (en) 2017-09-15 2018-09-10 METHOD FOR THE LYOPHILIZED PHARMACEUTICAL FORMULATION OF A THERAPEUTIC PROTEIN

Publications (1)

Publication Number Publication Date
LT3681483T true LT3681483T (lt) 2022-09-12

Family

ID=63686145

Family Applications (1)

Application Number Title Priority Date Filing Date
LTEPPCT/US2018/050305T LT3681483T (lt) 2017-09-15 2018-09-10 Terapinio baltymo farmacinės formos liofilizavimo būdas

Country Status (22)

Country Link
US (2) US20190083402A1 (lt)
EP (1) EP3681483B1 (lt)
JP (3) JP2020534255A (lt)
KR (2) KR20250093620A (lt)
CN (1) CN111148510A (lt)
AU (2) AU2018334502A1 (lt)
CA (1) CA3072600A1 (lt)
CL (1) CL2020000625A1 (lt)
CY (1) CY1125794T1 (lt)
DK (1) DK3681483T3 (lt)
EA (1) EA202090731A1 (lt)
ES (1) ES2925232T3 (lt)
HU (1) HUE059339T2 (lt)
IL (2) IL297824A (lt)
LT (1) LT3681483T (lt)
MA (1) MA50239A (lt)
MX (1) MX2020002896A (lt)
PL (1) PL3681483T3 (lt)
PT (1) PT3681483T (lt)
SG (1) SG11202001449VA (lt)
SI (1) SI3681483T1 (lt)
WO (1) WO2019055357A1 (lt)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20250093620A (ko) * 2017-09-15 2025-06-24 암젠 인크 치료 단백질의 동결건조된 약학적 제형을 위한 방법
JP7235770B2 (ja) 2018-05-10 2023-03-08 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 高濃度ｖｅｇｆ受容体融合タンパク質を含む製剤
CN120795059A (zh) 2018-08-27 2025-10-17 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
WO2022006336A1 (en) * 2020-07-01 2022-01-06 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
CN117241787A (zh) * 2021-06-01 2023-12-15 安进公司 制备冻干蛋白配制品的加速方法
EP4476356A1 (en) * 2022-03-24 2024-12-18 Richter Gedeon Nyrt. Method for the manufacture of biopharmaceuticals
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 (en) 1984-08-27 1987-11-25 The Board Of Trustees Of The Leland Stanford Junior University Chimeric receptors by dna splicing and expression
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
AU612370B2 (en) 1987-05-21 1991-07-11 Micromet Ag Targeted multifunctional proteins
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ES2284161T3 (es) 1990-01-12 2007-11-01 Amgen Fremont Inc. Generacion de anticuerpos xenogenicos.
KR100508289B1 (ko) 1998-04-21 2005-08-17 마이크로메트 에이지 Ｃｄ１９×ｃｄ３ 특이 폴리펩티드 및 그의 용도
MXPA04004459A (es) 2001-11-09 2005-05-16 Johnson & Johnson Composiciones liofilizadas de anticuerpo monoclonal.
WO2004039337A2 (en) 2002-10-31 2004-05-13 Protein Design Labs, Inc. Stable liquid pharmaceutical formulation of antibodies that are prone to isomerization
WO2006138181A2 (en) 2005-06-14 2006-12-28 Amgen Inc. Self-buffering protein formulations
JP5231810B2 (ja) * 2005-12-28 2013-07-10 中外製薬株式会社 抗体含有安定化製剤
US9283260B2 (en) 2006-04-21 2016-03-15 Amgen Inc. Lyophilized therapeutic peptibody formulations
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US9345661B2 (en) 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
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EP3125923B1 (en) * 2014-03-29 2024-10-16 Intas Pharmaceuticals Limited 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
KR20250093620A (ko) * 2017-09-15 2025-06-24 암젠 인크 치료 단백질의 동결건조된 약학적 제형을 위한 방법

Also Published As

Publication number Publication date
HUE059339T2 (hu) 2022-11-28
MX2020002896A (es) 2020-07-22
BR112020004902A2 (pt) 2020-09-15
AU2018334502A1 (en) 2020-03-12
AU2024266756A1 (en) 2024-12-12
JP2025024067A (ja) 2025-02-19
KR20200054251A (ko) 2020-05-19
IL272513B2 (en) 2023-04-01
ES2925232T3 (es) 2022-10-14
US12251474B2 (en) 2025-03-18
SG11202001449VA (en) 2020-03-30
SI3681483T1 (sl) 2022-10-28
PL3681483T3 (pl) 2022-09-26
CL2020000625A1 (es) 2020-08-21
EP3681483A1 (en) 2020-07-22
MA50239A (fr) 2020-07-22
IL297824A (en) 2023-01-01
DK3681483T3 (da) 2022-08-29
JP2023126930A (ja) 2023-09-12
EA202090731A1 (ru) 2020-06-11
IL272513B (en) 2022-12-01
IL272513A (en) 2020-03-31
US20190083402A1 (en) 2019-03-21
US20210369616A1 (en) 2021-12-02
WO2019055357A1 (en) 2019-03-21
PT3681483T (pt) 2022-08-22
JP2020534255A (ja) 2020-11-26
CY1125794T1 (el) 2026-02-25
CA3072600A1 (en) 2019-03-21
KR20250093620A (ko) 2025-06-24
CN111148510A (zh) 2020-05-12
EP3681483B1 (en) 2022-05-18

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