CN105189559B - 抗体制剂及其用途 - Google Patents

抗体制剂及其用途 Download PDF

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Publication number
CN105189559B
CN105189559B CN201480025774.8A CN201480025774A CN105189559B CN 105189559 B CN105189559 B CN 105189559B CN 201480025774 A CN201480025774 A CN 201480025774A CN 105189559 B CN105189559 B CN 105189559B
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China
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antibody
lyophilized formulation
formulation
disease
solution
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CN201480025774.8A
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English (en)
Chinese (zh)
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CN105189559A (zh
Inventor
M.拉斯特
W.伊泽
G.贝克
P.斯库夫卡
H.吉泽勒
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Takeda Pharmaceutical Co Ltd
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Takeda GmbH
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    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • 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
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Oncology (AREA)
  • Diabetes (AREA)
  • Virology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Communicable Diseases (AREA)
  • Epidemiology (AREA)
  • Biotechnology (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
CN201480025774.8A 2013-03-15 2014-03-17 抗体制剂及其用途 Active CN105189559B (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201361787225P 2013-03-15 2013-03-15
US61/787225 2013-03-15
EP13159325 2013-03-15
EP13159325.3 2013-03-15
PCT/EP2014/055279 WO2014140361A1 (en) 2013-03-15 2014-03-17 Formulation of an antibody and use thereof

Publications (2)

Publication Number Publication Date
CN105189559A CN105189559A (zh) 2015-12-23
CN105189559B true CN105189559B (zh) 2021-07-13

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Family Applications (1)

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CN201480025774.8A Active CN105189559B (zh) 2013-03-15 2014-03-17 抗体制剂及其用途

Country Status (6)

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US (2) US11433029B2 (enExample)
EP (1) EP2970465B1 (enExample)
JP (1) JP6407174B2 (enExample)
CN (1) CN105189559B (enExample)
CA (1) CA2903611C (enExample)
WO (1) WO2014140361A1 (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6594272B2 (ja) * 2016-09-02 2019-10-23 株式会社東芝 半導体装置及びその製造方法
CN110022855B (zh) * 2016-10-07 2024-07-16 瑞泽恩制药公司 室温稳定的冻干蛋白质
US20210388112A1 (en) * 2018-07-09 2021-12-16 National University Corporation Kumamoto University Cyclic Single-Chain Antibody
CA3122902A1 (en) * 2018-12-14 2020-06-18 Morphosys Ag Antibody formulations
CR20210435A (es) 2019-02-18 2021-09-20 Lilly Co Eli Formulación de anticuerpos terapéuticos
RU2754760C2 (ru) * 2019-04-02 2021-09-07 Закрытое Акционерное Общество "Биокад" Водная фармацевтическая композиция анти-il17a антитела и ее применение
CN112675126A (zh) * 2019-10-18 2021-04-20 百奥泰生物制药股份有限公司 抗cd20抗体制剂及其应用
US20230338526A1 (en) * 2019-10-12 2023-10-26 Bio-Thera Solutions, Ltd. Anti-cd20 antibody formulation and use of anti-cd20 antibody for treatment of cd20 positive diseases
CN113082203B (zh) * 2020-01-09 2023-10-20 鲁南制药集团股份有限公司 一种免疫抑制剂单克隆抗体的液体制剂
CN116782889A (zh) * 2020-11-16 2023-09-19 生物技术欧洲股份公司 增强的制剂稳定性和改善的冻干工艺
WO2022101461A1 (en) * 2020-11-16 2022-05-19 BioNTech SE Enhanced formulation stabilization and improved lyophilization processes
CN113855798A (zh) * 2021-09-30 2021-12-31 佛山汉腾生物科技有限公司 抗cd20的抗体制剂

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010011697A1 (en) * 2008-07-21 2010-01-28 Immunomedics Inc. Structural variants of antibodies for improved therapeutic characteristics
CN102695499A (zh) * 2009-06-18 2012-09-26 惠氏有限责任公司 小模块免疫药物的冻干制剂

Family Cites Families (15)

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US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US6685940B2 (en) * 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
ES2434840T3 (es) * 1995-07-27 2013-12-17 Genentech, Inc. Formulación de proteína liofilizada isotónica estable
JP4317010B2 (ja) 2001-07-25 2009-08-19 ピーディーエル バイオファーマ，インコーポレイティド ＩｇＧ抗体の安定な凍結乾燥医薬製剤
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
CA2612937C (en) * 2005-07-22 2014-05-06 Amgen Inc. Concentrated protein lyophilates, methods, and uses
US20090208492A1 (en) 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
WO2009007272A1 (en) * 2007-07-10 2009-01-15 F. Hoffmann-La Roche Ag Novel formulation
EP2234600B1 (en) 2007-12-21 2014-08-20 F. Hoffmann-La Roche AG Antibody formulation
EP2323629B1 (en) 2008-08-05 2019-10-09 Wyeth LLC Lyophilization above collapse
WO2010148321A1 (en) 2009-06-18 2010-12-23 Wyeth Llc Slow dissolution method for reconstitution of lyophilized material
EP2458990B1 (en) 2009-07-28 2016-03-30 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
AR078161A1 (es) 2009-09-11 2011-10-19 Hoffmann La Roche Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento.
EP2704751B1 (en) * 2011-05-02 2019-04-17 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
EP2727602A1 (en) 2012-10-31 2014-05-07 Takeda GmbH Method for preparation of a high concentration liquid formulation of an antibody

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010011697A1 (en) * 2008-07-21 2010-01-28 Immunomedics Inc. Structural variants of antibodies for improved therapeutic characteristics
CN102695499A (zh) * 2009-06-18 2012-09-26 惠氏有限责任公司 小模块免疫药物的冻干制剂

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
effect of moisture on the stability of a lyophilized humanized monoclonal antibody formulation;Breen ED.等;《PHARMACEUTICAL RESEARCH》;20010101;全文 *

Also Published As

Publication number Publication date
US20160022585A1 (en) 2016-01-28
US11433029B2 (en) 2022-09-06
US20140271636A1 (en) 2014-09-18
JP6407174B2 (ja) 2018-10-17
CN105189559A (zh) 2015-12-23
JP2016512218A (ja) 2016-04-25
WO2014140361A1 (en) 2014-09-18
US11576863B2 (en) 2023-02-14
EP2970465A1 (en) 2016-01-20
CA2903611C (en) 2023-11-07
EP2970465B1 (en) 2019-09-25
CA2903611A1 (en) 2014-09-18

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Effective date of registration: 20220208

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