CN105007896B - 包含抗体的治疗组合物 - Google Patents

包含抗体的治疗组合物 Download PDF

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Publication number
CN105007896B
CN105007896B CN201380068796.8A CN201380068796A CN105007896B CN 105007896 B CN105007896 B CN 105007896B CN 201380068796 A CN201380068796 A CN 201380068796A CN 105007896 B CN105007896 B CN 105007896B
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CN
China
Prior art keywords
hydrophilic polymer
biopharmaceuticals
preparation
peg
polymer chain
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.)
Expired - Fee Related
Application number
CN201380068796.8A
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English (en)
Chinese (zh)
Other versions
CN105007896A (zh
Inventor
M·特罗尔萨斯
J·斯坦库斯
詹姆斯·苏
赛义德·霍萨尼
约书亚·T·史密斯
沙地德·阿斯卡
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.)
Abbott Cardiovascular Systems Inc
Original Assignee
Abbott Cardiovascular Systems 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
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Publication of CN105007896A publication Critical patent/CN105007896A/zh
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Publication of CN105007896B publication Critical patent/CN105007896B/zh
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • 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
    • C07K16/24Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • 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
    • 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
    • A61K38/21Interferons [IFN]
    • A61K38/215IFN-beta
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CN201380068796.8A 2012-12-28 2013-12-27 包含抗体的治疗组合物 Expired - Fee Related CN105007896B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261747176P 2012-12-28 2012-12-28
US61/747,176 2012-12-28
PCT/US2013/078102 WO2014106116A2 (en) 2012-12-28 2013-12-27 Delivery of biologic therapeutics

Publications (2)

Publication Number Publication Date
CN105007896A CN105007896A (zh) 2015-10-28
CN105007896B true CN105007896B (zh) 2019-04-09

Family

ID=50000100

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201380068796.8A Expired - Fee Related CN105007896B (zh) 2012-12-28 2013-12-27 包含抗体的治疗组合物

Country Status (5)

Country Link
US (2) US9452138B2 (https=)
EP (1) EP2938323A2 (https=)
JP (1) JP6533932B2 (https=)
CN (1) CN105007896B (https=)
WO (1) WO2014106116A2 (https=)

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BRPI0611901A2 (pt) 2005-06-14 2012-08-28 Amgen, Inc composição, liofilizado, kit, e, processo para preparar uma composição
EP3057616B1 (en) 2013-10-16 2020-03-11 Outlook Therapeutics, Inc. Buffer formulations for enhanced antibody stability
WO2016118707A1 (en) 2015-01-21 2016-07-28 Oncobiologics, Inc. Modulation of charge variants in a monoclonal antibody composition
EP3078675A1 (en) 2015-04-10 2016-10-12 Ares Trading S.A. Induction dosing regimen for the treatment of tnf alpha mediated disorders
CA3010329A1 (en) * 2015-12-29 2017-07-06 Oncobiologics, Inc. Buffered formulations of bevacizumab
CN109563161A (zh) 2016-02-03 2019-04-02 安口生物公司 用于提高抗体稳定性的缓冲制剂
PT3528787T (pt) 2016-10-21 2026-03-11 Amgen Inc Formulações farmacêuticas e métodos para produzir as mesmas
WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
AR111190A1 (es) 2017-03-22 2019-06-12 Genentech Inc Composiciones en hidrogel de prodrogas entrecruzadas de ácido hialurónico y métodos relacionados
BR112021000180A2 (pt) 2018-07-09 2021-05-11 Regeneron Pharmaceuticals, Inc. método de produção de um hidrogel, e, hidrogel
KR20210096592A (ko) * 2018-08-23 2021-08-05 번스타인, 에릭, 에프 피부 질환을 치료하기 위해 항-vegf 화합물을 도포하고 이러한 화합물을 이용하기 위한 시스템, 장치, 및 방법
EP3886946A1 (en) 2019-06-05 2021-10-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
CN121197419A (zh) * 2019-09-30 2025-12-26 上海生物制品研究所有限责任公司 培干扰素和原癌基因产物靶向抑制剂在协同治疗肾癌中的应用
CN112569358B (zh) * 2019-09-30 2022-06-28 上海生物制品研究所有限责任公司 培干扰素和原癌基因产物靶向抑制剂在协同抑制肿瘤中的应用
WO2023038463A1 (ko) * 2021-09-09 2023-03-16 선바이오(주) 6-arm peg 수화겔의 시간 경과에 따른 졸-겔 전환
USD1120314S1 (en) 2022-11-30 2026-03-24 Regeneron Pharmaceuticals, Inc. Dose delivery device

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1569892A (zh) * 2004-04-30 2005-01-26 新峰生物科技(上海)有限公司 多臂树杈型聚乙二醇与蛋白质或多肽的结合物及其制备方法
CN101123988A (zh) * 2005-02-21 2008-02-13 株式会社Lg生命科学 蛋白药物的缓释组合物

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NL7908799A (nl) * 1978-12-22 1980-06-24 Tno Werkwijze voor de bereiding van een polymeermengsel, gevormde produkten, verkregen daaruit en polymeer- legering.
US5971953A (en) * 1998-01-09 1999-10-26 Bachynsky; Nicholas Dual chamber syringe apparatus
US6605273B2 (en) * 1999-04-08 2003-08-12 Schering Corporation Renal cell carcinoma treatment
US8828433B2 (en) 2005-04-19 2014-09-09 Advanced Cardiovascular Systems, Inc. Hydrogel bioscaffoldings and biomedical device coatings
AU2007245190B2 (en) * 2006-03-31 2011-07-21 Takeda Pharmaceutical Company Limited Pegylated factor VIII
US7732190B2 (en) 2006-07-31 2010-06-08 Advanced Cardiovascular Systems, Inc. Modified two-component gelation systems, methods of use and methods of manufacture
EP2014256A1 (en) * 2007-07-12 2009-01-14 Straumann Holding AG Composite bone repair material
US8642737B2 (en) * 2010-07-26 2014-02-04 Baxter International Inc. Nucleophilic catalysts for oxime linkage
US8524215B2 (en) * 2010-08-02 2013-09-03 Janssen Biotech, Inc. Absorbable PEG-based hydrogels
ES2537411T3 (es) * 2011-04-20 2015-06-08 Carbylan Therapeutics, Inc. Composiciones formadoras de gel in situ

Patent Citations (2)

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Publication number Priority date Publication date Assignee Title
CN1569892A (zh) * 2004-04-30 2005-01-26 新峰生物科技(上海)有限公司 多臂树杈型聚乙二醇与蛋白质或多肽的结合物及其制备方法
CN101123988A (zh) * 2005-02-21 2008-02-13 株式会社Lg生命科学 蛋白药物的缓释组合物

Also Published As

Publication number Publication date
WO2014106116A8 (en) 2015-06-18
WO2014106116A2 (en) 2014-07-03
EP2938323A2 (en) 2015-11-04
JP2016504369A (ja) 2016-02-12
US9452138B2 (en) 2016-09-27
US20140186446A1 (en) 2014-07-03
CN105007896A (zh) 2015-10-28
JP6533932B2 (ja) 2019-06-26
WO2014106116A3 (en) 2014-07-31
US20170042816A1 (en) 2017-02-16

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Granted publication date: 20190409

Termination date: 20211227