JP4948407B2 - 安定化処方 - Google Patents

安定化処方 Download PDF

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Publication number
JP4948407B2
JP4948407B2 JP2007525855A JP2007525855A JP4948407B2 JP 4948407 B2 JP4948407 B2 JP 4948407B2 JP 2007525855 A JP2007525855 A JP 2007525855A JP 2007525855 A JP2007525855 A JP 2007525855A JP 4948407 B2 JP4948407 B2 JP 4948407B2
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JP
Japan
Prior art keywords
formulation
protein
antibody
results
nacl
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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
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JP2007525855A
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English (en)
Japanese (ja)
Other versions
JP2008515775A (ja
JP2008515775A5 (OSRAM
Inventor
リ・リ
アンジェラ・カントー
シャノン・ビー・マクミラン
Original Assignee
ワイス・エルエルシー
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Publication of JP2008515775A publication Critical patent/JP2008515775A/ja
Publication of JP2008515775A5 publication Critical patent/JP2008515775A5/ja
Application granted granted Critical
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Classifications

    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Cell Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
JP2007525855A 2004-08-13 2005-08-12 安定化処方 Expired - Fee Related JP4948407B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US60131104P 2004-08-13 2004-08-13
US60/601,311 2004-08-13
PCT/US2005/028861 WO2006020935A2 (en) 2004-08-13 2005-08-12 Stabilizing formulations

Publications (3)

Publication Number Publication Date
JP2008515775A JP2008515775A (ja) 2008-05-15
JP2008515775A5 JP2008515775A5 (OSRAM) 2011-11-10
JP4948407B2 true JP4948407B2 (ja) 2012-06-06

Family

ID=35908214

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2007525855A Expired - Fee Related JP4948407B2 (ja) 2004-08-13 2005-08-12 安定化処方

Country Status (18)

Country Link
US (1) US8871201B2 (OSRAM)
EP (1) EP1784219B1 (OSRAM)
JP (1) JP4948407B2 (OSRAM)
KR (1) KR20070092197A (OSRAM)
CN (1) CN101022831A (OSRAM)
AR (1) AR051009A1 (OSRAM)
AU (1) AU2005272603A1 (OSRAM)
BR (1) BRPI0514340A (OSRAM)
CA (1) CA2575870A1 (OSRAM)
CR (1) CR8904A (OSRAM)
EC (1) ECSP077246A (OSRAM)
ES (1) ES2637854T3 (OSRAM)
IL (1) IL181265A0 (OSRAM)
MX (1) MX2007001599A (OSRAM)
NO (1) NO20070930L (OSRAM)
RU (1) RU2007109062A (OSRAM)
TW (1) TW200621282A (OSRAM)
WO (1) WO2006020935A2 (OSRAM)

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AU2007240507B2 (en) * 2006-04-21 2013-07-18 Novartis Ag Antagonist anti-CD40 antibody pharmaceutical compositions
US20080003220A1 (en) * 2006-04-21 2008-01-03 Amgen, Inc. Buffering agents for biopharmaceutical formulations
US20080070230A1 (en) * 2006-06-12 2008-03-20 Wyeth Methods for reducing or preventing liquid-liquid phase separation in high concentration protein solutions
EP1950225A1 (de) * 2007-01-25 2008-07-30 Octapharma AG Verfahren zur Steigerung von Proteinausbeuten
EP2142565A4 (en) 2007-03-29 2010-03-31 Abbott Lab CRYSTALLINE HUMAN ANTI-IL-12 ANTIBODIES
CN101969971A (zh) * 2007-11-30 2011-02-09 雅培制药有限公司 蛋白制剂及其制备方法
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
WO2010062896A1 (en) * 2008-11-28 2010-06-03 Abbott Laboratories Stable antibody compositions and methods for stabilizing same
US9265834B2 (en) 2009-03-05 2016-02-23 Ablynx N.V. Stable formulations of polypeptides and uses thereof
US10005830B2 (en) 2009-03-05 2018-06-26 Ablynx N.V. Antigen binding dimer-complexes, methods of making/avoiding and uses thereof
CN104490767A (zh) * 2009-05-04 2015-04-08 艾伯维生物技术有限公司 人抗TNF-α抗体的稳定高蛋白质浓度制剂
US9884117B2 (en) 2009-09-03 2018-02-06 Ablynx N.V. Stable formulations of polypeptides and uses thereof
MX358137B (es) 2011-07-01 2018-08-06 Biogen Idec Inc Composiciones del polipéptido de fusión tnfr: fc exentas de arginina y métodos de uso.
CA2857502C (en) 2011-11-30 2019-08-13 3M Innovative Properties Company Microneedle device including a peptide therapeutic agent and an amino acid and methods of making and using the same
JP6265970B2 (ja) * 2012-03-26 2018-01-24 サノフイ 安定なIgG4に基づく結合剤の製剤
US9592289B2 (en) 2012-03-26 2017-03-14 Sanofi Stable IgG4 based binding agent formulations
US8883979B2 (en) 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
EP2934587A4 (en) * 2012-12-18 2016-08-03 Merck Sharp & Dohme Liquid formulations for an anti-TNF-alpha-antibody
AU2014342610A1 (en) 2013-11-04 2016-06-02 Abbvie Stemcentrx Llc Anti-EFNA4 antibody-drug conjugates
PL3122426T3 (pl) 2014-03-28 2023-05-15 Duke University Leczenie raka sutka z zastosowaniem selektywnych modulatorów receptora estrogenowego
GB201412658D0 (en) 2014-07-16 2014-08-27 Ucb Biopharma Sprl Molecules
CN112986576A (zh) * 2014-07-21 2021-06-18 非链实验室 从δg的浓度依赖性来测定蛋白质聚集
BR112017023228A2 (en) 2015-04-29 2018-11-06 Radius Pharmaceuticals, Inc. methods for cancer treatment
GB201601073D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibodies
GB201601077D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibody molecule
GB201601075D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibodies molecules
CN109661577B (zh) 2016-08-18 2022-09-27 瑞泽恩制药公司 使用浓度相关的自相互作用纳米粒子光谱法确定蛋白质自缔合的可能性的测定
JP6884858B2 (ja) 2016-10-21 2021-06-09 アムジエン・インコーポレーテツド 医薬製剤及びその製造方法
EP3565542B1 (en) 2017-01-05 2024-04-10 Radius Pharmaceuticals, Inc. Polymorphic forms of rad1901-2hcl
SG11202013177WA (en) 2018-07-04 2021-01-28 Radius Pharmaceuticals Inc Polymorphic forms of rad 1901-2hcl
MA54946A (fr) 2019-02-12 2021-12-22 Radius Pharmaceuticals Inc Procédés et composés
EP4142792A4 (en) * 2020-05-01 2024-11-27 Kashiv Biosciences, LLC An improved process of purification of protein
TW202245823A (zh) * 2021-01-14 2022-12-01 南韓商韓兀生物製藥股份有限公司 無穩定劑或實質上無穩定劑之含有天凡諾賽普特(tanfanercept)的穩定眼用組成物
CN115541895B (zh) * 2022-11-29 2023-05-19 天津德祥生物技术股份有限公司 一种提高微流控反定检测卡灵敏度的配方液及应用

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Also Published As

Publication number Publication date
AR051009A1 (es) 2006-12-13
NO20070930L (no) 2007-05-14
KR20070092197A (ko) 2007-09-12
BRPI0514340A (pt) 2008-06-10
US8871201B2 (en) 2014-10-28
TW200621282A (en) 2006-07-01
RU2007109062A (ru) 2008-09-20
EP1784219B1 (en) 2017-05-17
ECSP077246A (es) 2007-05-30
CR8904A (es) 2007-08-28
CA2575870A1 (en) 2006-02-23
WO2006020935A2 (en) 2006-02-23
WO2006020935A3 (en) 2007-03-08
AU2005272603A1 (en) 2006-02-23
EP1784219A4 (en) 2010-02-17
US20060115472A1 (en) 2006-06-01
CN101022831A (zh) 2007-08-22
IL181265A0 (en) 2007-07-04
ES2637854T3 (es) 2017-10-17
MX2007001599A (es) 2007-04-10
EP1784219A2 (en) 2007-05-16
JP2008515775A (ja) 2008-05-15

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