JP2016530216A - 抗体組成物及びそのための緩衝系 - Google Patents

抗体組成物及びそのための緩衝系 Download PDF

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Publication number
JP2016530216A
JP2016530216A JP2016516187A JP2016516187A JP2016530216A JP 2016530216 A JP2016530216 A JP 2016530216A JP 2016516187 A JP2016516187 A JP 2016516187A JP 2016516187 A JP2016516187 A JP 2016516187A JP 2016530216 A JP2016530216 A JP 2016530216A
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JP
Japan
Prior art keywords
buffer
antibody
acid
pka
compound
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JP2016516187A
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English (en)
Japanese (ja)
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JP2016530216A5 (enExample
Inventor
ニコラス・スティーヴン・ジー
ビアンカ・フセッティ
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Innova Biosciences Ltd
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Innova Biosciences Ltd
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Publication of JP2016530216A5 publication Critical patent/JP2016530216A5/ja
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/001—Preparation for luminescence or biological staining
    • A61K49/0013—Luminescence
    • A61K49/0017—Fluorescence in vivo
    • A61K49/005—Fluorescence in vivo characterised by the carrier molecule carrying the fluorescent agent
    • A61K49/0058—Antibodies
    • 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
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6843—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a material from animals or humans
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6921—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere
    • A61K47/6923—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere the form being an inorganic particle, e.g. ceramic particles, silica particles, ferrite or synsorb
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/001—Preparation for luminescence or biological staining
    • A61K49/0013—Luminescence
    • A61K49/0017—Fluorescence in vivo
    • A61K49/0019—Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules
    • A61K49/0021—Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules the fluorescent group being a small organic molecule
    • A61K49/0041—Xanthene dyes, used in vivo, e.g. administered to a mice, e.g. rhodamines, rose Bengal
    • A61K49/0043—Fluorescein, used in vivo
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/001—Preparation for luminescence or biological staining
    • A61K49/0013—Luminescence
    • A61K49/0017—Fluorescence in vivo
    • A61K49/0019—Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules
    • A61K49/0045—Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules the fluorescent agent being a peptide or protein used for imaging or diagnosis in vivo
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/13—Labelling of peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Zoology (AREA)
  • Inorganic Chemistry (AREA)
  • Ceramic Engineering (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
JP2016516187A 2013-05-31 2014-05-30 抗体組成物及びそのための緩衝系 Pending JP2016530216A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB1309759.7A GB2516808A (en) 2013-05-31 2013-05-31 Antibody composition and buffer system therefor
GB1309759.7 2013-05-31
PCT/EP2014/061281 WO2014191560A1 (en) 2013-05-31 2014-05-30 Antibody composition and buffer system therefor

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2019163553A Division JP2020007343A (ja) 2013-05-31 2019-09-09 抗体組成物及びそのための緩衝系

Publications (2)

Publication Number Publication Date
JP2016530216A true JP2016530216A (ja) 2016-09-29
JP2016530216A5 JP2016530216A5 (enExample) 2017-07-06

Family

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JP2016516187A Pending JP2016530216A (ja) 2013-05-31 2014-05-30 抗体組成物及びそのための緩衝系
JP2019163553A Pending JP2020007343A (ja) 2013-05-31 2019-09-09 抗体組成物及びそのための緩衝系

Family Applications After (1)

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Country Status (9)

Country Link
US (1) US11046753B2 (enExample)
EP (1) EP3003385B1 (enExample)
JP (2) JP2016530216A (enExample)
CN (1) CN105592860B (enExample)
AU (1) AU2014273034B2 (enExample)
DK (1) DK3003385T3 (enExample)
ES (1) ES2762501T3 (enExample)
GB (2) GB2516808A (enExample)
WO (1) WO2014191560A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024020287A (ja) * 2018-09-21 2024-02-14 グリーン・クロス・コーポレイション 高効率の抗ｔｆｐｉ抗体組成物

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170189548A1 (en) * 2015-11-25 2017-07-06 Immunogen, Inc. Pharmaceutical formulations and methods of use thereof
CN111896752A (zh) * 2020-08-11 2020-11-06 上海捷门生物技术有限公司 一种适用于多种poct类仪器的c-反应蛋白试剂盒
CN113671188A (zh) * 2021-08-10 2021-11-19 江南大学 一种检测贝类食品中河豚毒素的时间分辨免疫定量试纸条
EP4218562A1 (en) 2022-01-28 2023-08-02 Charité - Universitätsmedizin Berlin Real-time breath antigen detection system and method thereof

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007074880A1 (ja) * 2005-12-28 2007-07-05 Chugai Seiyaku Kabushiki Kaisha 抗体含有安定化製剤
JP2008536917A (ja) * 2005-04-18 2008-09-11 イエダ リサーチ アンド ディベロップメント カンパニー リミテッド 安定化抗ｂ型肝炎ウイルス（ｈｂｖ）抗体製剤
JP2010513522A (ja) * 2006-12-21 2010-04-30 アムジエン・インコーポレーテツド ポリペプチドを含有する安定な緩衝化された製剤
JP2011528106A (ja) * 2008-07-16 2011-11-10 ラジオメーター・メディカル・アー・ペー・エス 高性能固相
JP2011241206A (ja) * 2010-04-23 2011-12-01 Arkray Inc 標識抗体の安定化方法
WO2011162210A1 (ja) * 2010-06-21 2011-12-29 協和発酵キリン株式会社 アミノ酸を利用したタンパク質の精製方法
WO2012123488A1 (en) * 2011-03-16 2012-09-20 F. Hoffmann-La Roche Ag Ion exchange chromatography with improved selectivity for the separation of polypeptide monomers, aggregates and fragments by modulation of the mobile phase
JP2012242394A (ja) * 2011-05-17 2012-12-10 Samsung Electronics Co Ltd 標的物質検出用キット及びこれを利用した標的物質検出方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0516873A1 (en) 1991-06-06 1992-12-09 THE STATE of ISRAEL Atomic Energy Commission Soreq Nuclear Research Center A method and kit for protein labelling with 99 mTC
ATE260674T1 (de) * 1998-08-17 2004-03-15 Pfizer Prod Inc Stabilisierte proteinzusammensetzung
AU2006295340B2 (en) 2005-08-05 2010-11-11 Amgen Inc. Stable aqueous protein or antibody pharmaceutical formulations and their preparation
CN101330931B (zh) * 2005-12-12 2012-09-05 创新生物科学有限公司 制备缀合物
US8877892B2 (en) * 2011-03-15 2014-11-04 Innova Biosciences Limited Conjugation reactions

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008536917A (ja) * 2005-04-18 2008-09-11 イエダ リサーチ アンド ディベロップメント カンパニー リミテッド 安定化抗ｂ型肝炎ウイルス（ｈｂｖ）抗体製剤
WO2007074880A1 (ja) * 2005-12-28 2007-07-05 Chugai Seiyaku Kabushiki Kaisha 抗体含有安定化製剤
JP2010513522A (ja) * 2006-12-21 2010-04-30 アムジエン・インコーポレーテツド ポリペプチドを含有する安定な緩衝化された製剤
JP2011528106A (ja) * 2008-07-16 2011-11-10 ラジオメーター・メディカル・アー・ペー・エス 高性能固相
JP2011241206A (ja) * 2010-04-23 2011-12-01 Arkray Inc 標識抗体の安定化方法
WO2011162210A1 (ja) * 2010-06-21 2011-12-29 協和発酵キリン株式会社 アミノ酸を利用したタンパク質の精製方法
WO2012123488A1 (en) * 2011-03-16 2012-09-20 F. Hoffmann-La Roche Ag Ion exchange chromatography with improved selectivity for the separation of polypeptide monomers, aggregates and fragments by modulation of the mobile phase
JP2012242394A (ja) * 2011-05-17 2012-12-10 Samsung Electronics Co Ltd 標的物質検出用キット及びこれを利用した標的物質検出方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024020287A (ja) * 2018-09-21 2024-02-14 グリーン・クロス・コーポレイション 高効率の抗ｔｆｐｉ抗体組成物

Also Published As

Publication number Publication date
GB201309759D0 (en) 2013-07-17
GB201522774D0 (en) 2016-02-03
US11046753B2 (en) 2021-06-29
WO2014191560A1 (en) 2014-12-04
AU2014273034B2 (en) 2019-11-21
ES2762501T8 (es) 2020-06-18
JP2020007343A (ja) 2020-01-16
US20160122416A1 (en) 2016-05-05
ES2762501T3 (es) 2020-05-25
AU2014273034A1 (en) 2016-01-28
CN105592860B (zh) 2021-02-02
GB2516808A (en) 2015-02-11
EP3003385B1 (en) 2019-09-18
GB2530217A (en) 2016-03-16
EP3003385A1 (en) 2016-04-13
DK3003385T3 (da) 2020-01-06
CN105592860A (zh) 2016-05-18

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