JP6176849B2 - アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤 - Google Patents

アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤 Download PDF

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Publication number
JP6176849B2
JP6176849B2 JP2013524738A JP2013524738A JP6176849B2 JP 6176849 B2 JP6176849 B2 JP 6176849B2 JP 2013524738 A JP2013524738 A JP 2013524738A JP 2013524738 A JP2013524738 A JP 2013524738A JP 6176849 B2 JP6176849 B2 JP 6176849B2
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antibody
preparation
protein
arginine
present
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JPWO2013012022A1 (ja
Inventor
大介 亀岡
大介 亀岡
誠也 安武
誠也 安武
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Chugai Pharmaceutical Co Ltd
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Chugai Pharmaceutical Co Ltd
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    • 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
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [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 cytokines, lymphokines, interferons
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
JP2013524738A 2011-07-19 2012-07-19 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤 Active JP6176849B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2011157654 2011-07-19
JP2011157654 2011-07-19
PCT/JP2012/068276 WO2013012022A1 (ja) 2011-07-19 2012-07-19 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤

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JPWO2013012022A1 JPWO2013012022A1 (ja) 2015-02-23
JP6176849B2 true JP6176849B2 (ja) 2017-08-09

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JP2017115935A Active JP6469765B2 (ja) 2011-07-19 2017-06-13 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤

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US (2) US9574005B2 (2)
EP (1) EP2735315B1 (2)
JP (2) JP6176849B2 (2)
WO (1) WO2013012022A1 (2)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9574005B2 (en) 2011-07-19 2017-02-21 Chugai Seiyaku Kabushiki Kaisha Stable Protein-containing preparation containing argininamide or analogous compound thereof
UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
EP3062814A1 (en) * 2013-10-29 2016-09-07 Albumedix A/S Antibody composition
BR112016014824A2 (pt) * 2013-12-27 2017-09-19 Chugai Pharmaceutical Co Ltd Método para purificar anticorpo que tem ponto isoelétrico baixo
TWI694836B (zh) * 2014-05-16 2020-06-01 英商葛蘭素史克智慧財產管理有限公司 抗體調配物
AU2015335743B2 (en) 2014-10-23 2020-12-24 Amgen Inc. Reducing viscosity of pharmaceutical formulations
AR104050A1 (es) * 2015-03-26 2017-06-21 Chugai Pharmaceutical Co Ltd Proceso de producción con iones de cobre controlados
KR20170134748A (ko) 2015-04-14 2017-12-06 추가이 세이야쿠 가부시키가이샤 Il-31 안타고니스트를 유효 성분으로서 함유하는 아토피성 피부염의 예방용 및/또는 치료용 의약 조성물
TW201726111A (zh) * 2015-09-30 2017-08-01 持田製藥股份有限公司 含高濃度抗體之液體製劑
JP7541810B2 (ja) 2016-03-03 2024-08-29 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 Angptl3阻害剤と組み合わせてpcsk9阻害剤を投与することにより高脂血症を有する患者を処置するための方法
JP7377596B2 (ja) * 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法
EA201992570A1 (ru) 2017-04-28 2020-03-20 Эмджен Инк. Составы на основе человеческих антител к rankl, а также способы их применения
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
AU2018263868A1 (en) 2017-05-02 2019-12-12 Merck Sharp & Dohme Llc Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies
US11103552B2 (en) 2018-05-10 2021-08-31 Regeneron Pharmaceuticals, Inc. High concentration VEGF receptor fusion protein containing formulations
KR102885113B1 (ko) 2018-10-18 2025-11-13 머크 샤프 앤드 돔 엘엘씨 항-rsv 항체의 제제 및 그의 사용 방법
CN120842406A (zh) 2018-10-31 2025-10-28 默沙东有限责任公司 抗人pd-1抗体晶体及其使用方法
CN113316458B (zh) 2018-11-07 2024-08-02 默沙东有限责任公司 抗lag3抗体和抗pd-1抗体的共制剂
US12559551B2 (en) * 2019-05-24 2026-02-24 Regeneron Pharmaceuticals, Inc. Stabilized formulations containing anti-ANGPTL3 antibodies
EP3763356A1 (en) * 2019-07-12 2021-01-13 Ludwig-Maximilians-Universität München Excipient for biotherapeutics
CN114728064B (zh) * 2019-11-20 2025-05-06 中外制药株式会社 含抗体制剂
JP2025078889A (ja) * 2022-02-03 2025-05-21 天野エンザイム株式会社 酵素製剤
TW202602486A (zh) 2024-03-07 2026-01-16 瑞士商Csl貝林股份有限公司 免疫球蛋白組成物及產生氣溶膠之方法

Family Cites Families (50)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS58201994A (ja) 1982-05-21 1983-11-25 Hideaki Hagiwara 抗原特異的ヒト免疫グロブリンの生産方法
JPS6013718A (ja) 1983-07-05 1985-01-24 Chemo Sero Therapeut Res Inst B型肝炎ワクチン
JPS60193925A (ja) * 1984-03-13 1985-10-02 Chemo Sero Therapeut Res Inst 凍結乾燥製剤化ワクチン
US4597966A (en) * 1985-01-09 1986-07-01 Ortho Diagnostic Systems, Inc. Histidine stabilized immunoglobulin and method of preparation
GB8607679D0 (en) 1986-03-27 1986-04-30 Winter G P Recombinant dna product
EP0585287B1 (en) 1990-07-10 1999-10-13 Cambridge Antibody Technology Limited Methods for producing members of specific binding pairs
GB9015198D0 (en) 1990-07-10 1990-08-29 Brien Caroline J O Binding substance
ATE300615T1 (de) 1990-08-29 2005-08-15 Genpharm Int Transgene mäuse fähig zur produktion heterologer antikörper
EP0628639B1 (en) 1991-04-25 1999-06-23 Chugai Seiyaku Kabushiki Kaisha Reconstituted human antibody against human interleukin 6 receptor
AU665025B2 (en) 1991-09-23 1995-12-14 Cambridge Antibody Technology Limited Production of chimeric antibodies - a combinatorial approach
ES2341666T3 (es) 1991-12-02 2010-06-24 Medimmune Limited Produccion de autoanticuerpos de repertorios de segmentos de anticue rpos expresados en la superficie de fagos.
CA2124967C (en) 1991-12-17 2008-04-08 Nils Lonberg Transgenic non-human animals capable of producing heterologous antibodies
JP2942412B2 (ja) * 1991-12-26 1999-08-30 鐘紡株式会社 化粧料
DE69333823T2 (de) 1992-03-24 2006-05-04 Cambridge Antibody Technology Ltd., Melbourn Verfahren zur herstellung von gliedern von spezifischen bindungspaaren
NZ255101A (en) 1992-07-24 1997-08-22 Cell Genesys Inc A yeast artificial chromosome (yac) vector containing an hprt minigene expressible in murine stem cells and genetically modified rodent therefor
CA2161351C (en) 1993-04-26 2010-12-21 Nils Lonberg Transgenic non-human animals capable of producing heterologous antibodies
GB9313509D0 (en) 1993-06-30 1993-08-11 Medical Res Council Chemisynthetic libraries
EP0731842A1 (en) 1993-12-03 1996-09-18 Medical Research Council Recombinant binding proteins and peptides
CA2194907A1 (en) 1994-07-13 1996-02-01 Kouji Matsushima Reshaped human antibody against human interleukin-8
CA2219361C (en) 1995-04-27 2012-02-28 Abgenix, Inc. Human antibodies derived from immunized xenomice
EP0823941A4 (en) 1995-04-28 2001-09-19 Abgenix Inc HUMAN ANTIBODIES DERIVED FROM IMMUNIZED XENO MOUSES
CA2226575C (en) 1995-07-27 2011-10-18 Genentech, Inc. Stabile isotonic lyophilized protein formulation
SK40599A3 (en) 1996-09-26 2000-06-12 Chugai Pharmaceutical Co Ltd Antibody against human parathormone related peptides
UA76934C2 (en) 1996-10-04 2006-10-16 Chugai Pharmaceutical Co Ltd Reconstructed human anti-hm 1.24 antibody, coding dna, vector, host cell, method for production of reconstructed human antibody, pharmaceutical composition and drug for treating myeloma containing reconstructed human anti-hm 1.24 antibody
US6677436B1 (en) 1998-04-03 2004-01-13 Chugai Seiyaku Kabushiki Kaisha Humanized antibody against human tissue factor (TF) and process of production of the humanized antibody
TWI242043B (en) 2000-03-10 2005-10-21 Chugai Pharmaceutical Co Ltd Polypeptide inducing apoptosis
US8632778B2 (en) 2000-08-11 2014-01-21 Chugai Seiyaku Kabushiki Kaisha Stabilized anti-interleukin-6 antibody-containing preparations
WO2002033072A1 (fr) 2000-10-20 2002-04-25 Chugai Seiyaku Kabushiki Kaisha Anticorps degrade, agoniste de tpo
JP5052736B2 (ja) 2001-05-30 2012-10-17 中外製薬株式会社 タンパク質製剤
AU2003211990A1 (en) 2002-02-14 2003-09-04 Chugai Seiyaku Kabushiki Kaisha Antibody-containing solution pharmaceuticals
JP4083634B2 (ja) 2002-07-11 2008-04-30 旭化成ファーマ株式会社 光に安定なカルシトニン水溶液
JP3976257B2 (ja) * 2002-09-17 2007-09-12 栄研化学株式会社 蛋白質の安定化方法
US20050158303A1 (en) 2003-04-04 2005-07-21 Genentech, Inc. Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations
ATE490787T1 (de) 2003-07-15 2010-12-15 Chugai Pharmaceutical Co Ltd Produktion von igm durch transformierte zellen und verfahren zur quantifizierung dieser igm- produktion
KR101367544B1 (ko) * 2005-06-10 2014-02-26 추가이 세이야쿠 가부시키가이샤 메글루민을 함유하는 단백질 제제의 안정화제, 및 그의이용
BRPI0620316A2 (pt) 2005-12-21 2011-11-08 Wyeth Corp formulações de proteìnas com viscosidades reduzida e seus usos
CA2638811A1 (en) 2006-02-03 2007-08-16 Medimmune, Llc Protein formulations
ES2892925T3 (es) 2006-03-31 2022-02-07 Chugai Pharmaceutical Co Ltd Métodos para controlar la farmacocinética en sangre de anticuerpos
JP2007332093A (ja) 2006-06-16 2007-12-27 Apro Life Science Institute Inc タンパク質のリフォールディング添加剤及びそれを用いたタンパク質の再生方法
CA2674608A1 (en) * 2007-01-09 2008-07-17 Wyeth Anti-il-13 antibody formulations and uses thereof
CA2682292A1 (en) * 2007-03-30 2008-10-09 Medimmune, Llc Aqueous formulation comprising an anti-human interferon alpha antibody
JP5119545B2 (ja) * 2007-06-19 2013-01-16 国立大学法人 筑波大学 蛋白質を含む液状組成物中における蛋白質の安定化方法
AU2008304748C1 (en) 2007-09-26 2014-06-12 Chugai Seiyaku Kabushiki Kaisha Modified antibody constant region
EP2206775B1 (en) 2007-09-26 2016-06-29 Chugai Seiyaku Kabushiki Kaisha Anti-il-6 receptor antibody
CA2708532C (en) 2007-12-05 2018-06-05 Chugai Seiyaku Kabushiki Kaisha Anti-il31ra antibody and use thereof
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
WO2009104369A1 (ja) 2008-02-22 2009-08-27 パナソニック株式会社 血漿に含まれる成分の検出方法ならびにそれに用いられる試薬および検出デバイス
AR080428A1 (es) 2010-01-20 2012-04-11 Chugai Pharmaceutical Co Ltd Formulaciones liquidas estabilizadas contentivas de anticuerpos
KR20130060227A (ko) * 2010-05-03 2013-06-07 제넨테크, 인크. 단백질-함유 제제의 점도 감소에 유용한 조성물 및 방법
US9574005B2 (en) 2011-07-19 2017-02-21 Chugai Seiyaku Kabushiki Kaisha Stable Protein-containing preparation containing argininamide or analogous compound thereof

Also Published As

Publication number Publication date
JP6469765B2 (ja) 2019-02-13
JP2017222654A (ja) 2017-12-21
EP2735315A4 (en) 2014-12-24
EP2735315A1 (en) 2014-05-28
US9574005B2 (en) 2017-02-21
WO2013012022A1 (ja) 2013-01-24
US10898572B2 (en) 2021-01-26
US20140206845A1 (en) 2014-07-24
US20170112930A1 (en) 2017-04-27
EP2735315B1 (en) 2019-10-02
JPWO2013012022A1 (ja) 2015-02-23

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