JP6265970B2 - 安定なIgG4に基づく結合剤の製剤 - Google Patents

安定なIgG4に基づく結合剤の製剤 Download PDF

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Publication number
JP6265970B2
JP6265970B2 JP2015503464A JP2015503464A JP6265970B2 JP 6265970 B2 JP6265970 B2 JP 6265970B2 JP 2015503464 A JP2015503464 A JP 2015503464A JP 2015503464 A JP2015503464 A JP 2015503464A JP 6265970 B2 JP6265970 B2 JP 6265970B2
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Prior art keywords
antibody
formulation
cxcr5
light
amino acid
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Japanese (ja)
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JP2015514090A5 (https=
JP2015514090A (ja
Inventor
ジュリア・シュニーダース
ダーク・ユーズナー
アーメド・ユーセフ
アンニカ・ハーゲンドルフ
マーティナ・カーシュ
サブリーナ・ラッゲバーグ
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Sanofi SA
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Sanofi SA
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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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • 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
    • C07K16/2875Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • 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)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Rheumatology (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2015503464A 2012-03-26 2013-03-26 安定なIgG4に基づく結合剤の製剤 Active JP6265970B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201261615539P 2012-03-26 2012-03-26
US61/615,539 2012-03-26
FR1351013 2013-02-06
FR1351013 2013-02-06
PCT/US2013/033881 WO2013148686A2 (en) 2012-03-26 2013-03-26 Stable igg4 binding agent formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2017205914A Division JP6820823B2 (ja) 2012-03-26 2017-10-25 安定なIgG4に基づく結合剤の製剤

Publications (3)

Publication Number Publication Date
JP2015514090A JP2015514090A (ja) 2015-05-18
JP2015514090A5 JP2015514090A5 (https=) 2016-03-17
JP6265970B2 true JP6265970B2 (ja) 2018-01-24

Family

ID=49261390

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2015503464A Active JP6265970B2 (ja) 2012-03-26 2013-03-26 安定なIgG4に基づく結合剤の製剤

Country Status (7)

Country Link
EP (3) EP4527855A3 (https=)
JP (1) JP6265970B2 (https=)
BR (2) BR122019026701B1 (https=)
CA (3) CA3123252C (https=)
PL (1) PL2830658T3 (https=)
RU (1) RU2644214C2 (https=)
WO (1) WO2013148686A2 (https=)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
LT3297653T (lt) 2015-05-22 2022-01-10 The Board Of Trustees Of The Leland Stanford Junior University Postbariatrinės hipoglikemijos gydymas glp-1 antagonistais
GB201608323D0 (en) * 2016-05-12 2016-06-29 Ucb Biopharma Sprl Pharmaceutical compositions
CN107446044B (zh) * 2016-05-30 2021-04-30 越海百奥药业(绍兴)有限公司 一种纯化抗体的方法及所用缓冲液
CN115998858A (zh) 2016-07-05 2023-04-25 赛诺菲 抗体制剂
TWI760345B (zh) * 2016-07-05 2022-04-11 法商賽諾菲公司 抗體調配物
KR20190079662A (ko) * 2016-11-11 2019-07-05 바이엘 악티엔게젤샤프트 연속적 유동 내의 오염물을 모니터링하기 위한 유체 스트림의 샘플링 방법
LT3541366T (lt) * 2016-11-21 2025-03-10 Amylyx Pharmaceuticals, Inc. Eksendino (9-39) buferiniai preparatai
GB201701194D0 (en) 2017-01-24 2017-03-08 Capella Bioscience Ltd Antigen binding molecules that bind light
TWI761453B (zh) 2017-03-01 2022-04-21 英商梅迪繆思有限公司 抗rsv單株抗體配製物
BR112019018022A2 (pt) * 2017-03-01 2020-06-02 Medimmune Limited Formulações de anticorpos monoclonais
GB201708655D0 (en) * 2017-05-31 2017-07-12 Ucb Biopharma Sprl Cell culture methods
US11312781B2 (en) 2018-01-24 2022-04-26 Capella Bioscience Ltd. Antigen binding molecules that bind LIGHT
JP2024502825A (ja) * 2020-12-30 2024-01-23 エーマックス バイオ, インコーポレイテッド 抗体の局所的延長放出

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2966592B2 (ja) * 1991-07-20 1999-10-25 萩原 義秀 安定化されたヒトモノクローナル抗体製剤
US5869619A (en) 1991-12-13 1999-02-09 Xoma Corporation Modified antibody variable domains
CN101721362B (zh) * 2002-02-14 2018-07-03 中外制药株式会社 包含抗体的溶液制剂
US8658773B2 (en) * 2011-05-02 2014-02-25 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
DK2236154T3 (en) * 2003-02-10 2018-06-25 Biogen Ma Inc IMMUNOGLOBULIN INFORMATION AND METHOD OF PREPARING IT
EP1532983A1 (en) * 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
TW200621282A (en) * 2004-08-13 2006-07-01 Wyeth Corp Stabilizing formulations
WO2006042333A2 (en) 2004-10-12 2006-04-20 Xencor, Inc. Prediction and assessment of immunogenicity
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
WO2007074880A1 (ja) * 2005-12-28 2007-07-05 Chugai Seiyaku Kabushiki Kaisha 抗体含有安定化製剤
AR060487A1 (es) * 2006-04-21 2008-06-18 Xoma Technology Ltd Composiciones farmaceuticas de antagonistas del anticuerpo anti- cd40
AU2007290570C1 (en) 2006-08-28 2013-08-15 Kyowa Kirin Co., Ltd. Antagonistic human LIGHT-specific human monoclonal antibodies
CL2007003583A1 (es) * 2006-12-11 2008-07-18 Hoffmann La Roche Formulacion farmaceutica estable, parenteral, del anticuerpo contra el peptido beta amiloide (abeta); y uso de la formulacion para el tratamiento de la enfermedad de alzheimer.
US20090208492A1 (en) * 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
MX338397B (es) 2007-08-29 2016-04-15 Sanofi Aventis Anticuerpos anti - cxcr5 humanizados, derivados de los mismos y su uso.

Also Published As

Publication number Publication date
EP2830658A2 (en) 2015-02-04
CA3123252C (en) 2023-08-22
WO2013148686A3 (en) 2013-11-28
CA2868401C (en) 2021-08-24
BR122019026701B1 (pt) 2023-01-24
CA3204402A1 (en) 2013-10-03
WO2013148686A2 (en) 2013-10-03
JP2015514090A (ja) 2015-05-18
BR112014023952B1 (pt) 2023-01-24
RU2014142990A (ru) 2016-05-20
BR112014023952A2 (pt) 2017-07-18
CA3123252A1 (en) 2013-10-03
EP4527855A3 (en) 2025-06-11
EP3431104A1 (en) 2019-01-23
PL2830658T3 (pl) 2019-02-28
EP4527855A2 (en) 2025-03-26
RU2644214C2 (ru) 2018-02-08
CA2868401A1 (en) 2013-10-03
EP2830658B1 (en) 2018-10-10

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