JP2013528570A - 安定化された抗体調製物およびその使用 - Google Patents

安定化された抗体調製物およびその使用 Download PDF

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Publication number
JP2013528570A
JP2013528570A JP2013502023A JP2013502023A JP2013528570A JP 2013528570 A JP2013528570 A JP 2013528570A JP 2013502023 A JP2013502023 A JP 2013502023A JP 2013502023 A JP2013502023 A JP 2013502023A JP 2013528570 A JP2013528570 A JP 2013528570A
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antibody
intact antibody
compound
formulation
region
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Japanese (ja)
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JP2013528570A5 (enExample
Inventor
グルニ、ロベール
スキャポッツァ、レオナルド
ウェステルメール、イボンヌ
フェウリンク、マリエケ
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ユニベルシテ ドゥ ジュネーブ
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Publication of JP2013528570A5 publication Critical patent/JP2013528570A5/ja
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    • 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
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0048Eye, e.g. artificial tears
    • 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
    • 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
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/02Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • 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
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • 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
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • 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
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • 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
    • C07K16/22Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Virology (AREA)
  • Dermatology (AREA)
  • Pulmonology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Rheumatology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Transplantation (AREA)
  • Pain & Pain Management (AREA)
  • Urology & Nephrology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2013502023A 2010-03-31 2011-03-31 安定化された抗体調製物およびその使用 Pending JP2013528570A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US31931310P 2010-03-31 2010-03-31
US61/319,313 2010-03-31
PCT/IB2011/051373 WO2011121560A2 (en) 2010-03-31 2011-03-31 Stabilized antibody preparations and uses thereof

Publications (2)

Publication Number Publication Date
JP2013528570A true JP2013528570A (ja) 2013-07-11
JP2013528570A5 JP2013528570A5 (enExample) 2014-04-24

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JP2013502023A Pending JP2013528570A (ja) 2010-03-31 2011-03-31 安定化された抗体調製物およびその使用

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US (1) US20130028920A1 (enExample)
EP (1) EP2552482A2 (enExample)
JP (1) JP2013528570A (enExample)
CA (1) CA2794631A1 (enExample)
WO (1) WO2011121560A2 (enExample)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013523717A (ja) * 2010-03-31 2013-06-17 ユニベルシテ ドゥ ジュネーブ 安定化された抗体調製物およびその使用
JP2016530319A (ja) * 2013-09-11 2016-09-29 アーシア セラピューティクス, インコーポレイテッド 有機ホスフェートを含有する液状タンパク質製剤
US11471479B2 (en) 2014-10-01 2022-10-18 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents

Families Citing this family (8)

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Publication number Priority date Publication date Assignee Title
US9155745B2 (en) 2009-06-16 2015-10-13 Universite De Geneve Bevacizumab formulations with lower aggregation propensity, comprising corticosteroid anti-inflammatory drugs
US20130090375A1 (en) * 2011-10-06 2013-04-11 Cornell University Virus-mediated delivery of bevacizumab for therapeutic applications
US9593137B2 (en) 2011-12-22 2017-03-14 Geron Corporation Guanine analogs as telomerase substrates and telomere length affectors
FR2995214B1 (fr) 2012-09-10 2014-11-21 Adocia Solution a viscosite reduite de proteine a concentration elevee
EP3617235A4 (en) * 2017-04-28 2020-12-16 Ajinomoto Co., Inc. COMPOUND CONTAINING A SUBSTANCE HAVING AFFINITY FOR A SOLUBLE PROTEIN, CLIVABLE FRACTION, AND REACTIVE GROUP, OR SALT OF THE SAME
EP3624846B1 (en) 2017-05-16 2024-08-07 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity including a combination of nicotinic acid and tryoptophan
WO2019018747A1 (en) * 2017-07-20 2019-01-24 Trustees Of Boston University DETECTION ASSAY OF TENOFOVIR
BR112020026348A2 (pt) 2018-08-30 2021-03-30 Regeneron Pharmaceuticals, Inc. Método para avaliar a estequiometria e distribuição de tamanho de complexos de proteínas, para selecionar um medicamento de proteína principal e para caracterizar complexos de proteínas, e, composição farmacêutica

Citations (2)

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JP2005503999A (ja) * 2001-01-31 2005-02-10 アイデック ファーマスーティカルズ コーポレイション 腫瘍性疾患の治療のためのcd23拮抗剤の使用
JP2013523717A (ja) * 2010-03-31 2013-06-17 ユニベルシテ ドゥ ジュネーブ 安定化された抗体調製物およびその使用

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DE3064888D1 (en) 1979-04-30 1983-10-27 Hoechst Ag Aqueous solutions of proteins stable against denaturization, process for their manufacture, and their utilization
US4362661A (en) 1979-08-09 1982-12-07 Teijin Limited Immunoglobulin composition having a high monomer content, and process for production thereof
AU3722984A (en) 1984-01-05 1985-07-11 Manlab Pty. Ltd. Reagents for immunoassay at elevated temperatures
US4808705A (en) 1986-12-19 1989-02-28 Cetus Corporation Stable formulations of ricin toxin a chain and of RTA-immunoconjugates and stabilizer screening methods therefor
AU2003219664A1 (en) * 2002-01-16 2003-09-02 Eliezer Rapaport Methods and therapeutic compositions in the treatment of advanced cancer
CA2512174A1 (en) * 2003-01-30 2004-08-12 Christian B. Allan Anti-integrin .alpha..nu..beta.3 antibody formulations and uses thereof
WO2004068115A2 (en) * 2003-01-30 2004-08-12 Bellbrook Labs, Llc Assay method for group transfer reactions
EP1532983A1 (en) 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
MX2007016306A (es) * 2005-06-15 2008-03-07 Schering Corp Formulaciones de anticuerpo anti-igf1r.
BRPI0717760A2 (pt) * 2006-10-17 2013-11-12 Dyax Corp Métodos para tratar um distúrbio relacionados à angiogênese, para prover uma terapia adjuvante pós-operatória, para sensibilizar a vasculatura tumoral a um decréscimo no vegf, para inibir o recrescimento tumoral em um indivíduo e para reduzir a freqüência de administração do agente de quimioterapia ou da radiação a um indivíduo, e, kit
WO2009009523A2 (en) * 2007-07-09 2009-01-15 Genentech, Inc. Prevention of disulfide bond reduction during recombinant production of polypeptides
WO2010132047A1 (en) * 2009-05-14 2010-11-18 Rensselaer Polytechnic Institute Guanosine/gmp gels and uses thereof

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JP2005503999A (ja) * 2001-01-31 2005-02-10 アイデック ファーマスーティカルズ コーポレイション 腫瘍性疾患の治療のためのcd23拮抗剤の使用
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Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013523717A (ja) * 2010-03-31 2013-06-17 ユニベルシテ ドゥ ジュネーブ 安定化された抗体調製物およびその使用
JP2016530319A (ja) * 2013-09-11 2016-09-29 アーシア セラピューティクス, インコーポレイテッド 有機ホスフェートを含有する液状タンパク質製剤
JP2018199735A (ja) * 2013-09-11 2018-12-20 イーグル バイオロジクス, インコーポレイテッド 有機ホスフェートを含有する液状タンパク質製剤
US10179172B2 (en) 2013-09-11 2019-01-15 Eagle Biologics, Inc. Liquid pharmaceutical formulations for injection comprising yellow 5 or orange G and uses thereof
JP2019178176A (ja) * 2013-09-11 2019-10-17 イーグル バイオロジクス, インコーポレイテッド 有機ホスフェートを含有する液状タンパク質製剤
US10646571B2 (en) 2013-09-11 2020-05-12 Eagle Biologics, Inc. Liquid protein formulations containing cimetidine
US10821183B2 (en) 2013-09-11 2020-11-03 Eagle Biologics, Inc. Liquid protein formulations containing 4-(3-butyl-1-imidazolio)-1-butane sulfonate (BIM)
US10821184B2 (en) 2013-09-11 2020-11-03 Eagle Biologics, Inc. Liquid protein formulations containing thiamine pyrophosphate (TPP)
US10849977B2 (en) 2013-09-11 2020-12-01 Eagle Biologics, Inc. Liquid Protein Formulations Containing Thiamine
US11819550B2 (en) 2013-09-11 2023-11-21 Eagle Biologics, Inc. Liquid protein formulations containing cyclic adenosine monophosphate (cAMP) or adenosine triphosphate (ATP)
US11986526B2 (en) 2013-09-11 2024-05-21 Eagle Biologics, Inc. Liquid protein formulations containing 4-ethyl-4-methylmorpholinium methylcarbonate (EMMC)
US11471479B2 (en) 2014-10-01 2022-10-18 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents

Also Published As

Publication number Publication date
US20130028920A1 (en) 2013-01-31
EP2552482A2 (en) 2013-02-06
WO2011121560A3 (en) 2012-03-01
CA2794631A1 (en) 2011-10-06
WO2011121560A2 (en) 2011-10-06

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