DOP2009000222A - Formulaciones estables de anticuerpo - Google Patents

Formulaciones estables de anticuerpo

Info

Publication number
DOP2009000222A
DOP2009000222A DO2009000222A DO2009000222A DOP2009000222A DO P2009000222 A DOP2009000222 A DO P2009000222A DO 2009000222 A DO2009000222 A DO 2009000222A DO 2009000222 A DO2009000222 A DO 2009000222A DO P2009000222 A DOP2009000222 A DO P2009000222A
Authority
DO
Dominican Republic
Prior art keywords
antibody
formulations
insulin
receptor
stabilization
Prior art date
Application number
DO2009000222A
Other languages
English (en)
Inventor
Arvind Srivastava
Joel Goldstein
Original Assignee
Imclone Llc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Imclone Llc filed Critical Imclone Llc
Publication of DOP2009000222A publication Critical patent/DOP2009000222A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La presente invencion se refiere a formulaciones y metodos para la estabilización de anticuerpos. En una modalidad, la invencion proporciona la formulación de solución estable de un anticuerpo IgG1 que se enlaza especificamente al receptor del factor-I similar a la insulina. En otra modalidad, la invencion proporciona metodos para estabilización de anticuerpo IgGl que se enlazan especificamente al receptor del factor-I de crecimiento similar a la insulina que comprende, liofilizar una formulación acuosa del anticuerpo. Las formulaciones pueden ser liofilizadas para estabilizar los anticuerpos durante el procesamiento y almacenaje, y despues las formulaciones pueden ser reconstituidas para administración farmaceutica.
DO2009000222A 2007-03-22 2009-09-18 Formulaciones estables de anticuerpo DOP2009000222A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US91974407P 2007-03-22 2007-03-22

Publications (1)

Publication Number Publication Date
DOP2009000222A true DOP2009000222A (es) 2009-12-15

Family

ID=39766776

Family Applications (1)

Application Number Title Priority Date Filing Date
DO2009000222A DOP2009000222A (es) 2007-03-22 2009-09-18 Formulaciones estables de anticuerpo

Country Status (18)

Country Link
US (1) US20100260766A1 (es)
EP (1) EP2136839A4 (es)
JP (1) JP2010522208A (es)
KR (1) KR20090113340A (es)
CN (1) CN101668540A (es)
AU (1) AU2008228823A1 (es)
BR (1) BRPI0809112A2 (es)
CA (1) CA2681743A1 (es)
CR (1) CR11005A (es)
DO (1) DOP2009000222A (es)
EA (1) EA200970880A1 (es)
EC (1) ECSP099642A (es)
IL (1) IL200321A0 (es)
MX (1) MX2009010179A (es)
TN (1) TN2009000382A1 (es)
UA (1) UA96473C2 (es)
WO (1) WO2008116103A2 (es)
ZA (1) ZA200905636B (es)

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US20160355591A1 (en) 2011-05-02 2016-12-08 Immunomedics, Inc. Subcutaneous anti-hla-dr monoclonal antibody for treatment of hematologic malignancies
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JP6113404B2 (ja) 2008-10-29 2017-04-12 アブリンクス エン．ヴェー． 単一ドメイン抗原結合分子の精製方法
CN104740631B (zh) 2008-10-29 2019-04-16 阿布林克斯公司 单域抗原结合性分子的制剂
BRPI0921845A2 (pt) * 2008-11-12 2019-09-17 Medimmune Llc formulação aquosa estéril estável, forma de dosagem unitária farmacêutica, seringa pré-carregada, e, métodos para tratar uma doença ou distúrbio, para tratar ou prevenir rejeição, para esgotar células t que expressam icos em um paciente humano, e para interromper arquitetura central germinal em um órgão linfóide secundário de um primata
EP2196476A1 (en) * 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
PE20120415A1 (es) 2008-12-12 2012-05-09 Boehringer Ingelheim Int Anticuerpos anti-igf
TWI609698B (zh) 2010-01-20 2018-01-01 Chugai Pharmaceutical Co Ltd 穩定化的含抗體溶液製劑
WO2012028683A1 (en) 2010-09-02 2012-03-08 Novartis Ag Antibody gel system for sustained drug delivery
CN103282042B (zh) * 2010-09-17 2014-12-10 巴克斯特国际公司 通过具有组氨酸的水性制剂在弱酸性至中性pH稳定的免疫球蛋白
EP3111954B1 (en) 2010-11-05 2019-04-03 Novartis Ag Methods of treating ankylosing spondylitis using anti-il-17 antibodies
CA2831572C (en) 2011-05-02 2019-11-26 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
EA034347B1 (ru) * 2011-10-26 2020-01-30 Амген Инк. Способ инактивации вирусов при получении антител
KR101600733B1 (ko) 2011-10-28 2016-03-09 프로테나 바이오사이언시즈 리미티드 알파-시누클레인을 인식하는 인간화된 항체
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AR094821A1 (es) * 2012-07-25 2015-09-02 Hanmi Pharm Ind Co Ltd Formulación líquida de un conjugado de péptido insulinotrópico de acción prolongada
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UA118441C2 (uk) 2012-10-08 2019-01-25 Протена Біосаєнсиз Лімітед Антитіло, що розпізнає альфа-синуклеїн
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US9700485B2 (en) 2013-04-24 2017-07-11 Corning Incorporated Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
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US10513555B2 (en) 2013-07-04 2019-12-24 Prothena Biosciences Limited Antibody formulations and methods
US9732154B2 (en) 2014-02-28 2017-08-15 Janssen Biotech, Inc. Anti-CD38 antibodies for treatment of acute lymphoblastic leukemia
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CA2944402A1 (en) 2014-04-08 2015-10-15 Prothena Biosciences Limited Blood-brain barrier shuttles containing antibodies recognizing alpha-synuclein
CA2973423C (en) * 2015-02-09 2023-09-05 Ucb Biopharma Sprl Pharmaceutical formulation
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MA43187B1 (fr) 2015-11-03 2021-02-26 Janssen Biotech Inc Formulations sous-cutanée d'anticorps anti-cd38 et leurs utilisations
JP6992262B2 (ja) * 2016-03-31 2022-02-15 東ソー株式会社 変性抗体測定試薬の製造方法
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Also Published As

Publication number Publication date
AU2008228823A1 (en) 2008-09-25
CA2681743A1 (en) 2008-09-25
CN101668540A (zh) 2010-03-10
MX2009010179A (es) 2010-03-15
KR20090113340A (ko) 2009-10-29
ECSP099642A (es) 2009-11-30
EP2136839A4 (en) 2010-04-07
CR11005A (es) 2010-08-05
EA200970880A1 (ru) 2010-02-26
WO2008116103A3 (en) 2009-01-08
JP2010522208A (ja) 2010-07-01
EP2136839A2 (en) 2009-12-30
BRPI0809112A2 (pt) 2014-08-26
TN2009000382A1 (en) 2010-12-31
UA96473C2 (ru) 2011-11-10
WO2008116103A2 (en) 2008-09-25
ZA200905636B (en) 2010-10-27
IL200321A0 (en) 2010-04-29
US20100260766A1 (en) 2010-10-14

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