JP2010522208A - 安定な抗体処方物 - Google Patents

安定な抗体処方物 Download PDF

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Publication number
JP2010522208A
JP2010522208A JP2009554753A JP2009554753A JP2010522208A JP 2010522208 A JP2010522208 A JP 2010522208A JP 2009554753 A JP2009554753 A JP 2009554753A JP 2009554753 A JP2009554753 A JP 2009554753A JP 2010522208 A JP2010522208 A JP 2010522208A
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JP
Japan
Prior art keywords
imc
formulation
antibody
concentration
liquid formulation
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Pending
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JP2009554753A
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English (en)
Japanese (ja)
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JP2010522208A5 (OSRAM
Inventor
アービンド・スリバスタバ
ジョエル・ゴールドスタイン
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ImClone LLC
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ImClone LLC
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Publication of JP2010522208A publication Critical patent/JP2010522208A/ja
Publication of JP2010522208A5 publication Critical patent/JP2010522208A5/ja
Pending legal-status Critical Current

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    • 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

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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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (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)
JP2009554753A 2007-03-22 2008-03-20 安定な抗体処方物 Pending JP2010522208A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US91974407P 2007-03-22 2007-03-22
PCT/US2008/057718 WO2008116103A2 (en) 2007-03-22 2008-03-20 Stable antibody formulations

Publications (2)

Publication Number Publication Date
JP2010522208A true JP2010522208A (ja) 2010-07-01
JP2010522208A5 JP2010522208A5 (OSRAM) 2011-04-28

Family

ID=39766776

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2009554753A Pending JP2010522208A (ja) 2007-03-22 2008-03-20 安定な抗体処方物

Country Status (18)

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

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016520075A (ja) * 2013-05-17 2016-07-11 アブリンクス エン．ヴェー． 免疫グロブリン単一可変ドメインの安定製剤及びその使用
JP2017071631A (ja) * 2010-09-17 2017-04-13 バクスアルタ ゲーエムベーハー 弱酸性〜中性のｐＨにおける、ヒスチジンを有する水性製剤を介した免疫グロブリンの安定化
JP2017184730A (ja) * 2016-03-31 2017-10-12 東ソー株式会社 変性抗体測定試薬の製造方法
CN108472369A (zh) * 2015-11-03 2018-08-31 詹森生物科技公司 抗cd38抗体的皮下制剂及其用途

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US20160279239A1 (en) 2011-05-02 2016-09-29 Immunomedics, Inc. Subcutaneous administration of anti-cd74 antibody for systemic lupus erythematosus and autoimmune disease
US20160355591A1 (en) 2011-05-02 2016-12-08 Immunomedics, Inc. Subcutaneous anti-hla-dr monoclonal antibody for treatment of hematologic malignancies
TW200838559A (en) * 2006-11-29 2008-10-01 Imclone Systems Inc Insulin-like growth factor-1 receptor antagonists for modulation of weight and liposity
PE20090368A1 (es) 2007-06-19 2009-04-28 Boehringer Ingelheim Int Anticuerpos anti-igf
EP4104821A1 (en) * 2008-10-29 2022-12-21 Ablynx N.V. Formulations of single domain antigen binding molecules
CA2739352C (en) 2008-10-29 2021-07-13 Wyeth Llc Methods for purification of single domain antigen binding molecules
CN102438652B (zh) * 2008-11-12 2014-08-13 米迪缪尼有限公司 抗体制剂
EP2196476A1 (en) * 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
RS54423B1 (sr) 2008-12-12 2016-04-28 Boehringer Ingelheim International Gmbh Anti-igf antitela
AR080428A1 (es) 2010-01-20 2012-04-11 Chugai Pharmaceutical Co Ltd Formulaciones liquidas estabilizadas contentivas de anticuerpos
WO2012028683A1 (en) 2010-09-02 2012-03-08 Novartis Ag Antibody gel system for sustained drug delivery
KR20180129991A (ko) 2010-11-05 2018-12-05 노파르티스 아게 Ｉｌ-１７ 길항제를 사용한 류마티스성 관절염의 치료 방법
WO2012151199A1 (en) 2011-05-02 2012-11-08 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
CN104136047B (zh) * 2011-10-26 2018-02-06 安姆根有限公司 减少或消除由暴露于uv光而引起的蛋白质修饰和降解的方法
EP3378535B1 (en) 2011-10-28 2023-01-04 Prothena Biosciences Limited Humanized antibodies that recognize alpha-synuclein
KR102086061B1 (ko) 2012-01-27 2020-03-11 프로테나 바이오사이언시즈 리미티드 알파-시누클레인을 인식하는 인간화된 항체
AR091902A1 (es) * 2012-07-25 2015-03-11 Hanmi Pharm Ind Co Ltd Formulacion liquida de un conjugado de insulina de accion prolongada
AR092862A1 (es) * 2012-07-25 2015-05-06 Hanmi Pharm Ind Co Ltd Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion
AR094821A1 (es) * 2012-07-25 2015-09-02 Hanmi Pharm Ind Co Ltd Formulación líquida de un conjugado de péptido insulinotrópico de acción prolongada
UA118441C2 (uk) 2012-10-08 2019-01-25 Протена Біосаєнсиз Лімітед Антитіло, що розпізнає альфа-синуклеїн
CN104870469A (zh) 2012-12-26 2015-08-26 沃克哈特有限公司 药物组合物
US20140255413A1 (en) 2013-03-07 2014-09-11 Boehringer Ingelheim International Gmbh Combination therapy for neoplasia treatment
US9700485B2 (en) 2013-04-24 2017-07-11 Corning Incorporated Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
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
US9603927B2 (en) 2014-02-28 2017-03-28 Janssen Biotech, Inc. Combination therapies with anti-CD38 antibodies
WO2015155694A1 (en) 2014-04-08 2015-10-15 Prothena Biosciences Limited Blood-brain barrier shuttles containing antibodies recognizing alpha-synuclein
EA202092609A1 (ru) 2014-12-04 2021-10-29 Янссен Байотек, Инк. Антитела к cd38 для лечения острого миелолейкоза
CA2973423C (en) * 2015-02-09 2023-09-05 Ucb Biopharma Sprl Pharmaceutical formulation
CN108136218B (zh) 2015-05-20 2022-12-13 詹森生物科技公司 用于治疗轻链淀粉样变性及其它cd38阳性血液恶性肿瘤的抗cd38抗体
AR104847A1 (es) * 2015-06-17 2017-08-16 Lilly Co Eli Formulación de anticuerpo anti-cgrp
US20170044265A1 (en) 2015-06-24 2017-02-16 Janssen Biotech, Inc. Immune Modulation and Treatment of Solid Tumors with Antibodies that Specifically Bind CD38
EP3606964A4 (en) 2017-04-03 2020-12-09 Immunomedics, Inc. SUBCUTANE ADMINISTRATION OF ANTIBODY DRUG CONJUGATES FOR CANCER THERAPY
JP2021502961A (ja) 2017-10-31 2021-02-04 ヤンセン バイオテツク，インコーポレーテツド 高リスク多発性骨髄腫の治療方法
JP7266108B2 (ja) 2019-02-18 2023-04-27 イーライ リリー アンド カンパニー 治療用抗体製剤
CN112206320B (zh) * 2019-07-12 2025-02-25 鲁南制药集团股份有限公司 一种cd47单克隆抗体冻干粉制剂及其制备工艺
CN113967195A (zh) * 2020-07-22 2022-01-25 三生国健药业（上海）股份有限公司 抗her2/pd1双特异性抗体冻干制剂及其制备方法

Citations (6)

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JPH0565233A (ja) * 1991-03-08 1993-03-19 Mitsui Toatsu Chem Inc モノクローナル抗体含有凍結乾燥製剤
JP2004292455A (ja) * 2002-02-14 2004-10-21 Chugai Pharmaceut Co Ltd 抗体含有溶液製剤
JP2004538287A (ja) * 2001-07-25 2004-12-24 プロテイン デザイン ラブス インコーポレイティド ＩｇＧ抗体の安定な凍結乾燥医薬製剤
WO2005016970A2 (en) * 2003-05-01 2005-02-24 Imclone Systems Incorporated Fully human antibodies directed against the human insulin-like growth factor-1 receptor
JP2006517581A (ja) * 2003-02-13 2006-07-27 ファイザー・プロダクツ・インク 抗インスリン様増殖因子ｉ受容体抗体の使用
WO2006138315A2 (en) * 2005-06-15 2006-12-28 Schering Corporation Anti-igf1r antibody formulations

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AR046071A1 (es) * 2003-07-10 2005-11-23 Hoffmann La Roche Anticuerpos contra el receptor i del factor de crecimiento de tipo insulinico y los usos de los mismos
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Patent Citations (6)

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Publication number Priority date Publication date Assignee Title
JPH0565233A (ja) * 1991-03-08 1993-03-19 Mitsui Toatsu Chem Inc モノクローナル抗体含有凍結乾燥製剤
JP2004538287A (ja) * 2001-07-25 2004-12-24 プロテイン デザイン ラブス インコーポレイティド ＩｇＧ抗体の安定な凍結乾燥医薬製剤
JP2004292455A (ja) * 2002-02-14 2004-10-21 Chugai Pharmaceut Co Ltd 抗体含有溶液製剤
JP2006517581A (ja) * 2003-02-13 2006-07-27 ファイザー・プロダクツ・インク 抗インスリン様増殖因子ｉ受容体抗体の使用
WO2005016970A2 (en) * 2003-05-01 2005-02-24 Imclone Systems Incorporated Fully human antibodies directed against the human insulin-like growth factor-1 receptor
WO2006138315A2 (en) * 2005-06-15 2006-12-28 Schering Corporation Anti-igf1r antibody formulations

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017071631A (ja) * 2010-09-17 2017-04-13 バクスアルタ ゲーエムベーハー 弱酸性〜中性のｐＨにおける、ヒスチジンを有する水性製剤を介した免疫グロブリンの安定化
JP2016520075A (ja) * 2013-05-17 2016-07-11 アブリンクス エン．ヴェー． 免疫グロブリン単一可変ドメインの安定製剤及びその使用
JP2019034967A (ja) * 2013-05-17 2019-03-07 アブリンクス エン．ヴェー． 免疫グロブリン単一可変ドメインの安定製剤及びその使用
CN108472369A (zh) * 2015-11-03 2018-08-31 詹森生物科技公司 抗cd38抗体的皮下制剂及其用途
JP2018537525A (ja) * 2015-11-03 2018-12-20 ヤンセン バイオテツク，インコーポレーテツド 抗ｃｄ３８抗体の皮下製剤及びその使用
JP7027321B2 (ja) 2015-11-03 2022-03-01 ヤンセン バイオテツク，インコーポレーテツド 抗ｃｄ３８抗体の皮下製剤及びその使用
JP2022185004A (ja) * 2015-11-03 2022-12-13 ヤンセン バイオテツク，インコーポレーテツド 抗ｃｄ３８抗体の皮下製剤及びその使用
JP7374275B2 (ja) 2015-11-03 2023-11-06 ヤンセン バイオテツク，インコーポレーテツド 抗ｃｄ３８抗体の皮下製剤及びその使用
JP2017184730A (ja) * 2016-03-31 2017-10-12 東ソー株式会社 変性抗体測定試薬の製造方法
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

Also Published As

Publication number Publication date
CN101668540A (zh) 2010-03-10
BRPI0809112A2 (pt) 2014-08-26
ZA200905636B (en) 2010-10-27
EP2136839A2 (en) 2009-12-30
EP2136839A4 (en) 2010-04-07
DOP2009000222A (es) 2009-12-15
ECSP099642A (es) 2009-11-30
US20100260766A1 (en) 2010-10-14
AU2008228823A1 (en) 2008-09-25
UA96473C2 (ru) 2011-11-10
KR20090113340A (ko) 2009-10-29
EA200970880A1 (ru) 2010-02-26
CR11005A (es) 2010-08-05
CA2681743A1 (en) 2008-09-25
WO2008116103A2 (en) 2008-09-25
IL200321A0 (en) 2010-04-29
MX2009010179A (es) 2010-03-15
WO2008116103A3 (en) 2009-01-08
TN2009000382A1 (en) 2010-12-31

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