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 (cg-RX-API-DMAC7.html
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 date
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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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Dermatology (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 (cg-RX-API-DMAC7.html) 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 (cg-RX-API-DMAC7.html)
EP (1) EP2136839A4 (cg-RX-API-DMAC7.html)
JP (1) JP2010522208A (cg-RX-API-DMAC7.html)
KR (1) KR20090113340A (cg-RX-API-DMAC7.html)
CN (1) CN101668540A (cg-RX-API-DMAC7.html)
AU (1) AU2008228823A1 (cg-RX-API-DMAC7.html)
BR (1) BRPI0809112A2 (cg-RX-API-DMAC7.html)
CA (1) CA2681743A1 (cg-RX-API-DMAC7.html)
CR (1) CR11005A (cg-RX-API-DMAC7.html)
DO (1) DOP2009000222A (cg-RX-API-DMAC7.html)
EA (1) EA200970880A1 (cg-RX-API-DMAC7.html)
EC (1) ECSP099642A (cg-RX-API-DMAC7.html)
IL (1) IL200321A0 (cg-RX-API-DMAC7.html)
MX (1) MX2009010179A (cg-RX-API-DMAC7.html)
TN (1) TN2009000382A1 (cg-RX-API-DMAC7.html)
UA (1) UA96473C2 (cg-RX-API-DMAC7.html)
WO (1) WO2008116103A2 (cg-RX-API-DMAC7.html)
ZA (1) ZA200905636B (cg-RX-API-DMAC7.html)

Cited By (4)

* Cited by examiner, † Cited by third party
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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
CN118324847A (zh) 2008-10-29 2024-07-12 阿布林克斯公司 单域抗原结合性分子的纯化方法
US9393304B2 (en) 2008-10-29 2016-07-19 Ablynx N.V. Formulations of single domain antigen binding molecules
JP5933975B2 (ja) * 2008-11-12 2016-06-15 メディミューン，エルエルシー 抗体製剤
EP2196476A1 (en) * 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
PT2376116E (pt) 2008-12-12 2016-02-24 Boehringer Ingelheim Int Anticorpos anti-igf
TWI505838B (zh) 2010-01-20 2015-11-01 Chugai Pharmaceutical Co Ltd Stabilized antibody solution containing
WO2012028683A1 (en) 2010-09-02 2012-03-08 Novartis Ag Antibody gel system for sustained drug delivery
CN104800844A (zh) 2010-11-05 2015-07-29 诺华有限公司 使用il-17拮抗剂治疗类风湿性关节炎的方法
CN103501825B (zh) 2011-05-02 2017-03-15 免疫医疗公司 用于小体积施用的同种异型选择的抗体的超滤浓缩
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
PT3378535T (pt) 2011-10-28 2023-02-06 Prothena Biosciences Ltd Anticorpos humanizados que reconhecem a alfa-sinucleína
WO2013112945A1 (en) 2012-01-27 2013-08-01 Neotope Biosciences Limited Humanized antibodies that recognize alpha-synuclein
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
NZ707168A (en) 2012-12-26 2016-09-30 Wockhardt Ltd Pharmaceutical composition of insulins
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
EP3129051A1 (en) 2014-04-08 2017-02-15 Prothena Biosciences Limited Blood-brain barrier shuttles containing antibodies recognizing alpha-synuclein
IL307913A (en) 2014-12-04 2023-12-01 Janssen Biotech Inc Anti-CD38 antibodies for the treatment of acute myeloid leukemia
EA035719B1 (ru) * 2015-02-09 2020-07-30 Юсб Биофарма Спрл Фармацевтический состав
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
WO2018187074A1 (en) 2017-04-03 2018-10-11 Immunomedics, Inc. Subcutaneous administration of antibody-drug conjugates for cancer therapy
CN111565751A (zh) 2017-10-31 2020-08-21 詹森生物科技公司 治疗高危多发性骨髓瘤的方法
MA55033A (fr) 2019-02-18 2021-12-29 Lilly Co Eli Formulation d'anticorps thérapeutique
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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ATE442862T2 (de) * 2000-10-12 2009-10-15 Genentech Inc Niederviskose konzentrierte proteinformulierungen
NO345566B1 (no) * 2001-06-26 2021-04-19 Amgen Inc OPGL bindende antistoff, farmasøytisk sammensetning samt anvendelse derav
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
MXPA06001634A (es) * 2003-08-13 2006-04-28 Pfizer Prod Inc Anticuerpos humanos modificados igf-1r.
AU2006247039B2 (en) * 2005-05-19 2011-03-03 Amgen Inc. Compositions and methods for increasing the stability of antibodies
BRPI0709229A2 (pt) * 2006-03-28 2011-06-28 Hoffmann La Roche formulação de anticorpo monoclonal humano anti-igf-ir

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

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