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

安定な抗体処方物 Download PDF

Info

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
Authority
JP
Japan
Prior art keywords
imc
formulation
antibody
concentration
liquid formulation
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2009554753A
Other languages
English (en)
Japanese (ja)
Other versions
JP2010522208A5 (enExample
Inventor
アービンド・スリバスタバ
ジョエル・ゴールドスタイン
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ImClone LLC
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 JP2010522208A publication Critical patent/JP2010522208A/ja
Publication of JP2010522208A5 publication Critical patent/JP2010522208A5/ja
Pending legal-status Critical Current

Links

Images

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

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

Families Citing this family (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
BR122018013284B1 (pt) * 2008-10-29 2022-03-03 Ablynx N.V Formulações de moléculas de ligação ao antígeno de domínio único, seu método de formulação e seu uso, kit ou artigo de fabricação, bem como método para preparar uma formulação reconstituída contendo uma molécula de sdab
RU2553214C2 (ru) 2008-10-29 2015-06-10 Аблинкс Н.В. Способы очистки однодоменных антигенсвязывающих молекул
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
MY150984A (en) 2008-12-12 2014-03-31 Boehringer Ingelheim Int Anti-agf antibodies
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
LT3757126T (lt) 2010-11-05 2025-12-10 Novartis Ag Psoriazinio artrito gydymo būdas, panaudojant il-17 antagonistus
JP6024025B2 (ja) 2011-05-02 2016-11-09 イミューノメディクス、インコーポレイテッドＩｍｍｕｎｏｍｅｄｉｃｓ， Ｉｎｃ． 少容量投与用のアロタイプ選択抗体の限外濾過濃縮
AU2012328753A1 (en) * 2011-10-26 2014-04-24 Amgen Inc. Methods of reducing or eliminating protein modification and degradation arising from exposure to UV light
LT3378535T (lt) 2011-10-28 2023-02-27 Prothena Biosciences Limited Humanizuoti antikūnai, atpažįstantys alfa-sinukleiną
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
AR094821A1 (es) * 2012-07-25 2015-09-02 Hanmi Pharm Ind Co Ltd Formulación líquida de un conjugado de péptido insulinotrópico de acción 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
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
US9603927B2 (en) 2014-02-28 2017-03-28 Janssen Biotech, Inc. Combination therapies with anti-CD38 antibodies
US9732154B2 (en) 2014-02-28 2017-08-15 Janssen Biotech, Inc. Anti-CD38 antibodies for treatment of acute lymphoblastic leukemia
US10562973B2 (en) 2014-04-08 2020-02-18 Prothena Bioscience Limited Blood-brain barrier shuttles containing antibodies recognizing alpha-synuclein
CN107406506A (zh) 2014-12-04 2017-11-28 詹森生物科技公司 用于治疗急性髓系白血病的抗cd38抗体
EA035719B1 (ru) * 2015-02-09 2020-07-30 Юсб Биофарма Спрл Фармацевтический состав
CR20170526A (es) 2015-05-20 2018-04-03 Janssen Biotech Inc ANTICUERPOS ANTI-CD38 PARA EL TRATAMIENTO DE AMILOIDOSIS DE CADENA LIGERA y OTRAS ENFERMEDADES MALIGNAS HEMATOLÓGICAS POSITIVAS PARA CD38
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
CA3044082A1 (en) 2017-04-03 2018-10-11 Immunomedics, Inc. Subcutaneous administration of antibody-drug conjugates for cancer therapy
EP3703749A1 (en) 2017-10-31 2020-09-09 Janssen Biotech, Inc. Methods of treating high risk multiple myeloma
JOP20210229A1 (ar) 2019-02-18 2023-01-30 Lilly Co Eli صيغة جسم مضاد علاجي
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)

* Cited by examiner, † Cited by third party
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
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

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4124480B2 (ja) * 1991-06-14 2008-07-23 ジェネンテック・インコーポレーテッド 免疫グロブリン変異体
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US6875432B2 (en) * 2000-10-12 2005-04-05 Genentech, Inc. Reduced-viscosity concentrated protein formulations
MY143582A (en) * 2001-06-26 2011-05-31 Amgent Fremont Inc Antibodies to opgl
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
CN1835975B (zh) * 2003-08-13 2012-11-21 辉瑞产品公司 经修饰的人类igf-1r抗体
WO2006125207A2 (en) * 2005-05-19 2006-11-23 Amgen Inc. Compositions and methods for increasing the stability of antibodies
EP1998806A1 (en) * 2006-03-28 2008-12-10 F. Hoffmann-Roche AG Anti-igf-1r human monoclonal antibody formulation

Patent Citations (6)

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

Similar Documents

Publication Publication Date Title
JP2010522208A (ja) 安定な抗体処方物
JP7551729B2 (ja) 抗体－薬物コンジュゲートの製剤及びその凍結乾燥方法
EP3506942B1 (en) Carrier-pd-l1 binding agent compositions for treating cancers
US7951368B2 (en) Compositions of specific binding agents to hepatocyte growth factor
US20090306348A1 (en) Antibody Formulation
JP2022065061A (ja) パクリタキセル－アルブミン－結合剤組成物並びに該組成物の使用及び製造方法
JP2009531371A (ja) 抗ｉｇｆ−１ｒヒト・モノクローナル抗体製剤
CN101466404A (zh) 抗-egfr抗体的冻干制剂
TW201422235A (zh) 抗－泌乳素受器抗體配方
WO2010069858A1 (en) Pharmaceutical composition
TW202543673A (zh) 抗體-藥物結合物之製劑及其冷凍乾燥方法
HK40004904A (en) Carrier-pd-l1 binding agent compositions for treating cancers
HK40004904B (en) Carrier-pd-l1 binding agent compositions for treating cancers
HK1130669A (zh) 抗-igf-1r人单克隆抗体制剂

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20110311

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20110311

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20121106

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20130507