JP2013527832A5 - - Google Patents

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JP2013527832A5
JP2013527832A5 JP2013501354A JP2013501354A JP2013527832A5 JP 2013527832 A5 JP2013527832 A5 JP 2013527832A5 JP 2013501354 A JP2013501354 A JP 2013501354A JP 2013501354 A JP2013501354 A JP 2013501354A JP 2013527832 A5 JP2013527832 A5 JP 2013527832A5
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Japan
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protein
poe sorbitan
polyethylene glycol
set composition
aqueous solution
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JP2013501354A
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English (en)
Japanese (ja)
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JP5937059B2 (ja
JP2013527832A (ja
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Priority claimed from PCT/US2011/029206 external-priority patent/WO2011119487A2/en
Publication of JP2013527832A publication Critical patent/JP2013527832A/ja
Publication of JP2013527832A5 publication Critical patent/JP2013527832A5/ja
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JP2013501354A 2010-03-22 2011-03-21 タンパク質含有製剤の安定化に有用な組成物及び方法 Active JP5937059B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US31632610P 2010-03-22 2010-03-22
US61/316,326 2010-03-22
PCT/US2011/029206 WO2011119487A2 (en) 2010-03-22 2011-03-21 Compositions and methods useful for stabilizing protein-containing formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2016094543A Division JP6742805B2 (ja) 2010-03-22 2016-05-10 タンパク質含有製剤の安定化に有用な組成物及び方法

Publications (3)

Publication Number Publication Date
JP2013527832A JP2013527832A (ja) 2013-07-04
JP2013527832A5 true JP2013527832A5 (https=) 2014-05-08
JP5937059B2 JP5937059B2 (ja) 2016-06-22

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ID=43977896

Family Applications (3)

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JP2013501354A Active JP5937059B2 (ja) 2010-03-22 2011-03-21 タンパク質含有製剤の安定化に有用な組成物及び方法
JP2016094543A Active JP6742805B2 (ja) 2010-03-22 2016-05-10 タンパク質含有製剤の安定化に有用な組成物及び方法
JP2018201804A Active JP6791929B2 (ja) 2010-03-22 2018-10-26 タンパク質含有製剤の安定化に有用な組成物及び方法

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2016094543A Active JP6742805B2 (ja) 2010-03-22 2016-05-10 タンパク質含有製剤の安定化に有用な組成物及び方法
JP2018201804A Active JP6791929B2 (ja) 2010-03-22 2018-10-26 タンパク質含有製剤の安定化に有用な組成物及び方法

Country Status (15)

Country Link
US (3) US9662395B2 (https=)
EP (2) EP2550018B1 (https=)
JP (3) JP5937059B2 (https=)
KR (3) KR102218495B1 (https=)
CN (3) CN104998269B (https=)
BR (1) BR112012021873B8 (https=)
CA (2) CA2792125C (https=)
ES (1) ES2722201T3 (https=)
HR (1) HRP20190751T1 (https=)
MX (1) MX354867B (https=)
PL (1) PL2550018T3 (https=)
RU (1) RU2584232C2 (https=)
SI (1) SI2550018T1 (https=)
TR (1) TR201905081T4 (https=)
WO (1) WO2011119487A2 (https=)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104998269B (zh) 2010-03-22 2019-06-11 弗·哈夫曼-拉罗切有限公司 对于稳定含有蛋白质的制剂有用的组合物和方法
RU2665810C2 (ru) 2011-10-31 2018-09-04 Дженентек, Инк. Содержащие антитела составы
KR102372245B1 (ko) 2013-11-21 2022-03-08 젠맵 에이/에스 항체-약물 접합체 동결건조 제제
RU2689145C2 (ru) * 2014-04-16 2019-05-24 Биокон Лтд. Стабильные белковые препараты, содержащие молярный избыток сорбитола
IS3008B (is) 2014-05-14 2018-12-15 Calor ehf Stöðgandi lausnir fyrir prótín og peptíð
EP3050557A1 (en) 2014-05-23 2016-08-03 Ares Trading S.A. Liquid pharmaceutical composition
ES2572919T3 (es) 2014-05-23 2016-06-03 Ares Trading S.A. Composición farmacéutica líquida
EP3053572A1 (en) * 2015-02-06 2016-08-10 Ares Trading S.A. Liquid pharmaceutical composition
SG11201805534TA (en) * 2016-01-13 2018-07-30 Genmab As Formulation for antibody and drug conjugate thereof
CN106771244B (zh) * 2016-12-28 2018-02-02 广州华弘生物科技有限公司 一种纤维蛋白原定量检测试剂盒及检测方法
CN106771148B (zh) * 2016-12-28 2018-03-06 广州华弘生物科技有限公司 一种免疫球蛋白m检测试剂盒及检测方法
TWI841554B (zh) 2018-03-21 2024-05-11 丹麥商珍美寶股份有限公司 以鉑為主之劑與抗組織因子抗體-藥物共軛物的組合治療癌症之方法
JP7171702B2 (ja) * 2018-03-23 2022-11-15 大塚製薬株式会社 標識化抗体分散液、spfs用キット
WO2019217455A1 (en) 2018-05-07 2019-11-14 Genmab A/S Methods of treating cancer with a combination of an anti-pd-1 antibody and an anti-tissue factor antibody-drug conjugate
TWI844571B (zh) 2018-10-30 2024-06-11 丹麥商珍美寶股份有限公司 使用抗血管內皮生長因子(vegf)抗體與抗組織因子(tf)抗體-藥物共軛體之組合以治療癌症之方法
BR112021019612A2 (pt) * 2019-04-01 2021-11-30 Genentech Inc Formulações, recipiente, artigo de fabricação, método para produzir a formulação e método para inibir a agregação de uma proteína presente em uma solução aquosa
US11513602B2 (en) 2019-09-10 2022-11-29 Wagner Spray Tech Corporation Gesture control of a fluid application system
CN111964942A (zh) * 2020-08-28 2020-11-20 湖南海尚仪器设备有限公司 基于工业环境污染物检测的采样方法
WO2022104389A1 (en) * 2020-11-16 2022-05-19 W. L. Gore & Associates, Inc. Formulations, methods, and pre-filled multi-dose injection devices without cloud point
CN112816684B (zh) * 2021-01-07 2024-08-30 武汉华美生物工程有限公司 血清淀粉样蛋白a的校准品稀释液、其制备方法及其应用
CA3236891A1 (en) * 2021-12-20 2023-06-29 Boehringer Ingelheim International Gmbh Method for determining the degree of oxidative degradation of polysorbate 20 in aqueous formulations
TW202602489A (zh) * 2024-03-15 2026-01-16 美商再生元醫藥公司 作為經穩定的蛋白質調配物之賦形劑的聚山梨醇酯及聚氧乙烯山梨糖醇酐

Family Cites Families (79)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB845274A (en) * 1955-10-06 1960-08-17 Gen Foods Corp Improved gelatin composition
US3773919A (en) 1969-10-23 1973-11-20 Du Pont Polylactide-drug mixtures
US4275149A (en) 1978-11-24 1981-06-23 Syva Company Macromolecular environment control in specific receptor assays
US4657760A (en) 1979-03-20 1987-04-14 Ortho Pharmaceutical Corporation Methods and compositions using monoclonal antibody to human T cells
US4515893A (en) 1979-04-26 1985-05-07 Ortho Pharmaceutical Corporation Hybrid cell line for producing complement-fixing monoclonal antibody to human T cells
EP0040409B1 (de) 1980-05-21 1984-11-14 Siemens Aktiengesellschaft Mosaiktafel mit geschlossener Frontseite
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
AU3722984A (en) * 1984-01-05 1985-07-11 Manlab Pty. Ltd. Reagents for immunoassay at elevated temperatures
US5206344A (en) 1985-06-26 1993-04-27 Cetus Oncology Corporation Interleukin-2 muteins and polymer conjugation thereof
US5091178A (en) 1986-02-21 1992-02-25 Oncogen Tumor therapy with biologically active anti-tumor antibodies
EP0545913B1 (en) 1986-08-18 1999-02-24 Emisphere Technologies, Inc. Delivery systems for pharmacological agents
US5183746A (en) 1986-10-27 1993-02-02 Schering Aktiengesellschaft Formulation processes for pharmaceutical compositions of recombinant β-
IL85035A0 (en) 1987-01-08 1988-06-30 Int Genetic Eng Polynucleotide molecule,a chimeric antibody with specificity for human b cell surface antigen,a process for the preparation and methods utilizing the same
JPS6475433A (en) * 1987-09-16 1989-03-22 Teijin Ltd Remedy for herpes simplex virus infection
ZA888577B (en) * 1987-11-27 1989-08-30 Akzo Nv Stabilization of antibodies
US5091313A (en) 1988-08-05 1992-02-25 Tanox Biosystems, Inc. Antigenic epitopes of IgE present on B cell but not basophil surface
US5720937A (en) 1988-01-12 1998-02-24 Genentech, Inc. In vivo tumor detection assay
EP0420937B1 (en) 1988-06-21 1994-11-09 Genentech, Inc. Therapeutic compositions for the treatment of myocardial infarction
US5530101A (en) 1988-12-28 1996-06-25 Protein Design Labs, Inc. Humanized immunoglobulins
US5225538A (en) 1989-02-23 1993-07-06 Genentech, Inc. Lymphocyte homing receptor/immunoglobulin fusion proteins
DE3920358A1 (de) 1989-06-22 1991-01-17 Behringwerke Ag Bispezifische und oligospezifische, mono- und oligovalente antikoerperkonstrukte, ihre herstellung und verwendung
US5013556A (en) 1989-10-20 1991-05-07 Liposome Technology, Inc. Liposomes with enhanced circulation time
US5225212A (en) 1989-10-20 1993-07-06 Liposome Technology, Inc. Microreservoir liposome composition and method
US5945098A (en) * 1990-02-01 1999-08-31 Baxter International Inc. Stable intravenously-administrable immune globulin preparation
EP1400536A1 (en) 1991-06-14 2004-03-24 Genentech Inc. Method for making humanized antibodies
AU2309692A (en) * 1991-07-03 1993-02-11 Cryolife, Inc. Method for stabilization of biomaterials
CA2113813C (en) 1991-08-14 2005-04-12 Paula M. Jardieu Immunoglobulin variants for specific fc epsilon receptors
DE69232137T2 (de) 1991-11-25 2002-05-29 Enzon Inc Multivalente antigen-bindende proteine
WO1994004188A1 (en) 1992-08-21 1994-03-03 Genentech, Inc. Method for treating an lfa-1-mediated disorder
US5736137A (en) 1992-11-13 1998-04-07 Idec Pharmaceuticals Corporation Therapeutic application of chimeric and radiolabeled antibodies to human B lymphocyte restricted differentiation antigen for treatment of B cell lymphoma
WO1994012158A1 (en) 1992-12-02 1994-06-09 Alkermes Controlled Therapeutics, Inc. Controlled release growth hormone containing microspheres
US5595721A (en) 1993-09-16 1997-01-21 Coulter Pharmaceutical, Inc. Radioimmunotherapy of lymphoma using anti-CD20
DK0733207T3 (da) 1993-12-10 1998-04-20 Genentech Inc Fremgangsmåder til diagnose af allergi og screening af anti-allergi-terapeutika
DK0739214T3 (da) 1994-01-18 1998-10-07 Genentech Inc Fremgangsmåde til behandling af parasitinfektionerunder anvendelse af IgE antagonister
US5702946A (en) 1994-03-03 1997-12-30 Genentech, Inc. Anti-IL-8 monoclonal antibodies for treatment of inflammatory disorders
DK0779806T3 (da) 1994-09-09 2000-11-27 Takeda Chemical Industries Ltd Præparat til forsinket frigivelse indeholdende et metalsalt af et peptid
IL117645A (en) 1995-03-30 2005-08-31 Genentech Inc Vascular endothelial cell growth factor antagonists for use as medicaments in the treatment of age-related macular degeneration
US5641870A (en) 1995-04-20 1997-06-24 Genentech, Inc. Low pH hydrophobic interaction chromatography for antibody purification
AU6267896A (en) 1995-06-07 1996-12-30 Imclone Systems Incorporated Antibody and antibody fragments for inhibiting the growth oftumors
NZ310644A (en) 1995-06-07 1999-08-30 Alkermes Inc Composition for sustained release of human growth hormone
ZA965368B (en) 1995-07-14 1997-01-14 Novo Nordisk As A pharmaceutical formulation
IL125255A (en) 1996-01-23 2002-02-10 Genentech Inc Anti-cd18 antibodies for treating stroke
US7147851B1 (en) 1996-08-15 2006-12-12 Millennium Pharmaceuticals, Inc. Humanized immunoglobulin reactive with α4β7 integrin
WO1998023761A1 (en) 1996-11-27 1998-06-04 Genentech, Inc. HUMANIZED ANTI-CD11a ANTIBODIES
US6037454A (en) 1996-11-27 2000-03-14 Genentech, Inc. Humanized anti-CD11a antibodies
JP3957765B2 (ja) 1997-04-07 2007-08-15 ジェネンテク・インコーポレイテッド 抗vegf抗体
EP0981618B2 (en) 1997-05-15 2011-08-24 Genentech, Inc. Anti-apo-2 antibody
US5994511A (en) 1997-07-02 1999-11-30 Genentech, Inc. Anti-IgE antibodies and methods of improving polypeptides
US6946129B1 (en) 1999-06-08 2005-09-20 Seattle Genetics, Inc. Recombinant anti-CD40 antibody and uses thereof
CA2376596C (en) 1999-06-25 2009-10-06 Genentech, Inc. Humanized anti-erbb2 antibodies and treatment with anti-erbb2 antibodies
AU1071701A (en) * 1999-09-29 2001-04-30 Trustees Of The University Of Pennsylvania, The Methods for rapid peg-modification of viral vectors, compositions for enhanced gene transduction, compositions with enhanced physical stability, and uses therefor
US6458387B1 (en) * 1999-10-18 2002-10-01 Epic Therapeutics, Inc. Sustained release microspheres
AU778199B2 (en) 1999-10-29 2004-11-25 Genentech Inc. Anti-prostate stem cell antigen (PSCA) antibody compositions and methods of use
UA83458C2 (uk) 2000-09-18 2008-07-25 Байоджен Айдек Ма Інк. Виділений поліпептид baff-r (рецептор фактора активації в-клітин сімейства tnf)
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
AU2002213441B2 (en) 2000-10-12 2006-10-26 Genentech, Inc. Reduced-viscosity concentrated protein formulations
US7321026B2 (en) 2001-06-27 2008-01-22 Skytech Technology Limited Framework-patched immunoglobulins
EP1507793A4 (en) 2001-10-17 2006-02-01 Human Genome Sciences Inc NEUTROKIN ALPHA AND NEUTROKIN ALPHA SPLICE VERSION
US20040093621A1 (en) 2001-12-25 2004-05-13 Kyowa Hakko Kogyo Co., Ltd Antibody composition which specifically binds to CD20
KR101033196B1 (ko) 2002-02-14 2011-05-09 이뮤노메딕스, 인코오포레이티드 항-cd20 항체 및 그 융합 단백질 및 이들의 이용방법
CN101928344B (zh) 2002-10-17 2014-08-13 根马布股份公司 抗cd20的人单克隆抗体
EP3263596A1 (en) 2002-12-16 2018-01-03 Genentech, Inc. Immunoglobulin variants and uses thereof
CN1798575A (zh) * 2003-04-04 2006-07-05 健泰科生物技术公司 高浓度抗体和蛋白制剂
US20050158303A1 (en) 2003-04-04 2005-07-21 Genentech, Inc. Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations
CA2525251C (en) 2003-05-09 2015-10-27 Duke University Cd20-specific antibodies and methods employing same
AR044388A1 (es) 2003-05-20 2005-09-07 Applied Molecular Evolution Moleculas de union a cd20
BRPI0414970A2 (pt) * 2003-06-24 2012-12-11 Baxter Int método para transporte de drogas ao cérebro
US20050079184A1 (en) 2003-08-08 2005-04-14 Immunomedics, Inc. Bispecific antibodies for inducing apoptosis of tumor and diseased cells
US8147832B2 (en) 2003-08-14 2012-04-03 Merck Patent Gmbh CD20-binding polypeptide compositions and methods
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
NZ563370A (en) 2005-06-20 2010-10-29 Genentech Inc Compositions and methods for the diagnosis and treatment of tumor
CN101237881B (zh) * 2005-08-03 2015-04-22 伊缪诺金公司 免疫偶联物剂型
WO2007019232A2 (en) * 2005-08-03 2007-02-15 Immunogen, Inc. Immunoconjugate formulations
WO2009090189A1 (en) * 2008-01-15 2009-07-23 Abbott Gmbh & Co.Kg Powdered protein compositions and methods of making same
BRPI0918978A2 (pt) * 2008-09-10 2015-12-01 Genentech Inc composições e métodos a prevenção da degradação oxidativa das proteínas
AR076640A1 (es) 2009-03-06 2011-06-29 Genentech Inc Formulacion con anticuerpo. metodo para estabilizar anticuerpo. articulo de manufactura
CN104998269B (zh) * 2010-03-22 2019-06-11 弗·哈夫曼-拉罗切有限公司 对于稳定含有蛋白质的制剂有用的组合物和方法
RU2013155695A (ru) * 2011-06-30 2015-08-10 Дженентек, Инк. Препараты антител против с-мет
WO2015198451A1 (ja) 2014-06-26 2015-12-30 楽天株式会社 情報処理装置、情報処理方法及び情報処理プログラム

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