CA2082169A1 - Freeze-dried preparation containing monoclonal antibody - Google Patents

Freeze-dried preparation containing monoclonal antibody

Info

Publication number
CA2082169A1
CA2082169A1 CA002082169A CA2082169A CA2082169A1 CA 2082169 A1 CA2082169 A1 CA 2082169A1 CA 002082169 A CA002082169 A CA 002082169A CA 2082169 A CA2082169 A CA 2082169A CA 2082169 A1 CA2082169 A1 CA 2082169A1
Authority
CA
Canada
Prior art keywords
freeze
monoclonal antibody
dried
solution
antigen
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.)
Abandoned
Application number
CA002082169A
Other languages
English (en)
French (fr)
Inventor
Tamotsu Fukuda
Yukio Shimazaki
Yasuyuki Kuroiwa
Shiro Takagi
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.)
Mitsui Toatsu Chemicals Inc
Original Assignee
Individual
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=12663510&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2082169(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Publication of CA2082169A1 publication Critical patent/CA2082169A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/12Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1203Gram-negative bacteria
    • C07K16/1214Pseudomonadaceae (F)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
CA002082169A 1991-03-08 1992-02-28 Freeze-dried preparation containing monoclonal antibody Abandoned CA2082169A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP3-43431 1991-03-08
JP4343191 1991-03-08

Publications (1)

Publication Number Publication Date
CA2082169A1 true CA2082169A1 (en) 1992-09-09

Family

ID=12663510

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002082169A Abandoned CA2082169A1 (en) 1991-03-08 1992-02-28 Freeze-dried preparation containing monoclonal antibody

Country Status (10)

Country Link
US (1) US5908826A (https=)
EP (2) EP0531539B1 (https=)
JP (1) JPH0565233A (https=)
AU (1) AU645187B2 (https=)
CA (1) CA2082169A1 (https=)
DE (2) DE69232617T2 (https=)
DK (2) DK0531539T3 (https=)
FI (1) FI924982A0 (https=)
NO (1) NO924279D0 (https=)
WO (1) WO1992015331A1 (https=)

Families Citing this family (48)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6800738B1 (en) 1991-06-14 2004-10-05 Genentech, Inc. Method for making humanized antibodies
GB9122820D0 (en) * 1991-10-28 1991-12-11 Wellcome Found Stabilised antibodies
JP2014148555A (ja) * 1995-07-27 2014-08-21 Genentech Inc タンパク質の処方
ES2434840T3 (es) * 1995-07-27 2013-12-17 Genentech, Inc. Formulación de proteína liofilizada isotónica estable
US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
JP3624543B2 (ja) * 1996-05-02 2005-03-02 東ソー株式会社 免疫反応試薬及びその製造方法
EP0852951A1 (de) 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
AU2444899A (en) * 1998-01-22 1999-08-09 Astrazeneca Ab Pharmaceutical formulation comprising an antibody and a citrate buffer
US6750330B1 (en) * 1998-05-14 2004-06-15 Ashley Davis Lyophilized tubulins
WO2001047554A1 (fr) * 1999-12-28 2001-07-05 Chugai Seiyaku Kabushiki Kaisha Compositions d'anticorps stables et preparations pour injection
JP5490972B2 (ja) * 2000-08-04 2014-05-14 中外製薬株式会社 タンパク質注射製剤
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
GB0113179D0 (en) * 2001-05-31 2001-07-25 Novartis Ag Organic compounds
MXPA04000747A (es) * 2001-07-25 2004-07-08 Protein Desing Labs Inc Formulacion farmaceutica liofilizada estable de anticuerpos igg.
US20040002451A1 (en) * 2002-06-20 2004-01-01 Bruce Kerwin Compositions of pegylated soluble tumor necrosis factor receptors and methods of preparing
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
MXPA05010555A (es) 2003-04-04 2006-03-09 Genentech Inc Formulaciones de proteina y anticuerpo de alta concentracion.
DE602004030451D1 (de) 2003-07-15 2011-01-20 Chugai Pharmaceutical Co Ltd Produktion von igm durch transformierte zellen und verfahren zur quantifizierung dieser igm-produktion
HUE026793T2 (en) * 2003-10-01 2016-07-28 Kyowa Hakko Kirin Co Ltd A method for stabilizing an antibody and a stabilized solution-type antibody preparation
EP1686137A4 (en) * 2003-10-09 2009-10-28 Chugai Pharmaceutical Co Ltd Method of stabilizing protein solutions
EP1688432B1 (en) * 2003-10-09 2011-08-03 Chugai Seiyaku Kabushiki Kaisha Igm high concentration stabilized solution
EP1712240B1 (en) * 2003-12-25 2015-09-09 Kyowa Hakko Kirin Co., Ltd. Stable water-based medicinal preparation containing antibody
EP1888637A2 (en) * 2005-05-19 2008-02-20 Amgen Inc. Compositions and methods for increasing the stability of antibodies
BRPI0611901A2 (pt) 2005-06-14 2012-08-28 Amgen, Inc composição, liofilizado, kit, e, processo para preparar uma composição
WO2007074880A1 (ja) 2005-12-28 2007-07-05 Chugai Seiyaku Kabushiki Kaisha 抗体含有安定化製剤
AR059066A1 (es) 2006-01-27 2008-03-12 Amgen Inc Combinaciones del inhibidor de la angiopoyetina -2 (ang2) y el inhibidor del factor de crecimiento endotelial vascular (vegf)
TW200831129A (en) * 2006-10-06 2008-08-01 Amgen Inc Stable formulations
EP2094247B1 (en) * 2006-10-20 2022-06-29 Amgen Inc. Stable polypeptide formulations
EP2136839A4 (en) * 2007-03-22 2010-04-07 Imclone Llc STABLE ANTIBODY FORMULATIONS
JP5322405B2 (ja) * 2007-06-07 2013-10-23 小林製薬株式会社 タンパク質含有組成物
AU2010221156A1 (en) 2009-03-06 2011-09-22 Genentech, Inc. Antibody formulation
PT3345615T (pt) 2010-03-01 2020-01-17 Bayer Healthcare Llc Anticorpos monoclonais otimizados contra inibidor da via do fator tecidual (tfpi)
WO2012028683A1 (en) 2010-09-02 2012-03-08 Novartis Ag Antibody gel system for sustained drug delivery
BR112013011176A2 (pt) 2010-11-05 2020-09-01 Novartis Ag métodos de tratamento de artrite reumatoide usando antagonistas de il-17
US8821865B2 (en) 2010-11-11 2014-09-02 Abbvie Biotechnology Ltd. High concentration anti-TNFα antibody liquid formulations
JP2012158615A (ja) * 2012-05-28 2012-08-23 Kobayashi Pharmaceutical Co Ltd 還元糖によるタンパク質変性を抑制する方法
US9592297B2 (en) 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
US8613919B1 (en) 2012-08-31 2013-12-24 Bayer Healthcare, Llc High concentration antibody and protein formulations
US9937171B2 (en) 2014-04-11 2018-04-10 Acerta Pharma B.V. Methods of blocking the CXCR-4/SDF-1 signaling pathway with inhibitors of bruton's tyrosine kinase
WO2015185998A2 (en) 2014-04-11 2015-12-10 Acerta Pharma B.V. Methods of blocking the cxcr-4/sdf-1 signaling pathway with inhibitors of bone marrow x kinase
TW201618774A (zh) 2014-08-11 2016-06-01 艾森塔製藥公司 使用btk抑制劑透過調變腫瘤微環境來治療實體腫瘤及其他疾病之方法
WO2016055982A1 (en) 2014-10-10 2016-04-14 Acerta Pharma B.V. Quinoline and quinazoline compounds
WO2016087994A1 (en) 2014-12-05 2016-06-09 Acerta Pharma B.V. Btk inhibitors to treat solid tumors through modulation of the tumor microenvironment
DK3334747T5 (da) 2015-08-13 2024-10-07 Amgen Inc Ladet dybdefiltrering af antigenbindende proteiner
US10736893B2 (en) 2015-11-06 2020-08-11 Acerta Pharma B.V. Imidazopyrazine inhibitors of Bruton's tyrosine kinase
US20240417445A1 (en) * 2023-06-13 2024-12-19 Grifols Worldwide Operations Limited Method for producing a lyophilized composition comprising polyclonal igm and composition obtained

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2149304A (en) * 1936-04-20 1939-03-07 Sharp & Dohme Inc Lyophilic biologically active substances
SU700132A1 (ru) * 1978-06-30 1979-11-30 Томский Ордена Трудового Красного Знамени Научно-Исследовательский Институт Вакцин И Сывороток Способ получени сухого препарата иммуноглобулина
JPS57140724A (en) * 1981-02-25 1982-08-31 Green Cross Corp:The Heat-treatment of aqueous solution containing cold insoluble globulin
JPS58167518A (ja) * 1982-03-29 1983-10-03 Nippon Sekijiyuujishiya ゼラチン誘導体添加静注用人免疫グロブリンの製造法
JPS6035263A (ja) * 1983-08-05 1985-02-23 Wako Pure Chem Ind Ltd 不溶性担体に固定化された免疫活性物質の安定化法及び該物質を構成単位として含む生理活性物質測定用試薬
JPS60146833A (ja) * 1984-01-10 1985-08-02 Green Cross Corp:The モノクロ−ナル抗体製剤
JP2565303B2 (ja) * 1984-05-25 1996-12-18 三井東圧化学株式会社 緑膿菌感染症の予防治療剤
US4650772A (en) * 1984-08-09 1987-03-17 Abbott Laboratories Monoclonal antibody stabilization
JPH0669961B2 (ja) * 1984-09-25 1994-09-07 株式会社ミドリ十字 免疫グロブリンの加熱処理方法
JPS61176532A (ja) * 1985-01-30 1986-08-08 Green Cross Corp:The プラスミノ−ゲンアクチベ−タ−前駆体の安定化方法
JPH0825902B2 (ja) * 1985-02-21 1996-03-13 株式会社ミドリ十字 γ−グロブリンの加熱処理方法
JPH0825903B2 (ja) * 1985-05-16 1996-03-13 株式会社ミドリ十字 γ―グロブリン含有水溶液
JPS6178731A (ja) * 1985-05-20 1986-04-22 Green Cross Corp:The 加熱処理免疫グロブリン製剤
DE3619565A1 (de) * 1986-06-11 1987-12-17 Behringwerke Ag Verfahren zur herstellung einer pasteurisierten immunglobulinpraeparation
JPS6388197A (ja) * 1986-09-30 1988-04-19 Tosoh Corp モノクロナル抗体の安定化方法
WO1988004669A1 (fr) * 1986-12-15 1988-06-30 Mitsui Toatsu Chemicals, Inc. Anticorps monoclonal humain et medicament pour la prophylaxie et le traitement de maladies infectieuses comprenant ledit anticorps en tant qu'ingredient efficace
ES2045027T3 (es) * 1987-08-10 1994-01-16 Miles Inc Igm purificadas.
JPH03504499A (ja) * 1988-05-27 1991-10-03 セントカー・インコーポレーテツド 抗体試薬のための配合物
WO1990011091A1 (en) * 1989-03-27 1990-10-04 Centocor, Inc. FORMULATIONS FOR STABILIZING OF IgM ANTIBODIES
JPH0384461A (ja) * 1989-08-28 1991-04-10 Green Cross Corp:The 免疫学的凝集反応試薬及びその製法
JPH0911350A (ja) * 1995-06-30 1997-01-14 Olympus Optical Co Ltd エネルギー硬化型樹脂を用いた光学素子の製造方法

Also Published As

Publication number Publication date
AU1337592A (en) 1992-10-06
EP0531539A4 (https=) 1995-04-05
FI924982L (fi) 1992-11-04
EP0841067B1 (en) 2002-05-22
FI924982A7 (fi) 1992-11-04
DE69232617T2 (de) 2002-10-31
DE69232617D1 (de) 2002-06-27
AU645187B2 (en) 1994-01-06
WO1992015331A1 (en) 1992-09-17
NO924279L (no) 1992-11-06
DE69225757T2 (de) 1998-12-03
FI924982A0 (fi) 1992-11-04
EP0841067A1 (en) 1998-05-13
EP0531539B1 (en) 1998-06-03
US5908826A (en) 1999-06-01
NO924279D0 (no) 1992-11-06
DK0841067T3 (da) 2002-07-15
DE69225757D1 (de) 1998-07-09
JPH0565233A (ja) 1993-03-19
EP0531539A1 (en) 1993-03-17
DK0531539T3 (da) 1998-10-12

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Legal Events

Date Code Title Description
EEER Examination request
FZDE Discontinued