DE69225757T2 - Lyophilische monoklonale antikörperpräparationen - Google Patents

Lyophilische monoklonale antikörperpräparationen

Info

Publication number
DE69225757T2
DE69225757T2 DE69225757T DE69225757T DE69225757T2 DE 69225757 T2 DE69225757 T2 DE 69225757T2 DE 69225757 T DE69225757 T DE 69225757T DE 69225757 T DE69225757 T DE 69225757T DE 69225757 T2 DE69225757 T2 DE 69225757T2
Authority
DE
Germany
Prior art keywords
freeze
solution
monoclonal antibodies
gelatin
monoclonal antibody
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.)
Expired - Fee Related
Application number
DE69225757T
Other languages
German (de)
English (en)
Other versions
DE69225757D1 (de
Inventor
Tamotsu Mobara-Shi Chiba-Ken 297 Fukuda
Yasuyuki Mobara-Shi Chiba-Ken 297 Kuroiwa
Yukio Mobara-Shi Chiba-Ken 297 Shimazaki
Shiro Mobara-Shi Chiba-Ken 29 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 Chemicals Inc
Original Assignee
Mitsui Chemicals Inc
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=DE69225757(T2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Mitsui Chemicals Inc filed Critical Mitsui Chemicals Inc
Application granted granted Critical
Publication of DE69225757D1 publication Critical patent/DE69225757D1/de
Publication of DE69225757T2 publication Critical patent/DE69225757T2/de
Anticipated expiration legal-status Critical
Expired - Fee Related 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/12Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1203Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-negative bacteria
    • C07K16/1214Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-negative bacteria from Pseudomonadaceae (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

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
DE69225757T 1991-03-08 1992-02-28 Lyophilische monoklonale antikörperpräparationen Expired - Fee Related DE69225757T2 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP4343191 1991-03-08
PCT/JP1992/000226 WO1992015331A1 (en) 1991-03-08 1992-02-28 Lyophilized monoclonal antibody preparation

Publications (2)

Publication Number Publication Date
DE69225757D1 DE69225757D1 (de) 1998-07-09
DE69225757T2 true DE69225757T2 (de) 1998-12-03

Family

ID=12663510

Family Applications (2)

Application Number Title Priority Date Filing Date
DE69225757T Expired - Fee Related DE69225757T2 (de) 1991-03-08 1992-02-28 Lyophilische monoklonale antikörperpräparationen
DE69232617T Expired - Fee Related DE69232617T2 (de) 1991-03-08 1992-02-28 Gefriergetrocknete Zubereitung, die einen monoklonalen Antikörper enthält

Family Applications After (1)

Application Number Title Priority Date Filing Date
DE69232617T Expired - Fee Related DE69232617T2 (de) 1991-03-08 1992-02-28 Gefriergetrocknete Zubereitung, die einen monoklonalen Antikörper enthält

Country Status (10)

Country Link
US (1) US5908826A (enExample)
EP (2) EP0841067B1 (enExample)
JP (1) JPH0565233A (enExample)
AU (1) AU645187B2 (enExample)
CA (1) CA2082169A1 (enExample)
DE (2) DE69225757T2 (enExample)
DK (2) DK0531539T3 (enExample)
FI (1) FI924982A7 (enExample)
NO (1) NO924279L (enExample)
WO (1) WO1992015331A1 (enExample)

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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
AU2228901A (en) * 1999-12-28 2001-07-09 Chugai Seiyaku Kabushiki Kaisha Stable antibody compositions and injection preparations
WO2002011753A1 (en) * 2000-08-04 2002-02-14 Chugai Seiyaku Kabushiki Kaisha Protein injection preparations
PT1324776E (pt) 2000-10-12 2009-12-23 Genentech Inc Formulações de proteína concentradas de viscosidade reduzida
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
GB0113179D0 (en) * 2001-05-31 2001-07-25 Novartis Ag Organic compounds
DE60235013D1 (de) * 2001-07-25 2010-02-25 Facet Biotech Corp Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab
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
EP3178492A1 (en) 2003-04-04 2017-06-14 Genentech, Inc. High concentration antibody and protein formulations
JP5452835B2 (ja) 2003-07-15 2014-03-26 中外製薬株式会社 形質転換細胞によるIgMの産生とその定量方法
JP4219932B2 (ja) * 2003-10-01 2009-02-04 協和発酵キリン株式会社 抗体の安定化方法及び安定化された溶液状抗体製剤
WO2005035573A1 (ja) * 2003-10-09 2005-04-21 Chugai Seiyaku Kabushiki Kaisha タンパク質溶液の安定化方法
ATE518888T1 (de) * 2003-10-09 2011-08-15 Chugai Pharmaceutical Co Ltd Stabilisierte lösung mit hoher igm-konzentration
WO2005063291A1 (ja) * 2003-12-25 2005-07-14 Kirin Beer Kabushiki Kaisha 抗体を含有する安定な水性医薬製剤
MX2007014148A (es) * 2005-05-19 2008-01-11 Amgen Inc Composiciones y metodos para incrementar la estabilidad de anticuerpos.
EP1909831A4 (en) 2005-06-14 2013-02-20 Amgen Inc SELF-BUFFING PROTEIN FORMULATIONS
JP5231810B2 (ja) * 2005-12-28 2013-07-10 中外製薬株式会社 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)
JP5631591B2 (ja) * 2006-10-06 2014-11-26 アムジエン・インコーポレーテツド 安定な抗体製剤
AU2007309616B2 (en) * 2006-10-20 2011-10-06 Amgen Inc. Stable polypeptide formulations
MX2009010179A (es) * 2007-03-22 2010-03-15 Imclone Llc Formulaciones estables de anticuerpo.
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
CN102414221A (zh) 2009-03-06 2012-04-11 健泰科生物技术公司 抗体配制剂
SI2542257T1 (en) 2010-03-01 2018-01-31 Bayer Healthcare Llc Optimized monoclonal antibodies against Tissue Factor Pathway Inhibitor (TFPI)
WO2012028683A1 (en) 2010-09-02 2012-03-08 Novartis Ag Antibody gel system for sustained drug delivery
PT3111954T (pt) 2010-11-05 2019-07-10 Novartis Ag Métodos de tratamento da espondilite anquilosante usando anticorpos anti-il-17
JP5919606B2 (ja) 2010-11-11 2016-05-18 アッヴィ バイオテクノロジー リミテッド 改良型高濃度抗tnfアルファ抗体液体製剤
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
WO2015181633A2 (en) 2014-04-11 2015-12-03 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
WO2016024227A1 (en) 2014-08-11 2016-02-18 Acerta Pharma B.V. Btk inhibitors to treat solid tumors through modulation of the tumor microenvironment
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
ES2964640T3 (es) 2015-08-13 2024-04-08 Amgen Inc Filtración en profundidad cargada de proteínas de unión al antígeno
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

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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
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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
ATE82136T1 (de) * 1987-08-10 1992-11-15 Miles Inc Gereinigtes igm.
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
JPH04504253A (ja) * 1989-03-27 1992-07-30 セントカー・インコーポレーテツド IgM抗体の安定化のための配合物
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Also Published As

Publication number Publication date
CA2082169A1 (en) 1992-09-09
DK0531539T3 (da) 1998-10-12
JPH0565233A (ja) 1993-03-19
EP0841067B1 (en) 2002-05-22
FI924982A0 (fi) 1992-11-04
DK0841067T3 (da) 2002-07-15
US5908826A (en) 1999-06-01
WO1992015331A1 (en) 1992-09-17
AU1337592A (en) 1992-10-06
EP0841067A1 (en) 1998-05-13
AU645187B2 (en) 1994-01-06
NO924279D0 (no) 1992-11-06
EP0531539A4 (enExample) 1995-04-05
FI924982L (fi) 1992-11-04
NO924279L (no) 1992-11-06
DE69232617D1 (de) 2002-06-27
EP0531539B1 (en) 1998-06-03
DE69225757D1 (de) 1998-07-09
FI924982A7 (fi) 1992-11-04
DE69232617T2 (de) 2002-10-31
EP0531539A1 (en) 1993-03-17

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Legal Events

Date Code Title Description
8327 Change in the person/name/address of the patent owner

Owner name: MITSUI CHEMICALS, INC., TOKIO/TOKYO, JP

8364 No opposition during term of opposition
8339 Ceased/non-payment of the annual fee