DE69232617T2 - Gefriergetrocknete Zubereitung, die einen monoklonalen Antikörper enthält - Google Patents

Gefriergetrocknete Zubereitung, die einen monoklonalen Antikörper enthält

Info

Publication number
DE69232617T2
DE69232617T2 DE69232617T DE69232617T DE69232617T2 DE 69232617 T2 DE69232617 T2 DE 69232617T2 DE 69232617 T DE69232617 T DE 69232617T DE 69232617 T DE69232617 T DE 69232617T DE 69232617 T2 DE69232617 T2 DE 69232617T2
Authority
DE
Germany
Prior art keywords
monoclonal antibody
freeze
solution
drying
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
DE69232617T
Other languages
German (de)
English (en)
Other versions
DE69232617D1 (de
Inventor
Tamotsu Fukuda
Yasuyuki Kuroiwa
Yukio Shimazaki
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 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=DE69232617(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 DE69232617D1 publication Critical patent/DE69232617D1/de
Publication of DE69232617T2 publication Critical patent/DE69232617T2/de
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/12—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1203—Gram-negative bacteria
    • C07K16/1214—Pseudomonadaceae (F)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins 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)
DE69232617T 1991-03-08 1992-02-28 Gefriergetrocknete Zubereitung, die einen monoklonalen Antikörper enthält Expired - Fee Related DE69232617T2 (de)

Applications Claiming Priority (1)

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

Publications (2)

Publication Number Publication Date
DE69232617D1 DE69232617D1 (de) 2002-06-27
DE69232617T2 true DE69232617T2 (de) 2002-10-31

Family

ID=12663510

Family Applications (2)

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
DE69225757T Expired - Fee Related DE69225757T2 (de) 1991-03-08 1992-02-28 Lyophilische monoklonale antikörperpräparationen

Family Applications After (1)

Application Number Title Priority Date Filing Date
DE69225757T Expired - Fee Related DE69225757T2 (de) 1991-03-08 1992-02-28 Lyophilische monoklonale antikörperpräparationen

Country Status (10)

Country Link
US (1) US5908826A (enExample)
EP (2) EP0531539B1 (enExample)
JP (1) JPH0565233A (enExample)
AU (1) AU645187B2 (enExample)
CA (1) CA2082169A1 (enExample)
DE (2) DE69232617T2 (enExample)
DK (2) DK0841067T3 (enExample)
FI (1) FI924982L (enExample)
NO (1) NO924279L (enExample)
WO (1) WO1992015331A1 (enExample)

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
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
CA2226575C (en) * 1995-07-27 2011-10-18 Genentech, Inc. Stabile isotonic lyophilized protein formulation
US6685940B2 (en) 1995-07-27 2004-02-03 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
JP4516711B2 (ja) * 1999-12-28 2010-08-04 中外製薬株式会社 安定な抗体組成物及び注射製剤
AU2001276737A1 (en) * 2000-08-04 2002-02-18 Chugai Seiyaku Kabushiki Kaisha Protein injection preparations
DE60139944D1 (de) 2000-10-12 2009-10-29 Genentech Inc Niederviskose konzentrierte proteinformulierungen
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
ATE454137T1 (de) * 2001-07-25 2010-01-15 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
PT1610820E (pt) 2003-04-04 2010-12-16 Novartis Ag Formulações de elevada concentração de anticorpos e proteínas
EP2204190A1 (en) 2003-07-15 2010-07-07 Chugai Seiyaku Kabushiki Kaisha IgM production by transformed cells and methods for quantifying said IgM production
CN100522998C (zh) * 2003-10-01 2009-08-05 协和发酵麒麟株式会社 抗体的稳定化方法和被稳定的溶液状抗体制剂
WO2005035574A1 (ja) 2003-10-09 2005-04-21 Chugai Seiyaku Kabushiki Kaisha IgM高濃度安定化溶液
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
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
AU2006247039B2 (en) * 2005-05-19 2011-03-03 Amgen Inc. Compositions and methods for increasing the stability of antibodies
JP2008543839A (ja) 2005-06-14 2008-12-04 アムジェン インコーポレーテッド 自己緩衝タンパク質製剤
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)
CA2665567C (en) * 2006-10-06 2012-07-03 Amgen Inc. Stable formulations
US7705132B2 (en) * 2006-10-20 2010-04-27 Amgen Inc. Stable polypeptide formulations
CA2681743A1 (en) * 2007-03-22 2008-09-25 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
PE20120359A1 (es) 2009-03-06 2012-04-13 Genentech Inc Formulacion con anticuerpo
PT2542257T (pt) 2010-03-01 2017-10-09 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
AU2011325134B2 (en) 2010-11-05 2014-10-23 Novartis Ag Methods of treating rheumatoid arthritis using IL-17 antagonists
TWI603739B (zh) 2010-11-11 2017-11-01 艾伯維生物技術有限責任公司 具有增進高濃度之抗－ＴＮＦα抗體之液體調配物
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
US8613919B1 (en) 2012-08-31 2013-12-24 Bayer Healthcare, Llc High concentration antibody and protein formulations
US9592297B2 (en) 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
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
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
US20170231995A1 (en) 2014-08-11 2017-08-17 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
WO2017077507A1 (en) 2015-11-06 2017-05-11 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
CA2049342A1 (en) * 1989-03-27 1990-09-28 Sally Bolmer 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
NO924279D0 (no) 1992-11-06
FI924982A0 (fi) 1992-11-04
EP0531539A1 (en) 1993-03-17
WO1992015331A1 (en) 1992-09-17
FI924982A7 (fi) 1992-11-04
EP0841067B1 (en) 2002-05-22
NO924279L (no) 1992-11-06
EP0531539A4 (enExample) 1995-04-05
CA2082169A1 (en) 1992-09-09
FI924982L (fi) 1992-11-04
DE69225757T2 (de) 1998-12-03
AU1337592A (en) 1992-10-06
DK0841067T3 (da) 2002-07-15
EP0531539B1 (en) 1998-06-03
DE69232617D1 (de) 2002-06-27
DK0531539T3 (da) 1998-10-12
AU645187B2 (en) 1994-01-06
DE69225757D1 (de) 1998-07-09
US5908826A (en) 1999-06-01
EP0841067A1 (en) 1998-05-13
JPH0565233A (ja) 1993-03-19

Similar Documents

Publication Publication Date Title
DE69225757T2 (de) Lyophilische monoklonale antikörperpräparationen
DE68908175T2 (de) Gefriergetrocknete formulierung für antikörperprodukte.
DE69223641T2 (de) Stabilisierte antikörper
EP0260610B1 (de) Monoklonale Antikörper gegen humanen Tumonekrosefaktor (TNF) und deren Verwendung
DE3486146T2 (de) Monoklonale antikörper gegen endotoxine von gramnegativen bakterien.
EP0941121B1 (de) Stabile lyophilisierte pharmazeutische zubereitungen von mono- oder polykonalen antikörpern
DE3825429C2 (de) Verfahren zur Herstellung eines intravenös verabreichbaren polyklonalen Immunglobulin-Präparates mit hohem IgM-Gehalt
DE3686410T2 (de) Stabilisierte zusammensetzungen von menschlichen aktivatoren des gewebeplasminogens.
DE3781104T2 (de) Pasteurisierung von immunoglobulinloesungen.
AT400441B (de) Zell-linien und verfahren zur herstellung von humanen monoklonalen antikörpern sowie kit und verfahren zur bestimmung der anwesenheit von p.aeruginosa
DE2751717A1 (de) Neue verbesserte gammaglobuline fuer intravenoese injektion und verfahren zu ihrer herstellung
EP0413188B1 (de) Verfahren zur Herstellung nicht modifizierter intravenös verabreichbarer IgM- und/oder IgA-haltige Immunglobulinpräparate
DE3701066C2 (de) Intravenös injizierbares Immunglobulin mit hohem Antikörpertiter gegenüber dem respiratorischen Syncytialvirus, Verfahren zu dessen Herstellung und pharmazeutische Zubereitung, welche dieses enthält
DE3703711C2 (enExample)
AT397803B (de) Humaner monoklonaler antikörper und hybridom zur herstellung desselben
DE3235924C2 (enExample)
EP0085747B2 (de) Intravenös verabreichbares humanes Immunglobulin und Verfahren zu dessen Herstellung
DE69631229T2 (de) Herstellung von virusinaktivierten intravenös injektierbaren Globulin aus Immunserum
DE3875852T2 (de) Gereinigtes igm.
DE2508132C3 (de) Verfahren zur Herstellung von Humanimmunglobulin-Derivaten und parenteral applizierbare Lösung hiervon
DE2403994A1 (de) Herstellung von antisera
DE3541044A1 (de) Neues, allgemein anwendbares antigen (psc-a) gegen pseudomonas aeruginosa, das als mittel zum schutz gegen pseudomonas aeruginosa-infektion wirkt
DE10029705A1 (de) Herstellung von IgY(AFc)-Antikörpern und deren Verwendung
CH684164A5 (de) Intravenös anwendbare Immunglobulinlösung.
DE3685700T2 (de) E87ag-antigen des pseudomonas aeruginosa, monoklonale antikoerper dagegen und hybridom.

Legal Events

Date Code Title Description
8363 Opposition against the patent
8339 Ceased/non-payment of the annual fee