DK0911037T3 - Ved stuetemperatur lagringsholdbart immunoglobulinpræparat til intravenøs injektion - Google Patents

Ved stuetemperatur lagringsholdbart immunoglobulinpræparat til intravenøs injektion

Info

Publication number
DK0911037T3
DK0911037T3 DK98119782T DK98119782T DK0911037T3 DK 0911037 T3 DK0911037 T3 DK 0911037T3 DK 98119782 T DK98119782 T DK 98119782T DK 98119782 T DK98119782 T DK 98119782T DK 0911037 T3 DK0911037 T3 DK 0911037T3
Authority
DK
Denmark
Prior art keywords
intravenous injection
shelf
life
room temperature
immunoglobulin preparation
Prior art date
Application number
DK98119782T
Other languages
Danish (da)
English (en)
Inventor
Yutaka Hirao
Motonori Hashimoto
Tae Kitamura
Yahiro Uemura
Original Assignee
Mitsubishi Pharma Corp
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=17768099&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK0911037(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Mitsubishi Pharma Corp filed Critical Mitsubishi Pharma Corp
Application granted granted Critical
Publication of DK0911037T3 publication Critical patent/DK0911037T3/da

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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
    • A61P37/04—Immunostimulants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/18—Ion-exchange chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Analytical Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Water Supply & Treatment (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
DK98119782T 1997-10-23 1998-10-23 Ved stuetemperatur lagringsholdbart immunoglobulinpræparat til intravenøs injektion DK0911037T3 (da)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP29137497 1997-10-23

Publications (1)

Publication Number Publication Date
DK0911037T3 true DK0911037T3 (da) 2002-12-02

Family

ID=17768099

Family Applications (1)

Application Number Title Priority Date Filing Date
DK98119782T DK0911037T3 (da) 1997-10-23 1998-10-23 Ved stuetemperatur lagringsholdbart immunoglobulinpræparat til intravenøs injektion

Country Status (11)

Country Link
US (2) US6159471A (es)
EP (1) EP0911037B2 (es)
KR (1) KR100632312B1 (es)
CN (2) CN1520885A (es)
AT (1) ATE224203T1 (es)
CA (1) CA2251342A1 (es)
DE (1) DE69808012T3 (es)
DK (1) DK0911037T3 (es)
ES (1) ES2182202T5 (es)
HK (1) HK1021698A1 (es)
PT (1) PT911037E (es)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2421736T3 (es) 1998-06-09 2013-09-05 Csl Behring Ag Procedimiento para la preparación de inmunoglobulinas para administración intravenosa y otros productos inmunoglobulínicos
ES2184594B1 (es) * 2001-01-17 2004-01-01 Probitas Pharma Sa Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
EP1391209A4 (en) * 2001-05-30 2009-12-16 Chugai Pharmaceutical Co Ltd PROTEIN PREPARATION
TW200300173A (en) * 2001-11-13 2003-05-16 Nisshin Oillio Ltd Process for producing concentrated/purified protein using clay mineral composition
EP3192528A1 (en) 2002-02-14 2017-07-19 Chugai Seiyaku Kabushiki Kaisha Formulation of anti-il6r antibody-containing solutions comprising a sugar as a stabilizer
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
MY150740A (en) * 2002-10-24 2014-02-28 Abbvie Biotechnology Ltd Low dose methods for treating disorders in which tnf? activity is detrimental
FR2854801B1 (fr) * 2003-05-12 2006-09-01 Khorionyx Implant injectable de globine insoluble
EP1532983A1 (en) 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
US7723306B2 (en) 2004-05-10 2010-05-25 Boehringer Ingelheim Pharma Gmbh & Co. Kg Spray-dried powder comprising at least one 1,4 O-linked saccharose-derivative and methods for their preparation
DE102004022927A1 (de) * 2004-05-10 2005-12-15 Boehringer Ingelheim Pharma Gmbh & Co. Kg 1,4 O-verknüpfte Saccharose-Derivate zur Stabilisierung von Antikörpern oder Antikörper-Derivaten
US7611709B2 (en) 2004-05-10 2009-11-03 Boehringer Ingelheim Pharma Gmbh And Co. Kg 1,4 O-linked saccharose derivatives for stabilization of antibodies or antibody derivatives
US7727962B2 (en) 2004-05-10 2010-06-01 Boehringer Ingelheim Pharma Gmbh & Co. Kg Powder comprising new compositions of oligosaccharides and methods for their preparation
EP2033615B1 (en) * 2006-06-28 2017-05-10 Fujimori Kogyo Co., Ltd. Liquid container
US20080214795A1 (en) * 2007-02-14 2008-09-04 Amgen Inc. Method of isolating antibodies by precipitation
US8168760B2 (en) 2007-03-29 2012-05-01 Abbott Laboratories Crystalline anti-human IL-12 antibodies
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
WO2011095543A1 (en) 2010-02-04 2011-08-11 Csl Behring Ag Immunoglobulin preparation
EP2361636A1 (en) 2010-02-26 2011-08-31 CSL Behring AG Immunoglobulin preparation and storage system for an immunoglobulin preparation
AU2010202125B1 (en) 2010-05-26 2010-09-02 Takeda Pharmaceutical Company Limited A method to produce an immunoglobulin preparation with improved yield
US8796430B2 (en) 2010-05-26 2014-08-05 Baxter International Inc. Method to produce an immunoglobulin preparation with improved yield
WO2011150284A2 (en) 2010-05-26 2011-12-01 Baxter International Inc. Removal of serine proteases by treatment with finely divided silicon dioxide
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
CN103608352A (zh) 2011-06-24 2014-02-26 旭化成医疗株式会社 蛋白制剂的制造方法
TWI629283B (zh) 2012-02-23 2018-07-11 巴克斯歐塔公司 來自血漿中的免疫球蛋白之ｉ-ｉｖ-１部分沉澱
CN103341187B (zh) * 2012-06-28 2016-06-22 四川远大蜀阳药业股份有限公司 一种终端灭活病原微生物的方法

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4378346A (en) * 1979-08-15 1983-03-29 Tankersley Donald L Intravenously injectable solution of plasma protein fraction free from bradykinin, kininogen and prekallikrein activators and processes for its production
FR2582515B1 (fr) * 1985-05-30 1988-11-04 Merieux Inst Procede de preparation de gamma-gobulines administrables par voie intraveineuse et gamma-globulines obtenues
JPH0662436B2 (ja) * 1986-05-19 1994-08-17 株式会社ミドリ十字 静注用免疫グロブリン製剤の製造方法
DE3641115A1 (de) * 1986-12-02 1988-06-16 Lentia Gmbh Verfahren zur herstellung eines intravenoes anwendbaren und in fluessiger form stabilen immunglobulins
JP2547556B2 (ja) † 1987-02-06 1996-10-23 株式会社 ミドリ十字 ｒ−グロブリンの液状製剤
JP2613409B2 (ja) * 1987-11-20 1997-05-28 株式会社ミドリ十字 抗エイズウイルス抗体陽性静注用免疫グロブリン製剤の製造方法
US5177194A (en) * 1990-02-01 1993-01-05 Baxter International, Inc. Process for purifying immune serum globulins
DE4125625C2 (de) † 1991-08-02 1999-12-02 Octapharma Ag Glarus Verfahren zur Herstellung von virusinaktivierten Immunglobulinlösungen
JPH0761935A (ja) * 1993-08-25 1995-03-07 Green Cross Corp:The 静注用免疫グロブリン製剤の製造方法
JP4003235B2 (ja) * 1994-09-30 2007-11-07 三菱ウェルファーマ株式会社 静注用免疫グロブリン製剤の製造方法
EP0764658B1 (de) * 1995-09-22 2002-01-02 ZLB Bioplasma AG Verfahren zur Gewinnung von Immunglobulinen aus Fraktionen, die bei der Fraktionierung von menschlichem Blutplasma entstehen
TW541179B (en) * 1997-03-19 2003-07-11 Green Cross Corp Process for preparing immunoglobulin preparation

Also Published As

Publication number Publication date
EP0911037A1 (en) 1999-04-28
ES2182202T3 (es) 2003-03-01
CA2251342A1 (en) 1999-04-23
ATE224203T1 (de) 2002-10-15
PT911037E (pt) 2002-12-31
DE69808012T3 (de) 2008-01-24
EP0911037B2 (en) 2007-06-13
DE69808012T2 (de) 2003-08-14
ES2182202T5 (es) 2007-12-01
HK1021698A1 (en) 2000-06-30
KR19990037317A (ko) 1999-05-25
KR100632312B1 (ko) 2007-05-14
CN1520885A (zh) 2004-08-18
US6485725B1 (en) 2002-11-26
US6159471A (en) 2000-12-12
CN1224620A (zh) 1999-08-04
CN1149100C (zh) 2004-05-12
DE69808012D1 (de) 2002-10-24
EP0911037B1 (en) 2002-09-18

Similar Documents

Publication Publication Date Title
DK0911037T3 (da) Ved stuetemperatur lagringsholdbart immunoglobulinpræparat til intravenøs injektion
DE69834741D1 (de) Cellulase aus actinomycetes und herstellungsverfahren dafür
DE69829308D1 (de) Cellulase aus actinomycetes und herstellungsverfahren dafür
EP1408108A3 (en) Cellulase producing actinomycetes, cellulase produced therefrom and method of producing same
DE69631595D1 (de) Harzzusammensetzung, damit hergestellte form und verfahren zu deren herstellung
IS4121A (is) Hliðstæð aðferð til framleiðslu á 2,6-Díamínópúrín afleiðum
DK0807173T3 (da) Fremgangsmåder til fremstilling af immunoglobuliner indeholdende beskyttelsesproteiner i planter og anvendelse deraf
DK0530447T3 (da) Fremgangsmåde til rensning af IgG-monoklonale antistoffer
DE69801154T2 (de) Verfahren zur herstellung von caprolactam in abwesenheit von katalysatoren durch kontakt von 6-aminocapronsäurederivaten mit überhitztem dampf
DK1171468T3 (da) Fremgangsmåde til stabilisering af kimære immunoglobuliner eller immunoglobulinfragmenter, samt stabiliseret anti-EGP-2-scFv-fragment
DE69412750T2 (de) Verfahren zur Herstellung von konjugierten Arylen- oder Heteroarylenvinylenpolymeren und damit hergestellten Gegenständen
DE59402292D1 (de) Verfahren zur Herstellung von 1,3,5-Triazinen
ATA171686A (de) Verfahren zur herstellung von gegen pseudomonas aeruginosa infektionen wirksamen praeparationen
DK1105508T3 (da) Fremgangsmåde til oprensning af biomolekyle- eller proteinkomplekser
DE68907735D1 (de) Genfragmente, die die variable region eines anti-hiv-antikoerpers codieren, von diesen exprimierte chimaere anti-hiv-antikoerper und verfahren zu deren herstellung.
DE59302304D1 (de) Verfahren zur Herstellung von 2-Chlor-5-methyl-pyridin
ES8304431A1 (es) "un metodo para preparar una inmunoglobulina adecuada para administracion intravenosa".
DK0676965T3 (da) Fremgangsmåde til at reducere immunogeniciteten af variable regioner på antistoffer
DE3675855D1 (de) Verfahren zur herstellung von hochmolekularen, gegebenenfalls verzweigten polyarylensulfiden.
WO1994025527A3 (en) Improved bonding resin and methods relating thereto
DE69520947T2 (de) Diarinopropanole abgeleitet von aminosäuren
DK0820468T3 (da) Fremgangsmåde til rensning af glycoproteiner, såsom erythropoietin
DE69811677T2 (de) Verfahren zur präparation von enantiomer-angereicherten, n-derivatisierten laktamen.
DE69410222D1 (de) Verfahren zur Herstellung von optisch aktiven Erythro-3-amino-1,2-epoxy-Verbindungen
EP1033136A4 (en) METHOD FOR PRODUCING IMMUNOGLOBULIN SOLUTIONS FOR INTRAVENOUS INJECTION THAT DO NOT CONTAIN PROTECTIVE AGENTS BY DOUBLE STERILIZATION AGAINST VIRUSES