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
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

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/34Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/36Extraction; 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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Analytical Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Water Supply & Treatment (AREA)
  • Communicable Diseases (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (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 (10)

Country Link
US (2) US6159471A (da)
EP (1) EP0911037B2 (da)
KR (1) KR100632312B1 (da)
CN (2) CN1149100C (da)
AT (1) ATE224203T1 (da)
CA (1) CA2251342A1 (da)
DE (1) DE69808012T3 (da)
DK (1) DK0911037T3 (da)
ES (1) ES2182202T5 (da)
PT (1) PT911037E (da)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW541179B (en) * 1997-03-19 2003-07-11 Green Cross Corp Process for preparing immunoglobulin preparation
DK2270044T3 (da) 1998-06-09 2015-01-26 Csl Behring Ag Flydende immunglobulin G (IgG) produkt
ES2184594B1 (es) * 2001-01-17 2004-01-01 Probitas Pharma Sa Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
JP5052736B2 (ja) * 2001-05-30 2012-10-17 中外製薬株式会社 タンパク質製剤
TW200300173A (en) * 2001-11-13 2003-05-16 Nisshin Oillio Ltd Process for producing concentrated/purified protein using clay mineral composition
CN101721362B (zh) 2002-02-14 2018-07-03 中外制药株式会社 包含抗体的溶液制剂
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
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
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
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
JP5493115B2 (ja) * 2006-06-28 2014-05-14 藤森工業株式会社 液体収納容器
WO2008100578A2 (en) * 2007-02-14 2008-08-21 Amgen Inc. Method of isolating antibodies by precipitation
RU2476442C2 (ru) 2007-03-29 2013-02-27 Эббот Лэборетриз Кристаллические антитела против il-12 человека
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
WO2011150284A2 (en) 2010-05-26 2011-12-01 Baxter International Inc. Removal of serine proteases by treatment with finely divided silicon dioxide
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
US8821865B2 (en) 2010-11-11 2014-09-02 Abbvie Biotechnology Ltd. High concentration anti-TNFα antibody liquid formulations
JP5711369B2 (ja) 2011-06-24 2015-04-30 旭化成メディカル株式会社 蛋白製剤の製造方法
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
ES2988823T3 (es) 2014-12-03 2024-11-21 Csl Behring Ag Producto farmacéutico con mayor estabilidad que comprende inmunoglobulinas

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
ATE211486T1 (de) * 1995-09-22 2002-01-15 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
US6159471A (en) 2000-12-12
PT911037E (pt) 2002-12-31
ES2182202T3 (es) 2003-03-01
DE69808012T3 (de) 2008-01-24
HK1021698A1 (en) 2000-06-30
DE69808012T2 (de) 2003-08-14
KR100632312B1 (ko) 2007-05-14
EP0911037B1 (en) 2002-09-18
CN1520885A (zh) 2004-08-18
KR19990037317A (ko) 1999-05-25
US6485725B1 (en) 2002-11-26
CA2251342A1 (en) 1999-04-23
EP0911037B2 (en) 2007-06-13
ES2182202T5 (es) 2007-12-01
ATE224203T1 (de) 2002-10-15
CN1149100C (zh) 2004-05-12
CN1224620A (zh) 1999-08-04
DE69808012D1 (de) 2002-10-24

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
FR2690920B1 (fr) Dérivés 1-hydrocarbyloxy-2,2,6,6-tétraméthylpipéridiniques de 1,3,5-triazines non-migrants comme stabilisants de matières polymères.
ES2142363T3 (es) Materiales y metodos para la hipersecrecion de aminoacidos.
WO2003022953A8 (en) Structural hot melt material and methods
DE59409751D1 (de) Verfahren zur Herstellung von hydroxyphenylsubstituierten 1,3,5-Triazinen
DK0530447T3 (da) Fremgangsmåde til rensning af IgG-monoklonale antistoffer
DE60328747D1 (de) Reinigung von polyreaktiven Autoantikörpern und deren Verwendungen
DE3788273D1 (de) Verfahren zur Herstellung von Harzen, welche bei Raumtemperatur härten.
DK1171468T3 (da) Fremgangsmåde til stabilisering af kimære immunoglobuliner eller immunoglobulinfragmenter, samt stabiliseret anti-EGP-2-scFv-fragment
DE69412750D1 (de) Verfahren zur Herstellung von konjugierten Arylen- oder Heteroarylenvinylenpolymeren und damit hergestellten Gegenständen
DK302190D0 (da) Fremgangsmaade til behandling af neurologiske tilstande
DE59402292D1 (de) Verfahren zur Herstellung von 1,3,5-Triazinen
ATE7184T1 (de) Waermeschrumpfbarer artikel und verfahren zu dessen herstellung.
DK1105508T3 (da) Fremgangsmåde til oprensning af biomolekyle- eller proteinkomplekser
ATE137221T1 (de) Verfahren zur herstellung von 2-chlor-5-methyl- pyridin
ATA171686A (de) Verfahren zur herstellung von gegen pseudomonas aeruginosa infektionen wirksamen praeparationen
DE69515426D1 (de) Versetzbahres Fahrbahnbegrenzungselement, Fahrbahnbegrenzung damit hergestellt und Verfahren zur Herstellung
CA2126182A1 (en) Humanized antibodies reactive with gpiib/iiia
ES8304431A1 (es) "un metodo para preparar una inmunoglobulina adecuada para administracion intravenosa".
DE69334156D1 (de) Verfahren zur Reduzierung der Immunogenizität der variablen Regionen von Antikörpern
WO1994025527A3 (en) Improved bonding resin and methods relating thereto
DE69811677D1 (de) Verfahren zur präparation von enantiomer-angereicherten, n-derivatisierten laktamen.