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

    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Analytical Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Oncology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Communicable Diseases (AREA)
  • Water Supply & Treatment (AREA)
  • Dermatology (AREA)
  • Epidemiology (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 (11)

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)
HK (1) HK1021698A1 (da)
PT (1) PT911037E (da)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4685238B2 (ja) 1998-06-09 2011-05-18 ツエー・エス・エル・ベーリング・アクチエンゲゼルシヤフト 静脈投与用免疫グロブリン及び他の免疫グロブリン生成物の製造法
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
JP4364645B2 (ja) * 2002-02-14 2009-11-18 中外製薬株式会社 抗体含有溶液製剤
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
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
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
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
CN101478945B (zh) * 2006-06-28 2013-07-31 藤森工业株式会社 液体收纳容器
US20080214795A1 (en) * 2007-02-14 2008-09-04 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
ES2716088T3 (es) 2010-02-04 2019-06-10 Csl Behring Ag Preparado de inmunoglobulina
EP2361636A1 (en) 2010-02-26 2011-08-31 CSL Behring AG Immunoglobulin preparation and storage system for an immunoglobulin preparation
US8772462B2 (en) 2010-05-26 2014-07-08 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
MX344727B (es) 2010-11-11 2017-01-05 Abbvie Biotechnology Ltd Formulaciones liquidas de anticuerpos anti-tnf-alfa de alta concentracion mejoradas.
EP2725033B1 (en) * 2011-06-24 2017-08-09 Asahi Kasei Medical Co., Ltd. Method for producing protein preparation
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
DK0764658T3 (da) * 1995-09-22 2002-04-22 Zlb Bioplasma Ag Fremgangsmåde til fremstilling af immunoglobuliner ud fra fraktioner, som opstår ved fraktionering af blodplasma fra mennesker
US6124437A (en) * 1997-03-19 2000-09-26 Welfide Corporation Immunoglobulin preparation and preparation process thereof

Also Published As

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

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