ES2182202T3 - Preparacion de inmunoglobulinas para inyeccion intravenosa apta para ser almacenada a temperatura ambiente. - Google Patents

Preparacion de inmunoglobulinas para inyeccion intravenosa apta para ser almacenada a temperatura ambiente.

Info

Publication number
ES2182202T3
ES2182202T3 ES98119782T ES98119782T ES2182202T3 ES 2182202 T3 ES2182202 T3 ES 2182202T3 ES 98119782 T ES98119782 T ES 98119782T ES 98119782 T ES98119782 T ES 98119782T ES 2182202 T3 ES2182202 T3 ES 2182202T3
Authority
ES
Spain
Prior art keywords
intravenous injection
stored
environmental temperature
immunoglobulin preparation
injection suitable
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 - Lifetime
Application number
ES98119782T
Other languages
English (en)
Other versions
ES2182202T5 (es
Inventor
Yutaka Hirao
Motonori Hashimoto
Tae Kitamura
Yahiro Uemura
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.)
Tanabe Pharma Corp
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=ES2182202(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
Publication of ES2182202T3 publication Critical patent/ES2182202T3/es
Application granted granted Critical
Publication of ES2182202T5 publication Critical patent/ES2182202T5/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], 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)
  • 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)

Abstract

LA INVENCION SE REFIERE A UN PROCEDIMIENTO PARA PRODUCIR UNA PREPARACION DE INMUNOGLOBULINA PARA INYECCION INTRAVENOSA, QUE COMPRENDE LOS SIGUIENTES PASOS: FRACCIONAR UNA SOLUCION QUE CONTIENE INMUNOGLOBULINA CON ENTRE UN 4 Y UN 10 % EN PESO DE GLICOL DE POLIETILENO QUE TIENE UN PESO MOLECULAR DE ENTRE 1,000 Y 10,000, CON UN VALOR DE PH DE ENTRE 4.5 Y 6.5, UNA FUERZA IONICA DE ENTRE 0.0001 Y 0.1 M Y UNA TEMPERATURA DE ENTRE 0 Y 4°C PARA RECUPERAR UNA FRACCION SOBRENADANTE CON UN PH DE ENTRE 3.5 Y 5.0.
ES98119782T 1997-10-23 1998-10-23 Preparacion de inmunoglobulinas para inyeccion intravenosa apta para ser almacenada a temperatura ambiente. Expired - Lifetime ES2182202T5 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP29137497 1997-10-23
JP9-291374 1997-10-23

Publications (2)

Publication Number Publication Date
ES2182202T3 true ES2182202T3 (es) 2003-03-01
ES2182202T5 ES2182202T5 (es) 2007-12-01

Family

ID=17768099

Family Applications (1)

Application Number Title Priority Date Filing Date
ES98119782T Expired - Lifetime ES2182202T5 (es) 1997-10-23 1998-10-23 Preparacion de inmunoglobulinas para inyeccion intravenosa apta para ser almacenada a temperatura ambiente.

Country Status (10)

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

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 (en) 1998-06-09 2015-01-26 Csl Behring Ag Liquid immunoglobulin G (IgG) product
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
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
DK0911037T3 (da) 2002-12-02
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

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