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.)
Mitsubishi 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=***_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
Application granted granted Critical
Publication of ES2182202T3 publication Critical patent/ES2182202T3/es
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 [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)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Water Supply & Treatment (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (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
JP9-291374 1997-10-23
JP29137497 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 (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
US6281336B1 (en) 1998-06-09 2001-08-28 Statens Serum Institut Process for producing immunoglobulins for intravenous administration and other immunoglobulin products
ES2184594B1 (es) * 2001-01-17 2004-01-01 Probitas Pharma Sa Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
US20040156835A1 (en) * 2001-05-30 2004-08-12 Taiji Imoto Protein preparation
TW200300173A (en) * 2001-11-13 2003-05-16 Nisshin Oillio Ltd Process for producing concentrated/purified protein using clay mineral composition
CN101066450A (zh) * 2002-02-14 2007-11-07 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
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
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
WO2008001496A1 (en) * 2006-06-28 2008-01-03 Fujimori Kogyo Co., Ltd. Liquid container
US20080214795A1 (en) * 2007-02-14 2008-09-04 Amgen Inc. Method of isolating antibodies by precipitation
MX2009010361A (es) 2007-03-29 2009-10-16 Abbott Lab Anticuerpos il-12 anti-humanos cristalinos.
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
US8796430B2 (en) 2010-05-26 2014-08-05 Baxter International Inc. Method to produce an immunoglobulin preparation with improved yield
AU2010202125B1 (en) 2010-05-26 2010-09-02 Takeda Pharmaceutical Company Limited A 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
EP2637690B1 (en) 2010-11-11 2016-09-21 AbbVie Biotechnology Ltd HIGH CONCENTRATION ANTI-TNFalpha ANTIBODY LIQUID FORMULATIONS
US9359397B2 (en) 2011-06-24 2016-06-07 Asahi Kasei Medical Co., Ltd. Method for manufacturing protein drug
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
CA2232420A1 (en) * 1997-03-19 1998-09-19 The Green Cross Corporation Immunoglobulin preparation and preparation process thereof

Also Published As

Publication number Publication date
CN1149100C (zh) 2004-05-12
EP0911037B1 (en) 2002-09-18
HK1021698A1 (en) 2000-06-30
CN1224620A (zh) 1999-08-04
DE69808012D1 (de) 2002-10-24
CA2251342A1 (en) 1999-04-23
ES2182202T5 (es) 2007-12-01
DK0911037T3 (da) 2002-12-02
DE69808012T2 (de) 2003-08-14
EP0911037B2 (en) 2007-06-13
PT911037E (pt) 2002-12-31
DE69808012T3 (de) 2008-01-24
CN1520885A (zh) 2004-08-18
US6485725B1 (en) 2002-11-26
EP0911037A1 (en) 1999-04-28
US6159471A (en) 2000-12-12
ATE224203T1 (de) 2002-10-15
KR100632312B1 (ko) 2007-05-14
KR19990037317A (ko) 1999-05-25

Similar Documents

Publication Publication Date Title
ES2182202T3 (es) Preparacion de inmunoglobulinas para inyeccion intravenosa apta para ser almacenada a temperatura ambiente.
EP1408108A3 (en) Cellulase producing actinomycetes, cellulase produced therefrom and method of producing same
DE69834741D1 (de) Cellulase aus actinomycetes und herstellungsverfahren dafür
DE69829308D1 (de) Cellulase aus actinomycetes und herstellungsverfahren dafür
DE69736177D1 (de) Mit aminosäuren stabilisierte erythropoietinlösung
SE9602638D0 (sv) An improved method for the capillary electrophoresis of nucleic acids, proteins and low molecular charged compounds
EP1911767A3 (en) Methods for producing immunoglobulins containing protection proteins in plants and their use
DK1386660T3 (da) Isolering af immunoglobuliner
DE3686637D1 (de) Novolakharz mit hohem molekulargewicht und verfahren zu dessen herstellung.
DE69430910D1 (de) Ethylencopolymer, dieses enthaltende thermoplastische harzzusammensetzung und verfahren zu seiner herstellung
DE69801154D1 (de) Verfahren zur herstellung von caprolactam in abwesenheit von katalysatoren durch kontakt von 6-aminocapronsäurederivaten mit überhitztem dampf
DE69422189D1 (de) Verfahren zur produktion von polytetrafluorethylen mit niedrigem molekulargewicht
DK0626452T3 (da) Vaccine mod infektion af Streptococcus suis
DE50003569D1 (de) Hochfeste polyesterfäden und verfahren zu deren herstellung
EP1418200A3 (en) Laser ray transmitting colored thermoplastic resin composition and method of laser welding
ATE204005T1 (de) Vernetzte polymerische ammoniumsalze
DE69428537D1 (de) Verfahren zur herstellung von stahlblech mit gerichteter magnetisierung unterverwendung von niedrigen brammenaufheiztemperaturen.
ATE7184T1 (de) Waermeschrumpfbarer artikel und verfahren zu dessen herstellung.
DK0496457T3 (da) Bitumen-polymer blandinger og en fremgangsmåde til fremstilling af disse
ATE30870T1 (de) Strahlungsvernetzung von polyamiden.
DE3675855D1 (de) Verfahren zur herstellung von hochmolekularen, gegebenenfalls verzweigten polyarylensulfiden.
DK0640608T3 (da) Mellemprodukter til syntese af cephalosporiner
DK0676965T3 (da) Fremgangsmåde til at reducere immunogeniciteten af variable regioner på antistoffer
ES2130192T3 (es) Procedimiento para la preparacion biotecnica de l-tienilalaninas en forma enantiomera pura, partiendo de acidos 2-hidroxi-3-tienil-acrilicos, y su empleo.
DE69426889D1 (de) Carbonatharz mit verbesserter fliessfaehigkeit, verfahren zu seiner herstellung und daraus hergestelltes duennwandiges teil