DE69808012D1 - Bei Raumtemperatur lagerfähiges Immunoglobolin-Präparat für intravenöse Injektion - Google Patents

Bei Raumtemperatur lagerfähiges Immunoglobolin-Präparat für intravenöse Injektion

Info

Publication number
DE69808012D1
DE69808012D1 DE69808012T DE69808012T DE69808012D1 DE 69808012 D1 DE69808012 D1 DE 69808012D1 DE 69808012 T DE69808012 T DE 69808012T DE 69808012 T DE69808012 T DE 69808012T DE 69808012 D1 DE69808012 D1 DE 69808012D1
Authority
DE
Germany
Prior art keywords
intravenous injection
preparation
immunoglobolin
stored
room temperature
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
DE69808012T
Other languages
English (en)
Other versions
DE69808012T2 (de
DE69808012T3 (de
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=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DE69808012(D1) "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 DE69808012D1 publication Critical patent/DE69808012D1/de
Publication of DE69808012T2 publication Critical patent/DE69808012T2/de
Application granted granted Critical
Publication of DE69808012T3 publication Critical patent/DE69808012T3/de
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
DE69808012T 1997-10-23 1998-10-23 Bei Raumtemperatur lagerfähiges Immunoglobolin-Präparat für intravenöse Injektion Expired - Lifetime DE69808012T3 (de)

Applications Claiming Priority (2)

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

Publications (3)

Publication Number Publication Date
DE69808012D1 true DE69808012D1 (de) 2002-10-24
DE69808012T2 DE69808012T2 (de) 2003-08-14
DE69808012T3 DE69808012T3 (de) 2008-01-24

Family

ID=17768099

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69808012T Expired - Lifetime DE69808012T3 (de) 1997-10-23 1998-10-23 Bei Raumtemperatur lagerfähiges Immunoglobolin-Präparat für intravenöse Injektion

Country Status (11)

Country Link
US (2) US6159471A (de)
EP (1) EP0911037B2 (de)
KR (1) KR100632312B1 (de)
CN (2) CN1149100C (de)
AT (1) ATE224203T1 (de)
CA (1) CA2251342A1 (de)
DE (1) DE69808012T3 (de)
DK (1) DK0911037T3 (de)
ES (1) ES2182202T5 (de)
HK (1) HK1021698A1 (de)
PT (1) PT911037E (de)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2527915T3 (es) 1998-06-09 2015-02-02 Csl Behring Ag Producto de inmunoglobulina G (IgG) líquido
ES2184594B1 (es) * 2001-01-17 2004-01-01 Probitas Pharma Sa Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
EP1391209A4 (de) * 2001-05-30 2009-12-16 Chugai Pharmaceutical Co Ltd Proteinzubereitung
TW200300173A (en) * 2001-11-13 2003-05-16 Nisshin Oillio Ltd Process for producing concentrated/purified protein using clay mineral composition
ES2536709T3 (es) 2002-02-14 2015-05-27 Chugai Seiyaku Kabushiki Kaisha Utilización de ácido acético para eliminar los problemas inducidos por el ión Fe en las formulaciones de anticuerpos anti-HM1.24 o anti-IL6R
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 (de) 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulinpräparationen mit erhöhter Stabilität
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
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
EP2033615B1 (de) * 2006-06-28 2017-05-10 Fujimori Kogyo Co., Ltd. Flüssigkeitsbehälter
US20080214795A1 (en) * 2007-02-14 2008-09-04 Amgen Inc. Method of isolating antibodies by precipitation
NZ598881A (en) * 2007-03-29 2013-11-29 Abbvie Inc Crystalline anti-human il-12 antibodies
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
CA2788863C (en) 2010-02-04 2020-07-07 Reinhard Franz Bolli Immunoglobulin preparation
EP2361636A1 (de) 2010-02-26 2011-08-31 CSL Behring AG Immunglobulinpräparat und Aufbewahrungssystem für ein Immunglobulinpräparat
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
AU2011325974B2 (en) 2010-11-11 2016-10-27 Abbvie Biotechnology Ltd. Improved high concentration anti-TNFalpha antibody liquid formulations
ES2641042T3 (es) * 2011-06-24 2017-11-07 Asahi Kasei Kuraray Medical Co., Ltd. Procedimiento para la fabricación de un fármaco proteínico
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
PT764658E (pt) * 1995-09-22 2002-06-28 Zlb Bioplasma Ag Processo para a obtencao de imunoglobulinas a partir de fraccoes que resultam do fraccionamento do plasma sanguineo humano
TW541179B (en) * 1997-03-19 2003-07-11 Green Cross Corp Process for preparing immunoglobulin preparation

Also Published As

Publication number Publication date
HK1021698A1 (en) 2000-06-30
US6159471A (en) 2000-12-12
EP0911037B1 (de) 2002-09-18
DK0911037T3 (da) 2002-12-02
CN1520885A (zh) 2004-08-18
KR19990037317A (ko) 1999-05-25
DE69808012T2 (de) 2003-08-14
KR100632312B1 (ko) 2007-05-14
ES2182202T5 (es) 2007-12-01
EP0911037A1 (de) 1999-04-28
CA2251342A1 (en) 1999-04-23
PT911037E (pt) 2002-12-31
CN1149100C (zh) 2004-05-12
CN1224620A (zh) 1999-08-04
DE69808012T3 (de) 2008-01-24
EP0911037B2 (de) 2007-06-13
ATE224203T1 (de) 2002-10-15
ES2182202T3 (es) 2003-03-01
US6485725B1 (en) 2002-11-26

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8366 Restricted maintained after opposition proceedings