ES2158877T3 - Composicion de inmunoglobulina de elevada concentracion y procedimiento de su preparacion. - Google Patents

Composicion de inmunoglobulina de elevada concentracion y procedimiento de su preparacion.

Info

Publication number
ES2158877T3
ES2158877T3 ES94120595T ES94120595T ES2158877T3 ES 2158877 T3 ES2158877 T3 ES 2158877T3 ES 94120595 T ES94120595 T ES 94120595T ES 94120595 T ES94120595 T ES 94120595T ES 2158877 T3 ES2158877 T3 ES 2158877T3
Authority
ES
Spain
Prior art keywords
immunoglobulin
preparation
elevada
procedure
concentration
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
ES94120595T
Other languages
English (en)
Inventor
Johann Dr Eibl
Yendra Dr Linnau
Wolfgang Dr Teschner
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.)
Baxter AG
Original Assignee
Baxter AG
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=6506449&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2158877(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Baxter AG filed Critical Baxter AG
Application granted granted Critical
Publication of ES2158877T3 publication Critical patent/ES2158877T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Mycology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

SE DESCRIBE UN PREPARADO DE INMUNOGLOBULINA ESTABLE, ALTAMENTE CONCENTRADO, TOLERABLE DE FORMA INTRAVENOSA, QUE MUESTRA UN CONTENIDO DE INMUNOGLOBULINA DESDE 13,5 HASTA 17,5 % (G/V), UNA OSMOLARIDAD DESDE 250 HASTA 600 MOS/L Y UNA VISCOSIDAD NO MAYOR DE 9 CP. EL PREPARADO DE INMUNOGLOBULINA POSEE UNA CAPACIDAD DE CONSERVACION DESTACADA Y POR MOTIVOS DE SU VISCOSIDAD REDUCIDA SE UTILIZA TAMBIEN COMO PREPARADO ALTAMENTE CONCENTRADO DE FORMA INTRAVENOSA SIN PROBLEMAS.
ES94120595T 1993-12-28 1994-12-23 Composicion de inmunoglobulina de elevada concentracion y procedimiento de su preparacion. Expired - Lifetime ES2158877T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE4344824A DE4344824C1 (de) 1993-12-28 1993-12-28 Hochkonzentriertes Immunglobulin-Präparat und Verfahren zu seiner Herstellung

Publications (1)

Publication Number Publication Date
ES2158877T3 true ES2158877T3 (es) 2001-09-16

Family

ID=6506449

Family Applications (1)

Application Number Title Priority Date Filing Date
ES94120595T Expired - Lifetime ES2158877T3 (es) 1993-12-28 1994-12-23 Composicion de inmunoglobulina de elevada concentracion y procedimiento de su preparacion.

Country Status (15)

Country Link
US (1) US5608038A (es)
EP (1) EP0661060B1 (es)
JP (1) JP3040678B2 (es)
AT (2) AT407707B (es)
CA (1) CA2138853A1 (es)
CZ (1) CZ284186B6 (es)
DE (2) DE4344824C1 (es)
DK (1) DK0661060T3 (es)
ES (1) ES2158877T3 (es)
FI (1) FI111224B (es)
HR (1) HRP941018B1 (es)
HU (1) HU220766B1 (es)
NO (1) NO315260B1 (es)
RU (1) RU2104713C1 (es)
YU (1) YU77994A (es)

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US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US6685940B2 (en) * 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
GB9610992D0 (en) 1996-05-24 1996-07-31 Glaxo Group Ltd Concentrated antibody preparation
EP0852951A1 (de) * 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
US6991790B1 (en) 1997-06-13 2006-01-31 Genentech, Inc. Antibody formulation
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
EP0999853B1 (en) * 1997-06-13 2003-01-02 Genentech, Inc. Stabilized antibody formulation
AU2002213441B2 (en) * 2000-10-12 2006-10-26 Genentech, Inc. Reduced-viscosity concentrated protein formulations
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
US7132100B2 (en) 2002-06-14 2006-11-07 Medimmune, Inc. Stabilized liquid anti-RSV antibody formulations
US7425618B2 (en) * 2002-06-14 2008-09-16 Medimmune, Inc. Stabilized anti-respiratory syncytial virus (RSV) antibody formulations
WO2004001007A2 (en) * 2002-06-21 2003-12-31 Idec Pharmaceuticals Corporation Buffered formulations for concentrating antibodies and methods of use thereof
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
US20060104968A1 (en) 2003-03-05 2006-05-18 Halozyme, Inc. Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminogly ycanases
US20050158303A1 (en) * 2003-04-04 2005-07-21 Genentech, Inc. Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations
CN1798575A (zh) 2003-04-04 2006-07-05 健泰科生物技术公司 高浓度抗体和蛋白制剂
RU2240136C1 (ru) * 2003-04-10 2004-11-20 Государственное учреждение "Московский научно-исследовательский институт эпидемиологии и микробиологии им. Г.Н.Габричевского МЗ РФ" Композиция, содержащая иммуноглобулины и целевые добавки
RU2264229C2 (ru) * 2003-07-28 2005-11-20 Ковшик Игорь Геннадьевич Препарат секреторного иммуноглобулина а, обладающий противовирусным и антибактериальным действием
US8008447B2 (en) * 2004-07-23 2011-08-30 Genentech, Inc. Crystallization of antibody or fragment thereof
JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
MX2007015476A (es) 2005-06-14 2008-02-25 Amgen Inc Formulaciones de proteina autoamortiguadoras.
US20070190057A1 (en) 2006-01-23 2007-08-16 Jian Wu Methods for modulating mannose content of recombinant proteins
AR059066A1 (es) 2006-01-27 2008-03-12 Amgen Inc Combinaciones del inhibidor de la angiopoyetina -2 (ang2) y el inhibidor del factor de crecimiento endotelial vascular (vegf)
CA2681752A1 (en) * 2007-03-29 2008-10-09 Abbott Laboratories Crystalline anti-human 1l-12 antibodies
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
TWI543768B (zh) * 2007-11-30 2016-08-01 艾伯維生物技術有限責任公司 蛋白質調配物及製造其之方法
TWI489994B (zh) 2008-03-17 2015-07-01 Baxter Healthcare Sa 供免疫球蛋白及玻尿酸酶之皮下投藥之用的組合及方法
WO2010062896A1 (en) * 2008-11-28 2010-06-03 Abbott Laboratories Stable antibody compositions and methods for stabilizing same
US20100158893A1 (en) * 2008-12-19 2010-06-24 Baxter International Inc. Systems and methods for obtaining immunoglobulin from blood
AR076640A1 (es) * 2009-03-06 2011-06-29 Genentech Inc Formulacion con anticuerpo. metodo para estabilizar anticuerpo. articulo de manufactura
MX2012003282A (es) 2009-09-17 2012-04-30 Baxter Healthcare Sa Co-formulacion estable de hialuronidasa e inmunoglobulina, y metodos de su uso.
HUE047173T2 (hu) 2010-03-01 2020-04-28 Bayer Healthcare Llc Optimalizált monoklonális ellenanyagok szöveti faktor útvonal inhibitor (TFPI) ellen
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
US8613919B1 (en) 2012-08-31 2013-12-24 Bayer Healthcare, Llc High concentration antibody and protein formulations
US9592297B2 (en) 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
AU2013203043B2 (en) 2013-03-15 2016-10-06 Takeda Pharmaceutical Company Limited Methods to produce a human plasma-derived igg preparation enriched in brain disease-related natural iggs
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
EP3071181B1 (en) 2013-11-18 2021-03-24 Formycon AG Pharmaceutical composition of an anti-vegf antibody
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
WO2015196091A1 (en) 2014-06-20 2015-12-23 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
EP3200804A4 (en) 2014-10-01 2018-04-18 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
RU2599029C1 (ru) * 2015-07-16 2016-10-10 Игорь Геннадьевич Ковшик Химерный иммуноглобулиновый препарат, обладающий специфическим противовирусным или антибактериальным действием
LT4209499T (lt) 2015-08-13 2024-11-25 Amgen Inc. Antigeną surišančių baltymų įkrautas giluminis filtravimas
AU2017345490B2 (en) 2016-10-21 2022-07-07 Amgen Inc. Pharmaceutical formulations and methods of making the same

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US4075193A (en) * 1976-11-26 1978-02-21 Parke, Davis & Company Process for producing intravenous immune globulin
AT359641B (de) * 1978-09-19 1980-11-25 Immuno Ag Verfahren zur herstellung eines intravenoes ver- abreichbaren antikoerperhaeltigen immunglobulin- praeparates
US4186192A (en) * 1978-12-18 1980-01-29 Cutter Laboratories, Inc. Stabilized immune serum globulin
JPS57203017A (en) * 1981-06-09 1982-12-13 Fujirebio Inc Purifying method of immunoglobulin
US4499073A (en) * 1981-08-24 1985-02-12 Cutter Laboratories, Inc. Intravenously injectable immune serum globulin
DK166763B1 (da) * 1983-03-16 1993-07-12 Immuno Ag Immunoglobulin-g-holdig fraktion
DE3483784D1 (de) * 1984-07-07 1991-01-31 Woelm Pharma Gmbh & Co Verfahren zur herstellung von gamma-globulin zur intravenoesen anwendung.
JPH0825902B2 (ja) * 1985-02-21 1996-03-13 株式会社ミドリ十字 γ−グロブリンの加熱処理方法
DE3619565A1 (de) * 1986-06-11 1987-12-17 Behringwerke Ag Verfahren zur herstellung einer pasteurisierten immunglobulinpraeparation
US5248767A (en) * 1986-06-11 1993-09-28 Behringwerke Aktiengesellschaft Process for the preparation of a pasteurized immunoglobulin preparation using ethanol
DE3825429C2 (de) * 1988-07-27 1994-02-10 Biotest Pharma Gmbh Verfahren zur Herstellung eines intravenös verabreichbaren polyklonalen Immunglobulin-Präparates mit hohem IgM-Gehalt
CH684164A5 (de) * 1992-01-10 1994-07-29 Rotkreuzstiftung Zentrallab Intravenös anwendbare Immunglobulinlösung.

Also Published As

Publication number Publication date
EP0661060B1 (de) 2001-05-23
JP3040678B2 (ja) 2000-05-15
FI946104L (fi) 1995-06-29
CZ284186B6 (cs) 1998-09-16
EP0661060A2 (de) 1995-07-05
US5608038A (en) 1997-03-04
CZ328494A3 (en) 1995-07-12
AT407707B (de) 2001-05-25
HUT70449A (en) 1995-10-30
HRP941018A2 (en) 1997-04-30
DK0661060T3 (da) 2001-07-30
NO945045D0 (no) 1994-12-27
FI946104A0 (fi) 1994-12-27
NO945045L (no) 1995-06-29
HRP941018B1 (en) 1999-12-31
ATA237894A (de) 2000-10-15
DE4344824C1 (de) 1995-08-31
CA2138853A1 (en) 1995-06-29
DE59409761D1 (de) 2001-06-28
JPH07206709A (ja) 1995-08-08
NO315260B1 (no) 2003-08-11
ATE201328T1 (de) 2001-06-15
EP0661060A3 (de) 1997-01-15
YU77994A (sh) 1997-03-07
HU9403795D0 (en) 1995-02-28
HU220766B1 (hu) 2002-05-28
FI111224B (fi) 2003-06-30
RU2104713C1 (ru) 1998-02-20

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