ES8106653A1 - Procedimiento para la fabricacion de gamma-globulina para administracion intravenosa - Google Patents

Procedimiento para la fabricacion de gamma-globulina para administracion intravenosa

Info

Publication number
ES8106653A1
ES8106653A1 ES495527A ES495527A ES8106653A1 ES 8106653 A1 ES8106653 A1 ES 8106653A1 ES 495527 A ES495527 A ES 495527A ES 495527 A ES495527 A ES 495527A ES 8106653 A1 ES8106653 A1 ES 8106653A1
Authority
ES
Spain
Prior art keywords
gamma
globulin
preparation
anticomplementary activity
intravenous administration
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
Application number
ES495527A
Other languages
English (en)
Other versions
ES495527A0 (es
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.)
Morishita Pharmaceuticals Co Ltd
Original Assignee
Morishita Pharmaceuticals Co Ltd
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
Priority claimed from JP12035779A external-priority patent/JPS5643218A/ja
Priority claimed from JP10561880A external-priority patent/JPS5731623A/ja
Application filed by Morishita Pharmaceuticals Co Ltd filed Critical Morishita Pharmaceuticals Co Ltd
Publication of ES8106653A1 publication Critical patent/ES8106653A1/es
Publication of ES495527A0 publication Critical patent/ES495527A0/es
Granted legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
    • Y10S530/827—Proteins from mammals or birds
    • Y10S530/829—Blood
    • Y10S530/83—Plasma; serum
    • Y10S530/831—Cohn fractions

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

PROCEDIMIENTO PARA LA OBTENCION DE GAMMA-GLOBULINA ADECUADA PARA SU ADMINISTRACION INTRAVENOSA. UNA MATERIA PRIMA DE GAMMA-GLOBULINA SE SUSPENDE EN UNA DISOLUCION ACUOSA DE 3 A 15 POR 100 DE UN MONOSACARIDO, DISACARIDO O AZUCAR DE ALCOHOL Y SE AJUSTA EL PH A UN VALOR ENTRE 7,0 Y 9,0. ESA SUSPENSION ACUOSA SE SOMETE A PRECIPITACION FRACCIONADA AÑADIENDO DEXTRAN DE PESO MOLECULAR MEDIO ENTRE 10.000 Y 70.000 HASTA UN 2 A 10 POR 100 P/V, Y DESPUES DE SEPARAR EL PRECIPITADO SE AÑADE AL LIQUIDO UN 15 A 35 POR 100 P/V DE SULFATO AMONICO, A UNA TEMPERATURA ENTRE 0 Y 10 GC. LA GAMMA-GLOBULINA ASI OBTENIDA, CON UNA ACTIVIDAD ANTICOMPLEMENTARIA INFERIOR A 20 POR 100 (C''H50), SE DISUELVE EN UNA DISOLUCION FISIOLOGICA ACUOSA SALINA Y SE AÑADE L-ARGININA, L-LISINA O UNA DE SUS SALES FISIOLOGICAMENTE COMPATIBLES, AJUSTANDO EL PH ENTRE 6,4 Y 7,2. LA MEZCLA SE ESTERILIZA Y LIOFILIZA POR METODOS CONVENCIONALES.
ES495527A 1979-09-17 1980-09-17 Procedimiento para la fabricacion de gamma-globulina para administracion intravenosa Granted ES495527A0 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP12035779A JPS5643218A (en) 1979-09-17 1979-09-17 Preparation of gamma-globulin for intravenous injection
JP10561880A JPS5731623A (en) 1980-07-30 1980-07-30 Production of gamma-globulin for intravenous injection

Publications (2)

Publication Number Publication Date
ES8106653A1 true ES8106653A1 (es) 1981-09-01
ES495527A0 ES495527A0 (es) 1981-09-01

Family

ID=26445874

Family Applications (1)

Application Number Title Priority Date Filing Date
ES495527A Granted ES495527A0 (es) 1979-09-17 1980-09-17 Procedimiento para la fabricacion de gamma-globulina para administracion intravenosa

Country Status (4)

Country Link
US (1) US4374763A (es)
EP (1) EP0025719A3 (es)
CA (1) CA1165236A (es)
ES (1) ES495527A0 (es)

Families Citing this family (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4362661A (en) * 1979-08-09 1982-12-07 Teijin Limited Immunoglobulin composition having a high monomer content, and process for production thereof
JPS56113713A (en) * 1980-02-14 1981-09-07 Chemo Sero Therapeut Res Inst Preparation of immunoglobulin with high content of monomer
US4396608A (en) * 1981-08-24 1983-08-02 Cutter Laboratories Intravenously injectable immune serum globulin
JPS5855432A (ja) * 1981-09-29 1983-04-01 Fujirebio Inc 静脈注射用免疫グロブリンの製法
ATE19735T1 (de) * 1982-02-08 1986-05-15 Schweiz Serum & Impfinst Intravenoes verabreichbares humanes immunglobulin und verfahren zu dessen herstellung.
JPS58180433A (ja) * 1982-04-16 1983-10-21 Fujirebio Inc 免疫グロブリンから抗補体作用物質の除去法
US4439421A (en) * 1982-08-30 1984-03-27 Baxter Travenol Laboratories, Inc. Stabilized gamma globulin concentrate
ATE66616T1 (de) * 1982-08-30 1991-09-15 Baxter Int Verfahren zur herstellung von gamma-globulin enthaltenden zusammensetzungen.
JPS59157017A (ja) * 1983-02-25 1984-09-06 Green Cross Corp:The 静脈投与用γ−グロブリン製剤
JPS6112629A (ja) * 1984-06-28 1986-01-21 Lion Corp 口腔内組成物
CA1310267C (en) * 1986-07-09 1992-11-17 Yutaka Hirao Process for heat treating chemically unmodified _-globulin
EP0317376B2 (fr) * 1987-10-23 1996-04-03 Centre Regional De Transfusion Sanguine De Lille Préparation de concentré de facteur IX humain de haute pureté et d'autres protéines plasmatiques
US5945098A (en) * 1990-02-01 1999-08-31 Baxter International Inc. Stable intravenously-administrable immune globulin preparation
US20020077276A1 (en) * 1999-04-27 2002-06-20 Fredeking Terry M. Compositions and methods for treating hemorrhagic virus infections and other disorders
ES2477996T3 (es) * 2000-08-11 2014-07-18 Chugai Seiyaku Kabushiki Kaisha Preparaciones estabilizadas que contienen un anticuerpo
AU1344102A (en) * 2000-10-12 2002-04-22 Genentech Inc Reduced-viscosity concentrated protein formulations
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
ES2184594B1 (es) * 2001-01-17 2004-01-01 Probitas Pharma Sa Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
AU2003219958B2 (en) 2002-02-27 2006-01-05 Immunex Corporation Polypeptide formulation
US7425618B2 (en) * 2002-06-14 2008-09-16 Medimmune, Inc. Stabilized anti-respiratory syncytial virus (RSV) antibody formulations
US7132100B2 (en) 2002-06-14 2006-11-07 Medimmune, Inc. Stabilized liquid anti-RSV antibody formulations
US20040002451A1 (en) 2002-06-20 2004-01-01 Bruce Kerwin Compositions of pegylated soluble tumor necrosis factor receptors and methods of preparing
US20040208869A1 (en) * 2003-01-30 2004-10-21 Medimmune, Inc. Uses of anti-integrin alphanubeta3 antibody formulations
ZA200507757B (en) 2003-04-04 2007-01-31 Genentech Inc High concentration antibody and protein formulations
US20060051347A1 (en) 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
CA2610839C (en) 2005-06-14 2019-06-25 Amgen Inc. Self-buffering protein formulations
TWI532498B (zh) 2008-03-17 2016-05-11 巴克斯特保健公司 供免疫球蛋白及玻尿酸酶之皮下投藥之用的組合及方法
RU2011140498A (ru) * 2009-03-06 2013-04-20 Дженентек, Инк. Препарат антител
EA026112B1 (ru) 2009-09-17 2017-03-31 Бакстер Хелскэа, С.А. Стабильная композиция, содержащая гиалуронидазу и иммуноглобулин, и способы ее применения
ES2642512T3 (es) 2010-03-01 2017-11-16 Bayer Healthcare Llc Anticuerpos monoclonales optimizados contra el inhibidor de la ruta del factor tisular (TFPI)
SG183561A1 (en) * 2010-04-27 2012-09-27 Scil Technology Gmbh Stable aqueous mia/cd-rap formulations
CN102532307B (zh) * 2012-02-22 2013-06-12 成都蓉生药业有限责任公司 一种制备人免疫球蛋白的方法
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
US20180105555A1 (en) * 2015-03-20 2018-04-19 Bristol-Myers Squibb Company Use of dextran for protein purification
MX2019004580A (es) 2016-10-21 2019-08-12 Amgen Inc Formulaciones farmaceuticas y metodos para prepararlas.

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3903262A (en) * 1972-03-13 1975-09-02 Cutter Lab Pharmaceutical compositions comprising intravenously injectable modified serum globulin, its production and use
CA1064396A (en) * 1975-02-18 1979-10-16 Myer L. Coval Fractional precipitation of gamma globulin with polyethylene glycol
DE2527064C3 (de) * 1975-06-18 1979-11-15 Biotest-Serum-Institut Gmbh, 6000 Frankfurt Verfahren zur Herstellung eines intravenösen Nativ-Human-Immunglobulin-Präparates mit natürlicher Halbwertszeit und gegenüber dem Ausgangsmaterial unveränderten Antikörperaktivität
JPS5234918A (en) * 1975-09-06 1977-03-17 Biotest Serum Institut Gmbh Production of gmmaglobulin suitable for dosing into vein
US4126605A (en) * 1975-12-29 1978-11-21 Plasmesco Ag Process of improving the compatibility of gamma globulins
US4124576A (en) * 1976-12-03 1978-11-07 Coval M L Method of producing intravenously injectable gamma globulin
DE2658334B2 (de) * 1976-12-23 1980-06-04 Behringwerke Ag, 3550 Marburg Verfahren zum Herstellen von Immunglobulinpraparationen mit verminderter Komplementbindung und ein diese enthaltendes Arzneimittel
JPS5822085B2 (ja) * 1977-07-19 1983-05-06 株式会社ミドリ十字 静注用ガンマ・グロブリン製剤
US4136094A (en) * 1977-08-31 1979-01-23 The Regents Of The University Of Minnesota Preparation of intravenous human and animal gamma globulins and isolation of albumin
AT359641B (de) * 1978-09-19 1980-11-25 Immuno Ag Verfahren zur herstellung eines intravenoes ver- abreichbaren antikoerperhaeltigen immunglobulin- praeparates
US4362661A (en) * 1979-08-09 1982-12-07 Teijin Limited Immunoglobulin composition having a high monomer content, and process for production thereof

Also Published As

Publication number Publication date
US4374763A (en) 1983-02-22
EP0025719A3 (en) 1981-12-16
EP0025719A2 (en) 1981-03-25
CA1165236A (en) 1984-04-10
ES495527A0 (es) 1981-09-01

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Legal Events

Date Code Title Description
FD1A Patent lapsed

Effective date: 19981103