ES2042519T3 - Metodo para producir preparados de inmunoglobulina para inyeccion intravenosa. - Google Patents

Metodo para producir preparados de inmunoglobulina para inyeccion intravenosa.

Info

Publication number
ES2042519T3
ES2042519T3 ES87107112T ES87107112T ES2042519T3 ES 2042519 T3 ES2042519 T3 ES 2042519T3 ES 87107112 T ES87107112 T ES 87107112T ES 87107112 T ES87107112 T ES 87107112T ES 2042519 T3 ES2042519 T3 ES 2042519T3
Authority
ES
Spain
Prior art keywords
treatment
weight
peg
recover
ionic strength
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
ES87107112T
Other languages
English (en)
Inventor
Yahiro Uemura
Katuhiro Uriyu
Kazuo Takechi
Yutaka Hirao
Tadakazu Suyama
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.)
GREEN CROSS CORP
Original Assignee
GREEN CROSS 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
Application filed by GREEN CROSS CORP filed Critical GREEN CROSS CORP
Application granted granted Critical
Publication of ES2042519T3 publication Critical patent/ES2042519T3/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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0023—Heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Abstract

EL METODO PARTE DE UNA FRACCION QUE CONTIENE INMUNOGLOBULINA Y COMPRENDE LAS SIGUIENTES ETAPAS DE TRATAMIENTO: A) TRATAMIENTO DE LA INDICADA FRACCION CON 4-10% EN PESO A VOLUMEN DE POLIETILENGLICOL (PEG) CON UN PESO MOLECULAR COMPRENDIDO NTRE 1000 Y 10000, A PH=4-6, FUERZA IONICA ENTRE 0,0001 Y 0,1M Y TEMPERATURA ENTRE 0 Y 4 GRADOS CENTIGRADOS, Y RECUPERAR EL SOBRENADANTE; B) TRATAMIENTO DEL SOBRENADANTE DE LA ETAPA A) CON 10-15% DE PESO A VOLUMEN DEL PEG CITADO A PH ENTRE 6 Y 9, FUERZA IONICA ENTRE 0,0001 Y 0,1 M Y TEMPERATURA DE 0 A 4 GRADOS CENTIGRADOS, Y RECUPERAR EL PRECIPITADO RESULTANTE, Y C) TRATAMIENTO TERMICO EN LA ETAPA DESEADA DE LA CITADA INMUNOGLOBULINA EN PRESENCIA DE UN ESTABILIZANTE BAJO CONDICIONES SUFICIENTES PARA INACTIVAR LOS VIRUS CONTAMINANTES. LAS PREPARACIONES OBTENIDAS DE ACUERDO CON LA INVENCION RETIENN INMUNOGLOBULINAS SIN ACTIVARLAS SUSTANCIALMENTE Y ESTAN PRACTICAMENTE EXENTAS DE CONTAMINANTES TALES COMO ANTICUERPOS ANTIGRUPO SANGUINEO HUMANO. CUANDO SE INACTIVAN LOS VIRUS CONTAMINANTES POR EFECTO DEL TRATAMIENTO TERMICO, DICHAS PREPARACIONES TIENEN BUENA SOLUBILIDAD Y ACTIVIDAD ANTICOMPLEMENTO BASTANTE BAJA.
ES87107112T 1986-05-19 1987-05-16 Metodo para producir preparados de inmunoglobulina para inyeccion intravenosa. Expired - Lifetime ES2042519T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP11442186 1986-05-19
JP23475786 1986-09-30
JP62021481A JPH0662436B2 (ja) 1986-05-19 1987-01-31 静注用免疫グロブリン製剤の製造方法

Publications (1)

Publication Number Publication Date
ES2042519T3 true ES2042519T3 (es) 1993-12-16

Family

ID=27283442

Family Applications (1)

Application Number Title Priority Date Filing Date
ES87107112T Expired - Lifetime ES2042519T3 (es) 1986-05-19 1987-05-16 Metodo para producir preparados de inmunoglobulina para inyeccion intravenosa.

Country Status (6)

Country Link
US (1) US5132406A (es)
EP (1) EP0246579B1 (es)
JP (1) JPH0662436B2 (es)
KR (1) KR960001473B1 (es)
DE (1) DE3786832T2 (es)
ES (1) ES2042519T3 (es)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0778025B2 (ja) * 1990-03-20 1995-08-23 日本赤十字社 免疫グロブリンｇの製造方法
AU6653094A (en) * 1992-12-16 1994-07-04 Immuno Aktiengesellschaft Process for preparing a virus-safe biological composition
DE4320294A1 (de) * 1993-06-18 1994-12-22 Immuno Ag Verwendung von humanem Protein C zur Verhinderung und Behandlung von Thrombozytenablagerungen
DE4434538C2 (de) * 1993-10-06 2000-08-10 Immuno Ag Verfahren zur Virusinaktivierung in Gegenwart eines Polyethers und eines chaotropen Agens
HRP940645A2 (en) * 1993-10-06 1996-12-31 Immuno Ag Process for virus deactivation in the presence of polyalkylene glycol and the pharmaceutical preparation thus obtained
US6632648B1 (en) * 1996-05-14 2003-10-14 Elan Drug Delivery Limited Methods of terminal sterilization of fibrinogen
TW541179B (en) * 1997-03-19 2003-07-11 Green Cross Corp Process for preparing immunoglobulin preparation
DK0911037T3 (da) 1997-10-23 2002-12-02 Mitsubishi Pharma Corp Ved stuetemperatur lagringsholdbart immunoglobulinpræparat til intravenøs injektion
US6162904A (en) * 1997-12-24 2000-12-19 Alpha Therapeutic Corporation Manufacturing method for intraveneously administrable immune globulin and resultant product
UA64742C2 (uk) * 1997-12-24 2004-03-15 Альфа Терапевтик Корпорейшн СПОСІБ ОДЕРЖАННЯ РОЗЧИНУ <font face="Symbol">g</font>-ГЛОБУЛІНУ, ПРИЗНАЧЕНОГО ДЛЯ ВНУТРІШНЬОВЕННОГО ВВЕДЕННЯ, І ПРОДУКТ, ЩО ОДЕРЖУЄТЬСЯ У ЦЕЙ СПОСІБ (ВАРІАНТИ)
US6441144B1 (en) 1999-05-20 2002-08-27 Alpha Therapeutic Corporation Method for repairing dual virally inactivated immune globulin for intravenous administration
EP1185290A4 (en) * 1999-06-15 2005-08-31 Alpha Therapeutic Corp PROCESS FOR PRODUCING INTRAVENOUS IMMUNOGLOBULIN AND RESULTING PRODUCT
AU2005229674B2 (en) * 2004-11-18 2010-11-04 Kedrion Melville Inc. Low concentration solvent/detergent process of immuneglobulin with pre-treatment
FR2895263B1 (fr) 2005-12-26 2008-05-30 Lab Francais Du Fractionnement Concentre d'immunoglobines g (lg) appauvri en anticorps anti-a et anti-b, et en igg polyreactives
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
BRPI0923541A2 (pt) 2008-12-22 2016-01-26 Hoffmann La Roche purificação de imunoglobulina
IN2012DN03219A (es) 2009-09-17 2015-10-23 Baxter Healthcare Sa
ES2381828B1 (es) 2012-03-20 2012-11-16 Grifols, S.A. PROCEDIMIENTO PARA OBTENER UNA COMPOSICION DE IgG MEDIANTE TRATAMIENTO TERMICO

Family Cites Families (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3869436A (en) * 1971-06-01 1975-03-04 Statens Bakteriologiska Lab Method for fractionating plasma proteins using peg and ion-exchangers
CA1064396A (en) * 1975-02-18 1979-10-16 Myer L. Coval Fractional precipitation of gamma globulin with polyethylene glycol
US4100149A (en) * 1975-08-28 1978-07-11 Rhone-Poulenc Industries Method of separating proteins by ion exchange
US4165370A (en) * 1976-05-21 1979-08-21 Coval M L Injectable gamma globulin
JPS6016406B2 (ja) * 1976-08-06 1985-04-25 マイヤ−、ル−イス、コ−バル 静脈内に投与可能なガンマ・グロブリンの製造法ならびにそれにより調製したガンマ・グロブリン
US4075193A (en) * 1976-11-26 1978-02-21 Parke, Davis & Company Process for producing intravenous immune globulin
US4124576A (en) * 1976-12-03 1978-11-07 Coval M L Method of producing intravenously injectable gamma globulin
DE2901822A1 (de) * 1979-01-18 1980-07-31 Biotest Serum Institut Gmbh Verfahren zur herstellung einer fuer die intravenoese applikation geeigneten immunglobulinloesung, die igm in ankonzentrierter form enthaelt
US4305870A (en) * 1979-01-31 1981-12-15 Immuno Aktiengesellschaft Fur Chemisch-Medizinische Produkte Intravenous plasma derivatives and their production
JPS55124719A (en) * 1979-03-22 1980-09-26 Kowa Co Preparation of immune globulin administrable by intravenous injection
US4278594A (en) * 1979-06-19 1981-07-14 David Amrani Process for separation and isolation of AHF, von Willebrand's ristocetin cofactor (VWF:RCF) and fibronectin from blood plasma
US4272521A (en) * 1979-07-16 1981-06-09 Cutter Laboratories, Inc. Purified immune serum globulin
JPS56113713A (en) * 1980-02-14 1981-09-07 Chemo Sero Therapeut Res Inst Preparation of immunoglobulin with high content of monomer
US4440679A (en) * 1980-03-05 1984-04-03 Cutter Laboratories, Inc. Pasteurized therapeutically active protein compositions
JPS5732228A (en) * 1980-08-05 1982-02-20 Green Cross Corp:The Preparation of immunoglobulin usable for intravenous injection
US4499073A (en) * 1981-08-24 1985-02-12 Cutter Laboratories, Inc. Intravenously injectable immune serum globulin
US4371520A (en) * 1981-10-28 1983-02-01 The Green Cross Corporation Process for preparing immunoglobulin suitable for intravenous injection
US4664913A (en) * 1982-05-24 1987-05-12 Xoma Corporation Method for treating plasma for transfusion
US4639513A (en) * 1984-02-02 1987-01-27 Cuno Inc. Intravenously injectable immunoglobulin G (IGG) and method for producing same
ATE36457T1 (de) * 1983-05-02 1988-09-15 Immuno Ag Verfahren zur inaktivierung von vermehrungsfaehigen krankheitserregern.
AT389815B (de) * 1984-03-09 1990-02-12 Immuno Ag Verfahren zur inaktivierung von vermehrungsfaehigen filtrierbaren krankheitserregern in blutprodukten
ATE59144T1 (de) * 1984-07-07 1991-01-15 Armour Pharma Gmbh Verfahren zur herstellung von gamma-globulin zur intravenoesen anwendung.
JPH0669961B2 (ja) * 1984-09-25 1994-09-07 株式会社ミドリ十字 免疫グロブリンの加熱処理方法
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
IT8504813V0 (it) * 1985-03-13 1985-03-13 Piovani Natalino Mega Snc Portapane con apertura frontale chiudibile mediante una serracinesca e fiancate ricoperte da carte protettivi
US4606825A (en) * 1985-04-22 1986-08-19 J. T. Baker Chemical Company Purification of immunoglobulin G

Also Published As

Publication number Publication date
DE3786832D1 (de) 1993-09-09
JPH0662436B2 (ja) 1994-08-17
KR960001473B1 (ko) 1996-01-31
EP0246579A3 (en) 1989-05-17
JPS63183539A (ja) 1988-07-28
US5132406A (en) 1992-07-21
KR880003633A (ko) 1988-05-28
DE3786832T2 (de) 1993-11-11
EP0246579A2 (en) 1987-11-25
EP0246579B1 (en) 1993-08-04

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