ES2059640T3 - Procedimiento para la fabricacion de un preparado de inmunoglobulina policlonal administrable por via intravenosa con alto contenido de igm. - Google Patents

Procedimiento para la fabricacion de un preparado de inmunoglobulina policlonal administrable por via intravenosa con alto contenido de igm.

Info

Publication number
ES2059640T3
ES2059640T3 ES89112014T ES89112014T ES2059640T3 ES 2059640 T3 ES2059640 T3 ES 2059640T3 ES 89112014 T ES89112014 T ES 89112014T ES 89112014 T ES89112014 T ES 89112014T ES 2059640 T3 ES2059640 T3 ES 2059640T3
Authority
ES
Spain
Prior art keywords
appropriate
preparation
immunoglobulin
procedure
manufacture
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
ES89112014T
Other languages
English (en)
Inventor
Wolfgang Dr Moller
Herbert Dr Dichtelmuller
Norbert Dr Kothe
Dieter Dr Rudnick
Detlef Dr Piechaczek
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.)
Biotest Pharma GmbH
Original Assignee
Biotest Pharma GmbH
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 Biotest Pharma GmbH filed Critical Biotest Pharma GmbH
Application granted granted Critical
Publication of ES2059640T3 publication Critical patent/ES2059640T3/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
    • 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
    • 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
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/12—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • Y10S424/00—Drug, bio-affecting and body treating compositions
    • Y10S424/806—Drug, bio-affecting and body treating compositions involving IgM
    • 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
    • Y10S530/863—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof involving IgM

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Communicable Diseases (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Abstract

PREPARADO DE INMUNOGLOBULINA POLICLONAL DE APLICACION INTRAVENOSA Y DE UTILIZACION EN TERAPIO Y PROFILAXIS DE INFECCIONES BACTERIZLES. EL PREPARADO DE INMUNOGLOBULINA TIENE UN CONTENIDO DE IGM DE UN 50% EN PESO CON RESPECTO AL CONTENIDO TOTAL DE INMUNOGLOBULINA Y UNA PEQUEÑA ACTIVIDAD ANTICOMPLEMENTARIA Y SE PRESENTA EN SOLUCION ACUOSA ESTABLES Y LIBRES DE VIRUS. PUEDEN CONSISTIR O CONTIENE ADICIONALMENTE MEZCLAS DE ANTICUERPOS IGM VARIOS MONOCLONALES. LA PRODUCCION PARTE DE UNA FRACCION HUMANA, ANIMAL O DE BACTERIAS CONTENIENDO INMUNOGLOBULINA. LA FRACCION SE TRATA CON UN INTERCAMBIADOR DE ANIONES. LA FRACCION TRATADA SE ELEVA CON UN GRADIENTE DE SALES O PH Y EL EXTREMO SE SOMETE A UNA FILTRACION GEL. ANTES O DESPUES DE LA CROMATOGRAFIA SE EFECTUA UN TRATAMIENTO CON (BETA)-PROPILACTONA Y PEG 4000 Y UN CALENTAMIENTO. ADEMAS PUEDE EFECTUARSE UN TRATAMIENTO CON (BETA)-PROPILACTONA Y LUZ ULTRAVIOLETA CON DETERGENTE O PASTERIZACION. EL PREPARADO SE COMPONE DE UNA MEACLA DE PROTEINA, AZUCARO ACIDO AMINICO.
ES89112014T 1988-07-27 1989-07-01 Procedimiento para la fabricacion de un preparado de inmunoglobulina policlonal administrable por via intravenosa con alto contenido de igm. Expired - Lifetime ES2059640T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE3825429A DE3825429C2 (de) 1988-07-27 1988-07-27 Verfahren zur Herstellung eines intravenös verabreichbaren polyklonalen Immunglobulin-Präparates mit hohem IgM-Gehalt

Publications (1)

Publication Number Publication Date
ES2059640T3 true ES2059640T3 (es) 1994-11-16

Family

ID=6359621

Family Applications (1)

Application Number Title Priority Date Filing Date
ES89112014T Expired - Lifetime ES2059640T3 (es) 1988-07-27 1989-07-01 Procedimiento para la fabricacion de un preparado de inmunoglobulina policlonal administrable por via intravenosa con alto contenido de igm.

Country Status (9)

Country Link
US (1) US5190752A (es)
EP (1) EP0352500B1 (es)
JP (1) JPH0662437B2 (es)
KR (1) KR0152256B1 (es)
AT (1) ATE94075T1 (es)
CA (1) CA1341505C (es)
DE (2) DE3825429C2 (es)
ES (1) ES2059640T3 (es)
PT (1) PT91170B (es)

Families Citing this family (34)

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DE3927112C1 (es) * 1989-08-17 1990-10-25 Biotest Pharma Gmbh, 6072 Dreieich, De
DE3927111C3 (de) * 1989-08-17 1994-09-01 Biotest Pharma Gmbh Verfahren zur Herstellung nicht modifizierter intravenös verabreichbarer IgM- und/oderIgA-haltiger Immunglobulinpräparate
US5256771A (en) * 1990-04-03 1993-10-26 Miles Inc. Heat treatment of IgM-containing immunoglobulins to eliminate non-specific complement activation
DE4344824C1 (de) * 1993-12-28 1995-08-31 Immuno Ag Hochkonzentriertes Immunglobulin-Präparat und Verfahren zu seiner Herstellung
US5429746A (en) * 1994-02-22 1995-07-04 Smith Kline Beecham Corporation Antibody purification
DE4424935C1 (de) * 1994-07-14 1996-03-21 Immuno Ag Humanes virussicheres monomeres Immunglobulin A und Verfahren zu seiner Herstellung
EP0835880A1 (de) * 1996-10-14 1998-04-15 Rotkreuzstiftung Zentrallaboratorium Blutspendedienst Srk Verfahren zur Herstellung eines IgM Präparates für die intravenöse Applikation
EP0852951A1 (de) 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
RU2122864C1 (ru) * 1996-12-26 1998-12-10 Московский научно-исследовательский институт эпидемиологии и микробиологии им.Г.Н.Габричевского Препарат иммуноглобулина для внутривенного введения и способ его получения
TW541179B (en) * 1997-03-19 2003-07-11 Green Cross Corp Process for preparing immunoglobulin preparation
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)
US8142780B2 (en) * 1998-08-20 2012-03-27 Strox Biopharmaceuticals, Llc Anti-bacterial antibodies
US6441144B1 (en) 1999-05-20 2002-08-27 Alpha Therapeutic Corporation Method for repairing dual virally inactivated immune globulin for intravenous administration
CA2967294C (en) 2003-05-16 2020-04-28 Mayo Foundation For Medical Education & Research Compositions and methods including a recombinant human mab that promotes cns remyelination
EP2204190A1 (en) 2003-07-15 2010-07-07 Chugai Seiyaku Kabushiki Kaisha IgM production by transformed cells and methods for quantifying said IgM production
JP4671864B2 (ja) 2003-10-09 2011-04-20 中外製薬株式会社 タンパク質溶液の安定化方法
JP4762717B2 (ja) 2003-10-09 2011-08-31 中外製薬株式会社 ＩｇＭ高濃度安定化溶液
US7597891B2 (en) * 2006-12-13 2009-10-06 Simon Michael R Synthesis of human secretory IgA for the treatment of Clostridium difficile associated diseases
US8119104B2 (en) * 2006-12-13 2012-02-21 Michael R. Simon Treatment of celiac disease with IgA
US7794721B2 (en) * 2006-12-13 2010-09-14 Simon Michael R Synthesis of human secretory IgM and the treatment of clostridium difficile associated diseases herewith
US8709413B2 (en) 2006-12-13 2014-04-29 Michael R. Simon Treatment of celiac disease with IgA
EP2244735A4 (en) 2007-10-02 2011-02-23 Avaxia Biologics Inc ANTIBODY THERAPY FOR USE IN THE DIGESTIVE TUBE
AU2008311076B2 (en) * 2007-10-09 2014-06-12 Board Of Regents Of The Nevada System Of Higher Education, On Behalf Of The University Of Nevada, Reno Laminins, derivatives, and compositions including same and method for their therapeutic use
WO2009104100A2 (en) * 2008-02-19 2009-08-27 Patrys Limited Antibody combinations, and methods of making and using same
AU2009246510B2 (en) * 2008-05-12 2014-02-13 Strox Biopharmaceuticals, Llc Staphylococcus aureus-specific antibody preparations
US20100330102A1 (en) 2009-06-26 2010-12-30 Wezen Biopharmaceuticals Srl A Socio Unico Immunoglobulin preparation for the treatment of hiv-1 infection
GB201006753D0 (en) 2010-04-22 2010-06-09 Biotest Ag Process for preparing an immunolobulin composition
US20180021376A1 (en) * 2011-03-04 2018-01-25 Rare Antibody Antigen Supply, Inc. Naming of KH1 through KH55 good healthy cells synthesizes the KH1 through KH55 proteins
KR20150118103A (ko) * 2013-02-06 2015-10-21 에이전시 포 사이언스, 테크놀로지 앤드 리서치 단백질 정제 방법
JP2017525752A (ja) * 2014-05-28 2017-09-07 レア アンチボディ アンチジェン サプライ インク 静注用免疫グロブリンの精製組成物及びリンパ球を調整しｂ型肝炎を治療するためのｋｈタンパク質
NZ726911A (en) 2014-06-03 2023-01-27 Xbiotech Inc Compositions and methods for treating and preventing staphylococcus aureus infections
US9913903B2 (en) 2015-08-06 2018-03-13 Grifols Worldwide Operations Limited Method for the treatment or prevention of infection-related immune conditions using a composition comprising IgM
PL3429622T3 (pl) 2016-03-14 2021-11-02 Biotest Ag Leczenie ciężkiego pozaszpitalnego zapalenia płuc
EP3275897A1 (en) 2016-07-27 2018-01-31 Biotest AG Process for preparing immunoglobulin compositions

Family Cites Families (17)

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Publication number Priority date Publication date Assignee Title
US4165370A (en) * 1976-05-21 1979-08-21 Coval M L 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
JPS56147724A (en) * 1980-04-18 1981-11-16 Teijin Ltd Igm derivative and immunoglobulin preparation for intravenous injection containing said compound as effective component
US4371520A (en) * 1981-10-28 1983-02-01 The Green Cross Corporation Process for preparing immunoglobulin suitable for intravenous injection
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
JPS59118718A (ja) * 1982-12-27 1984-07-09 Fujirebio Inc ＩｇＭの回収方法
DE3310150A1 (de) * 1983-03-21 1984-09-27 Lentia GmbH Chem. u. pharm. Erzeugnisse - Industriebedarf, 8000 München Verfahren zur herstellung einer nebenwirkungsfreien igg-immunglobulinloesung fuer die intravenoese applikation
JPS59184133A (ja) * 1983-04-01 1984-10-19 Teijin Ltd ＩｇＭの調製法
US4482483A (en) * 1983-04-06 1984-11-13 Armour Pharmceutical Company Composition of intravenous immune globulin
US4540573A (en) * 1983-07-14 1985-09-10 New York Blood Center, Inc. Undenatured virus-free biologically active protein derivatives
JPS6042336A (ja) * 1983-08-18 1985-03-06 Nippon Seiyaku Kk 免疫グロブリンの製造方法
US4604235A (en) * 1984-05-23 1986-08-05 J. T. Baker Chemical Company Purification of monoclonal antibodies
US4650772A (en) * 1984-08-09 1987-03-17 Abbott Laboratories Monoclonal antibody stabilization
DE3604947A1 (de) * 1986-02-17 1987-08-20 Biotest Pharma Gmbh Verfahren zur herstellung eines immunglobulinhaltigen praeparates und dessen verwendung zur prophylaxe und therapie von aids
DE3640513A1 (de) * 1986-11-27 1988-06-09 Biotest Pharma Gmbh Verfahren zur herstellung eines virussicheren, lagerstabilen und intravenoes vertraeglichen immunglobulin-g-praeparates
ES2045027T3 (es) * 1987-08-10 1994-01-16 Miles Inc Igm purificadas.
IL90281A (en) * 1988-06-06 1994-10-07 Miles Inc Preparations containing MGI antibodies

Also Published As

Publication number Publication date
PT91170B (pt) 1995-06-30
JPH0662437B2 (ja) 1994-08-17
DE58905514D1 (de) 1993-10-14
KR910002467A (ko) 1991-02-25
EP0352500A2 (de) 1990-01-31
PT91170A (pt) 1990-02-08
ATE94075T1 (de) 1993-09-15
EP0352500B1 (de) 1993-09-08
DE3825429A1 (de) 1990-02-01
JPH0278635A (ja) 1990-03-19
CA1341505C (en) 2006-05-09
KR0152256B1 (ko) 1998-10-15
EP0352500A3 (en) 1990-07-25
US5190752A (en) 1993-03-02
DE3825429C2 (de) 1994-02-10

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