JP3148222B2 - 非変性静脈内投与可能なＩｇＭ―及び／又は／ＩｇＡ―含有免疫グロブリン製剤及びその製造方法 - Google Patents

非変性静脈内投与可能なＩｇＭ―及び／又は／ＩｇＡ―含有免疫グロブリン製剤及びその製造方法

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Publication number
JP3148222B2
JP3148222B2 JP21445590A JP21445590A JP3148222B2 JP 3148222 B2 JP3148222 B2 JP 3148222B2 JP 21445590 A JP21445590 A JP 21445590A JP 21445590 A JP21445590 A JP 21445590A JP 3148222 B2 JP3148222 B2 JP 3148222B2
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JP
Japan
Prior art keywords
immunoglobulin
igm
anion exchanger
iga
solution
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 - Fee Related
Application number
JP21445590A
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English (en)
Japanese (ja)
Other versions
JPH03204822A (ja
Inventor
ウオルフガング・メーレル
デトレーフ・ピ―チヤチエック
Original Assignee
バイオテスト・フアルマ・ゲゼルシヤフト・ミト・ベシユレンクテル・ハフツング
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=6387263&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP3148222(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by バイオテスト・フアルマ・ゲゼルシヤフト・ミト・ベシユレンクテル・ハフツング filed Critical バイオテスト・フアルマ・ゲゼルシヤフト・ミト・ベシユレンクテル・ハフツング
Publication of JPH03204822A publication Critical patent/JPH03204822A/ja
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Anticipated expiration legal-status Critical
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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
    • 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
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • 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
    • 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
    • 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
    • A61L2/0082—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 chemical substances
    • A61L2/0088—Liquid substances
    • 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
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • 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
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04—Heat
    • 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
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61L2103/05—

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
JP21445590A 1989-08-17 1990-08-15 非変性静脈内投与可能なＩｇＭ―及び／又は／ＩｇＡ―含有免疫グロブリン製剤及びその製造方法 Expired - Fee Related JP3148222B2 (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE3927111A DE3927111C3 (de) 1989-08-17 1989-08-17 Verfahren zur Herstellung nicht modifizierter intravenös verabreichbarer IgM- und/oderIgA-haltiger Immunglobulinpräparate
DE3927111.0 1989-08-17

Publications (2)

Publication Number Publication Date
JPH03204822A JPH03204822A (ja) 1991-09-06
JP3148222B2 true JP3148222B2 (ja) 2001-03-19

Family

ID=6387263

Family Applications (1)

Application Number Title Priority Date Filing Date
JP21445590A Expired - Fee Related JP3148222B2 (ja) 1989-08-17 1990-08-15 非変性静脈内投与可能なＩｇＭ―及び／又は／ＩｇＡ―含有免疫グロブリン製剤及びその製造方法

Country Status (8)

Country Link
US (1) US5410025A (show.php)
EP (1) EP0413188B1 (show.php)
JP (1) JP3148222B2 (show.php)
AT (1) ATE117900T1 (show.php)
DE (2) DE3927111C3 (show.php)
DK (1) DK0413188T3 (show.php)
ES (1) ES2067600T3 (show.php)
GR (1) GR3015229T3 (show.php)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5256771A (en) * 1990-04-03 1993-10-26 Miles Inc. Heat treatment of IgM-containing immunoglobulins to eliminate non-specific complement activation
AU1809495A (en) * 1994-02-18 1995-09-04 Immuno Aktiengesellschaft Composition and method for preventing and treating inflammation with immunoglobulin a
US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
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
US5886154A (en) 1997-06-20 1999-03-23 Lebing; Wytold R. Chromatographic method for high yield purification and viral inactivation of antibodies
US6955917B2 (en) * 1997-06-20 2005-10-18 Bayer Healthcare Llc Chromatographic method for high yield purification and viral inactivation of antibodies
US6441144B1 (en) * 1999-05-20 2002-08-27 Alpha Therapeutic Corporation Method for repairing dual virally inactivated immune globulin for intravenous administration
CA2375560A1 (en) * 1999-06-15 2000-12-21 Alpha Therapeutic Corporation Manufacturing method for intravenous immune globulin and resultant product
SE0001128D0 (sv) * 2000-03-30 2000-03-30 Amersham Pharm Biotech Ab A method of producing IgG
US20020098182A1 (en) * 2000-09-28 2002-07-25 Richard Weisbart Treatment of immune-mediated diseases by oral administration of plasma fractions enriched in immunoglobulin G
EP1341552A2 (en) * 2000-09-28 2003-09-10 Research Corporation Technologies, Inc Treatment of immune-mediated diseases by oral administration of plasma fractions
FR2824568B1 (fr) * 2001-05-11 2004-04-09 Lab Francais Du Fractionnement Procede de preparation de concentres d'immunoglobulines humaines a usage therapeutique
US20040180045A1 (en) * 2001-09-28 2004-09-16 Richard Weisbart Treatment of immune-mediated diseases by oral administration of plasma fractions enriched in immunoglobulin G
DE102007001521A1 (de) 2007-01-10 2008-07-17 Matthias, Torsten, Dr. Verwendung von Cohn-Oncley-Fraktionen II und II/III zur Behandlung des systemischen Lupus erythematodes
GB201006753D0 (en) † 2010-04-22 2010-06-09 Biotest Ag Process for preparing an immunolobulin composition
EP2636684A1 (en) 2012-03-09 2013-09-11 CSL Behring AG Prevention of infection
EP2636681A1 (en) * 2012-03-09 2013-09-11 CSL Behring AG Process for enriching IgA
RU2644240C2 (ru) 2012-03-09 2018-02-08 Цсл Беринг Аг Композиции, содержащие секреторноподобные иммуноглобулины
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
US10570194B2 (en) 2015-08-06 2020-02-25 Grifols Worldwide Operations Limited Method for treating infectious diseases using a composition comprising plasma-derived immunoglobulin M (IgM)
EP3275897A1 (en) 2016-07-27 2018-01-31 Biotest AG Process for preparing immunoglobulin compositions
BR112022020211A2 (pt) * 2020-04-10 2022-11-22 Vanudis GmbH Anticorpos naturais em profilaxia e terapia

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3808189A (en) * 1973-03-15 1974-04-30 American Cyanamid Co Isolation of gamma globulin preparations enriched in iga and igm using polyethylene glycol
DE2404265C3 (de) * 1974-01-30 1980-05-29 Behringwerke Ag, 3550 Marburg Verfahren zum Abreichen von Immunglobulinen
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
DE2835843A1 (de) * 1978-08-16 1980-02-28 Blutspendedienst Dt Rote Kreuz Verfahren zur herstellung einer fuer die intravenoese anwendung geeigneten gammaglobulinloesung
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
ATE19735T1 (de) * 1982-02-08 1986-05-15 Schweiz Serum & Impfinst Intravenoes verabreichbares humanes immunglobulin und verfahren zu dessen herstellung.
US4639513A (en) * 1984-02-02 1987-01-27 Cuno Inc. Intravenously injectable immunoglobulin G (IGG) and method for producing same
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
DE3426903A1 (de) * 1984-07-20 1986-01-23 Biotest Pharma GmbH, 6000 Frankfurt Eine immunglobulinpraeparation in kombination mit einer anderen pharmakologisch wirksamen praeparation zur verwendung bei der behandlung von krankheiten
US4613501A (en) * 1984-12-21 1986-09-23 New York Blood Center, Inc. Inactivation of viruses in labile blood derivatives
NZ216094A (en) * 1985-05-15 1989-06-28 Commw Serum Lab Commission Method for purification of an immunoglobulin
US5159064A (en) * 1986-04-08 1992-10-27 Miles Inc. Preparation of virus-free antibodies
DE3640513A1 (de) * 1986-11-27 1988-06-09 Biotest Pharma Gmbh Verfahren zur herstellung eines virussicheren, lagerstabilen und intravenoes vertraeglichen immunglobulin-g-praeparates
DE3825429C2 (de) * 1988-07-27 1994-02-10 Biotest Pharma Gmbh Verfahren zur Herstellung eines intravenös verabreichbaren polyklonalen Immunglobulin-Präparates mit hohem IgM-Gehalt

Also Published As

Publication number Publication date
DE3927111C2 (show.php) 1991-11-28
GR3015229T3 (en) 1995-05-31
EP0413188B1 (de) 1995-02-01
DE59008404D1 (de) 1995-03-16
ES2067600T3 (es) 1995-04-01
DE3927111C3 (de) 1994-09-01
EP0413188A3 (en) 1991-06-05
DE3927111A1 (de) 1991-02-21
JPH03204822A (ja) 1991-09-06
EP0413188A2 (de) 1991-02-20
DK0413188T3 (da) 1995-03-27
ATE117900T1 (de) 1995-02-15
US5410025A (en) 1995-04-25

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