ES2721311T3 - Procedimiento de preparación de inmunoglobulinas - Google Patents

Procedimiento de preparación de inmunoglobulinas Download PDF

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Publication number
ES2721311T3
ES2721311T3 ES16159748T ES16159748T ES2721311T3 ES 2721311 T3 ES2721311 T3 ES 2721311T3 ES 16159748 T ES16159748 T ES 16159748T ES 16159748 T ES16159748 T ES 16159748T ES 2721311 T3 ES2721311 T3 ES 2721311T3
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ES
Spain
Prior art keywords
solution
preparation procedure
solution obtained
immunoglobulin preparation
immunoglobulin
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.)
Active
Application number
ES16159748T
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English (en)
Inventor
Debart Pere Ristol
Gamon Salvador Grancha
Nieto Juan Ignacio Jorquera
Tomas Maria Mercedes Faro
Grifols Nuria Jorba
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Instituto Grifols SA
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Instituto Grifols SA
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.)
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Publication date
Application filed by Instituto Grifols SA filed Critical Instituto Grifols SA
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Publication of ES2721311T3 publication Critical patent/ES2721311T3/es
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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • 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
    • A61K39/39516—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/24011—Flaviviridae
    • C12N2770/24311—Pestivirus, e.g. bovine viral diarrhea virus
    • C12N2770/24361—Methods of inactivation or attenuation
    • C12N2770/24363—Methods of inactivation or attenuation by chemical treatment

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Mycology (AREA)
  • Analytical Chemistry (AREA)
  • Water Supply & Treatment (AREA)
  • General Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Procedimiento de preparación de una solución de inmunoglobulinas a partir de una solución inicial de inmunoglobulinas con una pureza mayor o igual a un 96 % en presencia de un poliéter o polímero de glicol, caracterizado por que comprende las etapas de: a) añadir ácido caprílico o sales del mismo a la solución inicial a una concentración entre 9 mM y 15 mM; b) ajustar el pH de la solución obtenida en la etapa a) a un pH entre 5,0 y 5,2; c) incubar la solución obtenida en la etapa b) durante un tiempo y temperatura necesarios para la inactivación de virus envueltos; y d) llevar a cabo una etapa de ultrafiltración/diafiltración a la solución obtenida en la etapa c).
ES16159748T 2015-08-31 2016-03-10 Procedimiento de preparación de inmunoglobulinas Active ES2721311T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ES201531243 2015-08-31

Publications (1)

Publication Number Publication Date
ES2721311T3 true ES2721311T3 (es) 2019-07-30

Family

ID=55646274

Family Applications (1)

Application Number Title Priority Date Filing Date
ES16159748T Active ES2721311T3 (es) 2015-08-31 2016-03-10 Procedimiento de preparación de inmunoglobulinas

Country Status (8)

Country Link
US (1) US10358462B2 (es)
EP (1) EP3135687B1 (es)
ES (1) ES2721311T3 (es)
HU (1) HUE042984T2 (es)
MY (1) MY181270A (es)
PL (1) PL3135687T3 (es)
PT (1) PT3135687T (es)
TR (1) TR201905974T4 (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3638693A4 (en) 2017-06-12 2021-04-14 Kamada Ltd IMMUNOGLOBULIN COMPOSITIONS AND PROCESS FOR THEIR PREPARATION
RU2728724C2 (ru) * 2018-09-13 2020-07-30 Акционерное общество "Научно-производственное объединение по медицинским иммунобиологическим препаратам "Микроген" Способ получения вирусбезопасного раствора иммуноглобулина g человека для внутримышечного введения
WO2021244910A1 (en) * 2020-06-03 2021-12-09 Grifols Worldwide Operations Limited Hyperimmune igg and/or igm compositions and method for preparing thereof and method for obtaining hyperimmune human plasma from a donor

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4164495A (en) * 1976-04-06 1979-08-14 Nordisk Insulinlaboratorium Method of recovering immunoglobulin using a polyol and an alkanoic acid
JPS5874617A (ja) 1981-10-28 1983-05-06 Green Cross Corp:The 人由来血液凝固第７因子含有水溶液の加熱処理方法
DE3641115A1 (de) * 1986-12-02 1988-06-16 Lentia Gmbh Verfahren zur herstellung eines intravenoes anwendbaren und in fluessiger form stabilen immunglobulins
US5886154A (en) 1997-06-20 1999-03-23 Lebing; Wytold R. Chromatographic method for high yield purification and viral inactivation of antibodies
JP4685238B2 (ja) * 1998-06-09 2011-05-18 ツエー・エス・エル・ベーリング・アクチエンゲゼルシヤフト 静脈投与用免疫グロブリン及び他の免疫グロブリン生成物の製造法
ES2184594B1 (es) 2001-01-17 2004-01-01 Probitas Pharma Sa Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
MXPA06008435A (es) 2004-01-30 2007-05-23 Suomen Punainen Risti Veripalvelu Proceso de manufactura de una inmunoglobulina libre de virus.
ES2407380T5 (es) 2004-02-27 2017-07-07 Octapharma Ag Procedimiento para proporcionar una preparación de anticuerpos purificada, sin riesgo respecto a virus
ES2381828B1 (es) * 2012-03-20 2012-11-16 Grifols, S.A. PROCEDIMIENTO PARA OBTENER UNA COMPOSICION DE IgG MEDIANTE TRATAMIENTO TERMICO
EP3057987B1 (en) * 2013-10-18 2020-12-23 Novasep Process Purification of proteins
US10738078B2 (en) * 2014-11-03 2020-08-11 Bristol-Myers Squibb Company Use of caprylic acid precipitation for protein purification

Also Published As

Publication number Publication date
EP3135687A1 (en) 2017-03-01
MY181270A (en) 2020-12-21
US10358462B2 (en) 2019-07-23
PT3135687T (pt) 2019-05-21
PL3135687T3 (pl) 2019-09-30
HUE042984T2 (hu) 2019-07-29
US20170198009A1 (en) 2017-07-13
EP3135687B1 (en) 2019-04-10
TR201905974T4 (tr) 2019-05-21

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