BRPI0508096A - método de preparação de preparado de anticorpo seguro contra vìrus, vìrus inativo, purificado e fração contendo igg - Google Patents

método de preparação de preparado de anticorpo seguro contra vìrus, vìrus inativo, purificado e fração contendo igg

Info

Publication number
BRPI0508096A
BRPI0508096A BRPI0508096-7A BRPI0508096A BRPI0508096A BR PI0508096 A BRPI0508096 A BR PI0508096A BR PI0508096 A BRPI0508096 A BR PI0508096A BR PI0508096 A BRPI0508096 A BR PI0508096A
Authority
BR
Brazil
Prior art keywords
virus
solution
purified
preparation
safe
Prior art date
Application number
BRPI0508096-7A
Other languages
English (en)
Inventor
Juergen R Misch
Andrea Buchacher
Guenther Iberer
Original Assignee
Octapharma Ag
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34910983&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0508096(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Octapharma Ag filed Critical Octapharma Ag
Publication of BRPI0508096A publication Critical patent/BRPI0508096A/pt
Publication of BRPI0508096B1 publication Critical patent/BRPI0508096B1/pt
Publication of BRPI0508096B8 publication Critical patent/BRPI0508096B8/pt

Links

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
    • 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
    • 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
    • A61L2/0017—Filtration
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

MéTODO DE PREPARAçãO DE PREPARADO DE ANTICORPO SEGURO CONTRA VìRUS, VìRUS INATIVO, PURIFICADO E FRAçãO CONTENDO IgG. A presente invenção refere-se a um método de preparação de um preparado de anticorpo seguro contra vírus, vírus inativo, purificado, a partir de uma solução de partida compreendendo anticorpos e contaminantes, o método compreendendo as etapas de: (a) ajuste do pH da solução de partida para cerca de 4,6 a cerca de 4,95, em particular para cerca de 4,8 a cerca de 4,95, para produzir uma solução de intermediário; (b) adição de íons de caprilato e/ou heptanoato à solução de intermediário e manutenção do pH em cerca de 4,6 a cerca de 4,95, em particular em cerca de 4,8 a cerca de 4,95, com o que um precipitado é formado e os anticorpos estão essencialmente presentes no sobrenadante; (c) incubação da solução de sobrenadante sob condições de concentração, tempo, pH e temperatura de íon de caprilato e/ou heptanoato opcionalmente concentração e diafiltragem da solução filtrada antes do ajuste do pH; (d) aplicação da solução filtrada com pelo menos uma resina de troca de ânion e opcionalmente com duas resinas de troca de ânion diferentes sob condições que permitem a ligação de contaminantes à resina enquanto não permitindo ligação significante dos anticorpos à resina, onde uma preparação de anticorpo de vírus seguro e de vírus inativado, purificada, é produzida.
BRPI0508096A 2004-02-27 2005-02-25 método de preparação de um preparado de anticorpo seguro purificado contra vírus e vírus inativado BRPI0508096B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US54810704P 2004-02-27 2004-02-27
US60/548,107 2004-02-27
PCT/EP2005/050812 WO2005082937A2 (en) 2004-02-27 2005-02-25 A method of providing a purified, virus safe antibody preparation

Publications (3)

Publication Number Publication Date
BRPI0508096A true BRPI0508096A (pt) 2007-07-17
BRPI0508096B1 BRPI0508096B1 (pt) 2019-04-02
BRPI0508096B8 BRPI0508096B8 (pt) 2021-05-25

Family

ID=34910983

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0508096A BRPI0508096B8 (pt) 2004-02-27 2005-02-25 método de preparação de um preparado de anticorpo seguro purificado contra vírus e vírus inativado

Country Status (18)

Country Link
US (1) US7553938B2 (pt)
EP (2) EP1718675B2 (pt)
JP (1) JP5042817B2 (pt)
KR (1) KR101206788B1 (pt)
CN (1) CN1922207B (pt)
AU (1) AU2005217148B2 (pt)
BR (1) BRPI0508096B8 (pt)
CA (1) CA2557229C (pt)
DK (1) DK1718675T3 (pt)
ES (1) ES2407380T5 (pt)
IL (1) IL177541A (pt)
NO (1) NO20063784L (pt)
PL (1) PL1718675T3 (pt)
PT (1) PT1718675E (pt)
RU (1) RU2337109C2 (pt)
UA (1) UA87836C2 (pt)
WO (1) WO2005082937A2 (pt)
ZA (1) ZA200607119B (pt)

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KR20160068972A (ko) 2013-11-15 2016-06-15 노파르티스 아게 잔여 세포 배양 불순물의 제거
RU2561596C2 (ru) * 2013-12-18 2015-08-27 Федеральное государственное унитарное предприятие "Научно-производственное объединение по медицинским иммунобиологическим препаратам "Микроген" Министерства здравоохранения Российской Федерации Способ приготовления вирусинактивированных растворов иммуноглобулинов с низким остаточным содержанием каприловой кислоты
TWI671312B (zh) 2014-01-17 2019-09-11 美商健臻公司 無菌層析法及製法
TWI709569B (zh) 2014-01-17 2020-11-11 美商健臻公司 無菌層析樹脂及其用於製造方法的用途
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EP3137186B1 (en) * 2014-04-30 2021-01-27 Novo Nordisk A/S Methods for the purification of proteins using caprylic acid
US10550148B2 (en) 2014-06-16 2020-02-04 Emd Millipore Corporation Methods for increasing the capacity of flow-through processes
US10207225B2 (en) 2014-06-16 2019-02-19 Emd Millipore Corporation Single-pass filtration systems and processes
SG11201508171RA (en) 2014-06-25 2016-01-28 Emd Millipore Corp Compact spiral-wound filter elements, modules and systems
CN105592913B (zh) 2014-08-29 2018-04-03 Emd 密理博公司 用于使用单程切向流过滤系统和具有渗余物的再循环的切向流过滤系统过滤液体的方法
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Also Published As

Publication number Publication date
US20070173638A1 (en) 2007-07-26
EP1718675B1 (en) 2013-04-10
DK1718675T3 (da) 2013-07-15
CA2557229A1 (en) 2005-09-09
WO2005082937A3 (en) 2005-11-17
IL177541A (en) 2014-09-30
EP2277915A1 (en) 2011-01-26
ZA200607119B (en) 2007-04-25
UA87836C2 (ru) 2009-08-25
NO20063784L (no) 2006-09-25
US7553938B2 (en) 2009-06-30
ES2407380T3 (es) 2013-06-12
EP1718675A2 (en) 2006-11-08
PT1718675E (pt) 2013-05-21
BRPI0508096B1 (pt) 2019-04-02
RU2006134285A (ru) 2008-04-10
JP5042817B2 (ja) 2012-10-03
CA2557229C (en) 2012-07-10
PL1718675T3 (pl) 2013-09-30
IL177541A0 (en) 2006-12-10
AU2005217148A1 (en) 2005-09-09
KR101206788B1 (ko) 2012-11-30
ES2407380T5 (es) 2017-07-07
WO2005082937A2 (en) 2005-09-09
KR20060131920A (ko) 2006-12-20
RU2337109C2 (ru) 2008-10-27
CN1922207A (zh) 2007-02-28
BRPI0508096B8 (pt) 2021-05-25
EP1718675B2 (en) 2017-01-25
CN1922207B (zh) 2012-06-06
JP2007533660A (ja) 2007-11-22
AU2005217148B2 (en) 2011-09-08

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