MX9703552A - Proceso de purificacion de factor viii. - Google Patents

Proceso de purificacion de factor viii.

Info

Publication number
MX9703552A
MX9703552A MX9703552A MX9703552A MX9703552A MX 9703552 A MX9703552 A MX 9703552A MX 9703552 A MX9703552 A MX 9703552A MX 9703552 A MX9703552 A MX 9703552A MX 9703552 A MX9703552 A MX 9703552A
Authority
MX
Mexico
Prior art keywords
factor viii
harvest
solution
inhibitor
aqueous solution
Prior art date
Application number
MX9703552A
Other languages
English (en)
Inventor
Annelie Almstedt
Helena Sandberg
Anna-Lisa Smeds
Maria Wrangel
Anna Oestlin
Original Assignee
Pharmacia & Upjohn Ab
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 Pharmacia & Upjohn Ab filed Critical Pharmacia & Upjohn Ab
Publication of MX9703552A publication Critical patent/MX9703552A/es

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • C07K14/755Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S530/00Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
    • Y10S530/827Proteins from mammals or birds
    • Y10S530/829Blood
    • Y10S530/83Plasma; serum
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S530/00Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
    • Y10S530/827Proteins from mammals or birds
    • Y10S530/829Blood
    • Y10S530/83Plasma; serum
    • Y10S530/831Cohn fractions

Abstract

Las proteasas generalmente tienden a reducir la actividad del factor de coagulacion VIII mediante la degradacion de la molécula. La presente invencion se refiere a un proceso para reducir la influencia nociva de proteasas que dependen de metales sobre las moléculas de factor VIII recombinante, al añadir un inhibidor de proteasas que dependen de metales a una solucion después de la recoleccion. La solucion es adecuadamente la solucion de recoleccion o cualquier solucion acuosa que es alimentada a o que abandona el asilamiento básico, siendo la etapa inicial de la secuencia de purificacion. El inhibidor se selecciona de: i) agentes de acomplejamiento con una afinidad más fuerte para el ion metálico de la proteasa que para el ion o iones que estabilizan la molécula del factor VIII y ii) compuestos que se relacionan estructuralmente con el substrato natural de la proteasa y que contiene un residuo electronegativo. La presencia de un inhibidor, preferentemente un agente de acomplejamiento, después de la recoleccion permite un periodo de recoleccion prolongado y una produccion considerablemente mayor con una actividad de factor VIII esencialmente retenida. La invencion se refiere además a una solucion acuosa que contiene el factor VIII recombinante que ha sido purificado de acuerdo al actual proceso y el uso de tal solucion acuosa para la elaboracion de un medicamento para su administracion a un paciente que tiene los síntomas de hemofilia. También, la invencion se refiere a un método para el tratamiento de la hemofilia mediante la administracion de una cantidad terapéuticamente efectiva de factor VIII recombinante que ha sido purificado de acuerdo al actual proceso.
MX9703552A 1994-11-14 1995-11-14 Proceso de purificacion de factor viii. MX9703552A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE9403915A SE9403915D0 (sv) 1994-11-14 1994-11-14 Process A
PCT/SE1995/001351 WO1996015150A1 (en) 1994-11-14 1995-11-14 Process for purifying factor viii

Publications (1)

Publication Number Publication Date
MX9703552A true MX9703552A (es) 1997-08-30

Family

ID=20395964

Family Applications (1)

Application Number Title Priority Date Filing Date
MX9703552A MX9703552A (es) 1994-11-14 1995-11-14 Proceso de purificacion de factor viii.

Country Status (11)

Country Link
US (1) US5831026A (es)
EP (1) EP0784633B1 (es)
JP (1) JP3787154B2 (es)
AT (1) ATE302216T1 (es)
AU (1) AU691692B2 (es)
CA (1) CA2202875C (es)
DE (1) DE69534383T2 (es)
MX (1) MX9703552A (es)
NZ (1) NZ295811A (es)
SE (1) SE9403915D0 (es)
WO (1) WO1996015150A1 (es)

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US6605222B1 (en) * 1998-05-20 2003-08-12 Baxter Aktiengesellschaft Method for producing a factor VIII/von Willebrand factor complex
ATE365052T1 (de) 1999-02-22 2007-07-15 Univ Connecticut Neue albuminfreie faktor viii formulierungen
AU3194900A (en) * 1999-03-19 2000-10-09 Yamanouchi Pharmaceutical Co., Ltd. Method for screening cysteine protease inhibitor
US6338964B1 (en) * 1999-05-07 2002-01-15 Bayer Corporation Process and medium for mammalian cell culture under low dissolved carbon dioxide concentration
IL162239A0 (en) 2001-12-21 2005-11-20 Novo Nordisk Healthcare Ag Liquid composition of factor vii polypeptides
KR20040065278A (ko) * 2001-12-21 2004-07-21 노보 노르디스크 에이/에스 변경된 인자 ⅶ 폴리펩티드의 액체 조성물
US20040009918A1 (en) * 2002-05-03 2004-01-15 Hanne Nedergaard Stabilised solid compositions of modified factor VII
PT2283856T (pt) 2002-06-21 2017-12-26 Novo Nordisk Healthcare Ag Composições sólidas estabilizadas de polipéptidos do fator viia
AU2004222625A1 (en) * 2003-03-18 2004-09-30 Novo Nordisk Health Care Ag Liquid, aqueous, pharmaceutical compositions of factor VII polypeptides
US7897734B2 (en) * 2003-03-26 2011-03-01 Novo Nordisk Healthcare Ag Method for the production of proteins
CA2525224A1 (en) * 2003-05-23 2004-12-02 Michael Bech Jensen Protein stabilization in solution
EP1641487B1 (en) * 2003-06-25 2012-02-29 Novo Nordisk Health Care AG Liquid composition of factor vii polypeptides
ATE446768T1 (de) * 2003-07-01 2009-11-15 Novo Nordisk Healthcare Ag Flüssige wässrige pharmazeutische zusammnesetzung von factor vii polypeptiden
BRPI0413518A (pt) * 2003-08-14 2006-10-10 Novo Nordisk Healthcare Ag composição farmacêutica lìquida aquosa, método para preparar e uso da mesma, método para tratar uma sìndrome responsiva ao fator vii, e, recipiente hermético
ES2229931B1 (es) * 2003-10-03 2006-01-16 Grifols, S.A. Composicion liquida bilogicamente estable de fviii, de fvw o del complejo fviii/fvw humanos.
JP2007519623A (ja) * 2003-12-19 2007-07-19 ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト Vii因子ポリペプチドの安定化された組成物
EP1707634A1 (en) 2005-03-29 2006-10-04 Octapharma AG Method for isolation of recombinantly produced proteins
WO2008135498A2 (en) * 2007-05-04 2008-11-13 Novo Nordisk A/S Prevention of protein degradation in mammalian cell cultures
EP2113564A1 (en) * 2008-05-01 2009-11-04 Arecor Limited Protein formulation
BRPI0914695B1 (pt) * 2008-06-24 2022-04-19 Octapharma Ag Processo de purificação ou enriquecimento de fator fviii de coagulação
US9120873B2 (en) 2008-08-21 2015-09-01 Octapharma Ag Recombinantly produced human factor VIII and IX
SI2337580T1 (sl) * 2008-09-03 2012-06-29 Octapharma Ag Stabilizirani sestavki za rekombinanto proizveden faktor VIII
NZ593190A (en) 2008-11-07 2013-01-25 Baxter Int Factor viii formulations
GB0915480D0 (en) 2009-09-04 2009-10-07 Arecor Ltd Stable formulation of factor viii
BRPI1105317A2 (pt) 2011-01-24 2013-04-30 Fundacco Hemoct De Ribeirco Preto produÇço estÁvel e em larga escala de fviii humano em linhagem celular humana sk-hep-1

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Publication number Priority date Publication date Assignee Title
US4289691A (en) * 1980-01-18 1981-09-15 The Canadian Red Cross Society Method of obtaining intermediate purity factor VIII
US4406886A (en) * 1983-01-14 1983-09-27 University Patents, Inc. Purification of antihemophilia factor VIII by precipitation with zinc ions
FI86885C (fi) * 1984-04-20 1992-10-26 Genentech Inc Foerfarande foer framstaellning av human rekombinantfaktor viii och nukleinsyrasekvenser och vektorer anvaend daertill
US5149787A (en) * 1984-05-22 1992-09-22 The Blood Center Research Foundation Method for maintaining intact, non-degraded factor VIII/von-Willebrand factor during blood processing
US4710381A (en) * 1984-05-22 1987-12-01 The Blood Center Of Southeastern Wisconsin Method for maintaining intact, non-degraded factor VIII/von-Willebrand factor during blood processing
SE8501050D0 (sv) * 1985-03-05 1985-03-05 Kabivitrum Ab Biologically active fragments of human antihemophilic factor and method for preparation thereof
CA1329760C (en) * 1987-10-29 1994-05-24 Ted C. K. Lee Plasma and recombinant protein formulations in high ionic strength media
US4877608A (en) * 1987-11-09 1989-10-31 Rorer Pharmaceutical Corporation Pharmaceutical plasma protein formulations in low ionic strength media
US4981951A (en) * 1988-04-14 1991-01-01 Miles Inc. Lectin affinity chromatography of factor VIII
WO1990002175A1 (en) * 1988-08-16 1990-03-08 Novo Nordisk A/S A method of producing polypeptides by culturing eukaryotic cells in the presence of protease inhibitors
GB8827305D0 (en) * 1988-11-23 1988-12-29 British Bio Technology Compounds
US5110907A (en) * 1989-08-01 1992-05-05 Alpha Therapeutic Corporation Factor viii complex purification using heparin affinity chromatography
DE3926034C3 (de) * 1989-08-07 1996-11-21 Behringwerke Ag Verfahren zur Herstellung eines stabilen Faktors VIII
SE465222C5 (sv) * 1989-12-15 1998-02-10 Pharmacia & Upjohn Ab Ett rekombinant, humant faktor VIII-derivat och förfarande för dess framställning
IT1248723B (it) * 1990-06-12 1995-01-26 Scalvo S P A Processo per la purificazione del fattore viii e fattore viii ottenuto con tale processo
WO1992013944A1 (en) * 1991-02-04 1992-08-20 Berlex Laboratories, Inc. Endothelin converting enzyme
SE468050C (sv) * 1991-03-15 1998-02-11 Pharmacia & Upjohn Ab Rekombinant derivat av human faktor VIII
CA2078721A1 (en) * 1991-09-24 1993-03-25 Hiroshi Yonemura Process for preparing human coagulation factor viii protein complex
US5278289A (en) * 1991-11-12 1994-01-11 Johnson Alan J Antihemophilic factor stabilization
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AU670793B2 (en) * 1992-04-30 1996-08-01 Alpha Therapeutic Corporation Improved solubilization and stabilization of factor VIII complex
GB9211538D0 (en) * 1992-06-01 1992-07-15 Blake David R Antiinflammatory agent
CA2124690C (en) * 1992-10-02 2007-09-11 Thomas Osterberg Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
SE9301581D0 (sv) * 1993-05-07 1993-05-07 Kabi Pharmacia Ab Protein formulation
SE504074C2 (sv) * 1993-07-05 1996-11-04 Pharmacia Ab Proteinberedning för subkutan, intramuskulär eller intradermal administrering
IL113010A0 (en) * 1994-03-31 1995-10-31 Pharmacia Ab Pharmaceutical formulation comprising factor VIII or factor ix with an activity of at least 200 IU/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration

Also Published As

Publication number Publication date
DE69534383D1 (de) 2005-09-22
NZ295811A (en) 1998-08-26
EP0784633B1 (en) 2005-08-17
CA2202875A1 (en) 1996-05-23
US5831026A (en) 1998-11-03
WO1996015150A1 (en) 1996-05-23
SE9403915D0 (sv) 1994-11-14
JP3787154B2 (ja) 2006-06-21
CA2202875C (en) 2011-03-15
JPH10509144A (ja) 1998-09-08
EP0784633A1 (en) 1997-07-23
ATE302216T1 (de) 2005-09-15
DE69534383T2 (de) 2006-05-24
AU691692B2 (en) 1998-05-21
AU3943995A (en) 1996-06-06

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