BRPI0400375B8 - processo para remover vírus em soluções de fibrinogênio para aplicação terapêutica - Google Patents

processo para remover vírus em soluções de fibrinogênio para aplicação terapêutica

Info

Publication number
BRPI0400375B8
BRPI0400375B8 BRPI0400375A BRPI0400375A BRPI0400375B8 BR PI0400375 B8 BRPI0400375 B8 BR PI0400375B8 BR PI0400375 A BRPI0400375 A BR PI0400375A BR PI0400375 A BRPI0400375 A BR PI0400375A BR PI0400375 B8 BRPI0400375 B8 BR PI0400375B8
Authority
BR
Brazil
Prior art keywords
fibrinogen
therapeutic application
remove viruses
adjusted
fibrinogen solutions
Prior art date
Application number
BRPI0400375A
Other languages
English (en)
Inventor
Fernandez Rodrigues Jesús
Ristol Debart Pere
Original Assignee
Grifols Sa
Probitas Pharma 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.)
Filing date
Publication date
Application filed by Grifols Sa, Probitas Pharma Sa filed Critical Grifols Sa
Publication of BRPI0400375A publication Critical patent/BRPI0400375A/pt
Publication of BRPI0400375B1 publication Critical patent/BRPI0400375B1/pt
Publication of BRPI0400375B8 publication Critical patent/BRPI0400375B8/pt

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/75—Fibrinogen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/363—Fibrinogen
    • 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—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/022—Filtration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • 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
    • 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
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05—Living organisms or biological materials

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Epidemiology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Water Supply & Treatment (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Toxicology (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)

Abstract

"processo para remover vírus em soluções de fibrinogênio para aplicação terapêutica e fibrinogênio obtido pelo dito processo". o processo inicia-se com uma solução de fibrinogênio purificada ajustada, a solução purificada ajustada é congelada e, então, descongelada para uma temperatura entre 5 e 20<198>c, os materiais não dissolvidos associados com o fibrinogênio são subseqüentemente separados, a temperatura é ajustada e a solução resultante é finalmente submetida a nanofiltragem utilizando-se filtros para uma dimensão de poro menor do que 35 nm.
BRPI0400375A 2003-03-06 2004-03-02 processo para remover vírus em soluções de fibrinogênio para aplicação terapêutica BRPI0400375B8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES200300538A ES2214967B1 (es) 2003-03-06 2003-03-06 Procedimiento para la eliminacion de virus en soluciones de fibrinogeno y fibrinogeno obtenido por dicho procedimiento.
ES200300538 2003-03-06

Publications (3)

Publication Number Publication Date
BRPI0400375A BRPI0400375A (pt) 2005-01-04
BRPI0400375B1 BRPI0400375B1 (pt) 2018-05-08
BRPI0400375B8 true BRPI0400375B8 (pt) 2021-05-25

Family

ID=32749109

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0400375A BRPI0400375B8 (pt) 2003-03-06 2004-03-02 processo para remover vírus em soluções de fibrinogênio para aplicação terapêutica

Country Status (15)

Country Link
US (2) US7442308B2 (pt)
EP (1) EP1457497B1 (pt)
JP (1) JP4272562B2 (pt)
AR (1) AR043238A1 (pt)
AT (1) ATE410438T1 (pt)
AU (1) AU2004200745B8 (pt)
BR (1) BRPI0400375B8 (pt)
CA (1) CA2459690C (pt)
CL (1) CL2004000261A1 (pt)
DE (1) DE602004016900D1 (pt)
ES (2) ES2214967B1 (pt)
MX (1) MXPA04001829A (pt)
NZ (1) NZ531328A (pt)
PL (1) PL1457497T3 (pt)
PT (1) PT1457497E (pt)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2887883B1 (fr) 2005-06-29 2007-08-31 Lab Francais Du Fractionnement Procede de separation des proteines fibrinogene, facteur xiii et colle biologique d'une fraction plasmatique solubilisee et de preparation de concentres lyophilises desdites proteines
US20120177610A1 (en) * 2007-09-19 2012-07-12 Kieu Hoang Manufacturing and Purification Processes of Complex Protein found in Fraction IV to make a separated Apo, Transferrin , and Alpha 1 Anti strepsin (A1AT) or A combined Transferrin / Apo/Human Albumin/A1AT and all new found proteins
DK2242479T3 (da) 2007-12-28 2012-01-02 Baxter Int Modtryksfiltrering af proteiner
WO2010059232A1 (en) 2008-11-20 2010-05-27 Biogen Idec Ma Inc. Arginine inactivation of viruses
JP5755136B2 (ja) * 2009-03-27 2015-07-29 旭化成メディカル株式会社 高濃度モノクローナル抗体溶液中のウイルス除去方法
EP2619225B1 (en) 2010-09-20 2016-06-15 Octapharma AG Process for production of fibrinogen
US10112972B2 (en) 2012-03-13 2018-10-30 Octapharma Ag Process for production of fibrinogen and fibrinogen produced thereby
MX386767B (es) * 2012-06-21 2025-03-19 Takeda Pharmaceuticals Co Filtración de virus de medio de cultivo celular.
US10188965B2 (en) 2012-12-05 2019-01-29 Csl Behring Gmbh Hydrophobic charge induction chromatographic depletion of a protein from a solution
US20140154233A1 (en) 2012-12-05 2014-06-05 Csl Limited Method of purifying therapeutic proteins
LT3154597T (lt) * 2014-06-12 2019-02-25 Biosyn Arzneimittel Gmbh Naujos kartos biologiniu požiuriu saugių klh produktų, skirtų vėžiui gydyti, gavimo būdai, skirti konjuguotų terapinių vakcinų ir kaip stimuliuojančių agentų pagerinimui
CA2951735C (en) 2014-06-12 2020-06-30 Biosyn Arzneimittel Gmbh Preparation methods for a novel generation of biological safe klh products used for cancer treatment, for the development of conjugated therapeutic vaccines and as challenging agents
KR101841587B1 (ko) * 2016-01-12 2018-05-14 주식회사 녹십자홀딩스 피브리노겐의 정제방법
US20190167823A1 (en) * 2016-08-09 2019-06-06 Asahi Kasei Medical Co., Ltd. Method for treating solution contaminated with porcine circoviruses
FR3090321B1 (fr) 2018-12-21 2023-07-14 Lab Francais Du Fractionnement Procédé de filtration du fibrinogène
CN111848783B (zh) * 2020-07-29 2023-07-04 同路生物制药有限公司 一种人纤维蛋白原的制备方法
CN116744986A (zh) * 2020-12-25 2023-09-12 广州倍绣生物技术有限公司 纤维蛋白原除菌过滤
JP7645133B2 (ja) * 2021-06-04 2025-03-13 Ｋｍバイオロジクス株式会社 血液凝固第ｘｉｉｉ因子を含むフィブリノゲンの製造方法

Family Cites Families (17)

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US511154A (en) * 1893-12-19 Feed-gage for printing-presses
DE2624373C2 (de) * 1976-05-31 1983-02-03 Arnold Dr. 8782 Karlstadt Seufert Verfahren zur Herstellung von steril filtriertem Kryopräzipilat mit einer Anreicherung des Faktors VIII
FR2563357B1 (fr) * 1984-04-18 1987-12-04 Cormier Bernard Panneau de signalisation routiere
US5792835A (en) * 1991-09-05 1998-08-11 Baxter International Inc. Method of preparing a topical fibrinogen complex
US5330974A (en) * 1993-03-01 1994-07-19 Fibratek, Inc. Therapeutic fibrinogen compositions
JP3867931B2 (ja) * 1993-11-08 2007-01-17 財団法人化学及血清療法研究所 液状フィブリノゲン製剤
US5506127A (en) * 1994-09-21 1996-04-09 Proba; Zbigniew Therapeutic grade thrombin produced by chromatography
EP0860444A1 (en) 1997-02-24 1998-08-26 Stichting Centraal Laboratorium van de Bloedtransfusiedienst van het Nederlandse Rode Kruis (CLB) Method for removing viruses from a protein solution
US5981254A (en) * 1997-10-30 1999-11-09 Haemacure Corporation Process for producing thrombin from plasma
FR2772381B1 (fr) * 1997-12-15 2001-06-08 Lab Francais Du Fractionnement Procede de preparation par filtration d'une solution de facteur viii securisee viralement
ES2156731B1 (es) * 1999-05-31 2002-02-16 Grifols Grupo Sa Utilizacion del acido tranexamico para la preparacion de una composicion de fibrinogeno humano.
US6270672B1 (en) * 1999-08-06 2001-08-07 Baxter Aktiengesellschaft Devices and methods for removing pathogens from biological fluids
KR20020063597A (ko) 1999-12-20 2002-08-03 미츠비시 웰파마 가부시키가이샤 다공성막으로 처리되어 바이러스가 제거된 혈장 단백질조성물 및 그 제조 방법
DE10022092A1 (de) * 2000-05-08 2001-11-15 Aventis Behring Gmbh Stabilisiertes Protein-Präparat und Verfahren zu seiner Herstellung
JP2001335509A (ja) * 2000-05-31 2001-12-04 Nihon Pharmaceutical Co Ltd フィブリノーゲンを含有する溶液のウイルス除去法
IL136552A (en) * 2000-06-05 2005-05-17 Omrix Biopharmaceuticals Ltd Method for the inactivation of viruses by a solvent - detergent combination and by nanofiltration
DE10211632A1 (de) * 2002-03-15 2003-10-09 Aventis Behring Gmbh Verfahren zur Abtrennung von Viren aus einer Proteinlösung durch Nanofiltration

Also Published As

Publication number Publication date
BRPI0400375B1 (pt) 2018-05-08
JP4272562B2 (ja) 2009-06-03
AU2004200745B2 (en) 2008-07-03
AR043238A1 (es) 2005-07-20
CA2459690A1 (en) 2004-09-06
EP1457497B1 (en) 2008-10-08
PL1457497T3 (pl) 2009-06-30
US20080274974A1 (en) 2008-11-06
CA2459690C (en) 2010-11-02
EP1457497A1 (en) 2004-09-15
DE602004016900D1 (de) 2008-11-20
US7442308B2 (en) 2008-10-28
AU2004200745B8 (en) 2009-01-08
NZ531328A (en) 2004-10-29
BRPI0400375A (pt) 2005-01-04
ATE410438T1 (de) 2008-10-15
CL2004000261A1 (es) 2005-03-18
PT1457497E (pt) 2008-12-10
ES2214967A1 (es) 2004-09-16
ES2214967B1 (es) 2005-06-16
MXPA04001829A (es) 2004-09-08
US20040173527A1 (en) 2004-09-09
ES2312944T3 (es) 2009-03-01
AU2004200745A1 (en) 2004-09-23
JP2004269529A (ja) 2004-09-30

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Legal Events

Date Code Title Description
B25D Requested change of name of applicant approved

Owner name: GRIFOLS, S.A. (ES)

Free format text: ALTERADO DE: PROBITAS PHARMA, S.A.

B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B25G Requested change of headquarter approved

Owner name: GRIFOLS, S.A. (ES)

B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]
B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 02/03/2004 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 21A ANUIDADE.

B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2822 DE 04-02-2025 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.