ES2543829T3 - Procedimiento para la preparación del inhibidor de proteinasa alfa-1 - Google Patents

Procedimiento para la preparación del inhibidor de proteinasa alfa-1 Download PDF

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Publication number
ES2543829T3
ES2543829T3 ES00992709.6T ES00992709T ES2543829T3 ES 2543829 T3 ES2543829 T3 ES 2543829T3 ES 00992709 T ES00992709 T ES 00992709T ES 2543829 T3 ES2543829 T3 ES 2543829T3
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ES
Spain
Prior art keywords
proteinase inhibitor
alpha
exchange resin
aqueous solution
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 - Lifetime
Application number
ES00992709.6T
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English (en)
Other versions
ES2543829T5 (es
Inventor
Wytold Lebing
Mark D. Chavez
David W. Ownby
Susan Trukawinski
Woody D. Wood
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Grifols Therapeutics LLC
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Grifols Therapeutics LLC
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Publication date
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Application filed by Grifols Therapeutics LLC filed Critical Grifols Therapeutics LLC
Application granted granted Critical
Publication of ES2543829T3 publication Critical patent/ES2543829T3/es
Anticipated expiration legal-status Critical
Publication of ES2543829T5 publication Critical patent/ES2543829T5/es
Expired - Lifetime legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/81—Protease inhibitors
    • C07K14/8107—Endopeptidase (E.C. 3.4.21-99) inhibitors
    • C07K14/811—Serine protease (E.C. 3.4.21) inhibitors
    • C07K14/8121—Serpins
    • C07K14/8125—Alpha-1-antitrypsin

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Procedimiento para purificar el inhibidor de proteinasa a-1 a partir de una solución acuosa que contiene inhibidor de proteinasa alfa-1, que comprende las etapas de: (a) eliminar una parte de proteínas contaminantes de la solución acuosa para obtener una solución purificada que contiene inhibidor de proteinasa alfa-1, en el que dicha etapa de eliminación comprende las etapas de: (i) precipitar dicha parte de proteínas contaminantes de dicha solución acuosa mediante la adición de un polietilenglicol con un PM entre aproximadamente 3.000 y aproximadamente 4.000 a dicha solución acuosa a una concentración entre el 3% y el 15% en peso por volumen, y ajustar el pH de dicha solución acuosa de aproximadamente 5,0 a aproximadamente 6,0; y (ii) separar dicha parte precipitada de proteínas contaminantes de dicha solución acuosa, obteniendo de este modo dicha solución purificada que contiene inhibidor de proteinasa alfa-1; a continuación (b) diluir dicha solución purificada para reducir la conductividad de dicha solución purificada, de manera que el inhibidor de proteinasa alfa-1 se une a una resina de intercambio aniónico; a continuación (c) pasar dicha solución purificada a través de una resina de intercambio aniónico, de manera que el inhibidor de proteinasa alfa-1 se une a dicha resina de intercambio aniónico; a continuación (d) eluir el inhibidor de proteinasa alfa-1 de dicha resina de intercambio aniónico para obtener una solución eluida que contiene inhibidor de proteinasa alfa-1; a continuación (e) ajustar el pH, la conductividad y la concentración de proteína de dicha solución eluida que contiene inhibidor de proteinasa alfa-1, de manera que el inhibidor de proteinasa alfa-1 no se une a una resina de intercambio catiónico; (f) pasar la solución eluida a través de una resina de intercambio catiónico; y (g) recoger el flujo que atraviesa dicha resina de intercambio catiónico que contiene inhibidor de proteinasa alfa-1.

Description

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Claims (1)

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ES00992709T 2000-12-14 2000-12-14 Procedimiento para la preparación del inhibidor de proteinasa alfa 1 Expired - Lifetime ES2543829T5 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2000/042811 WO2002048176A1 (en) 2000-12-14 2000-12-14 Method of preparing alpha-1 proteinase inhibitor

Publications (2)

Publication Number Publication Date
ES2543829T3 true ES2543829T3 (es) 2015-08-24
ES2543829T5 ES2543829T5 (es) 2023-07-13

Family

ID=21742222

Family Applications (1)

Application Number Title Priority Date Filing Date
ES00992709T Expired - Lifetime ES2543829T5 (es) 2000-12-14 2000-12-14 Procedimiento para la preparación del inhibidor de proteinasa alfa 1

Country Status (9)

Country Link
EP (1) EP1343809B2 (es)
AU (1) AU2001245240A1 (es)
CA (1) CA2432641A1 (es)
ES (1) ES2543829T5 (es)
FI (1) FI1343809T4 (es)
NO (1) NO20032700L (es)
NZ (1) NZ526940A (es)
PT (1) PT1343809E (es)
WO (1) WO2002048176A1 (es)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002048176A1 (en) 2000-12-14 2002-06-20 Bayer Corporation Method of preparing alpha-1 proteinase inhibitor
US7777006B2 (en) 2002-12-31 2010-08-17 Csl Behring L.L.C. Method for purification of alpha-1-antitrypsin
EP1664123B2 (en) 2003-09-22 2011-11-30 Kamada Ltd. Large scale preparation of alpha-1 proteinase inhibitor and use thereof
WO2009059082A2 (en) * 2007-11-02 2009-05-07 Talecris Biotherapeutics, Inc. Method, composition, and article of manufacture for providing alpha-1 antitrypsin
CA2730018A1 (en) * 2008-07-18 2010-01-21 Talecris Biotherapeutics, Inc. Method of preparing alpha-1 proteinase inhibitor
CN102180966B (zh) * 2011-01-28 2013-04-03 哈尔滨派斯菲科生物制药股份有限公司 一种规模化生产人α1-抗胰蛋白酶的方法
BR112013030243A2 (pt) * 2011-05-26 2016-12-06 Baxter Healthcare Sa método para a medição de inibidor de alfa1-proteinase ativo em uma amostra
US9353165B2 (en) 2012-07-25 2016-05-31 Grifols, S.A. Purification of cell culture derived alpha1 protease inhibitor
CN108026507A (zh) * 2015-04-02 2018-05-11 K·黄 由组分vi制造afod静脉注射剂的方法
WO2017078947A1 (en) * 2015-10-21 2017-05-11 Cambryn Biologics, Llc Processes for purifying proteins from plasma

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2390074A (en) 1942-02-09 1945-12-04 Research Corp Protein product and process
US4379087A (en) 1982-06-17 1983-04-05 Cutter Laboratories, Inc. Method of preparing alpha-1-proteinase inhibitor
US4439358A (en) 1982-06-17 1984-03-27 Miles Laboratories, Inc. Method of preparing alpha-1-proteinase inhibitor
US4540573A (en) 1983-07-14 1985-09-10 New York Blood Center, Inc. Undenatured virus-free biologically active protein derivatives
US4697003A (en) 1985-11-01 1987-09-29 Miles Laboratories, Inc. Method of preparing alpha-1-proteinase inhibitor
US4656254A (en) * 1985-12-02 1987-04-07 Miles Laboratories, Inc. Method of preparing alpha-1-proteinase inhibitor and antithrombin III
US4629567A (en) 1986-03-07 1986-12-16 Smithkline-Rit Alpha-1-antiprotease purification
US4749783A (en) 1986-07-11 1988-06-07 Miles Laboratories, Inc. Viral inactivation and purification of active proteins
US5561064A (en) 1994-02-01 1996-10-01 Vical Incorporated Production of pharmaceutical-grade plasmid DNA
US6284874B1 (en) * 1994-06-17 2001-09-04 Alpha Therapeutic Corporation Process for separating α1-proteinase inhibitor from cohn fraction IV1 and IV4 paste
US5610285A (en) 1994-08-24 1997-03-11 Bayer Corporation Purification of α-1 proteinase inhibitor using novel chromatographic separation conditions
US5610825A (en) 1994-11-08 1997-03-11 Johnson; William J. Method and apparatus for the display of digitized analog signal loss
AU6884396A (en) 1995-09-07 1997-03-27 Ppl Therapeutics (Scotland) Ltd Purification of alpha-1 proteinase inhibitor
US5831003A (en) 1996-06-28 1998-11-03 Bayer Corporation Peptides which bind to prothrombin and thrombin
US5616693A (en) 1996-07-01 1997-04-01 Alpha Therapeutic Corporation Process for seperating alpha-1-proteinase inhibitor from COHN IV1 +1V4 paste
US6093804A (en) 1998-09-24 2000-07-25 American National Red Cross Method for purification of alpha-1 proteinase inhibitor
US6462180B1 (en) 1999-11-24 2002-10-08 Bayer Corporation Method of preparing α-1 proteinase inhibitor
WO2002048176A1 (en) 2000-12-14 2002-06-20 Bayer Corporation Method of preparing alpha-1 proteinase inhibitor

Also Published As

Publication number Publication date
EP1343809B2 (en) 2023-03-15
EP1343809B1 (en) 2015-06-24
NO20032700L (no) 2003-07-17
FI1343809T4 (fi) 2023-09-04
NO20032700D0 (no) 2003-06-13
EP1343809A1 (en) 2003-09-17
NZ526940A (en) 2005-06-24
WO2002048176A1 (en) 2002-06-20
PT1343809E (pt) 2015-09-22
ES2543829T5 (es) 2023-07-13
EP1343809A4 (en) 2004-08-18
CA2432641A1 (en) 2002-06-20
AU2001245240A1 (en) 2002-06-24

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