WO2009141384A3 - Procédé de purification de polypeptides de facteur vii à l'aide de résines d'affinité comportant des ligands spécifiques - Google Patents

Procédé de purification de polypeptides de facteur vii à l'aide de résines d'affinité comportant des ligands spécifiques Download PDF

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WO2009141384A3
WO2009141384A3 PCT/EP2009/056149 EP2009056149W WO2009141384A3 WO 2009141384 A3 WO2009141384 A3 WO 2009141384A3 EP 2009056149 W EP2009056149 W EP 2009056149W WO 2009141384 A3 WO2009141384 A3 WO 2009141384A3
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Prior art keywords
drug substance
affinity resin
factor vii
purification
specific ligands
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PCT/EP2009/056149
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WO2009141384A2 (fr
Inventor
Phaedria Marie St. Hilaire
Roice Michael
Janus Krarup
Christine Bruun SCHIØDT
Line Naomi Lund
Ib Johannsen
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Novo Nordisk A/S
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Publication of WO2009141384A2 publication Critical patent/WO2009141384A2/fr
Publication of WO2009141384A3 publication Critical patent/WO2009141384A3/fr

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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 - B01D15/36
    • B01D15/3804Affinity chromatography
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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    • B01J20/22Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising organic material
    • B01J20/26Synthetic macromolecular compounds
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    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/48Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424Serine endopeptidases (3.4.21)
    • C12N9/6437Coagulation factor VIIa (3.4.21.21)
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    • C12N9/50Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
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    • C12N9/647Blood coagulation factors not provided for in a preceding group or according to more than one of the proceeding groups
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    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21021Coagulation factor VIIa (3.4.21.21)
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Abstract

L'invention porte sur un procédé de purification d'une substance médicamenteuse d'un polypeptide de facteur VII. Ce procédé comporte les étapes: (a) de mise en contact de la substance médicamenteuse avec une résine d'affinité dans des conditions qui facilitent la liaison d'une partie de ladite substance médicamenteuse à ladite résine d'affinité ; (b) facultativement de lavage de ladite résine d'affinité contenant la substance médicamenteuse liée avec un tampon de lavage, et (c) d’élution de ladite résine d'affinité contenant la substance médicamenteuse liée avec un tampon d'élution, et de récupération de la substance médicamenteuse purifiée du polypeptide de facteur VII en tant qu'éluat, ladite résine d'affinité étant un matériau en phase solide sur lequel ont été immobilisés de manière covalente un ou plusieurs ligands de la formule générale (I), chacun de R1, R2 et R3 représentant une fraction organique d'une masse moléculaire de 15 à 1 000 g/mole, la masse moléculaire totale dudit ligand étant de 200 à 2 000 g/mole, ledit ligand étant immobilisé sur ledit matériau en phase solide par l'intermédiaire de l'une desdites fractions organiques R1, R2 et R3.
PCT/EP2009/056149 2008-05-21 2009-05-20 Procédé de purification de polypeptides de facteur vii à l'aide de résines d'affinité comportant des ligands spécifiques WO2009141384A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP08104053.7 2008-05-21
EP08104053 2008-05-21

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WO2009141384A2 WO2009141384A2 (fr) 2009-11-26
WO2009141384A3 true WO2009141384A3 (fr) 2010-02-25

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Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012017021A2 (fr) * 2010-08-03 2012-02-09 Graffinity Pharmaceuticals Gmbh Ligands pour la purification d'anticorps et de protéine de fusion à fc par chromatographie d'affinité
US9156879B1 (en) * 2010-10-29 2015-10-13 Merck Sharp & Dohme Corp. Chromatography media
CA2821711C (fr) 2010-12-15 2017-10-10 Baxter International Inc. Recuperation d'eluat par utilisation d'un gradient de conductivite
EP2690106A4 (fr) * 2011-03-24 2015-04-22 Kaneka Corp Composé de faible poids moléculaire liant les substances protéiques
KR20150013435A (ko) * 2012-02-08 2015-02-05 그라피니티 파머수티컬스 게엠베하 친화 크로마토그래피 IV에 의한 항체 및 Fc-융합 단백질 정제용 리간드
WO2014020152A1 (fr) * 2012-08-02 2014-02-06 Graffinity Pharmaceuticals Gmbh Ligands pour aphérèse et immunoabsorption
GB2513405A (en) 2013-04-26 2014-10-29 Adc Biotechnology Ltd Method of synthesising ADCs using affinity resins
GB201419185D0 (en) 2014-10-28 2014-12-10 Adc Biotechnology Ltd Method of synthesising ADCs using affinity resin
GB201419184D0 (en) 2014-10-28 2014-12-10 Adc Biotechnology Ltd Method of synthesising biomolecule-effector/reporter-conjugates using affinity resins
WO2018177369A1 (fr) * 2017-03-30 2018-10-04 江苏恒瑞医药股份有限公司 Procédé de préparation de conjugué anticorps-médicament
CN113952944B (zh) * 2021-12-23 2022-03-29 浙江湃肽生物有限公司深圳分公司 一种纯化九肽-1的方法

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WO2001083515A2 (fr) * 2000-04-28 2001-11-08 Accurate Polymers, Inc. Activite simulee de proteine a presentee par de petits ligands fixes a une surface de perle de cellulose
US6670455B1 (en) * 1999-08-06 2003-12-30 Aventis Behring Gmbh Process for the preparation in pure form of the protease activating blood clotting VII, its proenzyme or a mixture of both proteins by means of affinity chromatography
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FR2901707A1 (fr) * 2006-05-31 2007-12-07 Lab Francais Du Fractionnement Composition de facteur vii recombinant ou transgenique, chaque molecule de facteur vii possedant deux sites de n-glycosylation a motifs glycanniques definis

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