PROCESS FOR THE PREPARATION OF A DESIRED ERYTHROPOIETIN GLYCO-ISOFORM PROFILE

The present invention provides a process for the production of erythropoietin (EPO) with high purity and with a desired profile of EPO glycol-isoforms by using a combination of specific chromatographic steps in such a manner that the starting EPO glycol-isoform profile is changed or modified. The ap...

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Bibliographische Detailangaben
Hauptverfasser: FRANCKY, ANDREJ, GANTAR-KSELA, MATEJA, SVETINA, MONICA, SVETEK, JELKA, BRINC, MATJAZ
Format: Patent
Sprache:eng ; fre ; ger
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Zusammenfassung:The present invention provides a process for the production of erythropoietin (EPO) with high purity and with a desired profile of EPO glycol-isoforms by using a combination of specific chromatographic steps in such a manner that the starting EPO glycol-isoform profile is changed or modified. The applied chromatographic steps includes at least (a) dye affinity chromatography, and (b) hydrophobic chromatography and/or (c) anion-exchange chromatography. In a preferred embodiment, the process further includes (d) gel filtration chromatography. The present invention also provides a process for the determination of erythropoietin (EPO) glycol-isoform profile in an EPO containing composition.