Bioceuticals Arzneimittel Ag

Jan-Ole Hesse

Christof Schumann

Michael Mack

The invention relates to erythropoietin liquid formulations that are stable in storage and to a method for the production thereof. The invention particularly relates to erythropoietin liquid formulations, which contain at least four amino acids selected from the group consisting of leucine, isoleucine, threonine, glutamic acid, aspartic acid and phenylalanine, and in which the addition of preservatives, urea or human serum albumine can be foregone.

Erythropoietin liquid formulation

The invention relates to a method for producing recombined erythropoietin having a particularly high degree of purity (&#x2267;98%). The method consists of at least 5 chromatographic purification steps, i.e. at least two anion exchange chromatographs, at least one hydrophobic interaction chromatography, at least one affinity chromatography and at least one hydroxyapatite chromatography. In preferred embodiments, the method does not require any exclusion chromatography and any reversed-phase chromatography. The invention relates to, in particular, a method wherein the following chromatographic purification steps have the following order; i) a first anion exchange chromatography, ii) an affinity chromatography, which relates, preferably, to a dye affinity chromatography, iii) a hydrophobic interaction chromatography, iv) an hydroxyapatite chromatography and v) a second anion exchange chromatography.

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Bad Nauheim, Germany

Jan-Ole Hesse