Octapharma Ag

Maya Tiemeyer

Stefan Winge

Gustav Gilljam

Helena Sandberg

Carola Schröder

Elisabeth Casademunt

Peter Stenlund

A method of purifying a Growth Factor Protein in a purification sequence employing chromatography is provided. The method comprises performing at least one chromatography step using a multimodal resin, binding the Growth Factor Protein to the multimodal resin at a pH from 4 to 6.2, and eluting the Growth Factor Protein at a pH in the range of from 5.5 to 6.5. The elution of Growth Factor Protein is improved by addition of arginine and/or NaCl in the eluting buffer. Optionally the multimodal resin step is followed by a yeast derived affinity ligand resin step, which results in a purity of the product greater than 90%.

Process for the purification of a growth factor protein

A process of purifying the Growth Factor Protein G-CSF (Granulocyte Colony Stimulating Factor) in a purification sequence employing chromatography, comprising binding the G-CSF to Capto MMC&#x2122;, which is a multimodal resin that comprises a negatively charged 2-(benzoylamino) butanoic acid ligand, at a pH from 4 to 6.2; and eluting the G-CSF at a pH greater than 6.3.

A recombinant human factor VIII or IX protein having a human glycosylation pattern but the protein is devoid of N-glycolylneuraminic acid and/or the carbohydrate group Gal&#x3b1;-3Gal.

Growing community of inventors

Ladenburg, Germany

Maya Tiemeyer