AN EFFICIENT AND NOVEL PURIFICATION METHOD OF RECOMBINANT HG-CSF

摘要

The present invention relates to Recombinant human Granulocyte Colony Stimulating Factor (G-CSF) and describes a novel purification process for a simple, economically feasible, largely scalable production of pharmaceutically acceptable grade product with high recovery of rhG-CSF expressed from bacterial cells. The invention comprises of the conditions for isolation of protein inclusion bodies; complete refolding in to native form, purification of the protein by two-step chromatography and diafiltration. The end product of this invention viz. high purity G-CSF is suitable for direct injectable use. The efficiency of the protein recovery is 52% with more than 99% of monomer purity.