The present invention relates to a process for the isolation and purification of Granulocyte Colony Stimulating Factor (GCSF) comprising: i) producing recombinant human GCSF (rhu-GCSF) by high cell density fermentation of E. coli and isolation inclusion bodies; ii) solubilizing inclusion bodies obtained from step (i) to release GCSF; iii) refolding the GCSF protein obtained in the previous step; iv) clarification and purification of the GCSF protein obtained in the previous step; v) optionally conjugating purified GCSF obtained from the previous step with polyethylene glycol (PEG);and vi) optionally purifying the conjugated (pegylated) GCSF obtained in the previous step using cation exchange chromatography. It also refers to a pharmaceutical composition comprising said obtained pegylated GCSF. Said procedure is scalable and industrially viable for the purification of recombinant human GCSF.
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