Patent ID: 8449873

Claim:
A method for obtaining stable non-pegylated, non-glycosylated recombinant human G-CSF after stable long-term storage of said non-pegylated, non-glycosylated recombinant human G-CSF, comprising the steps of: (a) providing an aqueous acetate or glutamate buffered G-CSF composition containing non-pegylated, non-glycosylated recombinant human G-CSF and sorbitol; (b) cooling the G-CSF composition provided in step (a) to a temperature of −15° C. or lower to obtain a frozen G-CSF formulation; (c) storing the G-CSF composition obtained in step (b) in the frozen state; (d) thawing the frozen G-CSF composition of step (c) by gradually or linearly increasing the temperature of said frozen G-CSF composition over a time of at least 6 hours to a temperature within the range of from 2° C. to 8° C. and thereby obtaining a liquid G-CSF composition having a G-CSF content of at least 95% of the G-CSF content of the composition provided in step (a).