Long-term storage of non-glycosylated recombinant human G-CSF

A method of providing a pharmaceutical composition of non-glycosylated recombinant human G-CSF, said method comprising the steps of:

• (a) formulating non-glycosylated recombinant human G-CSF with an acetate or glutamate buffer and sorbitol to obtain an aqueous buffered G-CSF composition, wherein the amount of G-CSF is in the range of from 0.1 mg/ml to 8.0 mg/ml and wherein said composition has a volume of from 100 ml to 8 l;
• (b) cooling the G-CSF composition of step (a) to a temperature of −15° C. or below to obtain a frozen G-CSF composition;
• (c) storing the G-CSF composition obtained in step (b) in the frozen state over a period of at least one month;
• (d) increasing the temperature of the frozen G-CSF composition of step (c) to a temperature within the range of from 2° C. to 8° C. over a period of time of at least 6 hours to allow the composition to thaw and to obtain a liquid composition having a G-CSF content of at least 95% of the G-CSF content of the composition provided in step (a);
• and
• (e) filling the liquid composition obtained in step (d) into primary packagings for parenteral use.