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

摘要

The present invention provides a method for stable long-term storage of non-glycosylated recombinant human Granulocyte-Colony Stimulating Factor (“G-CSF”), wherein an aqueous acetate or glutamate buffered G-CSF composition containing the non-glycosylated recombinant human G-CSF and sorbital is cooled to a temperature of −15° C. or below to obtain a frozen G-CSF composition, which frozen composition is then stored in the frozen state and then increased in temperature to a temperature within the range of from 2° C. to 8° C. for a period of time adjusted 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 original composition.

主权项

1. A method for stable long-term storage of non-glycosylated recombinant human Granulocyte-Colony Stimulating Factor (G-CSF), said method comprising the steps of:
(a) providing an aqueous acetate or glutamate buffered G-CSF composition containing a non-glycosylated recombinant human G-CSF and sorbitol, 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-formulation provided in step (a) to a temperature of −15° C. or below to obtain a frozen G-CSF formulation; (c) storing the G-CSF-formulation 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).