Sandoz Ag

Thomas Lauber

Klaus Graumann

Helmut Lerch

Britta Deutel

Sabine Fuertinger

The present invention relates to stable pharmaceutical liquid formulations of the fusion protein TNFR:Fc comprising different buffer systems and stabilizers. In particular, it could be demonstrated that the physical stability of TNFR:Fc is significantly improved by using a citrate buffer system and lysine as stabilizer.

Stable pharmaceutical liquid formulations of the fusion protein TNFR:Fc

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 &#x2212;15&#xb0; 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&#xb0; C. to 8&#xb0; 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.

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

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 &#x2212;15&#xb0; 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&#xb0; C. to 8&#xb0; 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.

The present invention provides a method for stable long-term storage of non-glycosylated recombinant human G-CSF, wherein an aqueous acetate or glutamate buffered G-CSF composition containing non-glycosylated recombinant human G-CSF and sorbitol is cooled to a temperature of &#x2212;15&#xb0; C. or below to obtain a frozen G-CSF coFmposition, which frozen composition is then stored in the frozen state. The temperature of the frozen G-CSF composition is later increased to a temperature within the range of from 2&#xb0; C. to 8&#xb0; C. for a time selected to allow the G-CSF composition to thaw and to obtain a liquid G-CSF composition having a G-CSF content of at least 95% of the G-CSF content of the original composition.

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Kufstein, Austria

Thomas Lauber