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

Patent Number: 9387233

Patent Date: 2016-07-12

Patent type: utility

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.

Inventors

First Name Last Name City State Country
Klaus Graumann - - -
Helmut Lerch - - -
Thomas Lauber - - -

IPCs

Section Class Sub Class Group Sub Group
A 61 K 38 19
A 61 K 47 26
C 07 K 14 535
A 61 K 9 00
A 61 K 9 08
A 61 K 38 00

Assignee

Organization First Name Last Name City State Country
Sandoz AG - - - Arlesheim -