The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Jul. 12, 2016

Filed:

Jun. 17, 2014
Applicant:

Sandoz Ag, Basel, CH;

Inventors:

Klaus Graumann, Schwaz, AT;

Helmut Lerch, Stans, AT;

Thomas Lauber, Kufstein, AT;

Assignee:

Sandoz AG, , CH;

Attorney:
Primary Examiner:
Assistant Examiner:
Int. Cl.
CPC ...
A61K 38/19 (2006.01); A61K 47/26 (2006.01); C07K 14/535 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 38/00 (2006.01);
U.S. Cl.
CPC ...
A61K 38/193 (2013.01); A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 47/26 (2013.01); C07K 14/535 (2013.01); A61K 38/00 (2013.01);
Abstract

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.


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