Method for Preserving Polypeptides Using a Sugar and Polyethyleneimine
AssigneeStabilitech Ltd.
InventorJeffrey Drew
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Abstract
A method for preserving a polypeptide comprises (i) providing an aqueous solution of one or more sugars, a polyethyleneimine and said polypeptide wherein the concentration of polyethyleneimine is 25 μM or less based on the number-average molar mass (Mn) of the polyethyleneimine and the sugar concentration or, if more than one sugar is present, total sugar concentration is greater than 0.1 M; and (ii) drying the solution to form an amorphous solid matrix comprising said polypeptide.
Claims28
1-48. (canceled)
A method for preserving a polypeptide comprising:
- (i) providing an aqueous solution of one or more sugars, a polyethyleneimine and said polypeptide;
- and
- (ii) drying the solution to form an amorphous solid matrix comprising said polypeptide.
A method for preserving a vaccine immunogen comprising:
- (i) providing an aqueous solution of one or more sugars, a polyethyleneimine and said vaccine immunogen;
- and
- (ii) drying the solution to form an amorphous solid matrix comprising said vaccine immunogen.
A preserved product comprising a polypeptide or vaccine immunogen, one or more sugars and polyethylenimine, which product is in the form of an amorphous solid.
A method of preparing a vaccine comprising a vaccine immunogen, which method comprises:
- (a) providing an aqueous solution of one or more sugars, a polyethyleneimine and said vaccine immunogen wherein the concentration of polyethyleneimine is 15 μM or less based on the number-average molar mass (Mn) of the polyethyleneimine and the sugar concentration or, if more than one sugar is present, total sugar concentration is greater than 0.1M;
- and
- (b) optionally adding an adjuvant, buffer, antibiotic and/or additive to the admixture;
- and drying the solution to form an amorphous solid matrix comprising said vaccine immunogen.
Dependencies are inferred from the claim text.