Room temperature stable lyophilized protein
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsXiaolin Tang, David Brett Ludwig
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Abstract
Stable lyophilized therapeutic protein compositions and their methods of manufacture are provided. Specifically, the use of water as a solid cake plasticizer and protein stabilizer is described. Also, the inclusion of a multicomponent stabilizer comprising a larger molecular entity and a smaller molecular entity is described. Also, the inclusion of post-drying annealing under certain conditions improves protein stability. Proteins are predicted to remain stable over 24 months at 25° C.
Claims20
A lyophilized cake comprising a protein and a stabilizer, and having a moisture content greater than 2% and less than 10% by weight, wherein the stabilizer comprises trehalose.
A lyophilized cake comprising a protein and stabilizers, and having a moisture content from about 2.0% to about 10% by weight;
- wherein the stabilizers comprise sucrose and an additional stabilizer selected among a polyol, a sugar, an amino acid, a salt and combinations thereof.
A method of making a lyophilized cake, the method comprising:
- freezing a pre-lyophilized aqueous solution comprising a protein, a stabilizer, and water to form a frozen composition;
- primary drying the frozen composition to remove water;
- after the primary drying, secondary drying the frozen composition to attain a lyophilized cake comprising a moisture content between 2% and 10% by weight;
- and
- annealing the lyophilized cake at an annealing temperature below a glass transition temperature of the lyophilized cake.
Dependencies are inferred from the claim text.