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US 2020/0046834 A1Published application
Room temperature stable lyophilized protein
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsXiaolin Tang, David Brett Ludwig
Life of this patent
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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.
Claims21
A method of preparing a lyophilized cake, comprising:
- preparing a peptide or protein formulation, and
- subjecting the peptide or protein formulation to lyophilization to produce a lyophilized cake;
- wherein the peptide or protein formulation comprises a peptide or a protein.
Dependencies are inferred from the claim text.