Regeneron Pharmaceuticals, Inc.
ROOM TEMPERATURE STABLE LYOPHILIZED PROTEIN
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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.degree. C.
Status:
Application
Type:
Utility
Filling date:
6 May 2022
Issue date:
18 Aug 2022