Invention Grant
- Patent Title: Room temperature stable lyophilized protein
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Application No.: US16655634Application Date: 2019-10-17
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Publication No.: US11241498B2Publication Date: 2022-02-08
- Inventor: Xiaolin Tang , David Brett Ludwig
- Applicant: Regeneron Pharmaceuticals, Inc.
- Applicant Address: US NY Tarrytown
- Assignee: Regeneron Pharmaceuticals, Inc.
- Current Assignee: Regeneron Pharmaceuticals, Inc.
- Current Assignee Address: US NY Tarrytown
- Agency: Kramer Levin Naftalis & Frankel LLP
- Main IPC: A61K39/395
- IPC: A61K39/395 ; A61K9/08 ; A61K9/00 ; A61J1/14 ; A61K9/19 ; A61K47/02 ; A61K47/10 ; A61K47/18 ; A61K47/26 ; A61K38/00

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.
Public/Granted literature
- US20200046834A1 ROOM TEMPERATURE STABLE LYOPHILIZED PROTEIN Public/Granted day:2020-02-13
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