The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.
The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.
Patent No.:
Date of Patent:
Feb. 08, 2022
Filed:
Oct. 17, 2019
Applicant:
Regeneron Pharmaceuticals, Inc., Tarrytown, NY (US);
Inventors:
Xiaolin Tang, Old Tappan, NJ (US);
David Brett Ludwig, Saratoga, NY (US);
Assignee:
Regeneran Pharmaceuticals, Inc., Tarrytown, NY (US);
Attorney:
Primary Examiner:
Int. Cl.
CPC ...
A61K 39/395 (2006.01); A61K 9/08 (2006.01); A61K 9/00 (2006.01); A61J 1/14 (2006.01); A61K 9/19 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61K 38/00 (2006.01);
U.S. Cl.
CPC ...
A61K 39/39591 (2013.01); A61J 1/1412 (2013.01); A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 9/19 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01); A61K 38/00 (2013.01);
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.