US 12,449,198 B2
Target residual moisture content for lyophilized drug product
Xiaolin Tang, Old Tappan, NJ (US); Mary Kleppe, Milford, CT (US); Ravi Chari, Norwich, CT (US); and Franco Tzul, Cortlandt Manor, NY (US)
Assigned to Regeneron Pharmaceuticals, Inc., Tarrytown, NY (US)
Filed by Regeneron Pharmaceuticals, Inc., Tarrytown, NY (US)
Filed on Jun. 26, 2024, as Appl. No. 18/755,396.
Application 18/755,396 is a continuation of application No. 18/208,018, filed on Jun. 9, 2023, granted, now 12,066,246.
Application 18/208,018 is a continuation of application No. 17/985,250, filed on Nov. 11, 2022, granted, now 11,713,922, issued on Aug. 1, 2023.
Application 17/985,250 is a continuation of application No. 17/167,527, filed on Feb. 4, 2021, granted, now 11,525,629, issued on Dec. 13, 2022.
Claims priority of provisional application 62/969,961, filed on Feb. 4, 2020.
Prior Publication US 2024/0393045 A1, Nov. 28, 2024
Int. Cl. F26B 5/06 (2006.01); A61K 9/19 (2006.01)
CPC F26B 5/06 (2013.01) [A61K 9/19 (2013.01)] 19 Claims
OG exemplary drawing
 
1. A method for producing a lyophilized drug product, comprising:
obtaining a formulation comprising a formulated drug substance; and
subjecting the formulation to lyophilization to produce a lyophilized drug product, wherein the lyophilization comprises a first drying step and a secondary drying step, wherein the secondary drying step is conducted at a temperature below about 0° C., and the lyophilized drug product comprises a moisture content from about 3% to about 5%.