18757848. PROCESS FOR REDUCING SUBVISIBLE PARTICLES IN A PHARMACEUTICAL FORMULATION (Regeneron Pharmaceuticals, Inc.)
Contents
PROCESS FOR REDUCING SUBVISIBLE PARTICLES IN A PHARMACEUTICAL FORMULATION
Organization Name
Regeneron Pharmaceuticals, Inc.
Inventor(s)
Xiaolin Tang of Old Tappan NJ (US)
Daniel B. Dix of LaGrangeville NY (US)
Chen Li of Pleasantville NY (US)
William Markis of Passaic NJ (US)
PROCESS FOR REDUCING SUBVISIBLE PARTICLES IN A PHARMACEUTICAL FORMULATION
This abstract first appeared for US patent application 18757848 titled 'PROCESS FOR REDUCING SUBVISIBLE PARTICLES IN A PHARMACEUTICAL FORMULATION
Original Abstract Submitted
The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.
