Regeneron Pharmaceuticals, Inc.
Method of characterization of visible and/or sub-visible particles in biologics

Abstract:

A method for characterizing or quantifying one or more proteins in visible and/or sub-visible particles formed in a sample by detecting the at least one visible or sub-visible particle in the sample, isolating and capturing the at least one visible or sub-visible particle to identify a presence of a protein, and using a mass spectrometer to characterize the protein.