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US 2022/0034905 A1Published application
Method of characterization of visible and/or sub-visible particles in biologics
AssigneeRegeneron Pharmaceuticals, Inc.
InventorXiaobin Xu
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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.
Claims15
A method for identification of a host cell-protein in at least one visible or sub-visible particle in a sample, comprising:
- isolating and capturing the at least one visible or sub-visible particle;
- analyzing the at least one visible or sub-visible particle to identify a presence of a protein using Raman spectroscopy;
- subjecting the at least one visible or sub-visible particle using a mass spectrometry analysis;
- and
- identifying a presence of the host cell protein based on the mass spectrometry analysis.
2 more elements
Dependencies are inferred from the claim text.