Host Cell Protein Analysis using Enrichment Beads Coupled with Limited DigestionSisi Zhang 1, Hui Xiao 1, Ning Li 1
1Analytical Chemistry, Regeneron Pharmaceuticals Inc.
A protocol is presented for enriching host cell proteins (HCPs) from drug products (DP) and detecting peptides using proteome enrichment beads. The method is demonstrated using an in-house manufactured monoclonal antibody (mAb) drug substance (DS), which is a well-characterized reference material for evaluating and comparing different methods in terms of performance.
