Host Cell Protein Analysis using Enrichment Beads Coupled with Limited Digestion

We have developed a highly sensitive method to detect those low-abundance host cell proteins from the drug product using the protein enrichment beads. This approach help us to find the root cause and the risk associated with the drug product. There are multiple ways to improve the detection limit of HCP analysis.

And targeted methods including, but not limited to Protein A depletion, the limited digestion, the molecular weight cutoff, the immunoprecipitation, the targeted way to detect the host cell protein, including liquid chromatography, multiple reaction monitoring, and the nano liquid chromatography parallel reaction monitoring. The major challenge associated with HCP analysis is the significant dynamic range between antibody drug and host cell proteins. So most the methods aim to reduce amount of antibody and the enriched HCP before LC-MS analysis to decrease the dynamic range between antibody peptides and HCP peptides.