One challenge in biopharmaceutical development is the potential for low-level host cell proteins (HCPs) to remain in the final product, introducing a threat to product safety and efficacy. Monitoring of HCP levels is traditionally performed through enzyme-linked immunosorbent assay (ELISA), but this method lacks the specificity and coverage to identify and quantify individual HCPs. LC/MS technologies can overcome many challenges for HCP analysis, but better separation of peptides and broad dynamic range of the LC/MS system is important for this application. This study demonstrates an HCP analysis workflow including platforms and techniques for automated sample preparation, analysis, and data processing.

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