Use of biopharmaceuticals such as monoclonal antibodies (mAbs) has been growing rapidly. Since biopharmaceuticals are generated from biological sources, some of the low-level host cell proteins (HCPs) could remain in the final products even after multiple purification steps. Due to their potential to affect product safety and efficacy, HCP level must be monitored and controlled in drug products according to regulatory requirements.
This study demonstrates an end to end HCP analysis workflow including the Agilent AssayMAP Bravo for automated sample preparation, 6545XT AdvanceBio LC/Q‑TOF for LC-MS/MS analysis, and software for data analysis.
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