When To Leverage Mass Spectrometry For HCP Analytics: Best Practices

While the Host Cell Protein (HCP) ELISA is the cornerstone of biopharmaceutical safety, its reliance on a single numerical value can mask underlying risks to product stability and patient safety. Relying solely on these results leaves a gap in understanding which specific proteins persist through purification. Integrating mass spectrometry as an orthogonal method transforms this analytical blind spot into a strategic advantage. By identifying individual contaminants, such as problematic proteases or lipases, manufacturers move beyond simple monitoring into proactive risk management.

Strategic use of mass spectrometry provides the deep molecular insights required to confirm antibody coverage and optimize downstream chromatography. This dual-pronged approach is no longer just an option; it is becoming a benchmark for regulatory confidence and process robustness. To understand exactly how to balance these technologies and when to trigger advanced MS workflows, explore the full guide on best practices for HCP analytics.