In regulatory filings, LC‑MS HCP data is typically not limited to a single total value, but presented in a more detailed, risk‑based format. The output generally includes both an overall HCP level and the identification and quantification of individual HCPs, often reported in ppm.

In practice, filings usually focus on individual HCPs of concern, where their levels and clearance are explicitly discussed and justified. The full dataset (i.e. the complete list of identified HCPs) is often included as supporting information, while the main submission highlights those proteins that are relevant for product quality, safety, or process consistency.

So rather than choosing between total HCP or individual values, regulators increasingly expect a combination of both: a total or aggregated measure for overview, and individual HCP data to enable a risk‑based assessment and demonstrate control of critical impurities.

Thomas Kofoed, PhD, CEO of Alphalyse in Denmark, discussed key factors in implementing GMP-compatible LC-MS methods for release assays and highlighted successful cases where this approach has replaced traditional ELISA methods. Don’t miss his presentation and expert insights at the panel discussion.