Different response factors are addressed through internal calibration and signal normalisation. By using spiked‑in protein standards, we can normalise the MS response and reduce variability across proteins and runs.

Rather than determining individual response factors for each HCP, the approach relies on averaging across many peptides, providing robust and reproducible quantification that is fit for purpose.

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.