Yes, there are challenges in bringing LC‑MS HCP analysis into a GMP environment.

The main challenges are not in the MS technology itself, but in ensuring the entire workflow is controlled and compliant. This includes robust method validation, full qualification of instruments (IQ/OQ/PQ), and especially ensuring that data processing and software meet GMP and data integrity requirements.

Another challenge is the complexity of LC‑MS data, particularly for global HCP profiling, which must be handled in a reproducible and well‑documented way. This is why workflows often transition from more complex, untargeted methods to simplified, validated targeted assays for routine GMP use.

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.