We use a custom, project‑specific protein database tailored to the production system.

The database typically includes:

• The host cell proteome (e.g. CHO, E. coli, yeast)
• The product sequence(s) (e.g. mAb or recombinant protein)
• Common contaminants (e.g. keratins, trypsin)

Where relevant, we may also include:

• Sequence variants
• Expression system–specific annotations

This targeted approach ensures high-confidence identification and accurate quantification of HCPs, which is essential for GMP-compliant reporting.

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.