Case Study: Merck achieves automated, site-specific N-glycosylation monitoring with Genedata Expressionist

An Automated MS Data Workflow Enabling Targeted, Site-Specific N-Glycosylation Monitoring of Biopharmaceuticals

Merck faced a bottleneck in glycosylation characterization for monoclonal therapeutics: their standard 2‑AB UHPLC method produced only global glycan profiles, suffered co‑elution, and required days-to-weeks of manual peak integration and expert interpretation, limiting throughput and site‑specific insight. To address this, Merck worked with Genedata and evaluated Genedata Expressionist as an automated data‑processing platform to support LC‑MS glycopeptide mapping for site‑specific N‑glycosylation monitoring.

Using Genedata Expressionist, Merck implemented automated LC‑MS glycopeptide mapping workflows with custom glycan libraries and optimized MS conditions (e.g., switching to TFA to remove adducts). Genedata’s solution grouped isomers, flagged new peaks, and enabled “approved” batch workflows run by non‑MS experts, cutting processing time from weeks to minutes, increasing throughput from about 20 to 80 samples per week, and delivering more reproducible, site‑specific glycosylation data.

Merck

Diego Bertaccini

Senior Scientist, Biotech Process Sciences Analytics