Case Study: Merck achieves validated high-throughput LC–MS multi-attribute process characterization with Genedata Expressionist

Validation of LC–MS Multi-Attribute Method Supporting Biopharma Process Characterization

Merck’s Microbial Process Development Group (Merck KGaA, Martillac, France) needed a robust, high-throughput LC–MS multi-attribute method (MAM) to support Stage 1 process characterization and validation for a recombinant protein (Protein X). The challenge was to replace slower UHPLC–UV workflows with an MS-based method that could monitor multiple critical quality attributes (oxidation, deamidation, gluconoylation, truncation), handle tens of thousands of chromatograms from robotic workflows, produce auditable results, and meet regulatory/validation requirements. To do this they adopted Genedata’s enterprise solution, Genedata Expressionist.

Using Genedata Expressionist, Merck implemented automated, customizable workflows (peak‑mask builder, system suitability testing, and CQA monitoring) with automated reporting and audit-capable data management. Genedata’s platform enabled them to shorten LC–MS runs from 120 to 30 minutes, achieve throughput of ~300 samples/week, process the ~20,000 chromatograms needed for validation, and reduce total data analysis time to under one hour. The validated MAM delivered strong linearity, precision, accuracy and LOQ performance and, with Genedata’s 21 CFR Part 11–compliant features, is ready to support QC/GMP monitoring.

Merck

Cédric Mesmin

Mass Spectrometry Specialist