Automating Liquid Chromatography-based N-Glycan Data Analysis for CMC Biologics Development

March 10, 2026

Glycosylation plays a critical role in the safety and efficacy of therapeutic proteins and is widely recognized as a critical quality attribute (CQA). Consequently, accurate identification and quantification of glycans throughout drug development is essential. At Boehringer Ingelheim, the CMC Biologics Development department routinely supports N-glycan analysis of biologics from cell-line development up to clinical development. However, analyzing N-glycan data obtained via hydrophilic interaction liquid chromatography (HILIC) remains challenging, as peak evaluation is currently performed manually on a sample-by-sample basis—an approach that is both time-consuming and not scalable. Genedata Chromatics addresses this by streamlining manual workflows with automated peak identification, resulting in significant time savings, and facilitating glycosylation quantification in development activities.