Poster presented at WCB 2015, Nov. 2015
Glycosylation is one of the critical quality attributes of mAb-based biotherapeutics. Glycosylation changes can impact a biological drug’s safety, efficacy, clearance, and immunogenicity—making it necessary to accurately detect changes. Glycan profiling begins at cell line development, continues through process development and, in certain cases, extends through drug substance release. Current glycan analysis methods involve laborious multistep sample preparation—taking anywhere from a day to multiple days for 96 samples—followed by single-channel LC or CE separation. In this poster, we report an integrated glycan solution that can generate data from 96 samples in 7–9 hours. It consists of an easy magnetic bead-based sample prep, a 24-capillary-array CE instrument, and glycan-specific software for analysis.