Glycosylation Profile Sample Preparation in the µSI Process Analyzer System
Monitoring the glycosylation profile is critical for biosimilar products, where matching the glycosylation profile with the reference product is essential to establish similarity [Ref. 5]. Off-line glycosylation analysis involves manual bioreactor sampling followed by the execution of the following three assays in tandem: (1) product titer, (2) affinity purification, and (3) sample preparation and analysis using Hydrophilic Interaction Chromatography (HILIC), resulting in assay execution times of several days. In contrast, analysis times for the on-line glycosylation assay using the HILIC-LC integrated µSI process analyzer system are approximately 2 hours, providing rapid feedback on product quality and process performance.