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.