Rapid Monitoring of Monoclonal Antibody Quality Attributes

This application note presents the use of the ZipChip microfluidic capillary electrophoresis system coupled with mass spectrometry (ZipChip-MS) for the rapid monitoring of monoclonal antibody (mAb) quality attributes during bioprocessing. The study focuses on analyzing mAb samples from perfusion CHO cell culture bioreactors without the need for pre-purification, enabling the quantification of critical quality attributes such as glycosylation profiles and charge variant distributions. The method allows for time series analysis of these attributes throughout the culture duration, facilitating assessments of batch variability. The results indicate that the ZipChip CVA-MS method effectively detects and quantifies mAb CQAs at low concentrations, providing insights into bioprocess performance and product quality. The study also highlights that cell retention filtration does not significantly impact the measured attributes of the mAb harvested from the permeate, thus ensuring the reliability of the monitoring process. Overall, the ZipChip-MS method streamlines the analytical workflow, replacing multiple traditional techniques with a single, efficient assay.