Sensitive Screening Of Biosimilar Candidate mAbs From Clonal Cell Lines Using ZipChip CE-MS

The development of a biosimilar monoclonal antibody (mAb) includes cell line development and selection, in which many cell lines expressing the same originator molecule are developed. The resulting mAbs are analyzed for critical quality attributes (CQAs), including their glycosylation profile and charge variants, to select the cell lines closest to the originator. However, this clone screening process often involves low-concentration samples, making it difficult to analyze with traditional analytical methods.

This application note explores the use of microfluidic capillary electrophoresis-mass spectrometry (CE-MS) with the ZipChip CVA kit for sensitive and rapid screening of mAb charge variants and glycoforms in low-concentration samples. By using the NISTmAb as a model protein, we were able to detect all charge variants of the antibody down to 20 µg/mL. We also were able to identify distinct post-translational modifications in two biosimilar candidates compared to the originator product sample.

Access the full application note to learn how the use of the CVA kit with the ZipChip CE-MS platform enables rapid selection of clones based on produced mAbs’ glycosylation and charge variants.