Monoclonal Antibody Characterization by CE-SDS
Maurice Versus LabChip
Biologics, including monoclonal antibodies, vaccines, hormones, growth factors and polypeptides, among others, are sensitive to the manufacturing process. They are varied in their origin, makeup, effector function and delivery and therefore require thorough formulation development including characterization, quantitation and preservation. Biologics often compete with small-molecule drugs for similar therapeutic targets, particularly for cancer, type 2 diabetes mellitus and rheumatoid arthritis. However, because they are not chemically synthesized the way small-molecule drugs are, precision during manufacturing is essential to avoid variations in the product protein. Quality control is critical to maintaining not only the product’s quality but also its safety.
Accurate reporting of a biologic’s critical quality attributes (CQAs) is required for its commercialization. In the case of monoclonal antibodies (mAb), CQAs dealing with mAb fragmentation and post-translational modifications like glycosylation, are often inherent in the complex composition of a protein therapeutic1. To accurately analyze size/ fragment heterogeneity, one should evaluate several parameters specific to the instrument’s detection performance such as sensitivity, linearity, precision and resolution. Also, ease-of-use, reliability and sustainability are increasingly demanded in the industry.
The means for assessing mAb fragmentation and size migration have evolved from gel (SDS-PAGE) to capillary electrophoresis (CE-SDS). CE-SDS is a high-precision, high-accuracy analytical technology equipped with quantitative data integration that has effectively reduced turnaround time during screening and development. In this application note, we compare Maurice™ against PerkinElmer’s LabChip® GXII Touch, a chip-based electrophoretic separation system. Under reduced and non-reduced conditions, we evaluate CE-SDS separation using a reference mAb from the National Institute of Standards and Technology (NIST). Maurice and LabChip are assessed for their performance on linearity, sensitivity, precision, reproducibility and resolution, with the technological approach, workflow and data quality outlined for easy comparison.