Capillary sodium dodecyl sulfate gel electrophoresis (SDS-CGE) is an industry standard technique for determining the purity of protein-based species, including traditional monoclonal antibodies and next generation biomolecules. Purity assessment of these therapeutic entities and determination of any structural variances introduced during manufacturing is of high importance for the biopharmaceutical industry. However, as biopharmaceutical organizations increase the number of candidate molecules in their development pipeline, the throughput of analytical techniques is a major bottleneck.
In this poster, we present a new generation multi-capillary electrophoresis (CE) system that enables parallel processing to accelerate protein samples analysis, which could add to manufacturing improvements to potentially shortening product development workflows. This is done while maintaining accuracy and precision levels equivalent to a single capillary system. For IgG studies, the overall RSD% of the relative migration times and the corrected peak area of the heavy chain (HC) peak of 128 injections in the multi- capillary electrophoresis instruments is less than 2%. The reproducibility of this platform enables seamless transfer of methods among capillary based CE systems while maintaining a wide-linear dynamic range with of over 4 orders of magnitude sample concentration range, resulting in 2.4 μg/mL and 4 ng/mL LOD as well as 4.9 μg/mL and 10 ng/mL LOQ with the use of UV and LIF detectors, respectively, as demonstrated on a monoclonal antibody (NIST mAb).