DATE: October 10, 2017
TIME: 7:00 AM PT, 10:00 AM ET

Quality assessment of monoclonal antibodies can be a bottleneck in biopharmaceutical workflows because of the complexity and length of the workflows of conventional capillary electrophoresis (CE) systems. Microfluidic electrophoretic technology enables a simpler workflow with high resolution and sensitivity while offering time savings of 90%, completing analysis in 65 seconds per sample. Accelerating the speed of analysis in biotherapeutic workflows enables experimental determination of immense potential design spaces for both upstream and downstream development.

Percent purity analysis becomes especially important in downstream applications, such as formulation, stability and manufacturing quality control (QC). At these later development stages, the ability to detect impurities is essential as quality assessment is critical to successful commercialization. Therefore, resolution and sensitivity must be sufficient to accurately detect contaminants in minute concentrations relative to the main peak. Results must also be reproducible with minimal variance from sample to sample and from run to run to instill confidence in purity analysis as proteins move through development and manufacturing QC into a commercialization environment.

Here we demonstrate the utility of the LabChip® GXII Touch microfluidic system in applying microfluidic electrophoresis technology to protein impurity analysis using the Protein Clear™ HR Assay. This assay incorporates a percent purity reference standard with automated calibration and optimization software. Combining these technologies was shown to provide high degrees of resolution and reproducibility for sizing and percent purity of the light chain, heavy chain, and the non-glycosylated heavy chain peaks with relative standard deviations (RSDs) of 2% and 5% within and across runs.
 

Learning Objectives:

• Understand the role impurity analysis plays in biotherapeutic development
• See how microfluidic capillary electrophoresis compares to other methods