Capillary Electrophoresis for Upstream and Downstream Biopharmaceutical Development

In order to bring an antibody or other biologic drug to market, each step of the process needs to be carefully monitored. Charge heterogeneity and apparent molecular weight (MW) via SDS-PAGE are two of the most commonly assessed parameters. Ideally, similar methods should be used from the beginning of development (low expression, complex matrix) to late in production and QC (high concentration, pure material). Capillary techniques, such as iCE and CE-SDS, are currently used heavily in downstream product development but are best suited to purified and higher concentration samples. Here, we present the Simple Western that combines in one novel instrument, Peggy, capillary electrophoresis with an immunoassay to provide highly reproducible and fully automated analysis of monoclonal antibodies. This sensitive technology measures either size or charge in complex samples and provides critical charge heterogeneity, size, and product titer information without the need for sample purification. Data will be presented demonstrating the application of the Simple Western technique and the iCE technology for the analysis of monoclonal antibodies against VEGF and the ability of the two techniques to provide consistency of data across the whole range of product development. In addition we show examples for the unique capability of this technology to assess affinity information for these anti VEGF antibodies to different charge isoforms of VEGF.