Automation of ELISAs & evaluation of emerging technologies for high-throughput quantitation of protein impurities

Abstract

Background: Analysis of process-related protein impurities is critical to ensure process robustness and patient safety. Here, we report on automation of ELISA assays for quantitation of host cell protein and residual protein A. The automated assays were compared with three emerging technologies. Results: Data generated by the automated ELISA platform were comparable to manual results while the throughput was improved by three- to four-times and hands-on time reduced by six- to ten-times. The microfluidic assay enabled the broadest dynamic range and least sample consumption. The bead-based homogeneous assay was the least expensive. The automated ELISA platform demonstrated the highest throughput. Conclusion: Liquid-handler-based automation platform is determined to possess the maximum level of flexibility, adaptability and potential for improvement on assay throughput.