Intact mass assays have become a sensitive, high-throughput, and fast quantitative approach for the monitoring of multiple quality attributes of monoclonal antibody (mAb) therapeutics, including primary sequence, structure integrity, N-Glycans profile and other post-translational modifications. This is driven by recent improvement in instrumentation and method optimization. As a result, the demand for intact mass testing has increased significantly to support mAb process development at different stages and enable rapid decision-making. To accommodate such enhanced testing support need, we developed an automated workflow of intact mass assay with 3 modules: sample preparation, samples setup, and data processing and reporting. This automated workflow involves using Hamilton Vantage liquid handling system, vendor software, and a custom-built algorithm for reporting. This poster summaries the development and evaluation of the automated intact mass workflow, demonstrating its accuracy, precision and robustness with high sample throughput, flexibility with different method setup, and comparable quantitative results with the traditional manual approach. 

Key Words: Intact Mass, Automation, Multiple Quality Attributes, N-Glycans