High throughput Fast Capillary Electrophoresis-Mass Spectrometry Based Multi-Attribute Method Workflow for Simultaneous Monitoring of Multiple Product Quality Attributes for Cell Culture Processes

Description:
A high throughput capillary electrophoresis-mass spectrometry (CE-MS) based peptide mapping multi-attribute method (MAM) workflow has been developed for simultaneous monitoring product quality attributes (PQAs) for cell culture processes. The workflow contains four parts: automated sample preparation via Hamilton, CE-MS using ZipChip (908 Devices) with High-Resolution Mass spectrometry (HRMS), and automatic data processing using Byos® software. Hamilton enables automatic sample preparation, which greatly increases the throughput of sample preparation and reduces human intervention for peptide mapping. The total run time for CE separation is 15 min, resulting in greater than 5x improvement in run time compared to the LC-MS peptide mapping platform method. Additionally, CE-MS can offer orthogonal information compared to LC-MS, due its unique separation mechanism. The high selectivity and speed of the high-resolution mass spectrometer allows for extracted ion currents to be generated in an automated fashion in Byos® software, saving a considerable amount of analyst time. With this workflow, we have demonstrated that the CE-MS and LC-MS MAM workflows produce comparable results for two GSK proteins (mAb1 & mAb2). The high throughput CE-MS MAM workflow was also applied to mAb1 in-process samples to monitor and trend the multiple PQAs throughout the 17-day cell culture process to support process development.

Speaker: Jiangchao Chen - GSK