Enhanced Process And Quality Control For Multi-Column Chromatography Using UPLC Technologies

By Karl Rogler, Geert Lissens, Jean-Luc Beulay, Keith Gillette

Continuous processing has garnered significant attention for its potential to improve biologics production and enhance plant efficiency. This approach typically involves operating unit processes in a steady or cyclical manner over extended periods, reducing costly disruptions and downtime associated with frequent starting and stopping. Since operations run continuously, real-time process monitoring becomes essential to ensure product quality remains within the defined parameters. Rapid, actionable, integrated analytics can help downstream processing (DSP) teams with advanced process control and deviation management, ultimately facilitating the real-time release of batches. Here, two innovative technologies that address key purification challenges in DSP are explored: continuous multi-column chromatography (MCC) and advanced chromatography (LC) or liquid chromatography-mass spectrometry (LC-MS).