Implementation Of Multi-Column Chromatography Systems

The Mobius® Multi-Column Capture System is engineered to facilitate three-column operation for primary capture using affinity resins. This system enhances resin utility by cycling the capture of breakthrough on the second column while non-loading steps are performed on the third column. This approach allows for a semicontinuous elution stream, which enables continuous bioprocessing with minimal surge tankage. By increasing resin utilization, this technique reduces resin requirements to make multi-column chromatography beneficial for intensifying existing fed-batch processes and serving as a key operation within modern continuous processes.

This system offers flexibility for agile multi-product facilities such as Contract Development and Manufacturing Organizations (CDMOs) and other facilities producing early clinical phase material. Several aspects of the system require careful consideration for effective qualification at the manufacturing site. When employed within a continuous process, the system could operate for over 20 days of constant activity, significantly longer than typical batch process operations. This extended operation increases the relative risks of certain process concerns, which include bioburden management, flow path integrity maintenance, and software platform robustness. 

Learn more about this practical approach to qualifying such a system by accessing the full application note.