Multicolumn chromatography (MCC) is a technique proven to significantly improve performance of bio-processes by increasing specific productivity, reducing volume of resin used and enabling disposable, continuous and integrated processes. In particular, the mAb capture step has become a focal point for continuous bioprocess as Protein A is an order of magnitude more expensive than other resins.<br/>We have developed a simple technique that lets us employ a few single-column breakthrough curves to understand the design space with which to operate MCC. This process design tool enables us with a more complete understanding of MCC, allowing us to tailor an optimized method. Thus, we can use the tool to calculate the ideal product titer to maximize productivity and we can then apply this optimum titer for a process by employing an in line concentrator before MCC. The knowledge brought by the process design tool may also be applied to tailoring a process based on facility fit and manufacturing strategy, not just productivity. By combining the modeling technique with process economic calculations we can model the ideal strategy with which to operate the Protein A process to minimize process cost for different production scenarios, clinical vs. full scale manufacturing etc., based on facility fit. The data highlights the major impact of buffer consumption on the overall process cost and we can use the modeling tool to design a process with the ideal balance of productivity and capacity to minimize buffer consumption and therefore optimize process economics.

Tailoring continuous protein A mAb capture for facility fit and process economics

251st National Meeting (2016)

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