May 25, 2016

Integration of continuous upstream and downstream operations in mAb production

Process intensification is gaining interest as a strategy to reduce production costs, while improving product quality and throughput in the manufacturing of biopharmaceuticals. For a competitive production process, continuous or semi-continuous upstream and downstream processing can be employed. Compared with a process performed in batch runs, continuous processing allows for increased capacity utilization and eliminates or minimizes the need for intermediate hold-up steps. We describe the integration of a high-performing upstream cell culture process with downstream purification utilizing emerging technologies such as periodic counter-current (PCC) chromatography and straight-through processing (STP).

In this case study, we demonstrate the feasibility of integrated upstream and downstream mAb processing performed in a continuous manner. The developed process shows a performance equivalent to traditional processing performed in batch runs.

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