A continuous, perfusion-based bioprocessing platform offers many potential benefits for biopharmaceutical manufacturing.  These include smaller reactor sizes, steady-state cell culture conditions for expressed product consistency, and reduced process scale up requirements.We have now demonstrated that the steady-state nature of a well-designed perfusion process can be leveraged to conduct multiple, staged experiments within one bioreactor run.  Our strategy allows many different conditions to be efficiently tested in a shorter time frame. Multi-stage experiments (on an enzyme-producing CHO cell line) around pH, cell-specific perfusion rate, and filter exchange rate have identified operating regions in the process design space which are favorable to productivity and cell health.This multi-stage approach has also been used to implement a multi-parameter designed experiment in a relatively short amount of time. This DoE approach allows interactions between parameters and their effects on both cell culture and process quality to be assessed both efficiently and precisely.

Multi-staged experimental design for efficient process development of a continuous perfusion cell culture

245th National Meeting (2013)

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