Continuous processing is increasingly seen as having the potential to address the need for reduced manufacturing costs, improved product quality and increased flexibility, while at the same time reducing technology transfer risks. These benefits are also expected to be delivered with an ever-smaller facility footprint as well as being faster and more cost effective. Easier said than done!
In downstream processing, the barriers to continuous processing used to revolve around the limitations of the technology available, while perfusion bioreactor-based processes were viewed as taking a long time to develop and the economics for their use was not clear. As technologies have become more advanced, one of the primary factors holding companies back from making the shift to continuous processing is the lack of prior insight as to what results it will deliver. No company has yet adopted fully continuous processing for commercial biomanufacturing process, and the new technologies required for doing so are not mature and have not yet been evaluated based on cost performance.
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