Over the next couple of blogs, we’d like to take a closer look at continuous processing, including the challenges associated with it, focusing on the cost drivers for perfusion versus fed batch, and the potential for continuous downstream processing.
Continuous processing has increasingly been seen as having the potential to address the need for reduced manufacturing costs and increased flexibility, while at the same time reducing tech transfer risks. These benefits are also expected to be delivered with an increasingly 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 that 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.
The data simply has not been available for biopharma companies to evaluate the cost-effectiveness of continuous processing for their business. Until now!
With BioSolve Process, many of the major potential end users of continuous processing technologies have modelled their technologies in the software. They want to understand the impact of continuous processing to be accurately assessed for the potential benefit to the manufacture of new processes in development. This is early days and we and companies are starting to understand the values, and explore ways to assess risk mitigation.
In this series we will be using BioSolve Process to select a number of key areas to such as what are the economic drivers for perfusion processes, what is the potential of continuous in downstream, how do you assess risk and what are the strategic implications. If you’re interested, make sure you bookmark this blog for the latest insights.