In the past biopharmaceutical manufacture has been dominated by batch manufacturing methods. This trend is due to the ease of adherence to manufacturing regulations as each batch generated within the process can be easily monitored and tracked. On the other hand, continuous bioprocesses have been considered to be more complex and harder to validate. However in recent years the advances made in continuous bioprocessing has caused a resurgence of interest in this area, which can be attributed to the potential of higher productivities and process intensification. This can lead to smaller, more flexible facilities compared to traditional batch processes with large stainless steel facilities.<br/><br/>The aim of this study is to determine if the apparent benefits of continuous processing translate into cost savings when carrying out the manufacture of cell culture-derived biopharmaceuticals. A decisional tool was developed at University College London to evaluate the cost of implementing traditional batch or continuous processing at various stages of the drug development pathway and commercial manufacture. The case studies carried out assess the impact on the cost of goods when integrating perfusion cell culture and continuous chromatography into typical manufacturing processes. A range of scenarios has been investigated by modelling various demands, company scenarios and stages of manufacture. The analysis has determined the level of cost savings achieved when adopting continuous technologies and if the ranking of the technologies change under different scenarios. The use of sensitivity analysis has also identified the key cost drivers and where continuous technologies need to be developed to ensure they live up to their cost saving expectations. This will help the biopharmaceutical industry make better decisions regarding facilities of the future that incorporate continuous methods of manufacture.

Cost modelling of continuous and hybrid end-to-end bioprocesses for mAb production

2019 Spring National Meeting

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