Simplifying The Bioprocessing 4.0 Journey

By Artur Arsenio, Michael Koch, Johannes Wagner, and Ganesh Kumar

For many Biopharma companies, Bioprocessing 4.0 remains a Bête noire that is insurmountable. This is due to the perception that the cost, resources, and time required to adopt best practices are just too great to justify and will not provide a return on investment. There is also the belief that the concept of Industry 4.0  is better suited to other industries and is challenging to realize in biopharma. This is partly due to a lack of awareness of the benefits that digital technologies such as simulation/data connectivity and the use of digital twins can bring to a biologics’ manufacturing environment. Additionally, insufficient connectivity between bioprocess equipment from different suppliers and gaps in technology make end-to-end, fully autonomous bioprocessing seem frustratingly out of reach.

Initiatives including the recent Biophorum plug and play (2) to develop standard data interfaces are helping to move the goal posts, and implementing single-use (SU) technology can help with a Bioprocessing 4.0 approach. But it is often not as simple as connecting and qualifying systems into the manufacturing plant. Bottlenecks can occur if equipment is not easy to integrate with higher-level supervisory control and data acquisition (SCADA) and/or manufacturing execution systems (MES) systems. These issues mean many companies still perceive Bioprocessing 4.0 as a nice to have and something they will get round to when they have solved existing problems within their manufacturing network.

However, increasing adoption of process intensification is piling the pressure on manufacturers to develop a roadmap for Bioprocess 4.0 that addresses not just the roadblocks mentioned above but also enables real-time monitoring, prediction, control, and release of critical process parameters (CPPs) at the entire process level.