Introduction:
Applying smart, continuous manufacturing to biopharmaceuticals requires detailed digital models for each unit operation. However, achieving real-time quantification and control of a product’s critical quality attributes remains challenging. In a recent paper, researchers at the Indian Institute of Technology, Delhi, applied a combined framework of cyber-physical system (CPS) and digital twin (DT) for process automation of Chinese hamster ovary (CHO) cell clarification using acoustic wave separation (AWS) technology.
- The team monitored turbidity values from each AWS chamber and measured the effects of changes in critical process parameters on protein recovery in real-time.
- The control framework that emerged from combining the cyber-physical system with a digital-twin (CPS-DT) enabled an average deviation of less than 1% in the final separation chamber, leading to a cost savings of about 35% in costs of goods per gram of monoclonal antibodies.
- To implement this method, it is important to identify critical process parameters, develop high-fidelity virtual models for digital twins, map the cyber-physical interface, and implement continued process verification using the CPS-DT framework.
- This approach brings biopharmaceutical processing a step closer to Industry 4.0 goals by providing a framework for both automation and continuous, control-based process operations.
- The system is ready for industrial-scale implementation and can be enhanced to include features such as Internet-of-Things-enabled sensors, wireless sensor networks, cloud technologies, deep learning models, cybersecurity, and continued process verification.
Conclusion:
The combined framework of cyber-physical system and digital twin enables real-time quantification and control of critical quality attributes in the processing of biopharmaceuticals. This approach has the potential to improve efficiency, reduce costs, and bring biopharmaceutical processing closer to Industry 4.0 goals.
