Introduction:
Continuous biomanufacturing is an advantageous approach, but its implementation is limited by a lack of modeling and simulation tools. Existing tools rely on experiential and rule-of-thumb techniques. To address this gap, a comprehensive plant-wide model called KTB1 has been developed. This model integrates upstream and downstream processes and provides tailored strategies for monitoring, process design, optimization, and control. It allows biomanufacturers to evaluate different strategies and optimize their processes based on expert judgment and heuristics.
- Continuous biomanufacturing has numerous benefits, but lacks comprehensive modeling and simulation tools.
- KTB1 is a decision support tool that integrates upstream and downstream processes.
- KTB1 allows for monitoring, process design, optimization, and control strategies to be evaluated.
- The model is not validated with manufacturing data at scale but captures an entire plant’s dynamics.
- KTB1 can be adapted to other reaction types and is available open-source through GitHub.
Conclusion:
KTB1 is a comprehensive simulation model that fills the gap in continuous biomanufacturing. It integrates upstream and downstream processes and provides tailored strategies for monitoring, optimization, and control. While it is not validated with manufacturing data at scale, it captures the dynamics of an entire plant and offers valuable insights for process optimization. The open-source availability of KTB1 allows for further research and adaptation to different reaction types within the biopharmaceutical and bioprocessing industries.
