🔌 Fragmentation is common, leading to “technical islands.” A cohesive model for B4.0 is crucial.
🔍 The goal is to shift to in silico processes, enhancing operations through digital twins and advanced technologies.
🚀 A successful B4.0 could transform biomanufacturing, making it more agile and proactive.
Introduction:
The article “What’s Missing in Bioprocessing 4.0?” by Mike May, PhD, discusses the current challenges and fragmentation in the application of Bioprocessing 4.0 (B4.0) within the biomanufacturing industry, emphasizing the need for a cohesive operating model that leverages advanced technologies for efficient production processes.
- The transition to Bioprocessing 4.0 (B4.0) draws on concepts from Industry 4.0 (I4.0), focusing on interconnection through the Industrial Internet of Things (IIoT) to enhance manufacturing.
- Although B4.0 has garnered significant interest, adoption of I4.0 technologies remains limited, primarily among large pharmaceutical companies capable of substantial investments.
- A major hindrance to this transition is the lack of standardization and a unified approach, resulting in disconnected technological initiatives across the sector.
- Researchers propose an operating model for B4.0 that emphasizes transitioning from traditional process development to a digital twin approach, centering around plant-wide simulation and modeling.
- Implementing this model is expected to markedly change biomanufacturing, fostering more agile operations through advanced data integration and technology utilization.
Conclusion:
The article highlights the critical need for a structured framework in Bioprocessing 4.0 to advance the biomanufacturing industry. The proposed shift from in vivo/in vitro to in silico processing could lead to transformative changes, enhancing operational agility and efficacy. Future developments in this area could usher in additional paradigms, such as Bioprocess 5.0, which will further evolve the integration of human creativity with advanced technologies.
