With over 30+ years in science journalism, I’ve watched lots of topics get thrown around. There was big data and bioinformatics, then artificial intelligence (AI), virtual reality (VR), and augmented reality (AR). Often, journalists—including me—and even scientists start to use these terms as labels without stopping to explore what they really mean. That’s happening now with the concept of bioprocessing 4.0 (B4.0). What were the real goals of this transition?

At University College London, Peyman Moghadam, PhD, a chemical engineer and associate professor in data-driven materials engineering, studies a range of advanced manufacturing tools and techniques. Recently, Moghadam and his colleagues applied this knowledge to B4.0, which emerged from industry 4.0 (I4.0). These scientists described I4.0 as “the interconnection of business models, supply chain, and processes through the Industrial Internet of Things (IIoT) … to drive manufacturing forward.” In brief, B4.0 should apply the same approach to bioprocessing.

“Despite the widespread interest in the field, the level of adoption of I4.0 technologies in the biomanufacturing industry is scarce, often reserved to the big pharmaceutical manufacturers that can invest the capital in experimenting with new operating models, even though by now AI and IIoT have been democratized,” Moghadam and his colleagues reported. “This shift in approach to digitalization is hampered by the lack of common standards and know-how describing ways I4.0 technologies should come together.”

Part of the problem, according to Moghadam’s team, is the fragmentation of B4.0. Despite companies and academic institutions exploring AI and AR, computer vision, digital twins, and other technologies, Moghadam and his colleagues stated that this is creating “many small technical islands” without an “overarching goal and an operating model for Bioprocessing 4.0 which clearly outlines how these technologies should come together.”

A path to new bioprocessing***

In 20 pages with more than 60 abbreviations, Moghadam’s team outlined such an operating model for B4.0. Yes, many details are involved, but these experts provided a simple set of goals.

“Bioprocessing 4.0 should encompass the shift from in vivo or in vitro to in silico process development and control, with plant-wide modeling and simulation at its core,” Moghadam and his colleagues suggested. This will require the development of digital twins based on all of the knowledge about a bioprocess. But there’s even more.

“Experimental teams will perform only information-rich experiments suggested by the model, and the digital twin will be used for autonomous operation within validated ranges,” Moghadam’s team stated. “Engineers will focus on troubleshooting and advanced analysis, supported by AR and VR technologies integrated with data from [a manufacturing execution system] and centralized data hubs.”

So, there’s still lots of work to go from B4.0 as an idea to a reality. If that can be achieved, though, Moghadam and his colleagues believe that it will unleash “a paradigm shift toward more agile, proactive, and reactive biomanufacturing operations, driven by advanced digital technologies and data integration, fundamentally transforming the industry’s approach to process development and control.”

***Editor’s Note: As Mike May concludes above, “…there’s still lots of work to go from B4.0 as an idea to a reality.” And as this process continues to move forward, guess what? A Bioprocess 5.0 is already emerging. An obvious question is what is the difference? Well, in the October issue of GEN, Gareth MacDonald addresses this issue in his article. Here’s a sample of quotes from those in the industry already working with the 5.0 paradigm:

“Industry 4.0” focuses on the automation and digitization of processes, leveraging technologies like the Internet of Things (IoT), big data analytics and artificial intelligence (AI).”

“At first glance, an industry 5.0 biopharmaceutical manufacturing operation would look the same as a 4.0 operation—interconnected digital monitoring technologies passing data gathered at each automated unit operation to a central analytics and control hub.”

“However, in a 5.0 setup, there would be a stronger emphasis on human-machine collaboration. Cobots (collaborative robots) would work alongside human workers, augmenting their capabilities and performing tasks that require precision and strength.”

“Advanced human-machine interfaces, augmented reality (AR), and virtual reality (VR) tools would be more prevalent, enhancing the interaction between workers and technology.”

“Industry 5.0 has the potential to significantly enhance the quality of products and services by integrating human creativity and expertise with advanced technologies.”

Be sure to check out our October issue for this and other timely and topical articles.—John Sterling, Editor in Chief, GEN 

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