To paraphrase the old British joke, industrial revolutions are like buses: You wait for one and then two come along at once. In biopharma, the two revolutions are Biopharma 4.0 and Biopharma 5.0. Biopharma 4.0, which refers to the digitalization of biomanufacturing processes, aligns with Industry 4.0, a broader movement that dates to 2016, when World Economic Forum founder, Klaus Schwab, suggested that a fusion of technologies would blur the lines between the physical, digital, and biological spheres.1
By now, Industry 4.0 can be said to have arrived in various industries,2 but in biopharma, we’ve been craning our necks, straining to catch a glimpse of it. Well, it’s trundling toward us now, in the form of Biopharma 4.0, and right behind it is Biopharma 5.0. Like Industry 5.0, Biopharma 5.0 is an expression of the emerging ethos that technology and human intelligence should be combined to serve not just productivity and profitability needs, but also environmental and societal needs.
Admittedly, the bus analogy isn’t quite fair to Biopharma 4.0. There has been some progress. Still, most Biopharma 4.0 implementations on the factory floor have been limited in scope. Rather than set up fully digital lines, biomanufacturing firms have been investing in individual technologies.
Although the biopharma industry has been slow to adapt Industry 4.0 technologies, it may show more alacrity with Industry 5.0 technologies. “Industry 5.0 has the potential to significantly enhance the quality of products and services by integrating human creativity and expertise with advanced technologies,” says Amr van den Adel, PhD, a senior computing lecturer at the Eastern Institute of Technology in New Zealand. “For example, in the healthcare sector, it can lead to personalized medical devices and treatments tailored to individual patients. In manufacturing, it allows for more customized and innovative products, improving customer satisfaction and opening new market opportunities.
“Whereas Industry 4.0 emphasizes the integration of cyber-physical systems to create smart factories where machines can communicate and make decisions autonomously, Industry 5.0 brings humans back into the loop, emphasizing collaboration between advanced technologies and human intelligence. Also, Industry 5.0 prioritizes personalized production, sustainability, and societal well-being. Industry 4.0 is about optimizing efficiency and productivity. Industry 5.0 is about leveraging these gains to improve human life and address global challenges.”
Similar views of Industry 5.0 have been expressed by other authorities. For example, the European Commission, the executive arm of the European Union, recently presented this statement: “[Industry 5.0] provides a vison of industry that aims beyond efficiency and productivity as the sole goals and reinforces the role and the contribution of industry to society. It places the well-being of the worker at the center of the production process and uses new technologies to provide prosperity beyond jobs and growth while respecting the production limits of the planet.”3
Human-machine collaboration
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,” van den Adel observes, “there would be a stronger emphasis on human-machine collaboration.”
Such collaboration could be realized by collaborative robots, or cobots, that could work alongside human workers, augmenting their capabilities and performing tasks requiring precision and strength. “Cobots can perform repetitive tasks, handle hazardous substances, or assist in intricate processes,” van den Adel points out. “Human operators could focus on complex problem-solving, quality control, and innovation. Advanced human-machine interfaces, augmented reality, and virtual reality tools would be more prevalent, enhancing the interaction between workers and technology.”
Community building
According to Martin Keane, digital innovation manager at the U.K. Center for Process Innovation (CPI), Industry 5.0 is about more than cobots and systems innovation. It is also about changing the culture of a particular sector. “Industry 5.0 is less about a technological shift and more about taking into consideration a variety of perspectives when making decisions,” he elaborates. “For example, it could privilege environmental sustainability in production or help create engaging and fulfilling jobs for workers and the local community. This is an important consideration for all industry and requires an assessment on whether what we’re working on serves wider society.”
CPI is a U.K. government–linked social enterprise tasked with fostering the technologies of the future, particularly systems that enable less environmentally damaging processes. It operates the RNA Center of Excellence in Darlington, England, and the Medicines Manufacturing Innovation Center near Glasgow, Scotland.
Keane says that CPI intends to support manufacturers as they establish the IT infrastructure and staff training programs on which Industry 5.0 depends. “To put Industry 5.0 principles into practice and make decisions about what we’re doing on the factory floor, we need much more data,” he observes. “We also need to use tools such as machine learning.” He adds that vast amounts of data and new interfaces could help manufacturers look at tradeoffs and competing priorities more clearly.
According to Keane, Industry 5.0 involves more than data. It also involves community building, a task that the CPI is trying to address through the Medicines Manufacturing Innovation Center. It provides a forum where CPI researchers can work with the drug industry to find the best solutions to common challenges. “This community allows us to have a clearer picture of the considerations we need to look at,” Keane says. “We open our discussions to as wide a community as possible.”
Familiar costs, novel benefits
In biopharma, several large companies, such as Pfizer4 and GSK,5 have discussed their use of various “extended reality” techniques in staff training and facility validation. However, these companies represent a small minority. Most biopharma companies have been slow to adopt Industry 4.0 ideas, let alone Industry 5.0 ideas.
Historically, biopharma companies have been reluctant to change established processes due to the likelihood of additional regulatory hurdles. In a 2016 survey, McKinsey gave the pharma industry a “digital maturity” score of 27—the second-lowest rating awarded—citing its conservatism and unwillingness to invest in disruptive technologies.6
Similarly, concerns about high set-up costs are likely to be a factor delaying the adoption of 5.0. According to Keane, biopharma companies may struggle to justify investing in the technologies and infrastructure required until the benefits are clear. Indeed, implementing Industry 5.0 could seem too costly if no benefit other than profitability is recognized. Keane insists, however, that “there are many more factors to look at.”
If one zooms out from one company, Keane suggests, it’s easier to see the societal benefits of an Industry 5.0 mindset. For example, an Industry 5.0 process at an individual firm could lead to a higher price for one of the firm’s products. However, across the biopharma industry, the process could provide a societal benefit, one that could, at the least, offset the additional cost.
Environmental and workplace impacts
In combination, Industry 4.0 technologies and 5.0 principles can change how the biopharma industry thinks about the environment and the workplace. At present, the industry sees tight tradeoffs between profitability and environmental sustainability, and between profitability and employee headcount. However, with Industry 4.0 and 5.0, these tradeoffs may loosen.
“We may see companies being able to maximize the ability of humans as thinkers and not simply cogs in the machine,” Keane suggests. “It is worth considering that when all these elements come together, we might see better jobs, fewer environmental impacts, and lower costs.”
Value structure
Contract development and manufacturing organizations (CDMOs), in contrast with traditional biopharmaceutical companies, have always been early adopters. The competitive nature of the CDMO space incentivizes investment in technologies that help contractors offer more efficient services and outcompete rivals. And these dynamics—combined with growing industry interest in sustainability—is likely to accelerate adoption of Industry 5.0 ideas among CDMOs.
“For us, the shift to Bioprocessing 5.0 is exciting,” says J.D. Mowery, president and CEO of KBI Biopharma. “You can’t simply purchase Bioprocessing 5.0. It’s a blend of human excellence and highly customized and adaptable technologies. Bioprocessing 5.0 will allow CDMOs to differentiate themselves further.
“Bioprocessing 5.0 is also driving a shift in the industry’s value structure. Sustainability goals now live alongside the traditional pillars of revenue and productivity and are given almost equal weight. We feel strongly about this as a CDMO, but we’re also hearing it from our clients. Sustainability goals and action plans are not just ‘nice to haves’ anymore. They are absolutely required. They represent an opportunity for our industry to effect real change and establish leadership.”
According to Mowery, staff training will be critical in the transition from Bioprocessing 4.0, which was about technology, to Bioprocessing 5.0, which requires a more holistic approach. “With Bioprocessing 4.0, we saw a lot of digitalization,” he points out. “Steps and decisions previously occurring on the factory floor moved to the cloud, where insights were derived from massive amounts of data. And robotics and automation gained more prominence.
“In combination, digitalization and automation drove a lot of efficiency, but humans and technology were working almost independently. As the industry shifts to Bioprocessing 5.0, those two worlds are reuniting. The data and the AI are working hand in hand with the on-site expert to realize the best workflows and optimize biomanufacturing in real-time.”
Mowery expects that the lines between robots and humans on the factory floor will continue to blur. He also anticipates that there will be more human input and collaboration happening virtually.
“From a staffing standpoint, one challenge that will likely continue with Bioprocessing 5.0 is the need for bioinformatics and computational skills,” Mowery predicts. “We also need experts who understand robotics and artificial intelligence. There are a lot of folks studying these areas today, but we don’t have a huge reservoir of experts to draw on based on the youth of this field.
“Another, perhaps more nuanced, staffing challenge is that ingenuity and an entrepreneurial spirit will be needed to adapt and integrate with these advanced technologies and vice versa. That’s something that wasn’t as critical in earlier models of bioprocessing.”
References
- Schwab K. The Fourth Industrial Revolution: What It Means and How to Respond. World Economic Forum. Published January 14, 2016. Accessed September 12, 2024.
- Dutt D, Natarajan V, Wilson A, Robinson R. Steering into Industry 4.0 in the Automative Sector. In Industry 4.0 in Automotive: Digitizing the End-To-End Automotive Value Chain. Deloitte Insights/Automotive News. Published 2020. Accessed September 12,2024.
- Industry 5.0. European Commission. Accessed September 12, 2024.
- Goldenberg B. Pfizer XR/VR/AR Journey Case Study. ISM. Published October 9, 2023. Accessed September 12, 2024.
- How GlaxoSmithKline Used AR to Design a New Manufacturing Facility. ISM. Published October 6, 2023. Accessed July 27, 2024.
- Fox B, Paley A, Prevost M, Subramanian N. Closing the digital gap in pharma [Insight Article]. McKinsey & Company. Published November 23, 2016. Accessed September 12, 2024.
