Over the past dozen years, Industry 4.0 has revolutionized manufacturing technology, interconnecting machines seamlessly to deliver smart manufacturing through the automation and optimization of processes. Integrating technologies such as the industrial internet of things (IIoT), artificial intelligence (AI), machine learning (ML), and cloud and cognitive computing into manufacturing ecosystems delivers consistent quality and manufacturing flow, improved productivity, reduced downtime, streamlined processes and decreased costs.
 
On the back of Industry 4.0, Pharma 4.0, a framework to adapt Industry 4.0 to the pharma sector was introduced in 2017 by the International Society for Pharmaceutical Engineering (ISPE). A holistic, digitized operational model, Pharma 4.0 combines elements such as improved data quality, increased visibility, and transparency to drive deeper cross-enterprise collaboration. Integrating AI and ML, for example, adds intelligent and contextual analytics, enabling teams to better plan production and model different operational scenarios. Furthermore, the ability to optimize product lines enables greater manufacturing flexibility, an important factor as personalized medicine and small-batch, specialized therapeutics gain traction.
 
Manufacturing is now looking to the next step change, Industry 5.0, a concept defined by the European Union as:
 
·       Providing a vision of industry that aims beyond efficiency and productivity as the sole goals and reinforces the role and the contribution of industry to society;
·       Placing a greater emphasis on employee empowerment through leveraging new technologies to provide satisfaction that goes beyond jobs and growth;
·       Complementing Industry 4.0 by specifically putting research and innovation at the service of the transition to a more environmentally conscious, sustainable, human-centric and resilient industry.
 
Essentially, Industry 5.0 focuses on value – to people, to society, to the environment. It is a continuation of Industry 4.0, leveraging advanced technologies and automating many repetitive tasks, but is more opaque, with an onus on those technologies supporting, not superseding, a newly empowered workforce in meaningful ways. In the absence (so far) of an ISPE Pharma 5.0 model, let’s examine how Industry 5.0 might benefit pharma manufacturing.
 
Leveraging human expertise 
Industry 5.0 refocuses on the added value and unique qualities that human expertise brings to discovery, design and manufacturing. Strategically automating tasks enable humans and technology to work in sync to design and deploy more efficient, intelligent, data-driven pharma processes and decision-making. Applying human expertise and knowledge to higher value activities presents significant opportunities throughout the pharma product cycle. 
 
Consider, for example, paper-based records. Historically, from drug discovery through to product release, a significant amount of time was spent interacting with systems, recording, transferring and sharing data within cumbersome manual, paper-based systems. Digitizing, automating and streamlining those processes makes that information available automatically and immediately to relevant stakeholders, enabling scientists, for example, to focus on actual science! In a market increasingly driven by positive patient outcomes, freeing human imagination, creativity and curiosity to advance innovation and discovery in medicine, science and technology is key to delivering advanced therapeutics that can tangibly improve patients’ lives.
 
Individual growth
Central to Industry 5.0 is employee well-being, which is highly significant, given the cost of employee churn, recruitment and training, especially in markets where expertise is at a premium. Building long-term, inclusive relationships, empowering individuals to develop within an organization, boosts in-house expertise and confidence. It’s beneficial for business continuity, improves operations, morale and work quality, and encourages initiative. 
 
Greater cooperation between humans and machines, software and technology can improve employee experience and job satisfaction because people are operating in a higher value capacity. Leveraging technologies provides better insights, enabling staff to work smarter, optimize their time, drive process improvements and make better, more informed decisions. The upshot? Faster time to market, meaning patients have access to valuable therapeutics sooner.
 
Sustainability
As organizations look to manage environmental impacts, a core focus of Industry 5.0, intelligent technology can monitor manufacturing systems, uncover inefficiencies and seek to optimize natural resources and energy consumption, adapting and evolving with the product mix. 
 
Predictive intelligence supports sustainability by monitoring batch production and making adjustments in real time to ensure products meet defined specifications and parameters, reducing product waste. Predictive maintenance, based on AI and ML outputs, can also drive sustainability efforts by proactively alerting teams when plant or equipment is likely to require attention. This reduces the risk of unscheduled downtime where facilities are still consuming resources but not productive.
 
Transferable, flexible manufacturing
Historically, building a global manufacturing network site by site and meeting different regulatory requirements involved significant manual effort. Industry 5.0 will see humans and machines work together to design, model and transfer flexible manufacturing processes across an organization’s entire manufacturing ecosystem. 
 
The creation of a digital thread connects processes, systems, products and equipment in a single source of truth. Automatic adjustments can be made to meet location-specific regulatory and operational requirements. For example, organizations may deploy AI and ML to proactively monitor data parameters to ensure constant compliance or add collaborative robots and modular equipment that can be repurposed for different uses. Sharing data securely, accurately and instantaneously frees up teams to focus more of their energy on refining and optimizing manufacturing processes, rather than simply ensuring that those processes work. Maximizing the utilization of existing systems and capacity optimizes time to value, removing the need to create new manufacturing systems, new platforms, or build new facilities.
 
In closing
Industry 5.0 reflects changing societal attitudes in terms of the human experience, environmental concerns, and optimizing technological, natural and human resources in a value-added, sustainable, long-term way. The key to maximizing the benefits of Industry 5.0 is building on the advances of Industry 4.0 to get the best outcomes from every resource available.
 
There will be challenges to address, of course. The role of drug manufacturers, ultimately, is to deliver positive healthcare results for patients and they must weigh that against the risks of introducing new technologies and methodologies. Industry 5.0 is not an off-the-shelf process, but an evolution requiring a strategic, staggered approach to planning and preparation. Manufacturers must clearly define where they want to go and how to get there, starting with problems that are already understood and where value can be shown quickly to build momentum and trust in the process. It’s also important to plan for future needs. What will be required of manufacturing processes, and how can agility and flexibility be maximized from the start? 
 
As drug and therapeutic needs evolve, so must manufacturing. Manufacturers must be able to scale operations up and down flexibly and rapidly to meet the specific therapy needs and deliver more specialized, targeted treatments for smaller patient populations. Automation enables these needs to be met, augmented by human expertise that is free to operate in higher capacity functions such as creative design, innovation and scientific discovery.