Digital Technology Roadmap

The Digital Plant Maturity Model (DPMM)1 describes one characteristic of a Level 5: Adaptive Plant as “In-line, real-time, continuous, closed-loop, process verification and control with automated realtime quality release”. This is the pinnacle of ‘Industry 4.0’, a term coined around 2011 to outline the advantages that a wide array of digital technologies running in concert can bring to manufacturing and critical facilities. For most pharmaceutical manufacturers, the strategic advancements these technologies can deliver have not been realized.

While there are digital technologies in place delivering some value, they are not enterprise wide, not fully integrated, they do not leverage the full extent of the available infrastructure, and they are not working together. There is no single reason for the industry to lag in adopting these technologies. In such a highly regulated industry, there is inherent complexity and an unprecedented pace of change. However, the COVID-19 pandemic has shown that the industry can overcome real and perceived barriers for the common good. The pandemic demonstrated that digital technologies offer great value and can move the needle on all five drivers identified in the BioPhorum Technology Roadmap Vision 2.0², challenging the industry’s existing ways of investment, technology development and technology adoption with thresholds and timelines falling outside the norm. Strategic decision makers need to be informed and well supported in developing a value proposition for digital transformation to ensure that the investments they make are transformational.

Continuous, closed-loop control is not the goal for everyone. In this paper, the Digital Technology Roadmap working group outlines the foundational element that chart the course for pharmaceutical manufacturers who decide to take this journey and provides a vision of what that destination could look like in 10 years’ time. It outlines the current state of the industry, key challenges and barriers to adoption, and hints at the value that taking this journey will bring to patients, organizations and industry. This paper (which forms Part 1 of the Digital Technology Roadmap) looks at the problem statement and the work that has gone before. Part 2, to be published later, will provide practical guidance, tools and evidence to support an approach to digital transformation which focuses on what an organization needs to deliver, but also its need not to constrain itself for the future, and to look beyond the walls of the facility and use technology to deliver data accessibility with all the challenges that data sharing brings about. Beyond the facility, and organizations already embarked upon digital programs, there is an adoption curve that moves the industry toward a critical mass of transformational change which needs to be achieved for organizations to realize the full promise of Industry 4.0.

Transformational change is not a program but a mindset that enables organizations to remove siloed working, effect organizational change, enable an adaptive and optimized workforce, and in some cases remove the need for human operations in some facilities with remote support being utilized by exception. Biopharmaceutical manufacturing companies that are willing to undertake this digital journey in the face of the acknowledged regulatory challenges will see that the benefits to patients and the sustainability of their organization will far outweigh the perceived hurdles. Collaboration will be the key to reaching these goals, and if organizations are willing to share the load with their industry peers, the biopharmaceutical industry, and more importantly its patients, will share in the success.