2019 was a watershed year for life sciences manufacturing. It was a year when terms such as Industry 4.0, digitization, Internet of Things (IoT), advanced analytics and cybersecurity were at the forefront of all business discussions. As we moved into 2020, no one could have predicted the COVID-19 outbreak and lasting repercussions that have sent shock waves through society, disrupting the world as we know it and changing the way we think about work forever.
By looking at these trends through a client lens, we can better understand the forces shaping life sciences manufacturing in the immediate future.
Resilient Manufacturing through Cybersecurity
When we look at our most recently completed projects, we see significantly increased interest in cybersecurity and resilient manufacturing. Pharma is one of a few primary sectors targeted by cybercriminals looking to steal IP. The estimated cost of cybercrime in 2020 is £27 billion in the UK alone.
As a result, we’ve seen a greater prominence of cyber-engineering strategy project work. Our clients are adopting practices like robust cybersecurity maintenance processes (ensuring the highest level of protection at all times), cyber hygiene standard practices (to prevent compromised operational technology networks), and control systems security responses (including a suite of prepared tools and practices to be deployed when an intrusion is detected).
Much of the cybersecurity work we completed in 2019 focused on the operational technology design phase and the inclusion of cyber considerations once these networks are deployed. We see this trend continuing this year. Our new projects often include a secure infrastructure team in which the cybersecurity and infrastructure teams are combined into one.
A Need for More Flexible Production Strategies
More of our biopharma customers are expressing a need for flexibility, combined with simplified production strategies. One area where we’ve demonstrated this is in the adoption of single-use technology. Single-use, or disposable, bioprocessing equipment is now used widely throughout preclinical and clinical manufacturing and is increasingly being adopted for commercial products manufacturing. Our customers have quickly realized that this approach offers faster turnaround for smaller batches due to the avoidance of cleaning, sterilization and validation prior to usage.
We’ve also seen an increase in smaller production facilities and automated labs utilizing cell and gene therapies for personalized medicine approaches. Although this strategy unlocks greater flexibility, many of our clients are experiencing increased logistical complexity caused by the larger number of components and consumables required.
The number of contract manufacturers with whom we work is also on the rise. These facilities need flexible manufacturing practices that enable them to produce multiple medicines to meet industry demands.
More of our customers are also shifting toward continuous manufacturing, while also taking advantage of the increased optimization and cost savings that result. Continuous manufacturing continues to move away from preclinical and clinical efforts to include full-scale production in both drug substance and drug product manufacturing. Benefits include a reduction in production costs of 15% to 30%, increased overall equipment efficiency (OEE) of 75% in many cases, a 60% to 80% reduction in end-to-end batch lead time, as well as significant reductions in inventory and utility costs. This approach also requires smaller production facilities.
A move toward continuous processing has also followed the larger theme of digitization. The convergence of IT and operational technologies (IT-OT) has the potential to enable new capabilities across life sciences manufacturing for years to come.
Unlocking the Potential of Data
Clients also want more from the data they have on-hand. From our project experience, effective data analysis usually pivots around good-quality data. Engineers need fewer variables and more data points for those variables in order to work more effectively and draw genuine conclusions from the data. Our clients require a narrow, deep focus vs. a broad and superficial one. The general discussion and project objects have been about delivering answers to the big questions, such as, “How is my batch doing?” and, “Has this deviation affected product quality?”
Our clients need to derive genuine and actionable intelligence from their data – not just the ability to access and compile it. In this sense, data strategies need to be instilled at the design level to ensure operators, supervisors and executives have access to the data they require to build process and business excellence.
From our experience, integrity and contextualization of data is of paramount importance, as these qualities ensure enterprises get the most value out of what they have, thus unlocking the value and power of their data.
The Growing Need for a Remote Workforce
Pharma and biotech manufacturing are set to see changes over the coming years as the landscape continues to evolve at an unprecedented rate, and this will only be accelerated by COVID-19.
As the industry becomes more connected, and downtime prevention more critical, it will become more vital to monitor operations around the clock and provide access to technical support at any hour of the day. When this is combined with the need for social distancing, it’s accelerating the need for more flexible software systems that can be accessed and actioned electronically and, more importantly, remotely. Clients are finding that many issues can be resolved off-site through remote access servers and on-the-ground operators guided through repair processes without the need to deploy an engineer to site.
Plans to implement manufacturing execution systems are also being accelerated, as businesses look for ways to prevent the need for sending people on-site to sign paper-based batch records. Electronic batch records not only alleviate the need to be physically present on-site, but they also record all essential compliance information.
Innovations can also be seen in the way we implement and operate client systems, including greater use of electronic signatures and remote witness testing and sign-off.
As we plan for the coming months, we’ll continue to discern the actual implications of COVID-19 and the trends driving life sciences manufacturing.
A version of this blog first ran in Manufacturing Chemist.
See our COVID-19 resources page for additional insights and updates.
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