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Authored by Olivier Loeillot, vice president of bioprocess, Cytiva

Automating your manufacturing line used to be a project. The time to develop, code, test, and implement a custom solution was simply too costly, both in terms of time and money. Add in reliability issues and security risks and that left few companies willing to make the leap to automation, or Industry 4.0. There are three major factors, outside of the Covid-19 pandemic, that are accelerating this change.

Factor one: The benefits finally outweigh the risks

Automation is now a product. The benefits — precision, predictability, efficiency, and consistency — have either mitigated previous risks or eliminated them. Custom automation solutions when first introduced to the industry were time consuming and expensive to develop and implement. And they were risky in terms of both cyber security and performance. Automation created for per customer, per specific applications meant manufactures were putting brand new software onto their lines.  Even with testing and quality assurance done, it was impossible to put it through its paces prior to using it in real world applications. If a bug appeared, it had the potential to shut down the line until a fix was available causing significant financial loss. When automation software became a standard product, customers could finally be assured they were adding functionality that has been tested and proven time and again.

In terms of cyber security, that is a threat that will remain. Every industry must stay vigilant against hackers and put into place rigorous cyber protections. Standard software now has layers of firewalls built in. But the real game-changer for many has been the number of third-party vendors specializing in cyber security.

Another benefit of automating your bioprocess is the data. With automation infrastructure available, data can be aggregated and managed, generating insights through various applications in ways that people and paper rarely could. Records can also be easily and quickly accessed and investigated for regulatory control.

Factor two: Ground-breaking technology

The industry is always seeking ways to bring life changing therapies to patients safer and quicker. Until recently, innovation was focused primarily on creating a more efficient and safer development and manufacturing environment for drug substance. Throughout the past decade and a half, there have been tremendous breakthroughs in drug product. Automated fill and finishing machines have been a game changer in getting therapies into patients faster and safer.

Factor three: Expanded pipelines and new modalities

When expanding pipelines and new modalities combine with increased pressure to reduce time to market, getting it right earlier will be critical to success. Enter in silico solutions. In silico modeling is changing the way data is generated. Modeling increases the chances of getting it right earlier by eliminating failures and repeat work throughout the phases. Modeling done downstream can go onto become digital twins upstream. Mechanistic modeling and the creation of digital twins has only recently started to take off. But with the shifting of the industry trends, we will see more and more of in silico solutions.

Industry 4.0 is here and it’s just getting started. Late adopters may have a significant competitive advantage for both product development as well as manufacturing efficiencies. The key will be finding the right experienced partner to make the transition seamless. The possibilities that lie ahead are as exciting as they are endless.

Discover how Cytiva can assist in the accelerating to Industry 4.0.