Digital bioprocessing technologies can make drug production more efficient and improve product quality. However, manufacturers must guard against cyberattacks because where systems connect to the outside world, there are opportunities for hackers.

The threat posed by cyberattacks is serious, according to Howard Grimes, PhD, CEO of the U.S. Cybersecurity Manufacturing Innovation Institute, who says COVID-19 made clear just how vulnerable drug supply lines are to any sort of disruption.

“As we have observed as a function of the pandemic, our biopharmaceutical supply chains are extremely vulnerable to cyber security attacks,” he says. “The Cybersecurity Manufacturing Innovation Institute has focused on the development of new approaches to security by designing architecture that will protect the biopharmaceutical supply chains.”

This view is shared by Michael Mylrea, PhD, head of ICS cybersecurity & innovation at manufacturing and technology firm National Resilience, who notes that for bioprocessing technology suppliers’ cybersecurity is not always a priority.

“Most biopharmaceutical manufacturing systems are designed to prioritize functionality over cybersecurity. Thus, these systems lack basic monitoring, encryption, and authentication needed to secure the confidentiality, integrity, and availability of the system,” he explains.


A key difficulty, from a cybersecurity perspective, is the fact drug production lines are made up of multiple different technologies, running different operating systems that are often provided by different suppliers.

“Integrating multiple systems from different suppliers can provide expanded attack surface that can be exploited by cyber adversary,” continues Mylrea.

To address this, Mylrea and Grimes developed what they refer to as “biosecure digital twins”—replicas of manufacturing lines they use to identify potential points of attack for hackers.

“The digital twin is essentially a high-fidelity virtual representation of critical manufacturing processes. From a security perspective, this improves monitoring, detection, and mitigation of stealthy attacks that can go undetected by most conventional cybersecurity defenses,” explains Mylrea. “Beyond security, the biosecure digital twin can optimize performance and productivity by detecting when critical systems deviate from their ideal state and correct in real time to enable predictive maintenance that prevent costly faults and safety failures.”

BOLF strategy

The biosecure twins are part of a wider cybersecurity strategy Resilience uses. The Biopharma Observe, Orient, Decide Act Loop Framework (BOLF)—which was developed by Mylrea—is designed to prioritize quality, security, safety, and integrity.

“The framework provides a four-step approach to decision-making outputs from the digital twin to help end users leverage twin technology by distilling the available information, focusing the data on context, and rapidly making the best decision while remaining cognizant of changes that can be made as more data becomes available,” he tells GEN.

For companies, securing manufacturing operations against cyberattacks is a must from an operational standpoint and as part of the wider industry, according to Mylrea.

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