Abstract
U.S. national security, prosperity, economy, and well-being require secure, flexible, and resilient Biopharmaceutical Manufacturing. The COVID-19 pandemic reaffirmed that the biomedical production value-chain is vulnerable to disruption and has been under attack from sophisticated nation-state adversaries. Current cyber defenses are inadequate, and the integrity of critical production systems and processes are inherently vulnerable to cyber-attacks, human error, and supply chain disruptions. The following chapter explores how a BioSecure Digital Twin will improve U.S. manufacturing resilience and preparedness to respond to these hazards by significantly improving monitoring, integrity, security, and agility of our manufacturing infrastructure and systems. The BioSecure Digital Twin combines a scalable manufacturing framework with a robust platform for monitoring and control to increase U.S. biopharma manufacturing resilience. Then, the chapter discusses some of the inherent vulnerabilities and challenges at the nexus of health and advanced manufacturing. Next, the chapter highlights that as the Pandemic evolves, we need agility and resilience to overcome significant obstacles. This section highlights an innovative application of Cyber Informed Engineering to developing and deploying a BioSecure Digital Twin to improve the resilience and security of the biopharma industrial supply chain and production processes. Finally, the chapter concludes with a process framework to complement the Digital Twin platform, called the Biopharma (Observe, Orient, Decide, Act) OODA Loop Framework (BOLF), a four-step approach to decision-making outputs from the Digital Twin. The BOLF will 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.
Keywords
- Digital Twin
- Critical infrastructure
- Cybersecurity
- Resilience
- Advanced manufacturing
- Cyber informed engineering
- OODA Loop
This work was partially funded by the Department of Energy under contract DOE-EE0009046.
This is a preview of subscription content, access via your institution.
Buying options





References
Mylrea, M., Nielsen, M., Justin, J., Abbaszadeh, M.: AI driven cyber physical industrial immune system for critical infrastructures. In: Lawless, W.F., Sofge, D.A., Mittu, R. (eds.), Systems Engineering and Artificial Intelligence. Springer (2021, forthcoming)
Tao, F., Zhang, M.: Digital twin shop-floor: a new shop-floor paradigm towards smart manufacturing. IEEE Access 5, 20418–20427 (2017)
Mylrea, M.: AI systems engineering approach to digital twin for cyber physical anomaly detection. AAAI Presentation Abstract. 24 March 2021
Mylrea, M., Gourisetti, S.N.G.: Cybersecurity and optimization in smart “autonomous” buildings. In: Lawless, W., Mittu, R., Sofge, D., Russell, S. (eds.) Autonomy and Artificial Intelligence: A Threat or Savior?, pp. 263–294. Springer, Cham (2017). https://doi.org/10.1007/978-3-319-59719-5_12
Idaho National Laboratory. Cyber-informed Engineering Website. https://inl.gov/cce/. Accessed 28 July 2021
Bochman, A.A., Freeman, S.: Countering Cyber Sabotage: Introducing Consequence-driven, Cyber-informed Engineering [CCE]. CRC Press (2021)
Freeman, S.G., St Michel, C., Smith, R., Assante, M.: Consequence-driven cyber-informed engineering [CCE]. No. INL/EXT-16-39212. Idaho National Lab. [INL], Idaho Falls, ID [United States] (2016)
https://www.fda.gov/medical-devices/classify-your-medical-device/device-classification-panels
https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2021 Springer Nature Switzerland AG
About this chapter
Cite this chapter
Mylrea, M. et al. (2021). BioSecure Digital Twin: Manufacturing Innovation and Cybersecurity Resilience. In: Lawless, W.F., Llinas, J., Sofge, D.A., Mittu, R. (eds) Engineering Artificially Intelligent Systems. Lecture Notes in Computer Science(), vol 13000. Springer, Cham. https://doi.org/10.1007/978-3-030-89385-9_4
Download citation
DOI: https://doi.org/10.1007/978-3-030-89385-9_4
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-89384-2
Online ISBN: 978-3-030-89385-9
eBook Packages: Computer ScienceComputer Science (R0)