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Cyberbiosecurity in Advanced Manufacturing Models.

Donovan Guttieres1, Shannon Stewart1, Jacqueline Wolfrum1

  • 1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, United States.

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Protecting biopharmaceutical production from cyber threats is crucial for patient safety and pandemic response. Addressing vulnerabilities in advanced manufacturing is key to mitigating risks and ensuring medicine security.

Keywords:
biomanufacturingbioprocess riskscyber-physical systemscybersecuritydistributed manufacturingrisk mitigation

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Cybersecurity
  • Risk Management

Background:

  • Biopharmaceutical production relies heavily on digital technologies and cyber-physical systems.
  • Cyberbiosecurity breaches pose significant risks to patient data, production continuity, and global health security.
  • The increasing adoption of advanced manufacturing models introduces new vulnerabilities.

Purpose of the Study:

  • To analyze digital information flow within the biopharmaceutical manufacturing value chain.
  • To identify potential cyberbiosecurity risks associated with advanced manufacturing models like continuous and distributed systems.
  • To propose risk mitigation strategies for enhanced cybersecurity in biomanufacturing.

Main Methods:

  • Analysis of digital information flow in biopharmaceutical manufacturing.
  • Evaluation of cyberbiosecurity risks in advanced manufacturing paradigms.
  • Development of recommendations for risk mitigation.

Main Results:

  • Identified vulnerabilities in current and future biomanufacturing based on reliance on intellectual property, cyber-physical systems, and regulated environments.
  • Highlighted potential cyberbiosecurity risks emerging from continuous and distributed manufacturing systems.
  • Provided a framework for risk mitigation and establishing a proactive security culture.

Conclusions:

  • Advanced manufacturing offers benefits like cost reduction and personalized therapies but increases cyber attack concerns.
  • Proactive risk assessment and a robust security culture are essential for safeguarding biopharmaceutical production.
  • Enhanced cybersecurity is vital for maintaining the integrity and safety of medicines in a digitalized landscape.