Cyberbiosecurity in Advanced Manufacturing Models
Name
fbioe-07-00210.pdf
Description
Published version
Size
838.21 KB
Format
Adobe PDF
Checksum (MD5)
c30242aca36ba8643d03b7c24d97f4e2
Author(s)
Guttieres, Donovan G.
Stewart, Shannon R
Wolfrum, Jacqueline M
Springs, Stacy
Date Issued
September 2019
Journal
Frontiers in bioengineering and biotechnology
Publisher
Frontiers Media SA
Citation
Guttieres, Donovan et al. “Cyberbiosecurity in Advanced Manufacturing Models.” Frontiers in bioengineering and biotechnology, vol. 7, 2019, article 210 © 2019 The Author(s)
Version
Final published version
Abstract
Cybersecurity for the production of safe and effective biopharmaceuticals requires the attention of multiple stakeholders, including industry, governments, and healthcare providers. Cyberbiosecurity breaches could directly impact patients, from compromised data privacy to disruptions in production that jeopardize global pandemic response. Maintaining cybersecurity in the modern economy, where advanced manufacturing technologies and digital strategies are becoming the norm, is a significant challenge. Here, we highlight vulnerabilities in present and future biomanufacturing paradigms given the dependence of this industry sector on proprietary intellectual property, cyber-physical systems, and government-regulated production environments, as well as movement toward advanced manufacturing models. Specifically, we (1) present an analysis of digital information flow in a typical biopharmaceutical manufacturing value chain; (2) consider the potential cyberbiosecurity risks that might emerge from advanced manufacturing models such as continuous and distributed systems; and (3) provide recommendations for risk mitigation. While advanced manufacturing models hold the potential for reducing costs and increasing access to more personalized therapies, the evolving landscape of the biopharmaceutical enterprise has led to growing concerns over potential cyber attacks. Gaining better foresight on potential risks is key for implementing proactive defensive principles, framing new developments, and establishing a permanent security culture that adapts to new challenges while maintaining the transparency required for regulated production of safe and effective medicines.
MIT Department
Massachusetts Institute of Technology. Center for Biomedical Innovation
Terms of Use
Creative Commons Attribution 4.0 International license
Persistent DSpace Link
DOI of Published Version
https://doi.org/10.3389/fbioe.2019.00210
