Cyberbiosecurity in Advanced Manufacturing Models

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 t...

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Main Authors: Guttieres, Donovan G., Stewart, Shannon R, Wolfrum, Jacqueline M, Springs, Stacy
Other Authors: Massachusetts Institute of Technology. Center for Biomedical Innovation
Format: Article
Language:English
Published: Frontiers Media SA 2020
Online Access:https://hdl.handle.net/1721.1/126159
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author Guttieres, Donovan G.
Stewart, Shannon R
Wolfrum, Jacqueline M
Springs, Stacy
author2 Massachusetts Institute of Technology. Center for Biomedical Innovation
author_facet Massachusetts Institute of Technology. Center for Biomedical Innovation
Guttieres, Donovan G.
Stewart, Shannon R
Wolfrum, Jacqueline M
Springs, Stacy
author_sort Guttieres, Donovan G.
collection MIT
description 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.
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spelling mit-1721.1/1261592022-09-28T18:17:59Z Cyberbiosecurity in Advanced Manufacturing Models Guttieres, Donovan G. Stewart, Shannon R Wolfrum, Jacqueline M Springs, Stacy Massachusetts Institute of Technology. Center for Biomedical Innovation 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. 2020-07-13T18:03:39Z 2020-07-13T18:03:39Z 2019-09 2019-11-26T13:32:40Z Article http://purl.org/eprint/type/JournalArticle 2296-4185 https://hdl.handle.net/1721.1/126159 Guttieres, Donovan et al. “Cyberbiosecurity in Advanced Manufacturing Models.” Frontiers in bioengineering and biotechnology, vol. 7, 2019, article 210 © 2019 The Author(s) en 10.3389/fbioe.2019.00210 Frontiers in bioengineering and biotechnology Creative Commons Attribution 4.0 International license https://creativecommons.org/licenses/by/4.0/ application/pdf Frontiers Media SA Frontiers
spellingShingle Guttieres, Donovan G.
Stewart, Shannon R
Wolfrum, Jacqueline M
Springs, Stacy
Cyberbiosecurity in Advanced Manufacturing Models
title Cyberbiosecurity in Advanced Manufacturing Models
title_full Cyberbiosecurity in Advanced Manufacturing Models
title_fullStr Cyberbiosecurity in Advanced Manufacturing Models
title_full_unstemmed Cyberbiosecurity in Advanced Manufacturing Models
title_short Cyberbiosecurity in Advanced Manufacturing Models
title_sort cyberbiosecurity in advanced manufacturing models
url https://hdl.handle.net/1721.1/126159
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