Journal:Cyberbiosecurity for biopharmaceutical products
| Full article title | Cyberbiosecurity for biopharmaceutical products |
|---|---|
| Journal | Frontiers in Bioengineering and Biotechnology |
| Author(s) |
Mantle, Jennifer L.; Rammohan, Jayan; Romatseva, Eugenia F.; Welch, Joel T.; Kauffman, Leah R.; McCarthy, Jim; Schiel, John; Baker, Jeffrey C.; Strychalski, Elizabeth A.; Rogers, Kelley C; Lee, Kelvin H. |
| Author affiliation(s) |
National Institute for Innovation in Manufacturing Biopharmaceuticals, National Institute of Standards and Technology, U.S. Food and Drug Administration |
| Primary contact | Email: KHL at udel dot edu |
| Editors | Murch, Randall S. |
| Year published | 2019 |
| Volume and issue | 7 |
| Page(s) | 116 |
| DOI | 10.3389/fbioe.2019.00116 |
| ISSN | 2296-4185 |
| Distribution license | Creative Commons Attribution 4.0 International |
| Website | https://www.frontiersin.org/articles/10.3389/fbioe.2019.00116/full |
| Download | https://www.frontiersin.org/articles/10.3389/fbioe.2019.00116/pdf (PDF) |
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Abstract
Cyberbiosecurity is an emerging discipline that addresses the unique vulnerabilities and threats that occur at the intersection of cyberspace and biotechnology. Advances in technology and manufacturing are increasing the relevance of cyberbiosecurity to the biopharmaceutical manufacturing community in the United States. Threats may be associated with the biopharmaceutical product itself or with the digital thread of manufacturing of biopharmaceuticals, including those that relate to supply chain and cyberphysical systems. Here, we offer an initial examination of these cyberbiosecurity threats as they stand today, as well as introductory steps toward paths for mitigation of cyberbiosecurity risk for a safer, more secure future.
Keywords: cyberbiosecurity, cybersecurity, biopharmaceutical manufacturing, engineering biology, cell therapy, gene therapy, supply chain
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Notes
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