Cyberbiosecurity for Biopharmaceutical Products

Biopharmaceutical, Cybersecurity

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.

This paper offers 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.

Contributions are from: National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL, the biopharmaceutical Manufacturing USA institute); National Institute of Standards and Technology (NIST) Material Measurement Laboratory, Information Technology Laboratory, National Cybersecurity Center of Excellence, Office of Advanced Manufacturing; and Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration