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Cyberbiosecurity for Biopharmaceutical Products.
Mantle, Jennifer L; Rammohan, Jayan; Romantseva, Eugenia F; Welch, Joel T; Kauffman, Leah R; McCarthy, Jim; Schiel, John; Baker, Jeffrey C; Strychalski, Elizabeth A; Rogers, Kelley C; Lee, Kelvin H.
Afiliação
  • Mantle JL; National Institute for Innovation in Manufacturing Biopharmaceuticals, Newark, DE, United States.
  • Rammohan J; Material Measurement Laboratory, National Institute of Standards and Technology, Gaithersburg, MD, United States.
  • Romantseva EF; Material Measurement Laboratory, National Institute of Standards and Technology, Gaithersburg, MD, United States.
  • Welch JT; Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD, United States.
  • Kauffman LR; Material Measurement Laboratory, National Institute of Standards and Technology, Gaithersburg, MD, United States.
  • McCarthy J; Information Technology Laboratory, National Cybersecurity Center of Excellence, National Institute of Standards and Technology, Gaithersburg, MD, United States.
  • Schiel J; Material Measurement Laboratory, National Institute of Standards and Technology, Gaithersburg, MD, United States.
  • Baker JC; Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD, United States.
  • Strychalski EA; Material Measurement Laboratory, National Institute of Standards and Technology, Gaithersburg, MD, United States.
  • Rogers KC; Material Measurement Laboratory, National Institute of Standards and Technology, Gaithersburg, MD, United States.
  • Lee KH; Office of Advanced Manufacturing, National Institute of Standards and Technology, Gaithersburg, MD, United States.
Article em En | MEDLINE | ID: mdl-31214582
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Ano de publicação: 2019 Tipo de documento: Article