The Manufacturing Readiness Levels (MRLs) developed by the Department of Defense are well-established tools for describing the maturity of new technologies resulting from government-sponsored Research and Development programs, from the concept phase to commercial deployment. While MRLs are generally applicable to a wide range of industries and technologies, there is significant value in offering an industry-specific view on how the basic principles may be applied to biomanufacturing. This paper describes Biomanufacturing Readiness Levels (BRLs) developed by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a public/private partnership that is part of the Manufacturing USA network.
View Article and Find Full Text PDFCyberbiosecurity 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.
View Article and Find Full Text PDFEar Nose Throat J
January 2012
We conducted a study to determine if coating a suction cautery tip with an antistick phospholipid solution would decrease the amount of time required to complete primary pediatric adenoidectomies. The aim of the study was focused on two main criteria: the amount of surgical time required to complete each procedure and the number of times an operation had to be interrupted because the suction cautery tip needed to be cleaned (each interruption was called a "handback"). We obtained data prospectively during 61 pediatric adenoidectomies performed at our institution from February through June 2009.
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