Biomanufacturing readiness levels [BRL]-A shared vocabulary for biopharmaceutical technology development and commercialization.

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. NIIMBL brings together private, federal, nonprofit, and academic stakeholders to accelerate the deployment of innovative technologies for biopharmaceutical production and to educate and train a world-leading biomanufacturing workforce. We anticipate that these BRLs will lay the groundwork for a shared vocabulary for assessment of technology maturity and readiness for commercial biomanufacturing that effectively meets the needs of this critical, specialized, and highly regulated industry.

Cyberbiosecurity for Biopharmaceutical Products.

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.

The effects of an antistick phospholipid solution on pediatric electrocautery adenoidectomy.

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. These patients were randomized to undergo surgery either with (n = 31) or without (n = 30) the use of the antistick phospholipid solution (Electro Lube; Mectra Labs; Bloomfield, Ind.). The overall mean amount of time needed to complete an adenoidectomy was 6 minutes and 39 seconds (6:39); use of the antistick solution shortened the amount of surgical time by 1:45-a decrease of 23.2% (p = 0.0360). Likewise, surgeries performed with Electro Lube required an average of 3.0 fewer handbacks for cleaning during the operation (p < 0.0001). The benefits of the antistick solution were even more pronounced in patients with larger adenoids than in those with smaller adenoids.