An Assessment of the National Institute of Standards and Technology Material Measurement Laboratory Fiscal Year 2017 (2017) / Chapter Skim
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4 Biosystems and Biomaterials
4 Biosystems and Biomaterials
Pages 26-39
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ASSESSMENT OF TECHNICAL PROGRAMS Accomplishments The Microbial Metrology Group develops advanced measurements and standards for the exploitation of microbes to promote human health, precision medicine, advanced manufacturing, and other industrial applications. The group uses genomic and metagenomic approaches to improve measurements on 1 Some of the background information within this chapter was derived from the document NIST, "Made to Measure -- Building the Foundation for Tomorrow's Innovation in the Niological, Chemical, and Materials Sciences," pp.
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2373, a human epidermal growth factor receptor 2 (HER2) genomic DNA standard for gene copy number produced from five breast cancer cell lines.
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These efforts assist basic biomedical research, biomanufacturing of regenerative medicine products, nonanimal toxicology testing, drug development and testing, precision medicine, and other applications that depend on understanding and predicting complex cellular activities.9 Recent projects include detecting and measuring single-molecule RNAfluorescence in situ hybridization (RNA-FISH) in bacteria, new approaches for cell counting and RMs, and new methods for flow cytometry.
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bench to an industrial-scale fermenter. The BBD's regenerative medicine-related activities include cell counting, live cell imaging, flow cytometry, genome editing, tissue engineering (TE)
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concentration gradients are being used to challenge bacteria and measure the evolutionary process. The emergence and spread of antibiotic resistance is a global health crisis, and the BBD is developing novel measurement tools that will allow it to measure and better understand the process by which bacteria evolve resistance to existing and novel antibiotics.
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The standard consists of purified genomic DNA from five breast cancer cell lines with different amounts of HER2 gene amplification. This RM is available from NIST as SRM 2373.11 The BBD is also currently preparing an RM for measuring the receptor tyrosine kinase for protooncogene MET and epidermal growth factor receptor (EGFR)
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Opportunities and Challenges With the awarding of the Manufacturing USA Institutes, NIIMBL, and the Advanced Tissue Biofabrication Manufacturing Innovation Institute (ATB-MII) , and the passage of the 21st Century Cures Act, the active role that the BBD division has been playing in supporting regenerative medicine products is poised to ramp up even more.
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And so it has potential to greatly impact synthetic biology and regenerative medicine. The MML is working with the Physical Measurement Laboratory (PML)
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The group has the expertise and connections to fulfill the unmet need for standards and RMs to increase interlaboratory comparability and confidence in microbiome measurements. The Bioassay Methods Group is highly trained and motivated to bring quality assurance and quality control standards and methods for both qualifying and quantifying biological activity, wellness, and 34
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Some noteworthy examples of Department of Commerce (DOC) and NIST-named awards won by the BBD staff include the 2015 Bronze Medal for establishing reliability in flow cytometry measurements to improve clinical disease diagnosis, cell therapy manufacturing, and biomedical research, and the 2014 Bronze Medal for the development of a "clinically relevant measurement and standardization program for the critical evaluation of photo-polymerized dental restoratives."14 One external award won by the BBD was the 2016 Judson C
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The Microbial Metrology Group played a leading role in the workshop, which assembled microbiome researchers from federal agencies, academia, and industry in a precompetitive space to prioritize needs and form an action plan to move microbiome standards development forward. The workshop began as an effort to gather input on defining RMs, reference data, and RMs for human microbiome community measurements.
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These workshops have focused on standards for pathogen detection and identification and on the use of NGS technologies for clinical diagnostics and biothreat detection. The consensus outcome from the NIST-FDA workshop on microbial NGS-based standards for pathogen detection was for NIST and the FDA to jointly develop a mixed pathogen RM and associated data that will allow the community to assess the performance of their microbial detection systems and enable regulators to vet the performance claims made by the laboratories and companies creating and using these systems.
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was established between NIST and the SCB for gene, cell, and regenerative medicine and cell-based drug discovery to help coordinate standards development for regenerative medicine and advanced therapies. NCI's clinical trials reference laboratories have used NIST SRM 2373 to improve the confidence of the human epidermal growth factor receptor 2 (HER2)
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. Their leadership positions in relevant societies and organizations include the Society for Biomaterials, Tissue Engineering and Regenerative Medicine International Society-Americas (TERMIS-AM)
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