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3 Biomolecular Measurement
Pages 18-25

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From page 18...
... The work focuses on applied genetics, bioanalytical science, biomolecular structure and function, bioprocess measurements, and mass spectrometry. The BMD has the following groups and focus areas: the Mass Spectrometry Data Center develops mass spectral libraries for small molecules, metabolites, peptides, glycans, and proteins; the Applied Genetics Group develops standards and technology for deoxyribonucleic acid (DNA)
From page 19...
... The BMD has a welldefined mission and focus comprising a portfolio of thrusts that blend established and recognized excellence in mass spectroscopic data libraries and DNA forensics with rapidly growing strengths in biopharmaceuticals and a vision for future impact in precision medicine. The division achieves its impact through an excellent balance between top-down alignment with the strategic goals of the MML and bottom-up freedom given to individual investigators to formulate their own programs consistent with the divisions goals.
From page 20...
... The Applied Genetics Group is leveraging its expertise toward DNA-based precision medicine, contributing to the strategic goals of the division related to enabling reliable measurements for precision medicine. The strong connections between this group and industry, in the context of DNA forensics, can serve as a potential model of best practices for the BMD's nascent efforts in precision medicine.
From page 21...
... It would also need to describe the role of the IBBR in the context of the strategic goals of the BMD in order to establish new capabilities and expertise to enable protein production, to contribute to the NIIMBL, and to broadly impact biopharmaceutical manufacturing initiatives through improved measurement. The rationale for focusing efforts within the BMD on precision medicine is compelling, as the development of robust, reproducible, and accurate in vitro assays for protein biomarkers remains an important, yet largely unresolved, challenge.
From page 22...
... Some efforts within the division already fall into this area, including characterization of exosomes, field-flow fractionation, liposome characterization, vaccine characterization, and synthesis of reference nanoparticles based on the cross-linking of amino acids in a flow focusing device. Last, the BMD excels at addressing the critical measurement needs of the United States in key areas involving biomolecular technologies, including mass spectroscopy, DNA forensics, and biopharmaceuticals.
From page 23...
... Opportunities and Challenges The laboratory space occupied by the Bioprocess Measurements and Mass Spectrometry Data Center Groups in the BMD on the NIST campus in Gaithersburg, Maryland, was constructed in the early 1960s. In some of the facilities, evidence of leaking roofs was found.
From page 24...
... The NISTmAb (RM 8671) was shared and characterized from 2013 to 2015 by more than 100 participants from 11 biopharmaceutical companies, 5 instrument vendors, 5 universities, and the FDA.11 As previously mentioned, the characterization data formed the basis of a three-volume ACS book series, State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization, published in 2015-2016.
From page 25...
... Third, a key output and impact of the Applied Genetics Group, whose research focus is in DNA forensics, revolves around the evaluation of new technologies for forensic analysis. Developers of new reagents and instrumentation send their technologies to NIST for independent and objective third-party evaluations.


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