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Desu Chen, Joy Dunkers, Wolfgang Losert, Sumona Sarkar
Nanofiber scaffolds can induce osteogenic differentiation and cell morphology alterations of human bone marrow stromal cells (hBMSCs) without introduction of chemical cues. In this study, we investigate the predictive power of day 1 cell morphology
Qian Dong, Xinjian Yan, Yuxue Liang, Sanford Markey, Sergey L. Sheetlin, Concepcion Remoroza, William E. Wallace, Stephen Stein
This work presents methods for identifying and then creating a mass spectral library for disulfide-linked peptides originating from the NISTmAb. Analysis involved both partially- reduced and non-reduced proteins under neutral and weakly basic conditions
Kyle Anderson, Kerry Scott, Ioannis Karageorgos, Elyssia Gallagher, Venkata Tayi, Michael Butler, Jeffrey W. Hudgens
This database gives hydrogen-deuterium exchange mass spectrometry (HDX-MS) data from measurements of three purified IgG1 glycoform samples, predominantly G0F, G2F, and SAF, in isolation and in complexation with the high-affinity receptor, FcγR1a (CD64)
In silico approaches for next generation sequencing (NGS) data modeling have utility in the clinical laboratory as a tool for clinical assay validation. In silico NGS data can take a variety of forms including pure simulated data or manipulated data files
Alejandro Cano, Hana Rozhonova, Arlin B. Stoltzfus, David McCandlish, Joshua Payne
Evolutionary adaptation can be conceived as a series of substitutions representing mutation-fixation events. The changes that are more likely will appear more frequently in the aggregate spectrum of adaptive substitutions. Recent studies establish that
Laura Pierce, Sumona Sarkar, Leo Chan, Bo Lin, Jean Qiu
Fit-for-purpose cell viability measurement methods are urgently needed for the characterization and testing of cell and gene therapy products and their manufacturing processes. A recent Cell Viability Workshop held at the virtual Cell Therapy Analytical
We present a simple approach to reconstruction of NUS 2D spectral series as used in relaxation analysis. The approach treats this data as an ordinary 3D time-domain measurement whose imaginary part in the pseudo-dimension is zero, with familiar 3D NUS
Peter Vallone, James Huggett, Vladimir Benes, Jeremy Garson, Kathryn Harris, Mikael Kubista, Timothy McHugh, Jacob Moran-Gilad, Tania Nolan, Michael Pfaffl, Marc Salit, Greg Shipley, Jo Vandesompele
Reverse transcription (RT)-PCR, the principal diagnostic method applied in the world-wide struggle against COVID-19, is capable of detecting a single molecule of a viral genome. Correctly designed and practiced RT-PCR assays for SARS-CoV-2 should not cross
Linda Narhi, George M. Bou-Assaf, Kristen Gonzalez, Maryam Mazaheri, Steven Messick, Srivalli Telikepalli
The presence of visible particles that are not anticipated to be present in drug products is one of the most common causes of recalls, and warning letters1, 2. This critical quality attribute, which is typically determined during visual inspection (along
Debra Ellisor, Rebecca Pugh, Nina Buzby, Michael Weaver, Melissa Foley
The National Institute of Standards and Technology (NIST) has been collaborating with the San Francisco Bay Estuary Institute (SFEI) since 2009, providing biobanking services at the NIST Biorepository in Charleston, South Carolina in support of their
Lisa Borsuk, Carolyn R. Steffen, Kevin M. Kiesler, Peter Vallone, Katherine Gettings
The National Institute of Standards and Technology (NIST) U.S. population sample set of unrelated individuals was used to determine allele and haplotype frequencies for seven X-chromosome short tandem repeat (STR) loci in four linkage groups. DXS7132
The move from reading to writing the human genome offers new opportunities to improve human health. The United States National Institutes of Health (NIH) Somatic Cell Genome Editing (SCGE) Consortium aims to accelerate the development of safer and more
Victoria Yan Pillitteri, Kelley L. Dempsey, Chad Baer, Ron Rudman, Robert Niemeyer, Susan Urban
This publication describes an example methodology for assessing an organization's Information Security Continuous Monitoring (ISCM) program. It was developed directly from NIST guidance and is applicable to any organization, public or private. It can be
Clare M. Allocca, Marianna J. Bledsoe, Monique Albert, Sergey Anisimov, Elena Bravo, Marta Castelhano, Yehudit Cohen, Mieke DeWilde, Koh Furuta, Zisis Kozlakidis, Dunja Martin, Anabela Martins, Helen Morrin, Shannon McCall, Rebecca Pugh
The era of COVID-19 has brought about a number of novel challenges for the global biobanking community. To better position the biobanking community to cope with current and future challenges, the International Society for Biological and Environmental
Clare M. Allocca, Emma Snapes, Monique Albert, Marianna J. Bledsoe, Marta Castelhano, Mieke DeWilde, Koh Furuta, Zisis Kozlakidis, Dunja Martin, Anabela Martins, Shannon McCall, Brent Schacter
The COVID-19 era has brought about a number of novel challenges for the global biobanking community. An array of diverse tools exists to support quality and fitness-for-purpose in biobank operations. The International Society for Biological and
Hao-Wei Wang, Paul Patrone, Anthony Kearsley, Jessica Watson, Liang Lim, Jothir Pichaandi, Olga Ornatsky, Daniel Majonis, Rukmini Bhardwaj, Howard Mostowski, Steven Bauer, Heba Degheidy, Lili Wang
Cell-based therapies have emerged as a novel approach to treat cancer and other conditions. Quantitative flow cytometry plays an increasingly important role in predicting therapy outcome in a wide range of hematologic malignancies. Several studies
Linhua Tian, Elzafir B. Elsheikh, Paul Patrone, Anthony Kearsley, adolfas Gaigalas, Sarah L. Inwood, Sheng Lin-Gibson, Dominic Esposito, Lili Wang
Quantitative and robust serology assays are critical measurements underpinning global COVID-19 response to diagnostic, surveillance, and vaccine development. Here, we report a proof-of-concept approach for the development of quantitative, multiplexed flow
Bin Shao, Jayan Rammohan, Daniel Anderson, Nina Alperovich, David J. Ross, Christopher Voigt
We have developed a method to simultaneously count plasmid DNA, RNA transcripts, and protein expression in single living bacteria. From these data, the activity of a promoter in units of RNAP/s can be inferred. This work facilitates the reporting of
Megan Cleveland, Bharathi Anekella, Mike Brewer, Pei-Ju Chin, Heather Couch, Eric Delwart, Jim Huggett, Scott Jackson, Javier Martin, Serge Monpoeho, Tom Morrison, Siemon Ng, David Ussery, Arifa Khan
Adventitious virus testing assures product safety by demonstrating the absence of viruses that may have been unintentionally introduced during the manufacturing process. The capabilities of next-generation or high-throughput sequencing (NGS/HTS) for broad
Ramya Vishnubhotla, Sarah Robinson, Jon R. Askim, Christopher B. Montgomery, Kristen L. Steffens, Herman O. Sintim, Stephen Semancik
Conformational changes of single-stranded DNA (ssDNA) play an important role in a DNA strand's ability to bind to target ligands. A variety of factors can influence conformation, including temperature, ionic strength, pH, buffer cation valency, strand
Heather Evans, Kristen K. Greene, William M. Healy, Elizabeth Hoffman, Kate Rimmer, Anna V. Sberegaeva, Neil M. Zimmerman
The 2020 National Institute of Standards and Technology Environmental Scan provides an analysis of key external factors that could impact NIST and the fulfillment of its mission in coming years. The analyses were conducted through four separate lenses
John Erickson, Jeffrey Baker, Shawn Barrett, Ciaran Brady, Mark Brower, Ruben Carbonell, Tim Charlebois, Jon Coffman, Lisa Connell-Crowley, Michael Coolbaugh, Eric Fallon, Eric Garr, Christopher Gillespie, Roger Hart, Allison Haug, Gregg Nyberg, Michael Phillips, David Pollard, Maen Qadan, Irina Ramos, Kelley Rogers, Gene Schaefer, Jason Walther, Kelvin Lee
An ambitious ten-year collaborative program is described to invent, design, demonstrate and support commercialization of integrated biopharmaceutical manufacturing technology that will transform the industry. This capability will enable improved control
Darwin R. Reyes-Hernandez, Henne van Heeren, Suvajyoti Guha, Luke Herbertson, Alexios P. Tzannis, Jens Ducr?e, Hugo Bissig, Holger Becker
The microfluidics industry has grown steadily over the last 5 years worldwide, with the market for microfluidic medical devices experiencing a compound growth rate of 18%. The number of submissions to regulatory agencies such as the U.S. Food & Drug
Emina E. Torlakovic, Seshi Sompuram, Vani Kodela, Anika Schaedle, Paul DeRose, Steve Bogen, Lili Wang
Despite the widespread integration of immunohistochemistry (IHC) into routine surgical pathology, its use suffers from significant inter-laboratory disparities. The root cause and an unsolved technical challenge is the lack of metrology standards, the