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Bioscience

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Displaying 226 - 250 of 1261

Cautionary Note on Contamination of Reagents Used for Molecular Detection of SARS-CoV-2

May 3, 2021
Author(s)
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

Filling the Pharmacopeial Gaps of Visual Inspection Toward Standardization and Consistency of Visible Particle Testing

May 3, 2021
Author(s)
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

The San Francisco Estuary Institute Collection at the NIST Biorepository

April 28, 2021
Author(s)
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

Sequence-based U.S. population data for 7 X STR loci

April 26, 2021
Author(s)
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 NIH Somatic Cell Genome Editing program

April 7, 2021
Author(s)
Samantha Maragh
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

ISCMA: An Information Security Continuous Monitoring Program Assessment

March 31, 2021
Author(s)
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

Biobanking in the COVID-19 Era and Beyond: Part 1. How Early Experiences can Translate into Actionable Wisdom

March 26, 2021
Author(s)
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

Biobanking in the COVID-19 Era and Beyond: Part 2. A Set of Tool Implementation Case Studies

March 26, 2021
Author(s)
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

CD19 Expression Analysis Using Two Flow cytometric Quantitative Schemes: An approach for Identifying Robust B-cell Reference Control Materials

March 19, 2021
Author(s)
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

Towards Quantitative and Standardized Serological and Neutralization Assays for COVID-19

March 8, 2021
Author(s)
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

Single-cell measurement of plasmid copy number and promoter activity

March 5, 2021
Author(s)
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

Report of the 2019 NIST-FDA Workshop on Standards for Next Generation Sequencing Detection of Viral Adventitious Agents in Biologics and Biomanufacturing

February 22, 2021
Author(s)
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

Conformational Changes of Immobilized Polythymine due to External Stressors Studied with Temperature-Controlled Electrochemical Microdevices

February 17, 2021
Author(s)
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

National Institute of Standards and Technology Environmental Scan 2020

February 9, 2021
Author(s)
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

END TO END COLLABORATION TO TRANSFORM BIOPHARMACEUTICAL DEVELOPMENT & MANUFACTURING

January 22, 2021
Author(s)
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

Accelerating Innovation and Commercialization Through Standardization of Microfluidic-Based Medical Devices

January 5, 2021
Author(s)
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

Introduction and Clinical Validation of Metrology Standards for Immunohistochemistry

December 21, 2020
Author(s)
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

Chromosome-scale, haplotype-resolved assembly of human genomes

December 7, 2020
Author(s)
Justin Zook, Shilpa Garg, Heng Li
Haplotype-resolved or phased genome assembly provides a complete picture of genomes and their complex genetic variations. However, current algorithms for phased assembly either do not generate chromosome-scale phasing or require pedigree information, which

Crystal Structure of a Bivalent Antibody Fab Fragment

November 11, 2020
Author(s)
Salman Shahid, Mingming Gao, David Gallagher, Steven Foung, Zhen-Yong Keck, Thomas Fuerst, Roy Mariuzza
We determined the crystal structure to 1.8 Å resolution of the Fab fragment of an affinity- matured human monoclonal antibody (HC84.26.5D) that recognizes the E2 envelope glycoprotein of hepatitis C virus (HCV). Unlike conventional Fabs, which are

Conformational gating, dynamics and allostery in human monoacylglycerol lipase

October 28, 2020
Author(s)
Sergiy Tyukhtenko, Girija Rajarshi, Ioannis Karageorgos, Nikolai Zvonok, Kiran Vemuri, Jeffrey W. Hudgens, Xiaoyu Ma, Mahmoud L. Nasr, Alexandros Makriyannis, Kyle Anderson, Jason J. Guo, Gerhard Wagner
Inhibition of human Monoacylglycerol Lipase (hMGL) offers a novel approach for treating neurological diseases. The design of inhibitors, targeting active-inactive conformational transitions of the enzyme, can be aided by understanding the interplay between
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