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Search Publications by: David L. Duewer (Fed)

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Displaying 1 - 25 of 172

Interlaboratory Measurement of Adeno-Associated Virus: Comparative Quantification of Full and Empty Capsids

December 26, 2024
Author(s)
Sean Lehman, Wyatt N. Vreeland, Jerome Jacques, Sharee Adams-Hall, Shreya Ahuja, Adnan Arnaout, Hunter Balduf, Ivan Budyak, Thomas Cleveland, Dennis Delgado, James Deng, Brandon Doyle, David L. Duewer, Carsten Elger, Jeffrey Fagan, Tim Guo, Jorge Haller, Luisa Hilgenfeld, Van Hoang, Allison Huldin, Matthew Hyatt, Sambit Kar, Sandeep Kedia, Bashkim Kokona, Amy Liu, Li Ma, Diane McCarthy, He Meng, Easton Noble, Veronika Oettle, Andrew Pla, Thomas Powers, Dean Ripple, Herbert Runnels, Raphael Ruppert, Florian Semmelmann, Christopher Sims, Saurabh Singh, Ronald Toth, Austin Vogt, Sabine Wenzel, Neal Whitaker, Zhiwen Yang, Brandon Zhuang
Recombinant adeno-associated virus (AAV) is one of the main viral vector-based gene therapy platforms. AAV is a virus consisting of a ≈25 nm diameter capsid with a ≈4.7 kb cargo capacity. The safety and efficacy depend on the correct encapsidation of the

CCQM_Retrospectoscope Reference Manual: A detailed reference to the CCQM_Retrospectoscope, a suite of graphical tools for the meta-analysis of measurement results from CCQM studies

December 12, 2024
Author(s)
David L. Duewer, Christina Cecelski, Michael Nelson
This document is a detailed reference manual for the 1-September-2024 version of the CCQM_Retrospectoscope system. The CCQM_Retrospectoscope combines a nominally complete database of results from Consultative Committee for the Amount of Substance

NIST's Engagement with CCQM Studies from 1992 to 2023: History and Performance

May 21, 2024
Author(s)
David L. Duewer, Christina Cecelski, Megan Cleveland, Nancy Lin, Katrice Lippa, Jacqueline L. Mann, John L. Molloy, Michael Nelson, James E. Norris, Kenneth W. Pratt, Sumona Sarkar, Hratch G. Semerjian, Robert L. Watters
This report documents the engagement and measurement performance of the National Institute of Standards and Technology (NIST) in studies coordinated by the Consultative Committee for Amount of Substance: Metrology in Chemistry and Biology (CCQM) from 1992

CCQM_Retrospectoscope Reference Manual: A detailed reference to the CCQM_Retrospectoscope, a suite of graphical tools for the meta-analysis of measurement results from CCQM studies

September 12, 2023
Author(s)
David L. Duewer, Michael Nelson, Christina Cecelski
The CCQM_Retrospectoscope system combines a nominally complete database of results from Consultative Committee for the Amount of Substance: Metrology in Chemistry and Biology (CCQM) studies with a number of graphical tools for trying to make sense of the

Methods for the SI Value Assignment of the Purity of Organic Compounds (IUPAC Technical Report)

January 18, 2023
Author(s)
David L. Duewer, Katrice Lippa, Brian Lang, Blaza Toman, Michael Nelson, Kenneth W. Pratt, Steven Westwood, Yoshitaka Yoshitaka Shimuzu, Takeshi Saito, Beatrice Lalerle, Xinhua Dai, Stephen Davies, Marina Ricci, Annarita Baldan, Stefan Sarge, Haifeng Wang, Ralf D. Josephs, Michal Mariassy, Dietmar Pfieffer, John Warren, Wolfram Bremser, Stephen L.R. Ellison, Ting Huang, Ales Fajgelj, Lindsey Mackay, Robert Wielgosz
Metrological traceability to the SI of the result of an analysis for an organic compound is achieved through a calibration hierarchy anchored in a primary calibrator of the compound, the mass fraction content of which is established in a manner traceable

Interlaboratory Studies using the NISTmAb to Advance Biopharmaceutical Structural Analytics

May 5, 2022
Author(s)
Katharina Yandrofski, Trina Mouchahoir, M. Lorna De Leoz, David L. Duewer, Jeffrey W. Hudgens, Kyle Anderson, Luke Arbogast, Frank Delaglio, Robert Brinson, John Marino, Karen W. Phinney, Michael J. Tarlov, John E. Schiel
Biopharmaceuticals such as monoclonal antibodies are required to be rigorously characterized using a wide range of analytical methods. Various material properties must be characterized and well controlled to assure that clinically relevant features and

Assessment of Serum Total 25-Hydroxyvitamin D Assays for Vitamin D External Quality Assessment Scheme (DEQAS) Materials Distributed at Ambient and Frozen Conditions

November 9, 2021
Author(s)
Johanna Camara, Christopher T. Sempos, Emma L. Williams, Graham D. Carter, Julia C. Jones, Carolyn Burdette, Grace Hahm, Federica Nalin, David L. Duewer, Adam J. Kuszak, J. M. Betz, Andrew Hoofnagle, Pierre Lukas, E. Cavalier, Ramon Durazo-Arvizu, P. M. Crump, Christian Popp, Christian Beckert, Glen Van Slooten, Patrick Gradon, Joelle Morgand, Sarah Paul, Bruno Emanuelli, Angelo Maggio, Fiona Ivison, Ralf Fischer, Jody M. van den Ouweland, Chung S. Ho, Emmett W. Law, Jean-Nicolas Simard, Renaud Gonthier, Brett Holmquist, Manisha S. Patwardhan, Marcelo C. Batista, Heather Pham, Sarah Meadows, Eugene Jansen, Dilshad A. Khan, Kimberly Robyak, Mark Kilbane, Neil Parker, Vincent Chen, Robert Fitzgerald, Sohail Mushtaq, Michael W. Clarke, Norma Breen, Christine Simpson, Stephen A. Wise
The Vitamin D External Quality Assessment Scheme (DEQAS) distributes human serum samples four times per year to over 1000 participants worldwide for the determination of total serum 25-hydroxyvitamin D [25(OH)D)]. These samples are stored at −40 °C prior

Metrological Tools for the Reference Materials and Reference Instruments of the NIST Material Measurement Laboratory

September 16, 2021
Author(s)
Carlos R. Beauchamp, Johanna Camara, Jennifer Carney, Steven J. Choquette, Kenneth D. Cole, Paul C. DeRose, David L. Duewer, Michael Epstein, Margaret Kline, Katrice Lippa, Enrico Lucon, John L. Molloy, Michael Nelson, Karen W. Phinney, Maria Polakoski, Antonio Possolo, Lane C. Sander, John E. Schiel, Katherine E. Sharpless, Michael R. Winchester, Donald Windover
The National Institute of Standards and Technology (NIST), formerly the National Bureau of Standards, was established by the U.S. Congress in 1901 and charged with establishing a measurement foundation to facilitate U.S. and international commerce. NIST

Lessons From the NIST Micronutrients Quality Assurance Program for Vitamin C, 1993 to 2015: Sample Stability, Assay Reproducibility, and Use of Controls to Improve Comparability

November 11, 2020
Author(s)
David L. Duewer, Jeanice M. Brown Thomas, Katherine E. Sharpless, S A. Margolis
Vitamin C is a necessary micronutrient that is involved in many biological processes. In preserved human plasma and serum, vitamin C is most meaningfully analyzed as total ascorbic acid (TAA). From 1993 through 2015, the National Institute of Standards and

Metrological Tools for the Reference Materials and Reference Instruments of the NIST Material Measurement Laboratory

July 15, 2020
Author(s)
Carlos R. Beauchamp, Johanna Camara, Jennifer Carney, Steven J. Choquette, Kenneth D. Cole, Paul C. DeRose, David L. Duewer, Michael Epstein, Margaret C. Kline, Katrice Lippa, Enrico Lucon, Karen W. Phinney, Maria Polakoski, Antonio Possolo, Katherine E. Sharpless, John R. Sieber, Blaza Toman, Michael R. Winchester, Donald Windover
The National Institute of Standards and Technology (NIST), formerly the National Bureau of Standards, was established by the U.S. Congress in 1901 and charged with establishing a measurement foundation to facilitate U.S. and international commerce. NIST

NIST Reference Materials: Their Purpose and Their Future

March 15, 2020
Author(s)
Steven J. Choquette, David L. Duewer, Katherine E. Sharpless
The National Institute of Standards and Technology (NIST), formerly the National Bureau of Standards, was established by the U.S. Congress in 1901 and charged with establishing a measurement foundation to facilitate U.S. and international commerce. This