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Search Publications by: Karen W. Phinney (Fed)

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Displaying 1 - 25 of 187

Quantification of mRNA in Lipid Nanoparticles Using Mass Spectrometry

December 26, 2023
Author(s)
Mark Lowenthal, Abigail Antonishek, Karen W. Phinney
Lipid nanoparticle-encapsulated messenger RNA (LNP-mRNA) holds great promise as a novel modality for treating a broad range of diseases. The ability to quantify mRNA accurately in therapeutic products helps to ensure consistency and safety. Here we

Humanized Monoclonal Antibody IgG1k, NISTmAb RM 8671 Summary of 5 Year Stability Verification (5YSV)

March 31, 2023
Author(s)
Katharina Yandrofski, John E. Schiel, Trina Mouchahoir, Srivalli Telikepalli, N. Alan Heckert, Dean C. Ripple, Paul C. DeRose, Karen W. Phinney, John Marino
NISTmAb RM 8671 is an IgG1κ monoclonal antibody that has been extensively characterized and released as the first of its kind biopharmaceutical reference material in 2016. This material was intended primarily for use in evaluating the performance of

Development of an Improved Standard Reference Material for Folate Vitamers in Human Serum

December 12, 2022
Author(s)
Johanna Camara, Jeanita Pritchett, Yasmine Daniels, Mary Bedner, Michael Nelson, Mark Lowenthal, Zia Fazili, Christine Pfeiffer, Karen W. Phinney, Katherine E. Sharpless, Lane C. Sander, Katrice Lippa, James H. Yen, Adam Kuszak, Stephen Wise
The US National Institute of Standards and Technology (NIST) developed a Standard Reference Material® (SRM®) 3949 Folate Vitamers in Frozen Human Serum to replace SRM 1955 Homocysteine and Folate in Human Serum. The presence of increased endogenous levels

The Influence of Proteoforms: Assessing the Accuracy of Total VDBP Quantification by Proteolysis and LC-MS/MS

October 24, 2022
Author(s)
Lisa Kilpatrick, Roger Bouillon, Clay Davis, Clark Henderson, Andrew N. Hoofnagle, Steven Pauwels, Dirk Vanderschueren, Etienne Waelkens, Hans Wildiers, James H. Yen, Karen W. Phinney
Objectives: Vitamin D-binding protein (VDBP), a serum transport protein for 25-hydroxyvitamin D [25(OH)D], has three common proteoforms which have co-localized amino acid variations and glycosylation. A monoclonal immunoassay was found to differentially

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

Certification of Standard Reference Material(R) 3655 Glycans in Solution (Frozen)

April 12, 2022
Author(s)
Mark Lowenthal, Blaza Toman, Brian Lang, Karen W. Phinney
Standard Reference Material (SRM) 3655 is intended primarily for use as a calibration standard for the measurement of enzymatically released N-linked glycans. Applications of SRM 3655 include the benchmarking and comparability of analytical techniques, as

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

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

Absolute quantification of RNA or DNA using acid hydrolysis and mass spectrometry

October 22, 2019
Author(s)
Mark S. Lowenthal, Eva Quittman, Karen W. Phinney
Accurate, traceable quantification of ribonucleotide or deoxyribonucleotide oligomers is achievable using acid hydrolysis and isotope dilution mass spectrometry (ID-MS). In this work, formic acid hydrolysis is demonstrated to generate stoichiometric

Final Report for CCQM-K6.2: Determination of Total Cholesterol in Human Serum

June 7, 2018
Author(s)
Stephen Wise, Karen W. Phinney, David L. Duewer
Cholesterol is one of the most frequently measured substances in human blood/serum to assist in assessing the health status of individuals. Because of its clinical significance, CCQM-K6 Determination of Cholesterol in Serum was completed in 2000 as one of