U.S. flag

An official website of the United States government

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Search Publications by: Karen W. Phinney (Fed)

Search Title, Abstract, Conference, Citation, Keyword or Author
Displaying 1 - 25 of 94

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

State-of-the-art and trends for the SI traceable value assignment of the purity of peptides using the model compound angiotensin I

March 27, 2018
Author(s)
Ralf D. Josephs, Norbert Stoppacher, Adeline Daireaux, Tiphaine Choteau, Katrice Lippa, Karen W. Phinney, Steven Westwood, Robert Wielgosz
Accurate diagnosis, monitoring and treatment are cornerstones of a healthcare system and require reliable measurements. The traceability of measurement results to stated references, and the development of Reference Measurement Systems (RMS), provide

The NISTmAb Reference Material 8671 Value Assignment, Homogeneity, and Stability

March 1, 2018
Author(s)
John E. Schiel, Abigail Turner, Catherine A. Mouchahoir, Katharina S. Yandrofski, Srivalli Telikepalli, Jason King, Paul C. DeRose, Dean C. Ripple, Karen W. Phinney
The NISTmAb Reference Material (RM) 8671 is intended to be the common industry standard monoclonal antibody for pre-competitive research in harmonizing current state-of-the-art technology and designing next generation characterization technologies for

Baseline Assessment of 25-Hydroxyvitamin D Assay Performance: A Vitamin D Standardization Program (VDSP) Interlaboratory Comparison Study

August 18, 2017
Author(s)
Christopher T. Sempos, Stephen Wise, Karen W. Phinney, Susan Tai, Johanna Camara, Gary L. Myers, Ramon Durazo-Arvizu, Lu Tian, John H. Eckfeldt, Andrew N. Hoofnagle, W. Greg Miller, Lorin M. Bachmann, Ian S. Young, J Pettit, G. Caldwell, A Liu, S P. Brooks, K. Sarafin, M. Thamm, C. Scheidt-Nave, G. B. Mensink, M. Busch, M. Rabenberg, Kevin Cashman, Mairead Kiely, Michael Kinsella, K Galvan, J. Y. Zhang, K OH, S. W. Lee, C. L. Jung, L. Cox, G. Goldberg, K. Guberg, S. Meadows, A. Prentice, G. Swan, A. Tedstone, Graham D. Carter, Julia C. Jones, P. Brannon, R. M. Lucas, P. M. Crump, Glenville Jones, E. Cavalier, Joyce Merkel, J. M. Betz
The Vitamin D Standardization Program (VDSP) coordinated an interlaboratory study to assess the comparability of measurements of total 25-hydroxyvitamin D [25(OH)D] in human serum, which is the primary marker of vitamin D status. A set of 50 individual

Baseline assessment of 25-hydroxyvitamin D reference material and proficiency testing/external quality assurance material commutability - a vitamin D standardization program study

August 10, 2017
Author(s)
Karen W. Phinney, Christopher T. Sempos, Hubert W. Vesper, Julianne C. Botelho, M Dasti, Yasamin Rahmani, Susan Tai, Johanna Camara, Stephen A. Wise, Gary L. Myers, Ramon Durazo-Arvizu, Lu Tian, John H. Eckfeldt, Andrew N. Hoofnagle, W. Greg Miller, Lorin M. Bachmann, Ian S. Young, J Pettit, G. Caldwell, A Liu, S P. Brooks, K. Sarafin, M. Thamm, C. Scheidt-Nave, G. B. Mensink, M. Busch, M. Rabenberg, Kevin Cashman, Mairead Kiely, Albert Flynn, Kirsten D. Dowling, B. Quinn, K OH, S. W. Lee, C. L. Jung, L. Cox, G. Goldberg, K. Guberg, S. Meadows, A. Prentice, G. Swan, Alison Tedstone, Schleicher Rosemary, Christine M. Pfeiffer, Graham D. Carter, Julia Jones, P. Brannon, R. M. Lucas, Neil C. Binkley, P. M. Crump, Donald Wiebe, Glenville Jones, J. M. Betz, C. D. Faigen, Joyce Merkel, Elizabeth A. Yetley, Paul M. Coates
The Vitamin D Standardization Program (VDSP) coordinated a study to assess the commutability of reference materials and proficiency testing/external quality assurance materials for total 25-hydroxyvitamin D [25(OH)D] in human serum, the primary indicator

General steps to standardize the laboratory measurement of serum total 25-hydroxyvitamin D

August 1, 2017
Author(s)
Karen W. Phinney, Christopher T. Sempos, J. M. Betz, Johanna Camara, Graham D. Carter, E. Cavalier, Michael W. Clarke, Kirsten D. Dowling, Ramon Durazo-Arvizu, Andrew N. Hoofnagle, A Liu, Kurtis Sarafin, Stephen A. Wise, Paul M. Coates
The Vitamin D Standardization Program (VDSP) has collaborated with numerous groups and agencies to assemble a set of tools, i.e. a reference measurement system, that can be used to establish traceability of 25-hydroxyvitamin D [25(OH)D] assays to relevant

Development of Standard Reference Material (SRM) 2973 Vitamin D Metabolites in Frozen Human Serum (High Level)

July 24, 2017
Author(s)
Susan Tai, Michael Nelson, Brian Lang, Karen W. Phinney, Lane C. Sander, James H. Yen, J. M. Betz, Christopher T. Sempos, Stephen Wise
The National Institute of Standards and Technology (NIST), in collaboration with the National Institutes of Health, Office of Dietary Supplements (NIH-ODS) and the Vitamin D Standardization Program (VDSP), has recently issued a new serum-matrix Standard

Value Assignment of Vitamin D Metabolites in Vitamin D Standardization Program (VDSP) Serum Samples

June 16, 2017
Author(s)
Karen W. Phinney, Johanna Camara, Susan Tai, Lane C. Sander, Stephen A. Wise, Linde A. De Grande, Linda M. Thienpont, Antonio M. Possolo, Blaza Toman, Christopher T. Sempos, J. M. Betz, Paul M. Coates
Assay variability has been cited as an obstacle to establishing optimal vitamin D exposure. As part of the Vitamin D Standardization Program (VDSP) effort to standardize the measurement of total 25(OH)D, value assignment of total 25(OH)D in 50 single donor

Development of an Improved Standard Reference Material for Vitamin D Metabolites in Human Serum

April 4, 2017
Author(s)
Karen W. Phinney, Susan S. Tai, Mary Bedner, Johanna Camara, Rosalind R. Chia, Lane C. Sander, Katherine E. Sharpless, Stephen A. Wise, James H. Yen, Rosemary L. Schleicher, Madhulika Chaudhary-Webb, Khin L. Maw, Yasamin Rahmani, Hubert W. Vesper, Joseph M. Betz, Joyce Merkel, Christopher T. Sempos, Paul M. Coates, Ramon Durazo-Arvizu, Kurtis Sarafin, Stephen P. Brooks

Mass Spectral Library Quality Assurance by Inter-Library Comparison

April 2, 2017
Author(s)
William E. Wallace, Weihua Ji, Dmitrii V. Tchekhovskoi, Karen W. Phinney, Stephen E. Stein
A method to discover and correct errors in mass spectral libraries is described. Comparing across a set of highly curated reference libraries compounds that have the same chemical structure quickly identifies entries that are outliers. In cases where three

A new approach to quantification of mAb aggregates using peptide affinity probes

February 10, 2017
Author(s)
Crystal Cheung, Kyle Anderson, Pooja Patel, Keale Cade, Karen W. Phinney, Illarion Turko
Using mAbs as therapeutic molecules is complicated by the propensity of mAbs to aggregate at elevated concentrations, which can lead to a variety of adverse events in treatment. Here, we describe a proof-of-concept for new methodology to detect and