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Search Publications by: Kenneth D. Cole (Assoc)

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Displaying 1 - 25 of 67

Interlaboratory Assessment of Candidate Reference Materials for Lentiviral Vector Copy Number and Integration Site Measurements

April 21, 2025
Author(s)
Hua-Jun He, Zhiyong He, Steven Lund, Barbara Paugh, Jennifer McDaniel, Justin Zook, Sierra Miller, Samantha Maragh, Simona Patange, Mahir Mohiuddin, Alessandro Tona, John Elliott, Kenneth Cole, Sheng Lin-Gibson
Reference materials are essential for accurately measuring integrated lentiviral vector (LV) copy number (VCN) and integration sites for the safety and efficacy of lentivirus-based gene therapy. We conducted an interlaboratory study on NIST candidate

Quantitation and integrity evaluation of RNA genome in lentiviral vectors by direct reverse transcription-droplet digital PCR (direct RT-ddPCR)

September 2, 2023
Author(s)
Zhiyong He, Edward Kwee, Megan Cleveland, Kenneth Cole, Sheng Lin-Gibson, Hua-Jun He
Abstract Lentiviral vectors (LV) have proven to be powerful tools for stable gene delivery in both dividing and non-dividing cells. Approval of these LVs for use in clinical applications has been achieved by improvements in LV design. Critically important

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

Reference standards for accurate validation and optimization of assays that determine integrated Lentiviral vector copy number in transduced cells

July 11, 2021
Author(s)
Barbara S. Paugh, Lajos Baranyi, Andre Roy, Hua-Jun He, Lindsay Harris, Kenneth Cole, Caroline Raimund, Patricia S. Langan, Moria Artlip, Srikanta Jana, Rimas J. Orentas, Sheng Lin-Gibson, Winfried Krueger, Boro Dropuli?
Lentiviral vectors (LV) have emerged as a robust technology for therapeutic gene delivery into human cells as advanced medicinal products. As these products are increasingly commercialized, there are concomitant demands for their characterization to ensure

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

Development and Interlaboratory Evaluation of a NIST Reference Material RM 8366 for EGFR and MET Gene Copy Number Measurements

May 21, 2019
Author(s)
Hua-Jun He, Biswajit Das, Megan H. Cleveland, Chen Li, Corinne Camalier, Liang-Chu Liu, Kara L. Norman, Andrew Fellowes, Christopher McEvoy, Steven P. Lund, Jamie L. Almeida, Carolyn R. Steffen, Chris Karlovich, P. M. Williams, Kenneth D. Cole
The National Institute Standard and Technology (NIST) Reference Material RM 8366 was developed to improve the quality of gene copy measurements of EGFR (epidermal growth factor receptor) and MET (proto-oncogene, receptor tyrosine kinase), important targets

Multi-Laboratory Assessment of a New Reference Material for Quality Assurance of Cell-Free Tumor DNA Measurements

May 2, 2019
Author(s)
Hua-Jun He, Erica V. Stein, Yves Konigshofer, Thomas Forbes, Farol L. Tomson, Russell Garlick, Emiko Yamada, Tony Godfrey, Toshiya Abe, Koji Tamura, Michael Borges, Michael Goggins, Sandra Elmore, Margaret L. Gulley, Jessica L. Larson, Lando Ringel, Brian C. Haynes, Corinne Camalier, Chris Karlovich, Biswajit Das, P. M. Williams, Aaron Garnett, Anders Stahlberg, Stefan Filges, Lynn Sorbara, Mathew R. Young, Sudhir Srivastava, Kenneth D. Cole
We conducted a multi-laboratory assessment to determine the suitability of a new commercially- available reference material with 40 cancer variants in a background of wild-type DNA at four different variant allele fractions (VAF): 2%, 0.5%, 0.125%, and 0 %

NIST Spectroscopic Measurement Standards

May 1, 2018
Author(s)
Paul C. DeRose, Kenneth D. Cole, Aaron Urbas, Steven J. Choquette, Evelyn Solis, Erica V. Stein, John E. Schiel, Brian Lang, Hua-Jun He
Ultraviolet (UV) absorbance measurements provide a rapid and reliable method to determine protein concentrations. The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082as a pathlength standard for UV

Development of NIST Standard Reference Material 2082, a Pathlength Standard for Measurements in the Ultraviolet Spectrum

July 10, 2017
Author(s)
Brian Lang, Aaron A. Urbas, Paul C. DeRose, Hung-Kung Liu, John C. Travis, Steven J. Choquette, Kenneth D. Cole
New spectrophotometers and cuvettes have been designed to allow the measurement of absorbance values from samples using microliter volume sizes. These measurements are done using short pathlengths to decrease the sample volumes required. The major

Certified DNA Reference Materials to Compare HER2 Gene Amplification Measurements Using Next- Generation Sequencing Methods

September 1, 2016
Author(s)
Chih-Jian Lih, Robin D. Harrington, Kneshay Harper, David J. Sims, Paul McGregor, Corinne Camalier, Han Si, Biswajit Das, P. M. Williams, Hua-Jun He, Jamie L. Almeida, Steven Lund, Steven J. Choquette, Kenneth D. Cole
The National Institute of Standards and Technology (NIST) Standard Reference Materials 2373 is a set of genomic DNA samples prepared from five breast cancer cell lines with certified values for the ratio of the HER2 gene copy number to the copy numbers of

Standards for cell line authentication and beyond

June 14, 2016
Author(s)
Jamie L. Almeida, Kenneth D. Cole, Anne L. Plant
Different genomic technologies have been applied to cell line authentication, but only one method (short tandem repeat profiling) has been the subject of a comprehensive standard (ASN-0002). Here we discuss the power of this document, and why standards

Quantifying CD4 receptor protein in two human CD4+ lymphocyte preparations for quantitative flow cytometry

December 11, 2014
Author(s)
Meiyao M. Wang, Martin Misakian, Hua-Jun He, Peter Bajcsy, Jeffrey M. Davis, Kenneth D. Cole, Illarion Turko, Lili Wang, Fatima Abbasi
For quantitative flow cytometry, a biological cell reference material with a known biomarker expression level is needed to transform a linear arbitrary fluorescence intensity scale obtained with fluorescent microspheres to an antibody bound per cell (ABC)

Mouse Cell Line Authentication

February 13, 2013
Author(s)
Jamie L. Almeida, Carolyn R. Steffen, Kenneth D. Cole
The scientific community has responded to the misidentification of human cell lines with validated methods to authenticate these cells; however, there are few assays available for nonhuman cell line identification. We have developed a multiplex polymerase

Breast Cancer Biomarker Measurements and Standards

January 24, 2013
Author(s)
Kenneth D. Cole, Lili Wang, Hua-Jun He
Cancer is a heterogeneous disease characterized by changes in the levels and activities of important cellular proteins, including oncogenes and tumor suppressors. Genetic mutations cause changes in protein activity and protein expression levels that result
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