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Kenneth D. Cole

At NIST I work in teams on three major projects, development of cancer bio marker standards, cell line authentication methods, and bioprocessing measurements. We are currently completing work on a genomic DNA standard for HER2, a NIST standard reference material (SRM). This standard is produced from 5 breast cancer cell lines with different degrees of HER2 gene amplification. We are working on additional standards for biomarkers for copy number variations in cancer. A number of reports in high-visibility scientific journals have highlighted the problem of irreproducibility in biological measurements. Significant improvement in the quality of the measurements can be achieved through the routine use of standards (reference materials and methods) and conformation of results using interlaboratory testing. NIST is working with the Early Detection Research Network (part of the National Cancer Institute) to improve the quality of the measurements for the early detection of cancer. A promising new technology is the measurements of circulating tumor DNA (ctDNA) found in the blood and used to detect the genomic mutations present in tumors. Measurement of ctDNA has significant analytical challenges. We are working on standards to improve the measurements of ctDNA for cancer diagnosis and therapeutic monitoring.

Misidentified and contaminated cell lines are a serious problem in scientific research. We are working on developing multiplex methods to authenticate important cell lines used in research and production of biologicals. We are working on mouse, rat, and Chinese hamster ovary (CHO) cell lines. We are working on measurements to express and characterize protein therapeutics. CHO cells are commonly used to produce protein therapeutics in large amounts. In collaboration with a major bio-pharmaceutical company we are studying CHO genomic stability during production of protein therapeutics. We are also measuring the thermo dynamic properties of protein therapeutics including a NIST monoclonal antibody reference material (NISTmAb).

Postdoctoral research fellowships for U.S.citizens are available at NIST through the National Research Council (http://www.nist.gov/iaao/postdoc.cfm).

Representative Publications

Almeida, J.A., Hill, C.R., Cole, K.D. Authentication of African green monkey cell lines using human short tandem repeat markers. BMC Biotechnology 11, 102-112 (2011)

Wang, L., Abbasi, F., Ornatsky, O., Cole, K.D., Misakian, M., Gaigalas, A.K., He, Hua-Jun, Marti, G.E., Tanner, S., Stebbings, R. Characterization of human CD4+lymphocytes from different cell preparations as candidate biological cell reference materials for quantitative multiparameter flow cytometry. Cytometry Part A 81A, 567-575 (2012).

Cole, K.D., He, H.J., and Wang L. Breast Cancer Biomarker Measurements and Standards. Proteomics Clinical Applications 7, 17-29 (2013).

Almeida, J.L, Hill, C.R., Cole, K.D. Mouse Cell Line Authentication. Cytotechnology10.1007/s106160-013 (2013).

L.Wang, M. Misakian, H-J He, Hua-Jun; P. Bajcsy, J. Davis, K. Cole, I. Turko, L. Wang, Lili, F. Abbasi Characterization of Two Human CD4+ Lymphocyte Preparations for Quantitative Flow Cytometry Clinical Proteomics (in press).

B.L. Lang and Cole, K.D. Unfolding Properties of Recombinant Human Serum Albumin Products Are Due to Bioprocessing Steps. Biotechnology Progress. 2014 Sep 30. doi: 10.1002/btpr.1996.



Biosystems and Biomaterials Division
Bioassay Methods Group


Johns Hopkins University, M.S. in Information and Telecommunications Systems for Business

Postdoctoral Fellowships at the University of Arizona, Department of Biochemistry, and the University of South Carolina, Department of Chemistry Columbia, SC

Texas Tech University Health Sciences Center, Ph.D. in Medical Biochemistry

California State Polytechnic University, Pomona, CA, B.S. in Zoology


Phone: 1-301-975-2169
Email: Kenneth.Cole@nist.gov