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Megan Cleveland (Fed)

Research Biologist

Megan received a Ph.D. in Molecular Biology and Human Genetics from the Johns Hopkins School of Medicine, where she studied pancreas development in mice. At NIST, Megan focuses on biomanufacturing and clinical diagnostics. She is particularly interested in digital PCR and next generation sequencing. 

Megan is currently leading the release of NISTCHO as RM 8675. NISTCHO, previously released as RGTM 10197, is a mammalian cell line that produces a monoclonal antibody (cNISTmAb). NISTCHO is part of NIST's suite of biomanufacturing-related reference materials, along with NISTmAb (RM 8671). NISTCHO can be used to study processes that affect monoclonal antibody (mAb) production, as well as processes that improve mAb purification efficiency. NISTCHO is also used in educational settings to train the next generation of biomanufacturing professionals. 

Megan is also the technical project lead (TPL) for several virus reference materials, which help to harmonize and standardize diagnostic tests. Most recently, Megan led the production and release of RGTM 10263 (H5N1 (Avian Influenza) Synthetic RNA Fragments). This material is intended to provide diagnostics manufacturers and researchers with a non-hazardous material for PCR-based assay design and testing. 

Additionally, Megan is the TPL for NIST SRM 2365 (BK Virus DNA Quantitative Standard) and NIST SRM 2367 (JC Virus DNA Quantitative Standard)

During the COVID-19 pandemic, Megan produced Research Grade Test Material (RGTM 10169) for SARS-CoV-2 RNA. She worked with the Public Affairs Office to make a video about the creation of this material. RGTM 10169 was distributed to over 170 labs in 25 countries. 

Megan is also interested in using NGS to detect possible contaminants in biologically produced materials. She co-organized a NIST/FDA workshop in 2019 for Standards for NGS Detection of Viral Adventitious Agents in Biologics and Biomanufacturing. A summary of the workshop's output was published in 2020. She leads Subgroup B (Standards and Reference Materials) for the Advanced Virus Detection Technologies Interest Group (AVDTIG). She has also worked with the Genome in a Bottle (GiaB) consortium to examine results from targeted sequencing panels on GiaB benchmark genomes. Targeted sequencing panels may offer a cost-effective way of characterizing many clinically critical genomic regions.

A complete list of Dr. Cleveland's publications can be found here

Postdoctoral Research Opportunities

Megan is currently looking for applicants for the following opportunities:

Accurate Nucleic Acid Measurements for Molecular Diagnostics

Ensuring the Safety of Vaccines and Biologics

If you are interested in applying to either opportunity, please email Dr. Cleveland at megan.cleveland [at] nist.gov (megan[dot]cleveland[at]nist[dot]gov).

Publications

The Application of Digital PCR as a Reference Measurement Procedure to Support the Accuracy of Quality Assurance for Infectious Disease Molecular Diagnostic Testing

Author(s)
Samreen Falak, Denise O'Sullivan, Megan Cleveland, Simon Cowen, Eloise Busby, Alison Devonshire, Esmeralda Valiente, Gerwyn Jones, Martin Kammel, Mojca Milavec, Laura Vierbaum, Ingo Schellenberg, Heinz Zeichhardt, Andreas Kummrow, Peter Vallone, Rainer Macdonald, Jim Huggett
Background Nucleic Acid Amplification Tests (NAATs) are used to diagnose many infectious diseases. They are typically sensitive and specific and can be quickly

Standards and Metrology for Viral Vectors as Molecular Tools: Outcomes from a CCQM Workshop

Author(s)
Janathan Campbell, Neil Almond, Y Bae, Ravneet Bhuller, Andrea Briones, S-Y CHO, Megan Cleveland, Thomas Cleveland, Francis Galaway, Hua-Jun He, U Herbrand, Jim Huggett, Sarah Kempster, Ibolya Kepiro, Afifa Khan, Edward Kwee, Wilson Li, Sheng Lin-Gibson, Luise Luckau, Caterina Minelli, M Ryadnov, I Searing, Lili Wang, Alexandra Whale, Julian Braybrook
Viral vectors are agents enabling gene transfer and genome editing and have widespread utility across the healthcare and biotechnology sectors. In January 2023

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

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

Digital PCR for the Characterization of Reference Materials

Author(s)
Megan Cleveland, Hua-Jun He, Mojca Milavec, Young-Kyung Bae, Peter Vallone, Jim Huggett
Well characterized reference materials are essential to ensuring the harmonization and accuracy of nucleic acid-based tests (such as qPCR); digital PCR (dPCR)
Created September 17, 2019, Updated February 24, 2025