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nist-gov/www.nist.gov/topic-terms/engineering-synthetic-biology
Scott Williams 4063bef310 Initital commit.
2025-03-05 18:59:57 +00:00

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<h1 class="nist-page__title">Engineering / synthetic biology</h1>
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<h2 class="nist-block__title">Engineering / synthetic biology Topics</h2>
<ul>
<li><div class="views-field views-field-field-shared-section"><div class="field-content"><a href="/biofabrication" hreflang="en">Biofabrication</a></div></div></li>
<li><div class="views-field views-field-field-shared-section"><div class="field-content"><a href="/cell-free-systems" hreflang="en">Cell-free systems</a></div></div></li>
<li><div class="views-field views-field-field-shared-section"><div class="field-content"><a href="/genome-engineering" hreflang="en">Genome engineering</a></div></div></li>
<li><div class="views-field views-field-field-shared-section"><div class="field-content"><a href="/protein-engineering" hreflang="en">Protein engineering</a></div></div></li>
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<div class="text-with-summary margin-bottom-5">
<div class="nist-callout">
<p><span><span><span>Commercial-scale production of any high quality and consistent product relies on accurate measurements. Unlike static materials, biological systems and processes can be difficult to measure because they are always changing. NIST develops solutions for these measurement problems to help the U.S. maintain leadership of <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5173e6b8-8da9-4421-a34e-08a7ef021543" href="/node/1079006/nists-role-bioeconomy" title="NIST’s Role in the Bioeconomy">the global bioeconomy</a>.</span></span></span></p>
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<p><span><span>Engineering biology, also known as synthetic biology, enables the intentional design, manufacture and deployment of&nbsp;living cells, cell systems, and other biological processes to create materials and products that benefit us, like crops that resist drought and pests, renewable energy sources, advanced medicines, and more.&nbsp;</span></span></p>
<p><span><span>NIST’s measurement science and other technical activities support robust innovation and more sustainable manufacturing practices in distributed manufacturing centers, which help alleviate supply chain disruptions for synthetic biology’s most-needed products, like commodity chemicals and materials, and medicines.&nbsp;</span></span></p>
<h3><span><span><span><span>NIST research promotes:&nbsp;</span></span></span></span></h3>
<h2>Innovation</h2>
<p><span><span><span><span><span><span>We provide industry members and researchers with tools to automate the many complex processes required to intentionally design living cells to perform as factories. </span></span></span></span></span></span></p>
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<div class="video-embed-field"><div class="video-embed-field-lazy" data-video-embed-field-lazy="&lt;div class=&quot;video-embed-field-provider-nist-kaltura video-embed-field-responsive-video&quot;&gt;&lt;iframe width=&quot;854&quot; height=&quot;480&quot; frameborder=&quot;0&quot; allow=&quot;autoplay *; fullscreen *; encrypted-media *&quot; allowfullscreen=&quot;allowfullscreen&quot; src=&quot;https://www.kaltura.com/p/684682/embedPlaykitJs/uiconf_id/55674542?iframeembed=true&amp;amp;entry_id=0_ap1sg96i&quot;&gt;&lt;/iframe&gt;
&lt;/div&gt;
"><img alt="NIST Living Measurement Systems Foundry" loading="lazy" src="https://cdnsecakmi.kaltura.com/p/684682/sp/68468200/thumbnail/entry_id/0_ap1sg96i/width/1280" typeof="foaf:Image">
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<div class="video-embed-field-lazy-title">NIST Living Measurement Systems Foundry</div>
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<ul>
<li><span><span><span><span><span><span>The </span><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="3f8deb86-c9d8-4bc8-903f-83ab3f73650c" href="/programs-projects/nist-living-measurement-systems-foundry" title="NIST Living Measurement Systems Foundry">Living Measurement Systems Foundry</a><span> is a unique, flexible automation system for measuring the whole landscape of cells, from the genes that direct their growth to the substances they produce, and selecting cells for their desired functions.</span></span></span></span></span></span></li>
</ul>
<ul>
<li><span><span><span><span><span><span>The NIST Prototype Cell Assay Measurement Platform (</span><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="f88ba58b-0980-41a7-93f1-be0ae82214e8" href="/programs-projects/prototype-cell-assay-measurement-platform-p-camp" title="Prototype Cell Assay Measurement Platform (P-CAMP)">P-CAMP</a><span>) is a model biofoundry for rapid generation of robust protocols for biological and cellular measurements. It provides unique end-to-end automation to advance measurement science for emerging biotechnologies.</span></span></span></span></span></span></li>
<li><span><span><span><span><span><span>The&nbsp;<a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4bedbfab-1ebe-44df-a16c-e321035e0041" href="/programs-projects/nist-flow-cytometry-standards-consortium" title="NIST Flow Cytometry Standards Consortium  ">Flow Cytometry Standards Consortium</a>&nbsp;develops quantitative measurements and standards for the measurement of cell characteristics to support emerging biotechnologies and advanced biomanufacturing.&nbsp;</span></span></span></span></span></span></li>
</ul>
<ul>
<li>NIST partners with the research community and contributes to the development of measurement solutions, shared protocols, and standards for innovation in engineering biology through the <a href="https://biofoundries.org/">Global Biofoundry Alliance</a>, the<a href="https://www.buildacell.org/"> Build-A-Cell</a> collaboration, and the <a href="https://sbolstandard.org/">Synthetic Biology Open Language</a> standard.</li>
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<h2><span><span><span><strong><span><span><span>Commercialization </span></span></span></strong></span></span></span></h2>
<p><span><span><span><span><span><span>NIST develops cell-based reference materials that provide benchmarks for industry developers and regulators to check the quality of their measurements and laboratory processes—helping to ensure rapid development, efficient manufacturing processes, and safe, marketable products.</span></span></span></span></span></span>&nbsp;</p>
<ul>
<li><span><span><span><span><span><span><span>A&nbsp;</span></span></span><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="df5a7a7d-e6fd-445f-895f-9dcd6641b341" href="/programs-projects/living-yeast-cell-reference-material-rm-8230" title="Living Yeast Cell Reference Material (RM 8230)"><span><span><span>living cell reference material</span></span></span></a><span><span><span>&nbsp;will help researchers and product developers accurately count microbes as they are cultured. It can also be used as a safe material for training first responders to detect biothreats.&nbsp;</span></span></span></span></span></span></span></li>
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<figure class=" align-right nist-image--lightbox nist-image" role="group">
<div data-lightbox="https://www.nist.gov/sites/default/files/styles/2800_x_2800_limit/public/images/2018/12/04/nistmab_monoclonal_antibody.jpg?itok=cKYmsMjW" data-media-id="239596">
<img alt="A schematic of the NIST monoclonal antibody reference material. " height="220" loading="lazy" src="/sites/default/files/styles/220_x_220_limit/public/images/2018/12/04/nistmab_monoclonal_antibody.jpg?itok=25Ux_L6I" typeof="foaf:Image" width="212">
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<figcaption class="nist-image__caption">A schematic of the NIST monoclonal antibody reference material 8671.</figcaption>
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<li><span><span><span><span><span><span><span>The NIST Chinese Hamster Ovary cell line, or&nbsp;</span></span></span><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ea039fbf-4de7-4dca-b1b7-ad3d5697be3c" href="/programs-projects/nistcho" title="NISTCHO"><span><span><span>NISTCHO</span></span></span></a><span><span><span>, will allow biopharmaceutical manufacturers and academic and government researchers&nbsp;to develop new measurements and methods for assessing the biological processes that occur in the CHO cell line, which is used around the world to produce </span></span></span><a href="https://www.cancer.gov/publications/dictionaries/cancer-terms/def/monoclonal-antibody"><span><span>monoclonal antibodies</span></span></a><span><span><span> for medical therapies.&nbsp;</span></span></span></span></span></span></span></li>
<li><span><span><span><span><span><span><span>Artificial intelligence and machine learning are powerful tools for large-scale measurements of complex biological systems. Regulators need visibility into the computer algorithms behind these tools in order to gain trust in them, while industry requires similar trust that algorithms are reliable from one production run to another. NIST develops <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="23206916-9e15-4d86-b377-753821929906" href="/publications/four-principles-explainable-artificial-intelligence" title="Four Principles of Explainable Artificial Intelligence">“explainable” AI</a> and machine learning for control of </span></span></span><span><span><span>complex biological functions to meet industry’s product specifications.</span></span></span></span></span></span></span></li>
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<h2><span><span><span><strong><span><span><span>American Leadership of Standards </span></span></span></strong></span></span></span></h2>
<p><span><span><span><span><span><span>NIST works closely across the federal research enterprise and industrial biomanufacturing groups to contribute to national initiatives and develop measurement solutions and standards that facilitate commerce in the U.S., and American manufacturers’ participation in international markets.</span></span></span></span></span></span></p>
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<img alt="collage of biomanufacturing images" height="142" loading="lazy" src="/sites/default/files/styles/220_x_220_limit/public/images/2016/12/16/bio_manufacturing_pressrelease_hanacek.jpg?itok=N8o_utW-" typeof="foaf:Image" width="220">
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<span class="nist-image__credit-label">Credit:</span>
Hanacek/NIST
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<ul>
<li><span><span><span><span><span><span><span>We lead or contribute to standards development through Standards Development Organizations such as ISO and IEC to&nbsp;</span></span></span><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5f1665f6-39d8-4870-948c-ed178fdac67e" href="/mml/bbd/standards-and-tools" title=" Standards and Tools"><span><span><span>develop standards</span></span></span></a><span><span><span>&nbsp;for the industry, thus promoting U.S. competitiveness.</span></span></span></span></span></span></span></li>
<li><span><span><span><span><span><span>We coordinate with other government agencies on synthetic biology efforts, including participation in NSTC’s Interagency Synthetic Biology Working Group (</span></span><a href="https://beta.nsf.gov/sbwg"><span><span>SBWG</span></span></a><span><span>). </span></span></span></span></span></span></li>
<li><span><span><span><span><span><span>We participate in the </span></span></span><a href="https://ebrc.org/"><span><span>EBRC</span></span></a><span><span><span>, which, among other activities, develops&nbsp;</span></span></span><a href="https://ebrc.org/focus-areas/roadmapping/"><span><span><span>research roadmaps</span></span></span></a><span><span><span>&nbsp;to help overcome technical barriers in engineering biology.&nbsp;</span></span></span></span></span></span></li>
<li>NIST collaborates with <a href="https://www.manufacturingusa.com/">Manufacturing USA</a>&nbsp;institutes, including <a href="https://www.biomade.org/">BioMADE</a>, <a href="https://niimbl.force.com/s/">NIIMBL</a>, and <a href="https://www.armiusa.org/">BioFab USA</a>, to advance biomanufacturing.&nbsp;</li>
</ul>
<h2><span><span><span><strong><span><span><span>Safety and reliability</span></span></span></strong></span></span></span></h2>
<p><span><span><span>We host several consortia that provide insight into the needs of researchers, industry developers, and government regulators as they navigate the rapidly evolving biotechnology landscape.</span></span></span></p>
<figure class=" align-left nist-image--lightbox nist-image" role="group">
<div data-lightbox="https://www.nist.gov/sites/default/files/styles/2800_x_2800_limit/public/images/2018/01/11/genome_editing_working_groups._v3jpg.jpg?itok=fKuiVLvB" data-media-id="418301">
<img alt="Gene editing working group" height="391" loading="lazy" src="/sites/default/files/styles/480_x_480_limit/public/images/2018/01/11/genome_editing_working_groups._v3jpg.jpg?itok=CpGtUTRi" typeof="foaf:Image" width="395">
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<figcaption class="nist-image__caption">The NIST Genome Editing Consortium's working groups.</figcaption>
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<li>The <a href="https://www.nist.gov/programs-projects/nist-genome-editing-consortium">NIST&nbsp;Genome Editing Consortium</a>&nbsp;develops tools to help ensure the accuracy of measurements for altered DNA, helping genetic engineers and regulators have confidence in new techniques. The consortium has completed&nbsp;<a href="https://www.iso.org/standard/80679.html">a lexicon</a> to facilitate common understanding for this rapidly evolving field.&nbsp;</li>
<li><span><span><span><span><span><span><span><span>NIST is conducting&nbsp;</span></span></span></span><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="be9751e0-d6cd-4a1b-814f-f4609244381a" href="/programs-projects/integrated-lentiviral-vector-copy-number-measurements-invitation-participate" title="Integrated Lentiviral Vector Copy Number Measurements: Invitation to Participate in an Interlaboratory Testing Program Evaluating Genomic DNA Test Materials"><span><span><span><span>an interlaboratory testing program</span></span></span></span></a><span><span><span><span>&nbsp;for the measurement of DNA introduced into the genomes of target cells so that genetic engineers can quantify how well their techniques work.</span></span></span></span></span></span></span></span></li>
<li><span><span><span><span>The <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="b3670f8f-5e6e-453e-875b-9788e01fb478" href="/programs-projects/genome-bottle" title="Genome in a Bottle">Genome in a Bottle (GIAB) Consortium</a> develops reference materials, methods, and data to increase confidence in DNA sequencing as a clinical tool. In addition, this consortium works to <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="db7fb537-7390-4e85-b133-a50e4d652e01" href="/news-events/news/2022/03/first-complete-human-genome-poised-strengthen-genetic-analysis-nist-study" title="First Complete Human Genome Poised to Strengthen Genetic Analysis, NIST Study Shows">characterize the most challenging genome regions</a>, long sequences with many repeats, to provide a reference for genes critical to human health and to advance understanding of the accuracy of genome engineering and synthetic biology. </span></span></span></span></li>
</ul>
<div class="nist-callout">
<h2>Cyberbiosecurity</h2>
<p>Data is the foundation for harnessing the genomes of organisms for making useful products, developing the complex manufacturing processes of the bioeconomy, and of new treatments for devastating diseases. Protecting that data is vital for guarding valuable intellectual property, preventing malicious harm to manufacturers and patients, and protecting citizens' privacy. NIST's researchers in <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="37552501-95fd-4762-9eb6-8c9e641ca8aa" href="/news-events/events/2022/01/nccoe-virtual-workshop-cybersecurity-genomic-data" title="NCCoE Virtual Workshop on the Cybersecurity of Genomic Data">cybersecurity </a>and <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="f67ac922-0c84-4879-b01b-b6ec50d828f3" href="/publications/cyberbiosecurity-biopharmaceutical-products" title="Cyberbiosecurity for biopharmaceutical products">the biological sciences</a> work together to assess and mitigate potential harms from the misappropriation and misuse of data.&nbsp;</p>
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<h2> Key Accomplishments
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<div class="text-long"><ul>
<li><span><span><span><span><span><span><span>NIST provides the most </span></span></span><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="b3670f8f-5e6e-453e-875b-9788e01fb478" href="/programs-projects/genome-bottle" title="Genome in a Bottle"><span>authoritative characterization of human genome</span></a><span><span><span> references for use in benchmarking new methods of DNA analysis and&nbsp;technology development, optimization, and demonstration. These references have helped to advance global sequencing technology development and facilitated their use in emerging biotechnologies.&nbsp; </span></span></span></span></span></span></span></li>
<li>NIST worked with more than 100 companies to characterize a monoclonal antibody reference material, known as <a href="https://www.nist.gov/news-events/news/2016/07/extraordinary-standard-new-nist-protein-could-spur-biopharmaceutical">the NISTmAb</a>, that allows the biopharmaceutical industry to verify and improve their methods for quality control. Because its characteristics are so well known, the NISTmAb can also be used to evaluate new biomanufacturing methods and tools, accelerating innovation.&nbsp;</li>
<li><span><span><span><span><span><span><span>NIST in collaboration with JCVI and MIT, developed a measurement </span></span>approach<span><span> to characterize </span></span><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="2c52585f-3904-4265-b032-219a5e7d58b3" href="/news-events/news/2021/03/scientists-develop-cell-synthetic-genome-grows-and-divides-normally" title="Scientists Develop Cell With Synthetic Genome That Grows and Divides Normally"><span><span>genomically minimal cell models</span></span></a><span><span>, a critical step toward the grand challenge of understanding the role of every gene in a cell, as well engineering synthetic cells that could function as “cell factories” to produce drugs, advanced materials, food, and fuels.</span></span></span></span></span></span></span></li>
<li><span><span><span><span><span><span><span>NIST researchers </span></span></span><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7ca3964a-fbbd-476f-ab0a-90fdc57662c6" href="/news-events/news/2022/03/revamped-design-could-take-powerful-biological-computers-test-tube-cell" title="Revamped Design Could Take Powerful Biological Computers From the Test Tube to the Cell"><span><span>engineered RNA circuits to act as biological computers</span></span></a><span><span><span> to carry out a desired function. For example, RNA sensors embedded in cell factories offer the potential for nondestructive, real-time monitoring of cell function during the biomanufacturing process.</span></span></span> </span></span></span></span></li>
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<h2>The Research</h2>
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<h2 class="nist-block__title">Projects & Programs</h2>
<article
about="/programs-projects/nist-genome-editing-consortium" class="nist-teaser"
>
<div class="nist-teaser__image">
<div class="entity-reference"> <a href="/programs-projects/nist-genome-editing-consortium" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/thumbnail/public/images/2017/06/30/bigstock-177254398.jpg?itok=O-47Xo9F" width="100" height="54" alt="Genome editing technologies" typeof="foaf:Image" />
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<header>
<h3 class="nist-teaser__title"><a href="/programs-projects/nist-genome-editing-consortium"><span>NIST Genome Editing Consortium</span>
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<div class="nist-teaser__type">
<div class="nist-badge display-inline-block margin-y-1 nist-badge--blue boolean">Ongoing</div>
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</header>
<div class="nist-teaser__content">
<div class="text-with-summary"> Targeted genome editing , a method used to alter the DNA of living cells at desired locations, is poised to revolutionize science and medicine. To fight diseases, novel genome edited therapeutics, including those for use in regenerative medicine and infectious diseases, are being developed. Many
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</article>
<article
about="/programs-projects/nist-living-measurement-systems-foundry" class="nist-teaser"
>
<div class="nist-teaser__image">
<div class="entity-reference"> <a href="/programs-projects/nist-living-measurement-systems-foundry" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/thumbnail/public/images/2019/03/04/snapshot_12_12-13-2018_5-23_pm.png?itok=Rm7Tbs7V" width="100" height="56" alt="NIST Foundry for Living Measurement Systems" typeof="foaf:Image" />
</a>
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<header>
<h3 class="nist-teaser__title"><a href="/programs-projects/nist-living-measurement-systems-foundry"><span>NIST Living Measurement Systems Foundry</span>
</a></h3>
<div class="nist-teaser__type">
<div class="nist-badge display-inline-block margin-y-1 nist-badge--blue boolean">Ongoing</div>
</div>
</header>
<div class="nist-teaser__content">
<div class="text-with-summary"> To enable the production of high-throughput, high-quality data that meets the rapidly evolving needs of current and future stakeholders, NIST has established an automation facility for the growth, manipulation, sample preparation, and measurement of engineered microbes. The core of the facility
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</article>
<article
about="/programs-projects/nist-flow-cytometry-standards-consortium" class="nist-teaser"
>
<div class="nist-teaser__image">
<div class="entity-reference"> <a href="/programs-projects/nist-flow-cytometry-standards-consortium" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/thumbnail/public/images/2021/01/22/FlowCytometryConsortium_IdentifierGraphic.png?itok=sOhqxT62" width="100" height="66" alt="Flow Cytometry Consortium " typeof="foaf:Image" />
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<header>
<h3 class="nist-teaser__title"><a href="/programs-projects/nist-flow-cytometry-standards-consortium"><span>NIST Flow Cytometry Standards Consortium </span>
</a></h3>
<div class="nist-teaser__type">
<div class="nist-badge display-inline-block margin-y-1 nist-badge--blue boolean">Ongoing</div>
</div>
</header>
<div class="nist-teaser__content">
<div class="text-with-summary"> Advances in cell and gene-based therapeutics as well as other regenerative medicine products have increased the need for high quality, robust, and validated measurements for cell characterization. Flow cytometry, including imaging cytometry, has emerged as an important platform due to its ability to
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</article>
<article
about="/programs-projects/prototype-cell-assay-measurement-platform-p-camp" class="nist-teaser"
>
<div class="nist-teaser__content-wrapper">
<header>
<h3 class="nist-teaser__title"><a href="/programs-projects/prototype-cell-assay-measurement-platform-p-camp"><span>Prototype Cell Assay Measurement Platform (P-CAMP)</span>
</a></h3>
<div class="nist-teaser__type">
<div class="nist-badge display-inline-block margin-y-1 nist-badge--blue boolean">Ongoing</div>
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</header>
<div class="nist-teaser__content">
<div class="text-with-summary"> A systematic approach to the development of robust biological assay includes identifying and ranking the sources of variability in an assay protocol. With a focus on mammalian cellular assays, the Prototype Cell Assay Measurement Platform ( P-CAMP) laboratory was designed and built to take advantage
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<article
about="/programs-projects/integrated-lentiviral-vector-copy-number-measurements-invitation-participate" class="nist-teaser"
>
<div class="nist-teaser__image">
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<div class="text-with-summary"> NIST has produced genomic DNA test materials from transduced Jurkat cell lines with integrated lentiviral vector copy number (VCN) for evaluation as a candidate reference material. Transducing Jurkat (Clone E6-1) cell lines with a lentivirus expressing a green fluorescent protein were produced by
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