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Advance lentivirus and AAV therapies through patient safety testing and long term follow up during cell and gene therapy clinical trials with confidence.

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href='/en/Public/Services/Next-Generation-Sequencing/Whole-Plasmid-Sequencing-Plasmid-EZ' style='color:#585F69;font-size:14px'>Whole Plasmid Sequencing: Plasmid-EZ <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li></ul></div><div class='col-md-3 '><ul class='list-unstyled'><li><a class='GColor' href='/en/Public/Services/Sanger-Sequencing' style='color:#826ec3;font-size:17px'>Sanger Sequencing</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Sanger-EZ' style='color:#585F69;font-size:14px'>Sanger-EZ <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li><li><a href='/en/Public/Services/Sanger-Sequencing/AAV-ITR' style='color:#585F69;font-size:14px'>AAV-ITR Sanger Sequencing</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Purified-Templates' style='color:#585F69;font-size:14px'>Purified Templates</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Difficult-Template-Sequencing' style='color:#585F69;font-size:14px'>Difficult Template Sequencing</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Direct-Colony-Sequencing' style='color:#585F69;font-size:14px'>Direct Colony Sequencing</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/PCR-Purification' style='color:#585F69;font-size:14px'>PCR Purification</a></li><li><a href='/en/Public/Services/Sanger-Sequencing/Primer-Walking' style='color:#585F69;font-size:14px'>Primer Walking</a></li><br><li><a class='GColor' href='/en/Public/Services/Molecular-Genetics' style='color:#826ec3;font-size:17px'>PCR + Sanger Services</a></li><li><a href='/en/Public/Services/Molecular-Genetics/Bacterial-and-Fungal-Identification' style='color:#585F69;font-size:14px'>Bacterial and Fungal Identification</a></li><li><a href='/en/Public/Services/Molecular-Genetics/Mutation-Analysis' style='color:#585F69;font-size:14px'>Mutation Analysis</a></li><li><a href='/en/Public/Services/Molecular-Genetics/SNP-Genotyping' style='color:#585F69;font-size:14px'>SNP Genotyping</a></li><li><a href='/en/Public/Services/Molecular-Genetics/PCR-Plus-Sequencing-CRISPR-Analysis-Package' style='color:#585F69;font-size:14px'>PCR Plus Sequencing CRISPR Analysis Package</a></li><li><a href='/en/Public/Services/Molecular-Genetics/cDNA-Verification' style='color:#585F69;font-size:14px'>Confirmatory Sequencing & Cell Bank Characterization</a></li><li><a href='/en/Public/Services/Molecular-Genetics/Yeast-Colony-Sequencing' style='color:#585F69;font-size:14px'>Yeast Colony Sequencing</a></li><li><a href='/en/Public/Services/Molecular-Genetics/Fragment-Analysis' style='color:#585F69;font-size:14px'>Fragment Analysis</a></li><li><a href='/en/Public/Services/Molecular-Genetics/PCR-Solutions' style='color:#585F69;font-size:14px'>Quantitative PCR &amp; Digital PCR <sup style="color:#826ec3;"><strong>NEW&nbsp;</strong></sup></a></li><li><a href='/en/Public/Services/Molecular-Genetics/Nucleic-Acid-Extraction' style='color:#585F69;font-size:14px'>Nucleic Acid Extraction</a></li></ul></div><div class='col-md-3 '><ul class='list-unstyled'><li><a class='GColor' href='/en/Public/Services/Gene-Synthesis' style='color:#826ec3;font-size:17px'>DNA &amp; RNA Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Gene-Synthesis' style='color:#585F69;font-size:14px'>Gene Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Antibody-DNA-Synthesis' style='color:#585F69;font-size:14px'>Antibody Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/AAV-Plasmid-Synthesis' style='color:#585F69;font-size:14px'>AAV Plasmid Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Gene-Fragments' style='color:#585F69;font-size:14px'>Gene Fragments</a></li><li><a href='/en/Public/Services/Gene-Synthesis/CRISPR-Construct-Synthesis' style='color:#585F69;font-size:14px'>CRISPR Construct Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Synthetic-DNA-Libraries' style='color:#585F69;font-size:14px'>Synthetic DNA Libraries</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Single-Stranded-DNA-Synthesis' style='color:#585F69;font-size:14px'>ssDNA Synthesis</a></li><li><a href='/en/Public/Services/Gene-Synthesis/DNA-Cloning' style='color:#585F69;font-size:14px'>DNA Cloning</a></li><li><a href='/en/Public/Services/Gene-Synthesis/Site-Directed-Mutagenesis' style='color:#585F69;font-size:14px'>Site-Directed Mutagenesis<br></a></li><li><a href='/en/Public/Services/Gene-Synthesis/Viral-Package' style='color:#585F69;font-size:14px'>Viral Packaging <sup style="color:#826ec3;"><strong>NEW&nbsp;</strong></sup></a></li><li><a href='/en/Public/Services/Gene-Synthesis/Recombinant-Antibody-Production' style='color:#585F69;font-size:14px'>Recombinant Antibody Production <sup style="color:#826ec3;"><strong>NEW&nbsp;</strong></sup></a></li><li><a href='/en/Public/Services/Gene-Synthesis/Custom-mRNA-Synthesis' style='color:#585F69;font-size:14px'>Custom mRNA Synthesis <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li><br><li><a class='GColor' href='/en/Public/Services/Oligo' style='color:#826ec3;font-size:17px'>Oligo Synthesis Services</a></li><li><a href='/en/Public/Services/Oligo/Overnight-DNA-Oligos' style='color:#585F69;font-size:14px'>Overnight DNA Oligos</a></li><li><a href='/en/Public/Services/Oligo/Custom-DNA-and-RNA-Oligos' style='color:#585F69;font-size:14px'>Custom DNA and RNA Oligos</a></li><li><a href='/en/Public/Services/Oligo/Oligo-Retained-for-Sanger-Sequencing' style='color:#585F69;font-size:14px'>Oligo Retained for Sanger Sequencing</a></li></ul></div><div class='col-md-3 '><ul class='list-unstyled'><li><a class='GColor' href='/en/Public/Services/Plasmid-DNA-Prep' style='color:#826ec3;font-size:17px'>Plasmid DNA Preparation</a></li><li><a href='/en/Public/Services/Plasmid-DNA-Prep/Standard' style='color:#585F69;font-size:14px'>Standard Plasmid DNA Prep</a></li><li><a href='/en/Public/Services/Plasmid-DNA-Prep/Targeted-Yield' style='color:#585F69;font-size:14px'>Targeted Yield Plasmid DNA Prep</a></li><li><a href='/en/Public/Services/Plasmid-DNA-Prep/AAV-Plasmid-Preparation' style='color:#585F69;font-size:14px'>AAV Plasmid Preparation</a></li><br><li><a class='GColor' href='/en/Public/Services/Clinical-Services' style='color:#826ec3;font-size:17px'>PreClinical and Clinical Services</a></li><li><a href='/en/Public/Services/Clinical-Services/Clinical-Services-Overview' style='color:#585F69;font-size:14px'>Clinical Services</a></li><li><a href='/en/Public/Services/Clinical-Services/Microarray-Solutions' style='color:#585F69;font-size:14px'>Microarray Solutions <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Variant-Confirmation' style='color:#585F69;font-size:14px'>CLIA Variant Confirmation (PCR + Sanger)</a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Sanger-Sequencing' style='color:#585F69;font-size:14px'>CLIA Sanger Sequencing</a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Whole-Exome-Sequencing' style='color:#585F69;font-size:14px'>CLIA Whole Exome Sequencing</a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Whole-Genome-Sequencing' style='color:#585F69;font-size:14px'>CLIA Whole Genome Sequencing</a></li><li><a href='/en/Public/Services/Clinical-Services/Regulatory' style='color:#585F69;font-size:14px'>GLP-Compliant Overview</a></li><li><a href='/en/Public/Services/Clinical-Services/GLP-compliant-Confirmatory-Sequencing' style='color:#585F69;font-size:14px'>GLP Confirmatory Sequencing</a></li><li><a href='/en/Public/Services/Clinical-Services/GLP-compliant-SNP-Mutation-Analysis' style='color:#585F69;font-size:14px'>GLP SNP Mutation Analysis</a></li><li><a href='/en/Public/Services/Clinical-Services/GLP-compliant-Plasmid-Prep' style='color:#585F69;font-size:14px'>GLP Plasmid Prep</a></li><li><a href='/en/Public/Services/Clinical-Services/Nucleic-Acid-Extraction' style='color:#585F69;font-size:14px'>GLP Nucleic Acid Extraction</a></li><li><a href='/en/Public/Services/Clinical-Services/Biofluid-Processing-Overview' style='color:#585F69;font-size:14px'>Biofluid Processing</a></li><li><a href='/en/Public/Services/Clinical-Services/CLIA-Integration-Site-Analysis' style='color:#585F69;font-size:14px'>CLIA Integration Site Analysis <sup style="color:#826ec3; font-weight: bold;">NEW</sup></a></li></ul></div></div></div></li></ul></li><li class='dropdown'><a href='/en/Public/Research-Areas' data-toggle='dropdown' class='dropdown-toggle' style='color:white;height:52px;top:47px;padding-top:0;background-color:transparent;font-size:17px;font-weight:bold;'>RESEARCH AREAS</a><ul class='dropdown-menu'><li class='dropdown'><a class='GColor' href='/en/Public/Research-Areas/AAV' style='font-size:17px'>AAV Services</a><ul 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the location and frequency of vector integration.&nbsp; Azenta Life Sciences, formerly GENEWIZ, partners with you by implementing our pre-optimized ISA protocols through pre-clinical and clinical sample collection and management over the course of your trial in our labs designed to follow Good Clinical Practices (GCP) guidelines and GLP compliance. The result is total confidence in your study data working with a single, experienced clinical trial partner.&nbsp;</p> &nbsp;<br /> <a rel="noopener noreferrer" rel="noopener noreferrer" href="https://web.genewiz.com/clinical-inquiry" target="_blank"><button>Contact an Expert</button></a> <a rel="noopener noreferrer" rel="noopener noreferrer" href="https://www.genewiz.com/en/Public/Resources/FAQs/FAQs-Clinical-Services/#CLIA" target="_blank"><button>CLIA FAQs</button></a> </div> <div class="clia-exome-content-box" id="clia-exome-content-box-right"> <a rel="noopener noreferrer" rel="noopener noreferrer" href="https://www.genewiz.com/en/Public/Services/Molecular-Genetics/PCR-Solutions" target="_blank"><img alt="" src="/-/media/17001DqPCRdPCRWebBanRight2.ashx?la=en&amp;hash=667C0B7B2E5796BDD1BF6575F2DB2C22E6168950" /></a> </div> </div> </div> </div> <div class="headline-center Rich-Text-Edit-Area"> <div class="container"> <h2>What is Integration Site Analysis?</h2> <p> Integration site analysis (ISA) allows for the interrogation of a host genome for lentiviral vector insertion location and frequency after delivery of the therapeutic product. ISA is an important safety tool used to assess for clonal expansion in treated subjects.</p> </div> <br /> </div> <div class="headline-center Rich-Text-Edit-Area"> <style type="text/css"> .protocol { width: 1170px; display: inline-block; text-align: center; } .protocol img { width: 98%; display: block; margin-left: auto; margin-right: auto; } @media screen and (max-width: 1170px) { .protocol { width: auto; } } </style> <div class="protocol"> <div class="data-container"> <div class="container"> <h2 style="text-align: center; margin-bottom: 30px;">Azenta Lentiviral Integration Site Analysis Workflow</h2> <img alt="" src="/-/media/Images/16014-D_ISA-Lenti-Workflow_Img1.ashx?w=1170px&amp;la=en&amp;hash=70DBAD0D7B77AB7AC70D8EF0C9D3112B68EF85A5" width="1170px" /> </div> </div> </div> <style type="text/css"> .workflow-container { padding-top: 30px; background: #fffffff; } .workflow { text-align: left; width: 1170px; display: inline-block } .workflow1 { text-align: left; width: 1170px; display: inline-block } .workflow-step1 { vertical-align: top; width: 19%; padding: 10px; margin-bottom: 20px; display: inline-block; } .workflow-step { vertical-align: top; width: 19%; padding: 10px; margin-bottom: 20px; display: inline-block; } .workflow-step img { width: 120px; margin: 0 auto; margin-bottom: 20px; } .workflow-step1 img { width: 200px; margin: 0 auto; margin-bottom: 20px; } .workflow-step h2 { width: 80%; text-align: center; } .workflow-step h3 { text-align: center; font-size: 18px; font-family: sans-serif; border-bottom: none; } .workflow-step p { width: 80%; margin: 0 auto; text-align: left; font-size:11px; } .workflow-step1 p { width: 80%; margin: 0 auto; text-align: left; font-size:11px; } .workflow-step p1 { width: 80%; margin: 0 auto; text-align: left; font-size:15px; } .workflow-icon { text-align: center; } .workflow-icon1 { text-align: center; } @media only screen and (max-width: 1170px) { .workflow-container { width: auto; } .workflow { text-align: left; width: auto; } .workflow1 { text-align: left; width: auto; } .workflow-step { width: 100%; } .workflow-step1 { width: 100%; } } </style> <div class="workflow-container"> <div class="workflow"> <div class="workflow1"> <div class="workflow-step"> <div class="workflow-icon"> <img alt="Clinical-Icon" src="/-/media/Images/16014-D_ISA-Lenti-Workflow_Img2.ashx?la=en&amp;hash=E4D036FA643F6A7EDA5F28A3878BF726435B657F" /></div> <div class="workflow-icon"><strong> </strong> <!--<p1><strong>1. Construct Design</strong></p1>--> <br /> <p><strong>Sample Collection and Transport (optional):</strong> Automate multi-year timepoint collection and logistics for patient samples with <a href="https://www.azenta.com/services/sample-storage-services/sample-biological-material-storage" target="_blank">Azenta&rsquo;s cold-chain expertise</a>. </p> </div> </div> <div class="workflow-step"> <div class="workflow-icon"> <img alt="Clinical-Icon" src="/-/media/Images/16014-D_ISA-Lenti-Workflow_Img3.ashx?la=en&amp;hash=85EAA7165B73F9BFC57FCCD373ECB89071CE6560" /></div> <div class="workflow-icon"><strong> <!--<p1>2. 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Cloning and Plasmid Prep</p1>--> </strong> <br /> <p><strong>Patient Safety Testing:</strong> Genomic DNA is extracted, and the patient sample is evaluated using one of Azenta&rsquo;s analytically validated or fit-for-purpose assays in our CAP/CLIA-accredited laboratory. </p> </div> </div> <div class="workflow-step"> <div class="workflow-icon"> <img alt="Antibody-Icon" src="/-/media/Images/16014-D_ISA-Lenti-Workflow_Img3.ashx?la=en&amp;hash=85EAA7165B73F9BFC57FCCD373ECB89071CE6560" /></div> <div class="workflow-icon"><strong> <!--<p1>4. <em>In Vitro</em> Transcription</p1>--> </strong> <br /> <!--<p><strong><br /> Scalable Transcription:</strong>&nbsp; &nbsp; <br /> Mini- to giga-scale quantities of mRNA available to grow with your research program</p>--> </div> </div> <div class="workflow-step"> <div class="workflow-icon"> <img alt="Antibody-Icon" src="/-/media/Images/16014-D_ISA-Lenti-Workflow_Img5.ashx?la=en&amp;hash=214B2FF41BEF625569C17D8FF6BDD219EA57ACEA" /></div> <div class="workflow-icon"><strong> <!--<p1>5. mRNA Purification and QC</p1>--> </strong> <br /> <p><strong>Sample Storage and Management (optional):</strong> Store, process, and protect valuable patient samples and DNA for additional <a href="https://www.azenta.com/services/sample-storage-services/clinical-trial-services-support" target="_blank">clinical trial needs</a>. </p> </div> </div> </div> </div> </div> </div> <div class="headline-center Rich-Text-Edit-Area"> <div class="container"> <h2>Featured Application: Integration Site Analysis for Lentiviral Therapies </h2> <p> As the dominant viral delivery vector for approved cell therapies, lentivirus requires ISA in pre-clinical and clinical trials due to its possibility of altering expression of cellular genes which could contribute to tumorigenicity.&nbsp; Raw analytical data must be processed with a robust bioinformatics workflow to identify potential clonal expansions as well as annotate the breakpoint/integration site based on proximity to known oncogenes. Download the technical note below to compare ISA data from industry standard methods and find the best path forward for your lentiviral-based therapy.</p> </div> <br> </div> <div class="headline-center Rich-Text-Edit-Area"> <style type="text/css"> .body { text-align: center; display: inline-block; } .banner { width: 1170px; background-image: url('/-/media/Images/16014-D_ISA-CGT_WebBanFull-Med_Background.ashx'); background-size: cover; text-align: center; display: flex; padding: 10px; } .banner img { text-align: center; display: block; margin-left: auto; margin-right: auto; } #banner-left { width: 40%; padding: 20px; } #banner-right { width: 80%; padding: 10px; } #banner-right h1 { text-transform: none; letter-spacing: 1px; line-height: 30px; border-bottom: none; font-family: 'Roboto', sans-serif; font-weight: 400; font-size: 30px; margin: 0; margin-bottom: 5px; color: #FFFFFF } #banner-right h3 { text-transform: none; letter-spacing: 1px; line-height: 50px; border-bottom: none; font-family: 'Roboto', sans-serif; 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font-weight: 400; font-size: 20px; margin: 0; margin-bottom: 15px; color: #FFFFFF } #banner-left img { width: auto; height: auto; } #banner-right img { width: 90%; height: auto; } @media only screen and (max-width: 700px) { #banner-left img { width: 60%; } #banner-right button { font-size: 14px; } } </style> <div class="body"> <div class="banner"> <div id="banner-left"> <img alt="" src="-/media/.ashx" /></div> <div id="banner-right"> <div id="banner-right h1"> <h3>TECH NOTE</h3> <h1>Integration Site Analysis for Long-Term Safety Monitoring of Cell and Gene Therapy Products</h1> <div id="banner-right h3"> <br /> <a rel="noopener noreferrer" href="https://web.genewiz.com/tech-note/integration-site-analysis-safety-monitoring-cell-gene-therapy"><button>READ TECH NOTE</button></a> </div> </div> </div> </div> </div> </div> <script type="text/javascript" src="/assets/plugins/counter/jquery.counterup.min.js"></script> <script language="javascript" type="text/javascript"> jQuery(document).ready(function ($) { $(".row .category").find("img").addClass("img-responsive"); }); </script> <div class='Component-Frame pull-center Multi-column-TextBullet-Layout Component-BackGround-Default margin-top-0 margin-bottom-30 padding-top-10 padding-bottom-10'> <div class="container"> <div class="headline-center"> <h2>Azenta Features &amp; Benefits</h2> </div> <div class="headline-left"> </div> <div class="row category"> <div class="col-md-6 col-sm-6"> <div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"><i class="BlueCheck icon-custom icon-bg-light icon-4x fa fa-check"></i></div> <div class="content-boxes-in-v3"> <strong>Complete Trial Management</strong> &ndash; Experienced team that can facilitate and lead patient sample collection, processing/analysis, and management for pre-clinical and clinical studies </div> </div><div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"><i class="BlueCheck icon-custom icon-bg-light icon-4x fa fa-check"></i></div> <div class="content-boxes-in-v3"> <strong>Regulatory Accreditation</strong> &ndash; All wet laboratory steps for integration site analysis are performed in our CAP/CLIA-accredited laboratories with over 20 years of genomics experience </div> </div> </div> <div class="col-md-6 col-sm-6"> <div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"><i class="BlueCheck icon-custom icon-bg-light icon-4x fa fa-check"></i></div> <div class="content-boxes-in-v3"> <strong>Rapid Project Completion</strong> &ndash; Sample processing and data acquisition as fast as 20 business days to meet your project deadlines </div> </div><div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"><i class="BlueCheck icon-custom icon-bg-light icon-4x fa fa-check"></i></div> <div class="content-boxes-in-v3"> <strong>Fit-for-Purpose Assay Development</strong> &ndash; Use one of our pre-designed assays for the fastest processing or customize your assay and validation procedures to support specific regulatory submissions and safety assessments </div> </div> </div> </div> </div> </div><div class="headline-center Rich-Text-Edit-Area"> <style type="text/css"> a {text-decoration: none; cursor: pointer;} .title h1 { font-size: 20px; text-align: center; } .table { margin-top: 20px; } td { vertical-align: middle; } </style> <div class="container title"> <h2>Integration Site Analysis Highlights</h2> </div> <div class="table"> <div class="col-md-9 col-centered"> <table class="table table-responsive table-bordered"> <tbody class="panel panel-purple"> <tr class="panel-heading"> <td>Sample Type</td> <td>Analytically Validated Methodologies</td> <td>Estimated Completion Time&nbsp;</td> <td colspan="2">Data Deliverables*</td> <td>Adjacent Services</td> </tr> <tr> <td style="text-align:left; vertical-align: top;">Peripheral blood mononuclear cells (PBMC), cell pellet, whole blood, tissue, gDNA transduced sample</td> <td style="text-align: left; vertical-align: top;"> <p>- Target enrichment sequencing / hybridization - capture (TES)&nbsp;</p> <p>- Quantitative shearing linear amplification mediated - PCR (qsLAM)</p> </td> <td class="text-left" style="text-align: left; vertical-align: top;">Approximately 4 weeks</td> <td class="text-left" style="text-align: left; vertical-align: top;" colspan="2"> <p>- Integrations and frequencies</p> <p>- Clone characterization&nbsp;</p> <p>- Oncogene analysis</p> <p>- Integration hotspots</p> <p>- Longitudinal profiling</p> <p>- Vector integrity (TES)</p> </td> <td class="text-left" style="text-align: left; vertical-align: top;"> <p>- AAV ISA</p> <p>- Vector Copy Number (digital PCR VCN analysis)</p> <p>- Whole Genome Sequencing (WGS)</p> <p>- On &amp; off target analysis</p> </td> </tr> </tbody> </table> </div> </div> <p>*A comprehensive report containing the data deliverables listed above is provided after ISA completion within our clinical laboratory.</p> </div> <div class="headline-center Rich-Text-Edit-Area"> <style type="text/css"> .covid-banner { width: 1150px; 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