GENEWIZ from Azenta | GLP-compliant Confirmatory Sequencing

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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 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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 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Confirmatory sequencing that adheres to Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) as applicable to our services, and Good Clinical Practice (GCP) guidelines. Biologics testing solutions ensure reproducible results across the preclinical to production pipeline. The right sequence means the right product!</p> <p> </p> <a rel="noopener noreferrer" href="https://clims4.genewiz.com/CustomerHome/Index?lobId=9" target="_blank"><button>Request Quote</button> </a></div> <a rel="noopener noreferrer" target="_blank"> </a> <div class="ngs-content-box" id="ngs-content-box-right"><a rel="noopener noreferrer" target="_blank"> </a><a rel="noopener noreferrer" rel="noopener noreferrer" href="https://hubs.ly/Q02BXfg00" target="_blank"><img alt="" src="/-/media/16015-D_MicroarraySolutions_WebBanRight.ashx?la=en&hash=8F9231291A7052C181BDF63344413F45B2600B5E" /></a> </div> </div> </div> </div> <div class="headline-center Rich-Text-Edit-Area"> <div class="container"> <h2>SANGER SEQUENCING FOR BIOLOGICS TESTING</h2> <p style="text-align: left;"><span>Azenta Life Sciences, formerly GENEWIZ can characterize samples for identity and stability from preclinical stages through the manufacturing pipeline. We utilize validated methods according to ICH Q2 guidelines to support analysis of your monoclonal antibody therapeutics, immunotherapeutics, viral vectors, vaccines, and agricultural products.</span></p> <p style="text-align: left;">Simply provide your master cell bank (MCB), working cell bank (WCB), viral particles, viral vector, master virus stock (MVS), gDNA, mRNA, plasmids or PCR products. Azenta will design, develop, and optimize assays to verify identity and stability. Our experienced scientists and Quality Assurance Unit ensure that your samples are processed and results reported according to applicable regulatory standards to support IND, NDA, ANDA and BLA applications.</p> </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>APPLICATIONS</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"></div> <div class="content-boxes-in-v3"> <p style="font-size: 17px;"><strong>Monoclonal Antibody Cell Line Development</strong></p> <ul> <li>Heavy chain and light chain sequencing of MCB and WCB</li> </ul> </div> </div><div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"></div> <div class="content-boxes-in-v3"> <p style="font-size: 17px;"><strong><span>Agricultural Products</span></strong></p> <ul> <li>Plant strain characterization</li> </ul> </div> </div><div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"></div> <div class="content-boxes-in-v3"> <p style="font-size: 17px;"><strong><span>Vaccine Manufacturing</span></strong></p> <ul> <li>Characterization of master viral stocks/seeds (MVS)</li> </ul> </div> </div> </div> <div class="col-md-6 col-sm-6"> <div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"></div> <div class="content-boxes-in-v3"> <p style="font-size: 17px;"><strong>Gene Therapy</strong></p> <ul> <li>Plasmid confirmation</li> <li>Viral vector confirmation (lentivirus or AAV plasmids)</li> <li>Confirmation of genomic integrations</li> </ul> </div> </div><div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"></div> <div class="content-boxes-in-v3"> <p style="font-size: 17px;"><strong>Immunotherapy</strong></p> <ul> <li>Characterization of mRNA</li> </ul> </div> </div><div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"></div> <div class="content-boxes-in-v3"> <p style="font-size: 17px;"><strong>Medical Devices</strong></p> <ul> <li>Orthogonal testing for in vitro diagnostic validations</li> </ul> </div> </div> </div> </div> </div> </div><div class="headline-center Rich-Text-Edit-Area"> <style type="text/css"> .body { text-align: center; display: inline-block; } .banner1 { width: 1170px; background-image: url('/-/media/GLP-AAV-ITR-Seq-Ad-Background.ashx'); background-size: cover; text-align: center; display: flex; padding: 10px; } .banner1 img { text-align: center; display: block; margin-left: auto; margin-right: auto; } #banner1-left { width: 29%; padding: 15px; } #banner1-right { width: 70%; padding: 15px; padding-top: 25px; padding-bottom: 25px; } #banner1-right h1 { text-transform: none; letter-spacing: 1px; line-height: 50px; border-bottom: none; font-family: 'Roboto', sans-serif; font-weight: 400; font-size: 45px; margin: 0; margin-top: 15px; margin-bottom: 20px; color: #ffffff; } #banner1-right h3 { text-transform: none; letter-spacing: 1px; line-height: 20px; border-bottom: none; font-family: 'Roboto', sans-serif; font-weight: 400; font-size: 20px; margin: 0; margin-bottom: 20px; color: #ffffff; } #banner1-right p { text-transform: none; letter-spacing: 1px; line-height: 20px; border-bottom: none; font-family: 'Roboto', sans-serif; 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font-weight: 400; font-size: 15px; margin: 0; margin-bottom: 15px; color: #ffffff; } #banner1-right img { width: auto; height: auto; } #banner1-left img { width: 90%; height: auto; } @media only screen and (max-width: 700px) { #banner1-left img { width: 60%; } #banner1-right button { font-size: 14px; } } </style> <div class="body"> <div class="banner1"> <div id="banner1-left"> <div id="banner1-left h1"> </div> </div> <div id="banner1-right"> <h1>GLP-Compliant Sequencing of<br /> Full AAV Plasmid, Vectors, and<br /> Packaged Products</h1> <a rel="noopener noreferrer" rel="noopener noreferrer" href="https://web.azenta.com/glp-aav-itr-sequencing" target="_blank"><button>LEARN MORE</button></a> </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>Features & 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"></div> <div class="content-boxes-in-v3"> <p style="font-size: 17px;"><strong><span>Complete Solution: Nucleic Acid Extraction to Sanger Sequencing </span></strong></p> <span> <ul> <li>Nucleic acid extraction</li> <li>Assay development/optimization</li> <li>Complete sequencing of region of interest</li> <li>Detailed final report; includes a description of the methods, list of SOPs, raw data, and detailed results</li> </ul> </span> </div> </div><div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"></div> <div class="content-boxes-in-v3"> <p style="font-size: 17px;"><strong><span>State-of-the-Art, Dedicated GLP Laboratories </span></strong></p> <span> </span> <ul> <li>FDA and EPA GLP-compliant, reliable services</li> <li>Controlled facility, sample tracking, personnel, process, and documents</li> <li>Special handling for sensitive assays</li> <li>Follows GMP (as applicable to our services) and GCP guidelines</li> </ul> </div> </div><div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"></div> <div class="content-boxes-in-v3"> <p style="font-size: 17px;"><strong><span>Established <a href="https://www.genewiz.com/en/Public/Resources/Quality-Management-System">Quality Management System</a> </span></strong></p> <span> </span> <ul> <li>Quality Assurance Unit oversight</li> <li>Azenta is available for audits</li> </ul> </div> </div> </div> <div class="col-md-6 col-sm-6"> <div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"></div> <div class="content-boxes-in-v3"> <p style="font-size: 17px;"><strong><span>Outsource to the Industry Leader in Sanger Sequencing  </span></strong></p> <span> <ul> <li>Developed and documented processes</li> <li>Qualified instruments</li> <li>Trained personnel</li> <li>Dedicated, state-of-the-art regulatory laboratory</li> <li>Thorough quality assurance program saves you time, reagents, paperwork</li> </ul> </span> </div> </div><div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"></div> <div class="content-boxes-in-v3"> <p style="font-size: 17px;"><strong><span>Proprietary Protocols </span></strong></p> <span> <ul> <li>Complete sequencing, even in regions with high-GC content</li> <li>≥4x double-strand coverage</li> <li>TA Cloning, as needed<br><br></li> </ul> </span> </div> </div><div class="content-boxes-v3 margin-bottom-20"> <div class="col-md-2"></div> <div class="content-boxes-in-v3"> <p style="font-size: 17px;"><strong><span>Superior Support </span></strong></p> <span> <ul> <li>Dedicated Study Director ensures a single point of contact</li> <li>Expert technical support, and consistent, transparent communication</li> </ul> </span> </div> </div> </div> </div> </div> </div><div class="process-v1 Image-Slider Component-BackGround-Default margin-top-0 margin-bottom-30 padding-top-10 padding-bottom-10"> <div class="container"> <div class="headline-center margin-bottom-20"> <div class="row"> <h2>Sequence Confirmation Process</h2> </div> <div class="row"> <br /> </div> </div> <ul class="list-inline list-st row process-in headline-center"> <li style="text-align:center;cursor:pointer;" class="ImgSlili_1"> <div class="row headline-center"> <img src="/-/media/Images/Services/GLP/workflow/conformatory-seq/assay-design.ashx?h=110&la=en&w=210&hash=C4840652CB8821D5A7B295BA95F7E6B1BBA476E4" alt="" width="210" height="110" /> </div> <div class="row headline-center"> <h3>Assay Design</h3> <br><br> </div> <div class="SeqIcon SeqIcon_1"> <span class="SeqIcon_text">1</span> </div> </li> <li style="vertical-align:bottom;text-align:center;opacity:1" class="Img-arror Img_1"> <img src="/-/media/Gwz/arrow.ashx?h=50&la=en&w=70&hash=E9EE43042F03F59D57F7E4676486569A4310720A" alt="arrow" width="70" height="50" /> </li><li style="text-align:center;cursor:pointer;" class="ImgSlili_2"> <div class="row headline-center"> <img src="/-/media/Images/Services/GLP/workflow/conformatory-seq/sample-processing.ashx?h=110&la=en&w=210&hash=E354591120B5C0B9628A7CAA3E63FC5B8A7CB4CB" alt="" width="210" height="110" /> </div> <div class="row headline-center"> <h3>Sample<br /> Processing</h3> <br /> </div> <div class="SeqIcon SeqIcon_2"> <span class="SeqIcon_text">2</span> </div> </li> <li style="vertical-align:bottom;text-align:center;opacity:1" class="Img-arror Img_2"> <img src="/-/media/Gwz/arrow.ashx?h=50&la=en&w=70&hash=E9EE43042F03F59D57F7E4676486569A4310720A" alt="arrow" width="70" height="50" /> </li><li style="text-align:center;cursor:pointer;" class="ImgSlili_3"> <div class="row headline-center"> <img src="/-/media/Images/Services/GLP/workflow/conformatory-seq/data-analysis-reporting.ashx?h=110&la=en&w=210&hash=66ACF46BA4D8094A503A4E6D998D018D02C65353" alt="" width="210" height="110" /> </div> <div class="row headline-center"> <h3>Data Analysis & Reporting</h3> <br /> </div> <div class="SeqIcon SeqIcon_3"> <span class="SeqIcon_text">3</span> </div> </li> <li style="vertical-align:bottom;text-align:center;opacity:1" class="Img-arror Img_3"> </li> </ul> </div> <script language="javascript" type="text/javascript"> var i = 1; var iconCount = 0; var icons; var iconContent; var Flag; jQuery(document).ready(function ($) { icons = $(".SeqIcon"); iconContent = $(".icon-content"); //hide the content if (iconContent != null && jQuery(".content_1").length > 0) { iconContent.each(function (i) { if (i > 0) { $(this).hide(); } }); } //change the icon status if (icons != null) { iconCount = icons.length; $(icons[0]).addClass("SeqIcon_Sel"); Flag = setInterval(function () { if (i == iconCount) { i = 0; } SwcRCA(i); i++; }, 2000); } $("li[class^=ImgSlili]").bind("mousemove", function () { clearInterval(Flag); jQuery("div[class^='row icon-content content_']").hide(); jQuery(".Img-arror").find("img").attr("src", "/assets/img/gwz/arrow.png"); jQuery(icons).removeClass("SeqIcon_Sel"); jQuery(".content_" + $(this).attr("class").split("_")[1]).show(); jQuery(icons[$(this).attr("class").split("_")[1] - 1]).addClass("SeqIcon_Sel"); jQuery(".Img_" + $(this).attr("class").split("_")[1]).find("img").attr("src", "/assets/img/gwz/arrow_sel.png"); }); $("li[class^=ImgSlili]").bind("mouseleave", function () { i = 0; Flag = setInterval(function () { SwcRCA(i); i++; }, 2000); jQuery(icons[$(this).attr("class").split("_")[1] - 1]).removeClass("SeqIcon_Sel"); jQuery(".Img_" + $(this).attr("class").split("_")[1]).find("img").attr("src", "/assets/img/gwz/arrow.png"); }); }); function SwcRCA(i) { if (i == 0) { jQuery(icons[icons.length - 1]).removeClass("SeqIcon_Sel"); } else { jQuery(icons[i - 1]).removeClass("SeqIcon_Sel"); } jQuery("div[class^='row icon-content content_']").hide(); jQuery(icons[i]).addClass("SeqIcon_Sel"); jQuery(".content_" + (i + 1)).show(); //change the arrow color jQuery(".Img_" + (i)).find("img").attr("src", "/assets/img/gwz/arrow.png"); if (i != (icons.length - 1)) { jQuery(".Img_" + (i + 1)).find("img").attr("src", "/assets/img/gwz/arrow_sel.png"); } } </script> </div><div class="headline-center Rich-Text-Edit-Area"> <link href="https://fonts.googleapis.com/css?family=Roboto:300,400,500,700" rel="stylesheet" /> <style type="text/css"> .covid-banner { width: 1170px; height: auto; margin: 0 auto; background-image: url("/-/media/11037-D_Sanger-Troubleshoot_WebBanFull-Med_Background.ashx"); background-size: cover; background-position: center; text-align: left; padding: 0px 0 0px 0; } .covid-content { text-align: center; } .covid-box h3 { color: #ffffff; text-transform: none; letter-spacing: 1px; border-bottom: none; font-family: 'Roboto', sans-serif; font-weight: 450; line-height: 125%; font-size: 35px; margin: 0; padding-bottom: 15px; padding-top: 25px; } .covid-box h4 { color: #ffffff; text-transform: none; letter-spacing: 1px; line-height: 30px; border-bottom: none; font-family: 'Roboto', sans-serif; font-weight: 400; font-size: 35px; margin: 0; margin-bottom: 5px; } .covid-box p { color: #000000; text-transform: none; letter-spacing: 1px; border-bottom: none; font-family: 'Roboto', sans-serif; font-weight: 400; font-size: 15px; margin: 0; margin-bottom: 5px; } .covid-box button { padding: 8px 19px; color: #826ec3; letter-spacing: 1px; background: #ffffff; border: 2px solid #ffffff; border-radius: 0px; transition: all .2s ease-in-out; font-size: 15px } .covid-box button:hover { cursor: pointer; transform: scale(1.1); } .covid-box button:focus { outline: 0; } @media only screen and (max-width: 1170px) { .covid-banner { width: 100%; height: auto; } .covid-content { width: 90%; margin: 0 auto; } } </style> <br /> <div class="covid-banner"> <div class="covid-content"> <div class="covid-box"> <br /> <h3>Troubleshooting DNA Templates<br /> with Sanger Sequencing</h3> <a href="https://hubs.ly/Q02BXmbp0" target="_blank"> <br /> <button> READ BLOG</button> <br /> </a> <p> </p> </div> </div> </div> <p> </p> </div> <div class="headline-center Rich-Text-Edit-Area"> <div class="container"> <h2>GLP-COMPLIANT STANDALONE SANGER SEQUENCING</h2> <p>Standalone Sanger sequencing services are also available at the GLP-compliant level for integration into client analysis programs. </p> <p> </p> <p> </p> <p> </p> <h2> <span>Medical Device Validation and Clinical Sample Processing (510K and PMA)</span></h2> <p>Validation of Medical Device Assays coupled with GLP-compliant Sanger sequencing of clinical samples to support medical device applications are also available.</p> <p> </p> <p>For more information, please email <a href="mailto:regulatory@azenta.com">regulatory@azenta.com</a>.</p> <p> </p> </div> <br /> </div>  <div class="process-v1 How-To-Order Component-BackGround-Gray margin-top-0 padding-top-10 padding-bottom-10 "> <div class=" container"> <div class="headline-center"> <div class="row"> <h2>How to Order</h2> </div> <div class="row"> *Samples must arrive at the GENEWIZ New Jersey Laboratory before 10:00 am EST to qualify for Same Day service. Note that direct-sequencing templates are not available for our Same Day service.<br /> </div> </div> <ul class="list-inline row process-in process-border-3 col-xs-offset-0"> <li class="col-sm-3"> <div class="process-icon"> <i class="rounded-x dot-active"></i> </div> <a href='/Public/Resources/Sample-Submission-Guidelines/Molecular-Genetics-Sample-Submission-Guidelines' target='_blank'> <div class="process-desc"> <img src="/-/media/Images/Home/icons/Purple-Icons/prepare-samples_90x90_Purple.ashx?h=90&la=en&w=90&hash=D5B4727E901955084F0BAAA98461174597484501" alt="Building" width="90" height="90" /> </div> <div class="row"> <h3>Prepare Samples</h3> </div> </a> </li><li class="col-sm-3"> <div class="process-icon"> <i class="rounded-x dot-active"></i> </div> <a href='https://clims4usuat.genewiz.com/CustomerHome/Index' target='_blank'> <div class="process-desc"> <img src="/-/media/Images/Home/icons/Purple-Icons/place-an-order_90x90_Purple.ashx?h=90&la=en&w=90&hash=988021540FFC23F0D2CB56B780C2CBDEFC0ADEF0" alt="Building" width="90" height="90" /> </div> <div class="row"> <h3>Request Quote</h3> </div> </a> </li><li class="col-sm-3"> <div class="process-icon"> <i class="rounded-x dot-active"></i> </div> <a href='/Public/Resources/Sample-Submission-Guidelines/Molecular-Genetics-Sample-Submission-Guidelines' target='_blank'> <div class="process-desc"> <img src="/-/media/Images/Home/icons/Purple-Icons/submit-samples-to-GENEWIZ_90x90_Purple.ashx?h=90&la=en&w=90&hash=00BB21EF13939D24F31645E3B03BBBBCCAA466E7" alt="Building" width="90" height="90" /> </div> <div class="row"> <h3>Submit Samples to Azenta</h3> </div> </a> </li> </ul> <br /> <div class="headline-center HowToOrd"> <h3> <a href="mailto:regulatory@azenta.com"><em class="fa fa-envelope fa-icons blue-text"> </em></a> <a href="mailto:regulatory@azenta.com">Email</a> | <em class="fa fa-phone fa-icons 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