PAD for Cell & Gene Therapy

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href="https://missionbio.com/products/pharma-assay-development/">Pharma Assay Development</a></span> <span class="bread-arrow"></span> <span class="breadcrumb_last" aria-current="page">PAD for Cell & Gene Therapy</span></span></div></div> <section id="pharma-assay-hero" style="background-image: url('https://missionbio.com/wp-content/uploads/2024/04/cbedb81ab1cf11a70dee3be8f1074744.jpg')"> <div class="_1300-container inner-content"> <div class="apps-cols"> <div class="mission-copy"> <h1 class="h2-thin nm w">Drive Therapeutic  Success With Streamlined Analytical Characterization</h1> <div class="description"><p>Harness the full power of single-cell multi-omics through PAD services, and accelerate your cell and gene therapeutic development and manufacturing.</p> </div> <a style="color: #ffffff; margin: 30px 0 0 0; padding-top: 9px; padding-bottom: 9px;" class="button" href="#get_started" target="">GET STARTED</a> </div> </div> </div> </section> <section id="pad-panels-categories"> <div class="panels-categories"> <div class="_1300-container inner-content capabilities-links"> <div class="panels-links"> <a href="#pad-why" class="cap-link">KEY BENEFITS</a> <a href="#Case-Study" class="cap-link">CASE STUDY</a> <a href="#pad-support" class="cap-link">SUPPORT & PROCESS</a> <a href="#applications-resources" class="cap-link">RESOURCES</a> </div> </div> </div> </section> <section id="pad-why" class="pad-why"> <div class="_1300-container inner-content"> <h2 class="section-title">Why PAD Services for  Cell & Gene Therapy Development?</h2> <div class="description"><p>PAD services are the only way to fully leverage the Tapestri platform to consolidate assays, produce multi-attribute datasets, and glean powerful single-cell insights to advance your analytical characterization program. Our PAD team will work closely with you to develop, run, validate, and transfer these powerful assays to your site, CRO, or CDMO of choice to accelerate your release of market-ready cell and gene therapeutics.</p> </div> <div class="pipeline_block"> <h2 class="section-title">Expedite Your Therapy Development Pipeline</h2> <div class="white_bg"> <img src="https://missionbio.com/wp-content/uploads/2024/04/Application-of-sc-DNA-Sequencing-in-Drug-Development-Heme-Onc-2.png" alt="Pipeline"> </div> </div> </div> </section> <div id="Case-Study" class="panels-section case-study testimonial"> <div class="_1300-container inner-content panels-details"> <div class="mission-cols"> <div class="application-image case-study" style="background-image: url(https://missionbio.com/wp-content/uploads/2024/04/31bf176aa91a1467377ad437d05c7a2a.png);"> </div> <div class="panel-col"> <h2 class="h2-thin w">“For the first time, we are able to measure multiple therapeutic parameters simultaneously, such as vector copy number, transduction efficiency, gene editing outcomes, and genomic stability. And we can do it in a matter of days, minimizing sample usage and accelerating data insights that may provide critical indicators of safety and potency. The Tapestri® Platform’s ability to provide these analytics in a consistent, high-resolution manner at the single-cell level, while eliminating laborious steps, addresses the industry’s top concerns.”</h2> <p style="color: #FFF;" class="mb30">Chris Mason , Professor of Cell & Gene Therapy, University College London</p> </div> </div> </div> </div> <section id="pad-support" class="pad-support"> <div class="_1300-container inner-content"> <h2 class="section-title">PAD Services Support & Process</h2> <h4 class="section-subtitle">Fully Customized Single-Cell Analysis Integration </h4> <div class="description"><p>PAD services develop custom assays based on client need and drug development phase. We recognize and can aid in dealing with the heightened challenge of assessing the safety and efficacy of CGT products compared to conventional therapies due to the many potential variations between genetically altered cells.</p> <p> </p> <p>Once a custom assay is developed and validated, our PAD services team will provide the support and installation required to get the assay up and running.</p> <p> </p> </div> <div class="description_list"> <div class="white_bg"> <div class="description_list_item"> <div class="title">PHASE 1: FIT FOR PURPOSE ASSESSMENT</div> <div class="list"> <div class="list_item"><ul> <li>Sample: Control cell lines</li> <li>Includes client’s product specific panel</li> </ul> </div> <div class="list_item"><ul> <li>Initial analysis methods testing is conducted on a preliminary set of experiments to establish Tapestri for intended use</li> </ul> </div> </div> </div> <div class="description_list_item"> <div class="title">Phase 2: Preliminary assay validation</div> <div class="list"> <div class="list_item"><ul> <li>Sample: Experimental cell lines</li> <li>Intent is to confirm assay specificity, sensitivity, and linearity</li> </ul> </div> <div class="list_item"><ul> <li>Possibility to expand across multiple drug products or lots</li> </ul> </div> </div> </div> <div class="description_list_item"> <div class="title">Phase 3: Transfer GMP ready assay to Client or CDMO</div> <div class="list"> <div class="list_item"><ul> <li>Tapestri instrument installation, premium training</li> <li>Operational and performance qualifications (IOQ/PQ)</li> <li>Lot-controlled customized product bundle for transfer and assay qualification</li> </ul> </div> <div class="list_item"><h4>Deliverables:</h4> <ul> <li>Final transfer report</li> <li>Wet lab and sequencing procedures</li> <li>Cloud-hosted bioinformatics pipeline and user guide</li> <li>Formal documentation</li> </ul> </div> </div> </div> </div> </div> </div> </section> <section id="pad-blue_heading" class="pad-blue_heading"> <div class="_1300-container inner-content"> <h2 class="section-title">Our team has successfully supported design transfer to drug sponsors, CROs, and CDMOs, fully integrating the power of single-cell assays during drug manufacturing and lot release.</h2> </div> </section> <section id="applications-resources" class="h-resources" style=""> <div class="_1300-container inner-content"> <h2 class="section_title w" style="">Driving Success Through PAD Partnership</h2> <div class="h-resources-grid"> <div class="h-resource-card tn" data-ix="show-more-link"> <div class="h-resource-image tn" ></div> <div class="h-resource-content"> <div class="h-resource-category d tn"> PRESS RELEASE </div> <a href="https://missionbio.com/press/avance-cgt-assay-transfer/" class="h-resource-title-link"> Mission Bio Transfers First Tapestri GMP-Ready CGT Assay to Avance Biosciences for Cell-Based Therapies </a> <br/> <a href="https://missionbio.com/press/avance-cgt-assay-transfer/" class="more-link">LEARN MORE</a> </div> </div> <div class="h-resource-divider"></div> <div class="h-resource-card tn" data-ix="show-more-link"> <div class="h-resource-image tn" ></div> <div class="h-resource-content"> <div class="h-resource-category d tn"> PRESS RELEASE </div> <a href="https://missionbio.com/press/single-cell-transduction-assay-avrobio/" class="h-resource-title-link"> Mission Bio’s single-cell transduction assay adopted for AVROBIO’s gene therapy pipeline </a> <br/> <a href="https://missionbio.com/press/single-cell-transduction-assay-avrobio/" class="more-link">LEARN MORE</a> </div> </div> <div class="h-resource-divider"></div> <div class="h-resource-card p" data-ix="show-more-link"> <div class="h-resource-image p" style="background-image: url(/wp-content/themes/missionbio-v2/images-2/Posters.png);"></div> <div class="h-resource-content"> <div class="h-resource-category d pt">posters</div> <a 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