Molecular Bioanalysis - ProtaGene | Biodistribution

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document.querySelector('button.openMenu'), closeBtn = document.querySelector('button.closeMenu'); hamburgerBtn.onclick = function() { openMenu() } closeBtn.onclick = function() { closeMenu() } function closeMenu() { navDrawer.classList.add('closed') } function openMenu() { navDrawer.classList.remove('closed') } </script> <main class="main overflow-x-hidden"> <section class="pt-32 lg:pt-48 lg:pb-20 pb-8 bg-navy-900 text-white bg-cover bg-center lg:min-h-[410px]" > <div class="container mx-auto"> <div class="flex flex-wrap"> <div class="w-full lg:w-3/4"> <h1 class="text-orange-500 leading-tight mb-2"> Molecular Bioanalysis </h1> </div> </div> </div> </section> <section class="w-screen bg-white text-black relative overflow-hidden "> <div class="container lg:px-0 pt-8 lg:pt-70 pb-8 lg:pb-70 mx-auto relative overflow-hidden"> <div class="z-10 relative"> <div class="flex flex-wrap"> <div class="w-full lg:w-3/5 lg:pr-24"> <div class=""> <h2 class="text-orange-500">Molecular Biology Tools to Unlock the Full Potential of Your Gene Therapy Products</h2> </div> <div class="mt-4"> <div class="richtext"> <p>Biodistribution, transgene expression, and vector shedding are critical components of a gene therapy molecule’s development, providing crucial data for IND-enabling preclinical studies and safety evaluation during clinical development.</p> <p>Gene therapy carries potential risks, including unintended effects caused by the gene therapy vector. Biodistribution studies are critical for determining the distribution and persistence of the gene therapy vector in target and non-target tissues and are generally combined with transgene expression assessments to aid interpreting any observed adverse effects from the toxicology studies.</p> <p>A key aspect of clinical safety involves understanding the potential for vector shedding of the administered gene therapy. Evaluation of biofluids informs understanding of personal and environmental risks and is also a recommended part of preclinical development. Inadequate safety data could lead to regulatory approval challenges and delay time to the clinic.</p> </div> </div> </div> <div class="w-full lg:w-2/5 mt-4 lg:mt-0"> <div class=" 0"> <img decoding="async" data-aos="fade-up" src="https://www.protagene.com/wp-content/uploads/2023/05/ProtaGene-Bioanalytical-Services.png" alt=""> </div> </div> </div> </div> </div> </section> <section class="w-screen bg-navy-500 text-white relative overflow-hidden "> <div class="container lg:px-0 pt-8 lg:pt-70 pb-8 lg:pb-100 mx-auto relative overflow-hidden"> <div class="z-10 relative"> <div class="flex flex-wrap"> <div class="w-full lg:w-3/5 lg:pr-24"> <div class=""> <h2 class="">Speed Time to Market with Cutting-Edge Molecular Bioanalysis Approaches</h2> </div> <div class="mt-4"> <div class="richtext"> <p>Our molecular bioanalytical solutions are designed to enable preclinical assessment of safety risks and monitoring of gene therapies in the clinic.</p> <p><strong>ProtaGene offers:</strong></p> <ul> <li>Expert understanding of industry expectations for developing and validating molecular assays</li> <li>Established processes that maintain the integrity of sample analysis results while minimizing contamination risks</li> <li>State-of-the-art instrumentation and automation to enable high-throughput analysis of tissues, blood, and biofluids</li> <li>Bioanalytical labs designed and managed by a leading industry expert with 25+ years of experience</li> <li>New modern facilities, including automation, run under GLP compliance</li> </ul> </div> </div> <div class="mt-4"> <div> <a href="mailto:info@protagene.com" class="font-semibold inline-flex px-4 py-2 border-2 border-solid border-orange-500 text-orange-500 hover:text-white hover:bg-orange-500"> Talk to Our Experts </a> </div> </div> </div> <div class="w-full lg:w-2/5 mt-4 lg:mt-0"> <div class=" 0"> <img decoding="async" data-aos="fade-up" src="https://www.protagene.com/wp-content/uploads/2023/05/Pattern_square_04.png" alt=""> </div> </div> </div> </div> </div> </section> <section class="bg-white py-70"> <div class="container"> <div class="flex flex-wrap"> <div class="w-full lg:w-3/5 lg:pr-20"> <h2 class="text-orange-500"> Molecular Bioanalytical Solutions </h2> <div class="richtext mt-4"> <p>ProtaGene offers comprehensive bioanalytical solutions critical for analyzing viral vector performance and safety.</p> </div> <ul class="mt-8"> <li class=" border-t-2 border-gray-200 border-solid "> <a href="#section-1" class="items-center flex py-2 hover:text-orange-500"> <img decoding="async" src="https://www.protagene.com/wp-content/uploads/2021/11/bioinformatics.svg" alt="Icon for Biodistribution & Transgene Expression"> <p class="ml-4">Biodistribution & Transgene Expression</p> </a> </li> <li class=" border-t-2 border-gray-200 border-solid border-b-2"> <a href="#section-2" class="items-center flex py-2 hover:text-orange-500"> <img decoding="async" src="https://www.protagene.com/wp-content/uploads/2021/11/vector-analytics.svg" alt="Icon for Vector Shedding"> <p class="ml-4">Vector Shedding</p> </a> </li> </ul> </div> <div class="w-full lg:w-2/5 mt-8 lg:mt-0"> <img decoding="async" data-aos="fade-up" src="https://www.protagene.com/wp-content/uploads/2023/05/PTG3001_VectorShedding_Spotlight_V5-02.png" alt=""> </div> </div> </div> </section> <section id="section-1" class="py-50 bg-gray-200"> <div class="container mx-auto"> <div class="flex flex-wrap"> <div class="w-full lg:w-3/5 lg:pr-20 lg:pl-8"> <div class="flex items-start flex-col lg:flex-row"> <img decoding="async" class="mb-4" src="https://www.protagene.com/wp-content/uploads/2021/11/bioinformatics.svg" alt="Icon for Biodistribution & Transgene Expression"> <div class="lg:pl-4 mb-4"> <p class="text-15 font-bold text-orange-500"> Biodistribution & Transgene Expression </p> <div class="richtext"> <p>Gene therapies (for example, adeno-associated viral (AAV) and adenoviral (AdV) vectors) are targeted therapies administered to patients to treat a range of monogenic diseases. Safety and efficacy rely on the delivery of the therapeutic to the target tissue.</p> <p>Uptake by non-target tissues is common, risking patient safety and therapeutic effectiveness. Biodistribution studies are conducted during preclinical development to evaluate how gene therapies are taken up and retained <em>in vivo</em>. Understanding the biodistribution of a product in preclinical models is essential for assessing the risk during preclinical gene therapy development.</p> <p><b><a href="https://www.protagene.com/wp-content/uploads/2023/06/ProtaGene-Bioanalysis-Spotlight-Biodistribution-and-Transgene-Expression-062023.pdf" style="text-decoration:none!important;" class="font-semibold mt-8 inline-flex px-4 py-2 border-2 border-solid border-orange-500 text-orange-500 hover:text-white hover:bg-orange-500">Download Bioanalysis Spotlight</a></b></p> </div> </div> </div> </div> <div class="w-full lg:w-2/5"> <ul> <li class="flex pt-1" data-aos="fade-up" data-aos-delay="0"> <div class="py-2 mr-2"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="10px" height="10px" viewBox="0 0 10 10" version="1.1">  <title>bullet</title> <desc>Created with Sketch.</desc> <g id="Page" stroke="none" stroke-width="1" fill="none" fill-rule="evenodd"> <g id="01_Protagene_HP" transform="translate(-642.000000, -1841.000000)" fill="#E95A29"> <g id="Group-2" transform="translate(642.000000, 1841.000000)"> <g id="bullet"> <rect id="Rectangle" transform="translate(5.000000, 5.000000) rotate(-315.000000) translate(-5.000000, -5.000000) " x="2" y="2" width="6" height="6"/> </g> </g> </g> </g> </svg> </div> The levels delivered to diverse tissues and the persistence of the gene therapy vector are monitored over time to confirm the uptake and retention of the viral vectors in target and non-target tissues. </li> <li class="flex pt-1" data-aos="fade-up" data-aos-delay="50"> <div class="py-2 mr-2"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="10px" height="10px" viewBox="0 0 10 10" version="1.1">  <title>bullet</title> <desc>Created with Sketch.</desc> <g id="Page" stroke="none" stroke-width="1" fill="none" fill-rule="evenodd"> <g id="01_Protagene_HP" transform="translate(-642.000000, -1841.000000)" fill="#E95A29"> <g id="Group-2" transform="translate(642.000000, 1841.000000)"> <g id="bullet"> <rect id="Rectangle" transform="translate(5.000000, 5.000000) rotate(-315.000000) translate(-5.000000, -5.000000) " x="2" y="2" width="6" height="6"/> </g> </g> </g> </g> </svg> </div> Expression levels of the therapeutic transgene are also assessed in tissues shown to contain the vector. </li> <li class="flex pt-1" data-aos="fade-up" data-aos-delay="100"> <div class="py-2 mr-2"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="10px" height="10px" viewBox="0 0 10 10" version="1.1">  <title>bullet</title> <desc>Created with Sketch.</desc> <g id="Page" stroke="none" stroke-width="1" fill="none" fill-rule="evenodd"> <g id="01_Protagene_HP" transform="translate(-642.000000, -1841.000000)" fill="#E95A29"> <g id="Group-2" transform="translate(642.000000, 1841.000000)"> <g id="bullet"> <rect id="Rectangle" transform="translate(5.000000, 5.000000) rotate(-315.000000) 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unwanted replication of the vector is occurring.</p> <p>Therefore, vector shedding data provides critical information during the clinical development of these types of products.</p> <p> </p> <p><b><a href="https://www.protagene.com/wp-content/uploads/2023/06/ProtaGene-Bioanalysis-Spotlight-Vector-Shedding-062023.pdf" style="text-decoration:none!important;" class="font-semibold mt-8 inline-flex px-4 py-2 border-2 border-solid border-orange-500 text-orange-500 hover:text-white hover:bg-orange-500">Download Bioanalysis Spotlight</a></b></p> </div> </div> </div> </div> <div class="w-full lg:w-2/5"> <ul> <li class="flex pt-1" data-aos="fade-up" data-aos-delay="0"> <div class="py-2 mr-2"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="10px" height="10px" viewBox="0 0 10 10" version="1.1">  <title>bullet</title> <desc>Created with Sketch.</desc> <g id="Page" stroke="none" stroke-width="1" fill="none" fill-rule="evenodd"> <g id="01_Protagene_HP" 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