Quality Systems - ProtaGene

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bg-center lg:min-h-[410px]" style="background-image: url(https://www.protagene.com/wp-content/uploads/2021/11/Img17_Quality-Systems-scaled.jpg);"> <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"> Quality Systems </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-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="text-orange-500">Excellence in Quality Systems</h2> </div> <div class="mt-4"> <div class="richtext"> <p>ProtaGene’s experience and dedication to quality systems through our assay protocols and data management processes enable us to confidently navigate our clients’ needs throughout the regulatory journey. Quality Systems are key to the experience and value we provide clients and are a mainstay of our corporate culture.</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/2021/11/Img01_Quality-Systems.jpg" alt=""> </div> </div> </div> </div> </div> </section> <section class="w-screen flex justify-center items-center"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="1403px" height="138px" viewBox="0 0 1403 138" version="1.1">  <title>Section_Separator</title> <desc>Created with Sketch.</desc> <g id="Page" stroke="none" stroke-width="1" fill="none" fill-rule="evenodd"> <g id="17_Protagene_Quality" transform="translate(-17.000000, -1194.000000)"> <g id="Section_Separator" transform="translate(17.000000, 1194.000000)"> <g> <polygon id="Fill-1" fill="#FFFFFF" points="0.5 31 22.5 31 22.5 0 0.5 0"/> <polygon id="Fill-2" 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ProtaGene’s experienced team offers a wide range of support, including analytical method development, method validation, method transfer, stability testing, release testing for biopharmaceutical products, and highly sensitive data analyses platforms for applications such as integration site analysis.</p> </div> </div> </div> </div> </div> </div> </section> <section class="w-screen bg-gray-200 text-black relative overflow-hidden "> <div class="container lg:px-24 pt-8 lg:pt-50 pb-8 lg:pb-50 mx-auto relative overflow-hidden"> <div class="z-10 relative"> <div class="flex flex-wrap"> <div class="w-full lg:w-1/3"> <div class=""> <div class="richtext"> <p><strong>Good Manufacturing Practice (GMP)</strong></p> </div> </div> </div> <div class="w-full lg:w-2/3 lg:pl-16 mt-4 lg:mt-0"> <div class=" 0"> <div class="richtext"> <p>Our Dortmund and Heilbronn sites are regularly inspected by the local authorities in Arnsberg and Tübingen, respectively. The GMP certification was first issued in 2006 for GMP lot release testing of commercial protein products and continues to be GMP certified due to its rigorous quality management system that oversees all processes and meets the requirements of the EU and FDA GMP guidelines. </p> </div> </div> <div class="mt-4 1"> <div class="richtext"> <p><em>Coming soon: GMP to our Burlington, MA site. </em></p> </div> </div> </div> </div> </div> </div> </section> <section class="w-screen bg-white text-black relative overflow-hidden "> <div class="container lg:px-24 pt-8 lg:pt-50 pb-8 lg:pb-50 mx-auto relative overflow-hidden"> <div class="z-10 relative"> <div class="flex flex-wrap"> <div class="w-full lg:w-1/3"> <div class=""> <div class="richtext"> <p><strong>Good Clinical Practices (GCPs)<br /> Good Clinical Laboratory Practice (GCLP)<br /> Good Laboratory Practices (GLPs)</strong></p> </div> </div> </div> <div class="w-full lg:w-2/3 lg:pl-16 mt-4 lg:mt-0"> <div class=" 0"> <div class="richtext"> <p>For both Heidelberg and Boston sites, the quality management systems are GCP, GCLP, or GLP compliant as appropriate and oversees all processes related to clinical and non-clinical studies. In 2024, our site in Heidelberg obtained GLP accreditation, with the scope of service and consultancy for research, development, and implementation of innovative therapies, medical and biotechnological procedures such as integration site analysis.</p> </div> </div> </div> </div> </div> </div> </section> <section class="w-screen bg-gray-200 text-black relative overflow-hidden "> <div class="container lg:px-24 pt-8 lg:pt-50 pb-8 lg:pb-50 mx-auto relative overflow-hidden"> <div class="z-10 relative"> <div class="flex flex-wrap"> <div class="w-full lg:w-1/3"> <div class=""> <div class="richtext"> <p><strong>Quality Management Systems</strong></p> </div> </div> </div> <div class="w-full lg:w-2/3 lg:pl-16 mt-4 lg:mt-0"> <div class=" 0"> <ul id="random2355a54" class=" relative "> <li class="level-1 leading-6 "> <div class="flex"> <div class="py-2 mr-2"> <svg width="10px" height="10px" class="li-bullet" viewBox="0 0 10 10" xmlns="http://www.w3.org/2000/svg"> <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> </svg> </div> <p> Precise protocol-driven systems and procedures </p> </div> </li> <li class="level-1 leading-6 "> <div class="flex"> <div class="py-2 mr-2"> <svg width="10px" height="10px" class="li-bullet" viewBox="0 0 10 10" xmlns="http://www.w3.org/2000/svg"> <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> </svg> </div> <p> Traceable data and documentation </p> </div> </li> <li class="level-1 leading-6 "> <div class="flex"> <div class="py-2 mr-2"> <svg width="10px" height="10px" class="li-bullet" viewBox="0 0 10 10" xmlns="http://www.w3.org/2000/svg"> <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> </svg> </div> <p> Document control </p> </div> </li> <li class="level-1 leading-6 "> <div class="flex"> <div class="py-2 mr-2"> <svg width="10px" height="10px" class="li-bullet" viewBox="0 0 10 10" xmlns="http://www.w3.org/2000/svg"> <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> </svg> </div> <p> Intensive training programs </p> </div> </li> <li class="level-1 leading-6 "> <div class="flex"> <div class="py-2 mr-2"> <svg width="10px" height="10px" class="li-bullet" viewBox="0 0 10 10" xmlns="http://www.w3.org/2000/svg"> <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> </svg> </div> <p> Comprehensive inspection/auditing programs both internally and externally </p> </div> </li> </ul> </div> <div class="mt-4 1"> <div class="richtext"> <p><strong>System for qualification of equipment, particularly computerized systems based on Good Automated Manufacturing Practice (GAMP)</strong></p> </div> </div> <div class="mt-4 2"> <ul id="randomc01b66c" class=" relative "> <li class="level-1 leading-6 "> <div class="flex"> <div class="py-2 mr-2"> <svg width="10px" height="10px" class="li-bullet" viewBox="0 0 10 10" xmlns="http://www.w3.org/2000/svg"> <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> </svg> </div> <p> Qualification of Subcontractors and Service Providers </p> </div> </li> </ul> </div> </div> </div> </div> </div> </section> <section class="w-screen bg-white text-black relative overflow-hidden "> <div class="container lg:px-24 pt-8 lg:pt-50 pb-8 lg:pb-50 mx-auto relative overflow-hidden"> <div class="z-10 relative"> <div class="flex flex-wrap"> <div class="w-full lg:w-1/3"> <div class=""> <div class="richtext"> <p><strong>Complete Data Integrity</strong></p> </div> </div> </div> <div class="w-full lg:w-2/3 lg:pl-16 mt-4 lg:mt-0"> <div class=" 0"> <div class="richtext"> <p>Excellence in data integrity is critical to meeting clients’ needs and adhering to GMP, GCP, and GCLP guidelines. To ensure data integrity, we have implemented a multi-layered approach:</p> </div> </div> <div class="mt-4 1"> <ul id="random83ed357" class=" relative "> <li class="level-1 leading-6 "> <div class="flex"> <div class="py-2 mr-2"> <svg width="10px" height="10px" class="li-bullet" viewBox="0 0 10 10" xmlns="http://www.w3.org/2000/svg"> <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> </svg> </div> <p> LIMS-driven processes for CMC and sample analysis </p> </div> </li> <li class="level-1 leading-6 "> <div class="flex"> <div class="py-2 mr-2"> <svg width="10px" height="10px" class="li-bullet" viewBox="0 0 10 10" xmlns="http://www.w3.org/2000/svg"> <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> </svg> </div> <p> Proper handling of user rights </p> </div> </li> <li class="level-1 leading-6 "> <div class="flex"> <div class="py-2 mr-2"> <svg width="10px" height="10px" class="li-bullet" viewBox="0 0 10 10" xmlns="http://www.w3.org/2000/svg"> <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> </svg> </div> <p> Robust cybersecurity programs </p> </div> </li> <li class="level-1 leading-6 "> <div class="flex"> <div class="py-2 mr-2"> <svg width="10px" height="10px" class="li-bullet" viewBox="0 0 10 10" xmlns="http://www.w3.org/2000/svg"> <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> </svg> </div> <p> The appointment of system administrators </p> </div> </li> <li class="level-1 leading-6 "> <div class="flex"> <div class="py-2 mr-2"> <svg width="10px" height="10px" class="li-bullet" viewBox="0 0 10 10" xmlns="http://www.w3.org/2000/svg"> <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> </svg> </div> <p> Adhering to FDA 21 CFR Part 11 audit trail requirements </p> </div> </li> <li class="level-1 leading-6 "> <div class="flex"> <div class="py-2 mr-2"> <svg width="10px" height="10px" class="li-bullet" viewBox="0 0 10 10" xmlns="http://www.w3.org/2000/svg"> <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" 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