IVD Assay Development | OEM Services

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Areas</a> </div> </div> </div> </div> </div> </li> <li class="nav-item dropdown"> <a class="nav-link dropdown-toggle" href="#" id="navbarDropdown-therapeutic-manufacturing" data-toggle="dropdown" role="button" aria-haspopup="true" aria-expanded="false"> Therapeutic Manufacturing <span class="icon-bt-icon-caret-cropped menu-caret js-caret d-inline-block"></span> </a> <div class="dropdown-menu dropdown-menu-therapeutic-manufacturing" aria-labelledby="navbarDropdown-therapeutic-manufacturing"> <div class="row"> <div class="col sub-menu-wrapper"> <div class="sub-menu-header"> Reagents & Kits<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/reagents/cell-culture-reagents/serum-free-animal-free" class="dropdown-item text-wrap" data-drupal-link-system-path="node/3576">Animal-Free Cell Culture</a> <a href="/reagents/elisa-kits" class="dropdown-item text-wrap" data-drupal-link-system-path="node/176">ELISA Kits</a> <a 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href="/gmp-products/ruo-to-gmp" class="dropdown-item text-wrap" data-drupal-link-system-path="node/3421">Transition to GMP </a> <a href="/gmp-products/loa-request" class="dropdown-item text-wrap" data-drupal-link-system-path="node/13326">DMF/LOA Request</a> </div> </div> </div> <div class="col sub-menu-wrapper"> <div class="sub-menu-header"> Instruments<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/brands/proteinsimple" class="dropdown-item text-wrap" data-drupal-link-system-path="node/3281">ProteinSimple Instruments</a> <a href="/instruments/ice" class="dropdown-item text-wrap" data-drupal-link-system-path="node/256">iCE Maurice</a> <a href="/instruments/imagers" class="dropdown-item text-wrap" data-drupal-link-system-path="node/536">Imagers</a> <a href="/instruments/luminex" class="dropdown-item text-wrap" data-drupal-link-system-path="node/241">Luminex</a> <a href="/instruments/micro-flow-imaging" class="dropdown-item text-wrap" data-drupal-link-system-path="node/526">Micro-Flow Imaging</a> <a href="/instruments/simple-plex" class="dropdown-item text-wrap" data-drupal-link-system-path="node/541">Simple Plex Ella</a> <a href="/instruments/simple-western" class="dropdown-item text-wrap" data-drupal-link-system-path="node/521">Simple Western</a> <a href="/instruments/single-cell-dispensers" class="dropdown-item text-wrap" data-drupal-link-system-path="node/6361">Single Cell Dispensers</a> <a href="/instruments/single-cell-western" class="dropdown-item text-wrap" data-drupal-link-system-path="node/531">Single Cell Western</a> <a href="/instruments" class="dropdown-item text-wrap" data-drupal-link-system-path="node/6731">View All Instruments</a> </div> </div> </div> <div class="col sub-menu-wrapper"> <div class="sub-menu-header"> Applications<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/methods/bioprocessing" class="dropdown-item text-wrap">Bioprocessing</a> </div> </div> </div> <div class="col sub-menu-wrapper"> <div class="sub-menu-header"> Research Areas<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/research-areas/cell-and-gene-therapy" class="dropdown-item text-wrap" data-drupal-link-system-path="node/51">Cell & Gene Therapy</a> <a href="/applications/immuno-oncology-clinical" class="dropdown-item text-wrap" data-drupal-link-system-path="node/2066">Immuno-Oncology</a> </div> </div> </div> </div> </div> </li> <li class="nav-item dropdown"> <a class="nav-link dropdown-toggle" href="#" id="navbarDropdown-diagnostics" data-toggle="dropdown" role="button" aria-haspopup="true" aria-expanded="false"> Diagnostics <span class="icon-bt-icon-caret-cropped menu-caret js-caret d-inline-block"></span> </a> <div class="dropdown-menu dropdown-menu-diagnostics" aria-labelledby="navbarDropdown-diagnostics"> <div class="row"> <div class="col sub-menu-wrapper"> <div class="sub-menu-header"> Controls & Reagents<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/diagnostics/clinical-quality-controls" class="dropdown-item text-wrap" data-drupal-link-system-path="node/7606">Clinical Quality Controls</a> <a href="/diagnostics/molecular-quality-controls" class="dropdown-item text-wrap" data-drupal-link-system-path="node/5596">Molecular Controls</a> <a href="/diagnostics/controls-reagents/rnascope-ish-probe-high-risk-hpv" class="dropdown-item text-wrap" data-drupal-link-system-path="node/5981">RNAscope™ ISH Probe High Risk HPV</a> </div> </div> </div> <div class="col sub-menu-wrapper"> <div class="sub-menu-header"> Kits<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/diagnostics/amplidex-genetic-testing-kits" class="dropdown-item text-wrap" data-drupal-link-system-path="node/5581">Genetics</a> <a href="/diagnostics/quantidex-oncology-testing-kits" class="dropdown-item text-wrap" data-drupal-link-system-path="node/5586">Oncology</a> </div> </div> </div> <div class="col sub-menu-wrapper"> <div class="sub-menu-header"> Technology<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/diagnostics/exosome" class="dropdown-item text-wrap" data-drupal-link-system-path="node/5486">Exosome Platform</a> </div> </div> </div> <div class="col sub-menu-wrapper"> <div class="sub-menu-header"> OEM Services<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/diagnostics/ivd-assay-development" class="dropdown-item text-wrap is-active" data-drupal-link-system-path="node/10881" aria-current="page">IVD Assay Development</a> <a href="/diagnostics/ivd-contract-manufacturing" class="dropdown-item text-wrap" data-drupal-link-system-path="node/7381">IVD Contract Manufacturing</a> <a href="/diagnostics/molecular-quality-controls/oem-and-commercial-services" class="dropdown-item text-wrap" data-drupal-link-system-path="node/6781">Molecular Diagnostic OEM Services</a> </div> </div> </div> <div class="col sub-menu-wrapper"> <div class="sub-menu-header"> Companion Diagnostics<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/diagnostics/companion-diagnostics" class="dropdown-item text-wrap" data-drupal-link-system-path="node/5631">Companion Diagnostics Services</a> <a href="/diagnostics/companion-diagnostics/multiomics" class="dropdown-item text-wrap" data-drupal-link-system-path="node/10616">Multiomics Platform</a> </div> </div> </div> </div> </div> </li> <li class="nav-item dropdown"> <a class="nav-link dropdown-toggle" href="#" id="navbarDropdown-services" data-toggle="dropdown" role="button" aria-haspopup="true" aria-expanded="false"> Services <span class="icon-bt-icon-caret-cropped menu-caret js-caret d-inline-block"></span> </a> <div class="dropdown-menu dropdown-menu-services" aria-labelledby="navbarDropdown-services"> <div class="row"> <div class="col sub-menu-wrapper"> <div class="sub-menu-header"> Custom Quotes<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/services/bulk-quotes" class="dropdown-item text-wrap" data-drupal-link-system-path="services/bulk-quotes">Bulk Quote Discounts</a> <a href="/services/custom-formulation" class="dropdown-item text-wrap" data-drupal-link-system-path="services/custom-formulation">Custom Formulation Quotes</a> <a href="/reagents/rnascope-ish-technology/probes/custom" class="dropdown-item text-wrap" data-drupal-link-system-path="node/12571">RNAscope Custom Probe Design Quote</a> </div> </div> </div> <div class="col sub-menu-wrapper"> <div class="sub-menu-header"> Custom Services<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/services/custom-services" class="dropdown-item text-wrap" data-drupal-link-system-path="node/1891">All Custom Services</a> <a href="/services/custom-antibody-services" class="dropdown-item text-wrap" data-drupal-link-system-path="node/906">Custom Antibody Services</a> <a href="/services/custom-cell-and-gene-therapy-services" class="dropdown-item text-wrap" data-drupal-link-system-path="node/1281">Custom Cell & Gene Therapy Services</a> <a href="/services/custom-compound-library-service" class="dropdown-item text-wrap" data-drupal-link-system-path="node/2126">Custom Compound Library Services</a> <a href="/services/custom-elisa-services" class="dropdown-item text-wrap" data-drupal-link-system-path="node/261">Custom ELISA Services</a> <a href="/services/gene-engineering-services-tcbuster" class="dropdown-item text-wrap" title="Gene Engineering Services: Bio-Techne" data-drupal-link-system-path="node/1136">Custom Gene Engineering Services</a> <a href="/services/custom-luminex-services" class="dropdown-item text-wrap" data-drupal-link-system-path="node/271">Custom Luminex Services</a> <a href="/services/custom-protein-services" class="dropdown-item text-wrap" data-drupal-link-system-path="node/1441">Custom Protein Services</a> <a href="/services/custom-simple-plex-services" class="dropdown-item text-wrap" data-drupal-link-system-path="node/6296">Custom Simple Plex Services</a> <a href="/services/custom-targeted-protein-degradation-services" class="dropdown-item text-wrap" data-drupal-link-system-path="node/861">Custom Targeted Protein Degradation Services</a> <a href="/services/professional-assay-services-rnascope" class="dropdown-item text-wrap" data-drupal-link-system-path="node/12306">RNAscope Professional Assay Services</a> </div> </div> </div> <div class="col sub-menu-wrapper"> <div class="sub-menu-header"> Instrument Services<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/services/certified-service-provider-program" class="dropdown-item text-wrap" data-drupal-link-system-path="node/5446">Certified Service Provider (CSP) Program</a> <a href="/resources/instrument-services" class="dropdown-item text-wrap" data-drupal-link-system-path="node/5471">Contract Services</a> <a href="/services/instrument-services/simple-western-service-plans" class="dropdown-item text-wrap" data-drupal-link-system-path="node/3181">Simple Western Service Plans</a> </div> </div> </div> <div class="col sub-menu-wrapper"> <div class="sub-menu-header"> Licensing<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/services/biotechnology-licensing-partnering" class="dropdown-item text-wrap" data-drupal-link-system-path="node/1101">Biotechnology Licensing and Partnering</a> </div> </div> </div> </div> </div> </li> <li class="nav-item dropdown"> <a class="nav-link dropdown-toggle" href="#" id="navbarDropdown-resources" data-toggle="dropdown" role="button" aria-haspopup="true" aria-expanded="false"> Resources <span class="icon-bt-icon-caret-cropped menu-caret js-caret d-inline-block"></span> </a> <div class="dropdown-menu dropdown-menu-resources" aria-labelledby="navbarDropdown-resources"> <div class="row"> <div class="col sub-menu-wrapper"> <div class="sub-menu-header"> Product & Instrument Tools<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/resources/cofa-finder-tool" class="dropdown-item text-wrap" data-drupal-link-system-path="resources/cofa-finder-tool">Certificate of Analysis (COA) Finder Tool</a> <a href="/resources/calculators" class="dropdown-item text-wrap" data-drupal-link-system-path="node/7416">Calculators</a> <a href="/resources/flow-cytometry-panel-builder" class="dropdown-item text-wrap" data-drupal-link-system-path="node/8821">Flow Cytometry Panel Builder</a> <a href="/luminex-assay-customization-tool" class="dropdown-item text-wrap" data-drupal-link-system-path="luminex-assay-customization-tool">Luminex Assay Customization Tool</a> <a href="/resources/product-insert-lookup-tool" class="dropdown-item text-wrap" data-drupal-link-system-path="resources/product-insert-lookup-tool">Product Insert Lookup Tool</a> <a href="/resources/rnascope-citations" class="dropdown-item text-wrap" data-drupal-link-system-path="resources/rnascope-citations">RNAscope Citations</a> <a href="/resources/simple-plex-panel-builder" class="dropdown-item text-wrap" data-drupal-link-system-path="resources/simple-plex-panel-builder">Simple Plex Panel Builder</a> <a href="/resources/simple-western-kit-builder" class="dropdown-item text-wrap" data-drupal-link-system-path="resources/simple-western-kit-builder">Simple 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url('https://resources.bio-techne.com/bio-techne-assets/images/diagnostics/ivd-contract-manufacturing-v2-1500x340.jpg'); background-position: top center; background-repeat: no-repeat; background-size: cover;"> <div> <div class="paragraph paragraph--type--h1-2-2-text-to-media paragraph--view-mode--default"> <div class="container-fluid container-wide"> <div class="layout layout--twocol-section layout--twocol-section--50-50"> <div class="layout__region layout__region--first"> <div class="hero-content-wrap"> <div class="field_block:paragraph:h1_2_2_text_to_media:field_indv_h1"> <div><h1>IVD Assay Development</h1></div> </div> <div class="field_block:paragraph:h1_2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>With over 40 years of experience in clinical diagnostics, Bio-Techne stands as a trusted expert in developing and manufacturing in vitro diagnostic products. Whether you're a pre-commercial startup or a multinational corporation seeking to enhance your capabilities, Bio-Techne offers tailored solutions to meet your specific needs.</p></div> </div> <div class="field_block:paragraph:h1_2_2_text_to_media:field_call_to_action_global"> <a href="#form" class="btn btn-primary" type="link"> Let's Discuss Your IVD Needs </a> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> <div class="field_block:paragraph:h1_2_2_text_to_media:field_indv_media"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/banners/ivd-assay-development-hero-foreground-480x480-v2.png" alt="IVD Assay Development" fetchpriority="high" > </div> </div> </div> </div> </div> </div> </div> </div> </div> </section> </div> </div> </header> </div> <div id="main" class="container-fluid container-wide"> <div class="row"> <div class="col-md-12"> <div> <div id="block-bio-techne-global-breadcrumbs" class="system_breadcrumb_block"> <nav role="navigation" aria-labelledby="system-breadcrumb"> <h2 id="system-breadcrumb" class="visually-hidden">Breadcrumb</h2> <ol> <li> <a href="/">Home</a> </li> <li> <a href="/diagnostics">Diagnostics</a> </li> <li> IVD Assay Development </li> </ol> </nav> </div> </div> </div> </div> <main> <section class="section"> <div> <div id="block-bio-techne-global-content" class="system_main_block"> <article> <div> <div> <div> <div class="paragraph paragraph--type--_-2-text-to-media mb-4 paragraph--view-mode--default"> <div class="container-fluid container-wide"> <div class="layout layout--twocol-section layout--twocol-section--50-50"> <div class="layout__region layout__region--first"> <div class="hero-content-wrap"> <div class="field_block:paragraph:2_2_text_to_media:field_header_2_global"> <div><h2>Services Offered</h2></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>FDA-compliant and platform agnostic phase-based Design Control processes are utilized for product development of diagnostic assays (<a href="https://www.cliniqa.com/Products/RaichemReagents.aspx" target="_blank">reagents</a>, <a href="https://www.bio-techne.com/diagnostics/clinical-quality-controls">calibrators</a>, <a href="https://www.bio-techne.com/diagnostics/clinical-quality-controls">controls</a>, <a href="/diagnostics/clinical-quality-controls#calibration-verifiers">calibration verifiers</a>, and <a href="/diagnostics/clinical-quality-controls#calibration-verifiers">proficiency testing materials</a>) from research and development to product transfer.</p> <ul> <li>IVD Assay Development</li> <li>Technology Transfers</li> <li>Packaging Development</li> <li>Stability Testing</li> <li>Regulatory Support</li> <li>Technical Support</li> <li>Custom QC Testing</li> </ul></div> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> <div class="field_block:paragraph:2_2_text_to_media:field_indv_media"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/drd-services-offered-525x315.png" alt="close-up of vials in lab" loading="lazy" > </div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--_-2-media-to-text mb-4 paragraph--view-mode--default"> <div class="container-fluid container-wide"> <div class="layout layout--twocol-section layout--twocol-section--50-50"> <div class="layout__region layout__region--first"> <div class="hero-content-wrap"> <div class="field_block:paragraph:2_2_media_to_text:field_indv_media"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/drd-benefits-of-outsourcing-ivd-assay-525x315.png" alt="scientist with vial at computer" loading="lazy" > </div> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> <div class="field_block:paragraph:2_2_media_to_text:field_header_2_global"> <div><h2>Benefits of Outsourcing IVD Assay Development</h2></div> </div> <div class="field_block:paragraph:2_2_media_to_text:field_lg_sngl_frmtd_text_global"> <div><p>✓ Access Bio-Techne’s product library & expertise</p> <p>✓ Increase speed to market</p> <p>✓ Manage Budget & Capital</p> <p>✓ Free up internal resources</p> <p>✓ Dependable Manufacturing and Supply</p></div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--section paragraph--view-mode--default"> <div> <div> <div class="paragraph paragraph--type--individual-button mb-4 paragraph--view-mode--default w-100"> <div class="row"> <div class="col"> <a href="#form" class="btn btn-primary" type="link" > Request Information about IVD Assay Development </a> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--section paragraph--view-mode--default mb-4"> <div> <div> <div class="paragraph paragraph--type--full-page-text-with-media mb-4 paragraph--view-mode--default"> <div><h2>IVD Assay Development Phases</h2></div> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/ivd-assay-develpment-icon-banner.png" alt="IVD Assay Development Workflow" loading="lazy" > </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-phase-0-research-amp-planning4" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Phase 0: Research & Planning</h5> </a> </div> <div class="collapse" id="expPara-phase-0-research-amp-planning4" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/icons/light-research-assess-icon-150x150.png" alt="Research/Assess Icon" loading="lazy" > </div> <br/> <div><ul> <li>Assay development projects start with research and planning, along with customer meetings to define product requirements.  <ul> <li>Thorough research is performed on the target to understand its chemical and biological properties, its binding partners, and isoforms, to assess specificity </li> <li>Research into applicable predicate assays </li> <li>Investigation into reagents: candidate antibodies, proteins, enzymes, etc. and their availability are determined </li> <li>Dedicated program manager is assigned to the project </li> </ul> </li> </ul></div> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-phase-1-initial-optimization3" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Phase 1: Initial Optimization</h5> </a> </div> <div class="collapse" id="expPara-phase-1-initial-optimization3" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/icons/light-optimize-icon-150x150.png" alt="Optimize Icon" loading="lazy" > </div> <br/> <div><ul> <li>Much of the assay optimization occurs in this phase. Reagents are assessed to determine the best combination to meet the product requirements determined in Phase 0  <ul> <li>Assay is designed to meet CLSI guidelines </li> <li>If applicable onboarding and training to a new platform is the first step in this phase </li> <li>Project updates shared regularly (weekly --> monthly)</li> <li>The optimal reagents are evaluated for assay specificity, quantification ranges (LOB, LOD, LOQ), sample performance, and initial stability </li> </ul> </li> </ul></div> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-phase-2-feasibility16" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Phase 2: Feasibility</h5> </a> </div> <div class="collapse" id="expPara-phase-2-feasibility16" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/icons/light-checklist-icon-150x150.png" alt="Checklist Icon" loading="lazy" > </div> <br/> <div><ul> <li>Pilot lots of reagents are examined to verify assay performance before entry into Phase 3  <ul> <li>Incorporated minor changes identified in Phase 1 testing to improve robustness</li> <li>2 reagent lots produced with varying biologically derived components </li> </ul> </li> </ul></div> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-phase-3-development23" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Phase 3: Development</h5> </a> </div> <div class="collapse" id="expPara-phase-3-development23" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/icons/light-list-icon-150x150.png" alt="List Icon" loading="lazy" > </div> <br/> <div><ul> <li>In Phase 3 all required testing determined in Phase 0 is performed  <ul> <li>The 3 lots of reagents with varied biologically derived components </li> <li>Performance testing against CLSI guidelines is performed </li> <li>Calibrators and controls are produced with traceable material. </li> <li>Regulatory dossier is provided to support customer quality and regulatory requirements </li> <li>Stability studies initiated</li> </ul> </li> </ul> <p> </p></div> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-phase-4-transfer-to-operations14" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Phase 4: Transfer to Operations</h5> </a> </div> <div class="collapse" id="expPara-phase-4-transfer-to-operations14" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/icons/light-stages-icon-150x150.png" alt="Stages Icon" loading="lazy" > </div> <br/> <div><ul> <li>Transfer of the assay from the development team to Operations, QC and QA</li> <li>Scale-up to achieve commercial volumes </li> <li>If applicable, kitting is performed </li> </ul></div> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-phase-5-commercial-launch-to-customer13" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Phase 5: Commercial Launch to Customer</h5> </a> </div> <div class="collapse" id="expPara-phase-5-commercial-launch-to-customer13" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/icons/light-product-distribution-icon-150x150.png" alt="Product Distribution Icon" loading="lazy" > </div> <br/> <div><ul> <li>Establish supply agreement that meets commercial needs </li> <li>Implement logistics plan to distribute bulk materials or finished kits to customer sites </li> </ul></div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--card-paragraph paragraph--view-mode--default card-para-default"> <div class="row card_row"> <div class="col-md-4"> <div class="h-100"> <div class="bg-white border rounded flex-column d-flex h-100"> <div class="card-img-top text-center mb-3" style="background-repeat: no-repeat; background-color: #f5f5f5; height:200px; width: 100%;"> <div class="teaser-valign-container" style=""> <div class="valign"> <img src="https://resources.bio-techne.com/bio-techne-assets/images/products/drd-technology-deployed-teaser-v2.png" alt="technology deployed" loading="lazy" > </div> </div> </div> <h3 class="card_title_htag"> <div><h2>Technology Deployed:</h2></div> </h3> <div class="card_description flex-grow-1"> <div><ul> <li>Chemiluminescence</li> <li>Homogeneous Immunoassay</li> <li>Clinical Chemistry</li> <li>Lateral Flow</li> <li>ELISA</li> </ul></div> </div> <div class="card-bottom-link"></div> </div> </div> </div> <div class="col-md-4"> <div class="h-100"> <div class="bg-white border rounded flex-column d-flex h-100"> <div class="teaser-card-image-crop mb-3"> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/quickit-lab-photo-bt.jpg" alt="Quickit Lab Photo - Bio-Techne" loading="lazy" > </div> <h3 class="card_title_htag"> <div><h2>Recent Development Projects:</h2></div> </h3> <div class="card_description flex-grow-1"> <div><ul> <li>Neuro/Alzheimer's markers</li> <li>Regenerative Medicine</li> <li>Toxicology: <ul> <li>Therapeutic Drug Monitoring (TDM)</li> <li>Drugs of Abuse</li> </ul> </li> <li>Cell & Gene Therapy</li> </ul></div> </div> <div class="card-bottom-link"></div> </div> </div> </div> <div class="col-md-4"> <div class="h-100"> <div class="bg-white border rounded flex-column d-flex h-100"> <div class="card-img-top text-center mb-3" style="background-repeat: no-repeat; background-color: #f5f5f5; height:200px; width: 100%;"> <div class="teaser-valign-container" style=""> <div class="valign"> <img src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-gmp-capabilities-quality-compliance.png" alt="Quality compliance" loading="lazy" > </div> </div> </div> <h3 class="card_title_htag"> <div><h2>Our Commitment to Quality</h2></div> </h3> <div class="card_description flex-grow-1"> <div><ul> <li>ISO 13485:2016</li> <li>Health Canada</li> <li>FDA 21 CFR Part 820</li> <li>MDSAP</li> <li>ISO 14001</li> <li>US DEA</li> <li>ISO 9001:2015</li> <li>USDA</li> <li>IVDD (IVDR in process)<br>  </li> </ul> <p> </p> <p> </p></div> </div> <div class="card-bottom-link"></div> </div> </div> </div> </div> </div> </div> <div> <div class="thin-banner banner_wrapper"> <div class="banner-dark"> <div> <div><h2>SOLUTIONS THAT EMPOWER DIAGNOSTICS</h2></div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--card-paragraph paragraph--view-mode--default card-para-default"> <h2>Additional IVD Capabilities</h2> <div class="row card_row"> <div class="col-md-4"> <div class="h-100"> <div class="bg-white border rounded flex-column d-flex h-100"> <a href="#form" > <div class="teaser-card-image-crop mb-3"> <img src="https://resources.bio-techne.com/bio-techne-assets/images/diagnostics/quality-controls-products-white-525x315.jpg" alt="Diagnostic Quality Controls Products Image" loading="lazy" > </div> </a> <a class="card_title_link" href="#form" > <h3 class="card_title_htag"> <div><h3>Custom Controls & Calibrators</h3></div> </h3> </a> <div class="card_description flex-grow-1"> <div><ul> <li>Hematology/Flow Cytometry</li> <li>Cardiac Markers</li> <li>Serum Proteins</li> <li>Urinalysis & Urine Chemistry</li> <li>Blood Gas/Electrolytes</li> <li>CO-Oximetry</li> <li> <p>Glucose/Diabetes</p> </li> </ul> <p> </p></div> </div> <div class="card-bottom-link"> <div> <a href="#form" > Request More Information about Custom Controls & Calibrators </a> </div> </div> </div> </div> </div> <div class="col-md-4"> <div class="h-100"> <div class="bg-white border rounded flex-column d-flex h-100"> <a href="https://www.bio-techne.com/diagnostics/ivd-contract-manufacturing" > <div class="teaser-card-image-crop mb-3"> <img src="https://resources.bio-techne.com/bio-techne-assets/images/diagnostics/ivd-manufacturing-service-capabilities_525x300.jpg" alt="hplc auto-sampler" loading="lazy" > </div> </a> <a class="card_title_link" href="https://www.bio-techne.com/diagnostics/ivd-contract-manufacturing" > <h3 class="card_title_htag"> <div><h3>IVD Contract Manufacturing</h3></div> </h3> </a> <div class="card_description flex-grow-1"> <div><ul> <li>Custom Controls & Calibrators</li> <li>Assay Development</li> <li>IVD Manufacturing</li> <li>Technology Transfer</li> <li>Packaging Development</li> <li>Regulatory Support</li> </ul></div> </div> <div class="card-bottom-link"> <div> <a href="https://www.bio-techne.com/diagnostics/ivd-contract-manufacturing" > Learn More </a> </div> </div> </div> </div> </div> <div class="col-md-4"> <div class="h-100"> <div class="bg-white border rounded flex-column d-flex h-100"> <a href="https://www.biospacific.com/" > <div class="card-img-top text-center mb-3" style="background-repeat: no-repeat; background-color: #f5f5f5; height:200px; width: 100%;"> <div class="teaser-valign-container" style=""> <div class="valign"> <img src="https://resources.bio-techne.com/bio-techne-assets/images/diagnostics/ivd-raw-materials-antibody-v2_480x480.png" alt="IVD Raw Materials" loading="lazy" > </div> </div> </div> </a> <a class="card_title_link" href="https://www.biospacific.com/" > <h3 class="card_title_htag"> <div><h3>IVD Raw Materials</h3></div> </h3> </a> <div class="card_description flex-grow-1"> <div><ul> <li>Cancer</li> <li>Cardiovascular</li> <li>Drugs</li> <li>Endocrine/Thyroid</li> <li>Serum Proteins</li> <li>Infectious Disease</li> <li>Steroids</li> <li>reKom Biotech</li> </ul></div> </div> <div class="card-bottom-link"> <div> <a href="https://www.biospacific.com/" > https://www.biospacific.com/ </a> </div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--section paragraph--view-mode--default"> <div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><h3>Contact Us for IVD Assay Development<a name="form"></a></h3> <p><a name="form"> </a></p></div> </div> </div> <div> <div id="block-bio-techne-global-content" class="paragraph"> <article> <div class="row"> <div 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