In Vitro Diagnostics Contract Manufacturing Services | Custom Assay Development

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We provide Contract Manufacturing Services ranging from raw material sourcing and assay development to final packaging and distribution.</p></div> </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> <article> <div class="youtube-video-place"> <lite-youtube videoid="m4XkoUjyUgk" params="rel=0" style="background-image: url('https://img.youtube.com/vi/m4XkoUjyUgk/maxresdefault.jpg');"> <a href="https://www.youtube.com/embed/m4XkoUjyUgk?autoplay=1" class="lty-playbtn" title="Diagnostics Reagent Division at Bio-Techne"> <span class="lyt-visually-hidden">Diagnostics Reagent Division at Bio-Techne</span> </a> </lite-youtube> </div> </article> </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 Contract Manufacturing </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--section paragraph--view-mode--default"> <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/diagnostics/ivd-manufacturing-service-capabilities_525x300.jpg" alt="hplc auto-sampler" 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>Service Capabilities</h2></div> </div> <div class="field_block:paragraph:2_2_media_to_text:field_lg_sngl_frmtd_text_global"> <div><p>Bio-Techne is a proven leader in the IVD industry, providing the broad expanse of tools, knowledge, and guidance you need to solve complex challenges and improve lab diagnostics. Our services include:</p> <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> <li>Technical Support</li> <li>Stability Programs</li> </ul> <p>Bio-Techne has an extensive library of recombinant antigens and antibodies to help you compress your development cycle.</p></div> </div> <div class="field_block:paragraph:2_2_media_to_text:field_call_to_action_global"> <a href="#form" class="btn btn-primary" type="link"> Contact Us About IVD Contract Manufacturing </a> </div> </div> </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--_-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/diagnostics/ivd-manufacturing-capabilities_525x300.jpg" alt="manufacturing quality control" 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>Manufacturing Capabilities</h2></div> </div> <div class="field_block:paragraph:2_2_media_to_text:field_lg_sngl_frmtd_text_global"> <div><p>Whether you’re a pre-commercial startup that needs a custom formulation or a multinational looking to outsource manufacturing, we can help accelerate your business. We offer this expertise in partnership, acting as an extension of your organization by learning your requirements and delivering the right solution.</p> <ul> <li>Liquid Formulation/Filling</li> <li>Powder Formulation</li> <li>Powder Blending and Filling</li> <li>Reagent Tablets</li> <li>Lyophilization</li> <li>Off-line/In-line Labeling</li> <li>Kit Assembly/Packaging</li> <li>Final Product Testing</li> </ul> <p>The process has three phases – proof-of-concept phase, development/optimization phase, scale-up and technical transfer phase.</p></div> </div> </div> </div> </div> </div> </div> </div> </div> </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>Benefits of OEM Contract Manufacturing</h2></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><ul> <li>Access specialized equipment and technology for efficient and high-quality production</li> <li>Reduce capital expenditure on manufacturing facilities and equipment</li> <li>Increase production capacity and scalability</li> <li>Improve cost-effectiveness and efficiency</li> <li>Reduce time-to-market for new products</li> </ul> <p><strong>Product transfer specialists</strong> - We minimize the pain of changing vendors, using an established framework to simplify product transfers and ensure a smooth transition.</p> <p><strong>Custom solutions</strong> - We take the time to learn your unique requirements and give you the right solution.</p> <p><strong>Quality & Regulatory</strong> – We design and manufacture products to meet the exacting requirements of our customers to meet global regulatory requirements.</p></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_call_to_action_global"> <a href="#form" class="btn btn-primary" type="link"> Contact Us About OEM Contract Manufacturing </a> </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> <a href="https://www.bio-techne.com#form" title="Contact Us About OEM Contract Manufacturing " target="_self" > <img src="https://resources.bio-techne.com/bio-techne-assets/images/diagnostics/benefits-oem-manufacturing_525x300.jpg" alt="amber vial production line" loading="lazy" > </a> </div> </div> </div> </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"> <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/custom-control-callibrators_480x480.png" alt="custom controls & calibrators" loading="lazy" > </div> </div> </div> <h3 class="card_title_htag"> <div><h3>Custom Controls & Calibrators</h3></div> </h3> <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></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/bio-techne-assets/images/diagnostics/immunoassay-development_480x480.png" alt="Immunoassay Development" loading="lazy" > </div> </div> </div> <h3 class="card_title_htag"> <div><h3>Immunoassay Development</h3></div> </h3> <div class="card_description flex-grow-1"> <div><ul> <li>Assay Design</li> <li>Optimization</li> <li>Validation</li> <li>Commercial Production</li> <li>Support</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"> <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/" > View IVD Products </a> </div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><p><strong>Regulatory & Quality Systems</strong> - US FDA, cGMP, IVDR, ISO 13485:2016, 9001:2015, 14001, Health Canada, MDSAP, USDA, US DEA</p></div> </div> </div> <div> 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