GMP Manufacturing Facility for Cytokines and Growth Factors

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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 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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" data-drupal-link-system-path="node/10881">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 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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 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</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" 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GMP Proteins" > <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/gmp-facility-front.jpg" alt="GMP Protein Production Facility" loading="lazy" > </a> </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_lg_sngl_frmtd_text_global"> <div><p>Cell and gene therapies represent some of the most revolutionary medical treatments today. At Bio-Techne, our mission is to deliver innovative solutions that enable cell and gene therapies to reach more patients. We have invested in building our new manufacturing facility because we recognize the growing demand for larger quantities of critical cytokines.</p> <p>Choosing a partner that can grow with you is a crucial component in the pathway to success. R&D Systems, a Bio-Techne brand, has a rich history of producing the most widely used proteins in the world. Our expertise in protein development and manufacturing, combined with stringent quality control and experienced regulatory support, allows us to offer industry-leading GMP proteins for cell therapy manufacturing.</p></div> </div> <div class="field_block:paragraph:2_2_media_to_text:field_call_to_action_global"> <a href="#table" class="btn btn-primary" type="link"> View Available GMP Proteins </a> </div> </div> </div> </div> </div> </div> </div> <div> <div class="thin-banner banner_wrapper"> <div class="banner-dark"> <div> <div><h2>Interested in Seeing Our GMP Manufacturing Facility?</h2></div> <a href="/gmp-products/gmp-facility-tour-request" > <button type="button" class="btn btn-primary"> Request a Video Tour </button> </a> </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_lg_sngl_frmtd_text_global"> <div><p> </p><p> </p><p>Our new state of the art GMP manufacturing facility was built with cell therapies in mind. It is entirely animal-free and has large-scale bioreactors with room for expansion, backed by experienced manufacturing, quality, and regulatory teams. Watch the video to learn more about our GMP capabilities.</p><p> </p><p> </p><p> </p></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_call_to_action_global"> <a href="/gmp-proteins/gmp-cytokines-for-cell-therapy-manufacturing-case-study#form" class="btn btn-primary" type="link"> Consult with a GMP Specialist </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> <article> <div class="youtube-video-place"> <lite-youtube videoid="H6w_32k51RQ" params="rel=0" style="background-image: url('https://img.youtube.com/vi/H6w_32k51RQ/maxresdefault.jpg');"> <a href="https://www.youtube.com/embed/H6w_32k51RQ?autoplay=1" class="lty-playbtn" title="Bio-Techne's GMP Manufacturing Facilities - Invested In the Next Generation of Therapeutics"> <span class="lyt-visually-hidden">Bio-Techne's GMP Manufacturing Facilities - Invested In the Next Generation of Therapeutics</span> </a> </lite-youtube> </div> </article> </div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="testimonial"> <div > <div class="row"> <div class="col-md-4"> <div class="left-title"> <h2>Customer Success Stories</h2> </div> </div> <div class="col-md-8"> <div class="right-card bg-white border rounded p-5 mb-4"> <div class="carousel slide" id="carouselIndicators" data-ride="carousel"> <div class="row"> <div class="col-md-12"> <div class="carousel-inner"> <div class="carousel-item active">  <div class="paragraph paragraph--type--individual-testimonial individual-testimonial paragraph--view-mode--default"> <div class="testimonial-info-group"> <div class="row"> <div class="col-lg-3 offset-lg-1 col-sm-12"> <div class="text-center text-lg-left"> <div class="individual-testimonial__headshot"> </div> </div> </div> <div class="col-10 offset-1 col-sm-10 offset-sm-1 col-md-8 offset-md-2 col-lg-6 offset-lg-0"> <div class="testimonial-info"> <div class="individual-testimonial__info"> <span class="individual-testimonial__name"> Senior Director </span><br/> <span class="individual-testimonial__position"> Manufacturer of hiPSCs </span><br/> </div> </div> </div> <div class="col-12 col-sm-12 col-md-12 col-lg-2 quote-column text-center"> <img class="quote" loading="lazy" src="/themes/custom/bio_techne_global/images/testimonials-quote.svg"/> </div> </div> </div> <div class="row"> <div class="col-10 offset-1 col-md-10 offset-md-1 col-sm-10"> <div class="individual-testimonial__testimonial"> "We are buying a lot of Bio-Techne's GMP-grade and AF-grade cytokines & growth factors to develop new cell therapy processes. Our Product Specialist has been extremely helpful, responsive, and knowledgeable in getting us everything we need, including custom formulation products and the detailed paperwork and information needed for cGMP work." </div> </div> </div> </div> </div> </div> </div> </div> <div class="row"> <div class="col-md-12"> <ol class="carousel-indicators"> <li data-target="#carouselIndicators" data-slide-to="0" class="active"> </li> </ol> </div> </div> <a class="carousel-control-prev" href="#carouselIndicators" role="button" data-slide="prev"> <span class="carousel-control-prev-icon" aria-hidden="true"></span> <span class="sr-only">Previous</span> </a> <a class="carousel-control-next" href="#carouselIndicators" role="button" data-slide="next"> <span class="carousel-control-next-icon" aria-hidden="true"></span> <span class="sr-only">Next</span> </a> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--header"> <div> <div><h2>Key Features of Our New Facility</h2></div> </div> </div> </div> <div> <div class="paragraph paragraph--type--section paragraph--view-mode--default mb-4"> <div> <div> <div class="paragraph paragraph--type--_-3-media-to-text paragraph--view-mode--default mb-4"> <div class="container-fluid container-wide"> <div class="layout layout--twocol-section layout--twocol-section--25-75"> <div class="layout__region layout__region--first"> <div class="hero-content-wrap"> <div class="field_block:paragraph:1_3_media_to_text:field_indv_media"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/dw_cgt-page-update_stry0144954.png" alt="GMP Capabilities" loading="lazy" > </div> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> <div class="field_block:paragraph:1_3_media_to_text:field_lg_sngl_frmtd_text_global"> <div><ul> <li>Entire facility dedicated to manufacturing GMP proteins</li> <li>Animal-free facility – No animal components are allowed in the facility</li> <li>Capacity – 61,000 sq. ft. to meet your supply requirements now and in the future</li> <li>Expandability – Available space to add additional capacity</li> <li>ISO 5/7/8 cleanrooms for the entire production process</li> </ul></div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><p><strong>Certifications and Regulatory Guidelines Followed in the GMP Manufacturing Facility</strong></p> <ul> <li>USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products</li> <li>Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products</li> </ul></div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--button-row paragraph--view-mode--default"> <div class="row"> <div class="col"> <div class="list-grid-wrap"> <div class="row"> <div class="col-md-4"> <a href="/gmp-products/gmp-proteins" class="btn btn-primary" type="link"> GMP Proteins </a> </div> <div class="col-md-4"> <a href="/gmp-products/gmp-capabilities" class="btn btn-primary" type="link"> GMP Capabilities </a> </div> <div class="col-md-4"> <a href="/services/custom-cell-and-gene-therapy-services" class="btn btn-primary" type="link"> Custom CGT Services </a> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--header"> <div> <div><h2>Cytokines and Growth Factors from Our GMP Manufacturing Facility</h2></div> </div> </div> </div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><p><a name="table"></a></p></div> </div> </div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><figure class="responsive-figure-table"><table class="overflow-auto table table-bordered"> <tbody> <tr> <td><strong>GMP Protein (Human)</strong></td> <td><strong>Source</strong></td> <td><strong>Preclinical Animal-Free Protein</strong></td> </tr> <tr> <td><a href="/p/proteins-enzymes/recombinant-human-bdnf-gmp-protein-cf_bt-bdnf-gmp">BDNF</a></td> <td><em>E.coli</em></td> <td><a href="/p/proteins-enzymes/recombinant-human-bdnf-protein-animal-free_bt-bdnf-afl">BT-BDNF-AFL</a></td> </tr> <tr> <td><a href="/p/proteins-enzymes/recombinant-human-betacellulin-gmp-protein-cf_bt-btc-gmp">Betacellulin</a></td> <td><em>E.coli</em></td> <td><a href="/p/proteins-enzymes/recombinant-human-betacellulin-protein-animal-free_bt-btc-afl">BT-BTC-AFL</a></td> </tr> <tr> <td><a href="/p/proteins-enzymes/recombinant-human-fgf-basic-fgf2-gmp-protein-cf_bt-fgfb-gmp">FGF basic/FGF2</a></td> <td><em>E.coli</em></td> <td><a href="/p/proteins-enzymes/recombinant-human-fgf-basic-fgf2-protein-animal-free_bt-fgfb-afl">BT-FGFB-AFL</a></td> </tr> <tr> <td><a href="/p/proteins-enzymes/recombinant-human-flt-3-ligand-flt3l-gmp-protein-cf_bt-ft3l-gmp">Flt-3 Ligand/FLT3L</a></td> <td><em>E.coli</em></td> <td><a href="/p/proteins-enzymes/recombinant-human-flt-3-ligand-flt3l-protein-animal-free_bt-ft3l-afl">BT-FT3L-AFL</a></td> </tr> <tr> <td><a href="/p/proteins-enzymes/recombinant-human-il-2-gmp-protein-cf_bt-002-gmp">IL-2 * </a>‡</td> <td><em>E.coli</em></td> <td><a href="/p/proteins-enzymes/recombinant-human-il-2-protein-animal-free_bt-002-afl">BT-002-AFL</a></td> </tr> <tr> <td><a href="/p/proteins-enzymes/recombinant-human-il-4-gmp-protein-cf_bt-004-gmp">IL-4</a></td> <td><em>E.coli</em></td> <td><a href="/p/proteins-enzymes/recombinant-human-il-4-protein-animal-free_bt-004-afl">BT-004-AFL</a></td> </tr> <tr> <td><a href="/p/proteins-enzymes/recombinant-human-il-7-gmp-protein-cf_bt-007-gmp">IL-7 *</a> ‡</td> <td><em>E.coli</em></td> <td><a href="/p/proteins-enzymes/recombinant-human-il-7-protein-animal-free_bt-007-afl">BT-007-AFL</a></td> </tr> <tr> <td><a href="/p/proteins-enzymes/recombinant-human-il-10-gmp-protein-cf_1064-gmp">IL-10</a></td> <td><em>E.coli</em></td> <td><a href="/p/proteins-enzymes/recombinant-human-il-10-animal-free-protein_afl1064">AFL1064</a></td> </tr> <tr> <td><a href="/p/proteins-enzymes/recombinant-human-il-15-gmp-protein-cf_bt-015-gmp">IL-15 *</a> ‡</td> <td><em>E.coli</em></td> <td><a href="/p/proteins-enzymes/recombinant-human-il-15-protein-animal-free_bt-015-afl">BT-015-AFL</a></td> </tr> <tr> <td><a href="/p/proteins-enzymes/recombinant-human-il-21-gmp-protein-cf_bt-021-gmp">IL-21</a></td> <td><em>E.coli</em></td> <td><a href="/p/proteins-enzymes/recombinant-human-il-21-protein-animal-free_bt-021-afl">BT-021-AFL</a></td> </tr> <tr> <td><a href="/p/proteins-enzymes/recombinant-human-scf-gmp-protein-cf_bt-scf-gmp">SCF</a></td> <td><em>E.coli</em></td> <td><a href="/p/proteins-enzymes/recombinant-human-scf-protein-animal-free_bt-scf-afl">BT-SCF-AFL</a></td> </tr> <tr> <td><a href="/p/proteins-enzymes/recombinant-human-vegf-165-gmp-protein-cf_bt-vegf-gmp">VEGF</a></td> <td><em>E.coli</em></td> <td><a href="/p/proteins-enzymes/recombinant-human-vegf-165-protein-animal-free_bt-vegf-afl">BT-VEGF-AFL</a></td> </tr> </tbody> </table></figure> <p>*GMP-grade IL-2, IL-7, and IL-15 are available through our joint venture partnership with ScaleReady.</p> <p>‡Liquid formulations for GMP and animal-free preclinical grades of these cytokines are now available. <strong><a href="/reagents/proteins/liquid-cytokines-workflow">Request further information</a></strong>.</p></div> </div> </div> <div> <div class="thin-banner 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h-100"> <a href="https://resources.bio-techne.com/bio-techne-assets/images/literature/fl-key-considerations-for-cytokine-supplier-selection.pdf" > <div class="teaser-card-image-crop mb-3"> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/fastfacts-flyer-teaser-box-508x215.jpg" alt="FastFacts Flyer " loading="lazy" > </div> </a> <a class="card_title_link" href="https://resources.bio-techne.com/bio-techne-assets/images/literature/fl-key-considerations-for-cytokine-supplier-selection.pdf" > <h3 class="card_title_htag"></h3> </a> <div class="card_description flex-grow-1"> <div><p>Integrate RUO-grade cytokines with equivalent GMP-grade options early in your discovery process. Take advantage of our cytokine performance consistency, supply chain, and GMP custom services.</p></div> </div> <div class="card-bottom-link"> <div> <a href="https://resources.bio-techne.com/bio-techne-assets/images/literature/fl-key-considerations-for-cytokine-supplier-selection.pdf" > Read Article </a> </div> </div> </div> </div> </div> <div class="col-md-6"> <div class="h-100"> <div class="bg-white border rounded flex-column d-flex h-100"> <a href="https://calendly.com/cell-and-gene-therapy-specialists/lets-talk-gmp-1" > <div class="teaser-card-image-crop mb-3"> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/phd_scheme_teaser card.png" alt="PhD Scheme - Programs" loading="lazy" > </div> </a> <a class="card_title_link" href="https://calendly.com/cell-and-gene-therapy-specialists/lets-talk-gmp-1" > <h3 class="card_title_htag"></h3> </a> <div class="card_description flex-grow-1"> <div><p>Not finding what you need? Speak with a Cell & Gene Therapy Specialist and let us know exactly what GMP raw materials will fit your process.</p></div> </div> <div class="card-bottom-link"> <div> <a href="https://calendly.com/cell-and-gene-therapy-specialists/lets-talk-gmp-1" > Let's Talk GMP - Set Up An Appointment </a> </div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--header"> <div> <div><h3>Analysis of the Activity, Lot-to-Lot Consistency, and Purity of GMP-grade Recombinant Human IL-2</h3></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/graphs/ces-sds-maurice-il-2-graph.png" alt="Analysis of the activity, lot-to-lot consistency and purity of R&D Systems GMP-grade Recombinant Human IL-2 protein" 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_lg_sngl_frmtd_text_global"> <div><p>(<strong>A</strong>) Three independent lots of <a href="/p/proteins-enzymes/recombinant-human-il-2-gmp-protein-cf_bt-002-gmp">GMP-grade Recombinant Human IL-2</a> (R&D Systems, Catalog # BT-002-GMP) were tested for their ability to stimulate proliferation of CTLL-2 mouse cytotoxic T cells. The ED<sub>50</sub> for this effect is 0.03-0.25 ng/mL. Each trace on the graph represents data obtained from GMP-grade Recombinant Human IL-2 from a different manufacturing run, demonstrating the lot-to-lot consistency of the protein. (<strong>B</strong>, <strong>C</strong>) The purity of the three independent lots of GMP-grade Recombinant Human IL-2 shown in part A were assessed by CE-SDS on <a href="/p/imaged-capillary-electrophoresis-ice/maurice_090-000">Maurice</a> (ProteinSimple, Catalog # 090-000) under reducing (R; part B) and non-reducing (NR; part C) conditions and visualized in Compass for iCE software. The gel views obtained from the Compass software are shown.</p></div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--header"> <div> <div><h3>Analysis of the Activity, Lot-to-Lot Consistency, and Purity of GMP-grade Recombinant Human IL-7</h3></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/ces-sds-maurice-il-7-graph-500x656-100-v2.jpg" alt="Activity, lot-to-lot consistency and purity testing of R&D Systems GMP-grade Recombinant Human IL-7" 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_lg_sngl_frmtd_text_global"> <div><p>(<strong>A</strong>) Three independent lots of <a href="/p/proteins-enzymes/recombinant-human-il-7-gmp-protein-cf_bt-007-gmp">GMP-grade Recombinant Human IL-7</a> (R&D Systems, Catalog # BT-007-GMP) were tested for their ability to stimulate proliferation of PHA-activated human peripheral blood lymphocytes. The ED<sub>50</sub> for this effect is 0.1-0.5 ng/mL. Each trace on the graph represents data obtained from GMP-grade Recombinant Human IL-7 from a different manufacturing run, demonstrating the lot-to-lot consistency of the protein. (<strong>B</strong>, <strong>C</strong>) The purity of the three independent lots of GMP-grade Recombinant Human IL-7 shown in part A were assessed by CE-SDS on <a href="/p/imaged-capillary-electrophoresis-ice/maurice_090-000">Maurice</a> (ProteinSimple, Catalog # 090-000) under reducing (R; part B) and non-reducing (NR; part C) conditions and visualized in Compass for iCE software. The gel views obtained from the Compass software are shown. The IS band is a 10 kDa <a href="/p/imaged-capillary-electrophoresis-ice/maurice-ce-sds-25x-internal-standard_046-144">Maurice CE-SDS Internal Standard Marker</a> (ProteinSimple, Catalog # 046-144) that was added to each sample to calculate the relative migration time (RMT). </p></div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--header"> <div> <div><h3>Analysis of the Activity, Lot-to-Lot Consistency, and Purity of GMP-grade Recombinant Human IL-10 </h3></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/ces-sds-maurice-il-10-graph-500x656-100-v4.jpg" alt="Activity, lot-to-lot consistency and purity testing of R&D Systems GMP-grade Recombinant Human IL-10" 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_lg_sngl_frmtd_text_global"> <div><p>(<strong>A</strong>) Three independent lots of <a href="/p/proteins-enzymes/recombinant-human-il-10-gmp-protein-cf_1064-gmp">GMP-grade Recombinant Human IL-10</a> (R&D Systems, Catalog # 1064-GMP) were tested for their ability to stimulate proliferation of MC/9-2 mouse mast cells. The ED<sub>50</sub> for this effect is 0.0750-0.750 ng/mL. Each trace on the graph represents data obtained from GMP-grade Recombinant Human IL-10 from a different manufacturing run, demonstrating the lot-to-lot consistency of the protein. (<strong>B, C</strong>) The purity of the three independent lots of GMP-grade Recombinant Human IL-10 shown in part A were assessed by CE-SDS on <a href="/p/imaged-capillary-electrophoresis-ice/maurice_090-000">Maurice</a> (ProteinSimple, Catalog # 090-000) under reducing (R; part B) and non-reducing (NR; part C) conditions and visualized in Compass for iCE software. The gel views obtained from the Compass software are shown. The IS band is a 10 kDa <a href="/p/imaged-capillary-electrophoresis-ice/maurice-ce-sds-25x-internal-standard_046-144">Maurice CE-SDS Internal Standard Marker</a> (ProteinSimple, Catalog # 046-144) that was added to each sample to calculate the relative migration time (RMT). </p></div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--header"> <div> <div><h2>Frequently Asked Questions about our GMP Facility</h2></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-1-how-can-bio-technes-new-facility-support-my-process12" role="button" aria-expanded="false" aria-controls="expPara"> <h5>1. How can Bio-Techne’s new facility support my process?</h5> </a> </div> <div class="collapse" id="expPara-1-how-can-bio-technes-new-facility-support-my-process12" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><h5>Security of Supply & Scalability</h5> <p>Bio-Techne’s new GMP manufacturing facility can ensure the security of supply for GMP proteins due to the expanded manufacturing capacity and enhanced ability to scale. The facility is designed to supply customers with raw materials for commercial manufacture, ensuring the availability of qualified raw materials from clinical stage to therapeutic commercialization.</p> <h5>Transitioning from Pre-Clinical to GMP Grade</h5> <p>This facility is a dedicated animal-free manufacturing space, meaning no animal components are allowed in the facility to minimize risk and ensure product consistency. The pre-clinical and GMP proteins manufactured in this facility undergo the same manufacturing process in animal-free conditions to facilitate your transition from pre-clinical to GMP grade proteins. Manufacturing the different grades in the same manner eases your transition from pre-clinical to GMP by reducing the variability of the product’s performance, ultimately enabling you to get to the clinic sooner.</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-2-can-i-test-different-lots-of-gmp-proteins-from-bio-techne19" role="button" aria-expanded="false" aria-controls="expPara"> <h5>2. Can I test different lots of GMP proteins from Bio-Techne?</h5> </a> </div> <div class="collapse" id="expPara-2-can-i-test-different-lots-of-gmp-proteins-from-bio-techne19" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><p>We can work with you to provide different lots for testing and share historical activity data, when available. <a href="https://calendly.com/cell-and-gene-therapy-specialists/lets-talk-gmp-1?month=2021-12" target="_blank">Contact Us</a> to discuss your testing needs.</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-3-how-does-bio-techne-define-animal-free-for-gmp-proteins16" role="button" aria-expanded="false" aria-controls="expPara"> <h5>3. How does Bio-Techne define “animal-free” for GMP proteins?</h5> </a> </div> <div class="collapse" id="expPara-3-how-does-bio-techne-define-animal-free-for-gmp-proteins16" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><p>Bio-Techne has a strict definition of animal-free: No animal-containing materials are used anywhere in the manufacturing process or facility, and no equipment has ever been exposed to animal products. Our animal-free proteins share the same biological activities as those produced for our standard research grade, easing the transition between protein formats. We obtain animal-free Certificates of Origin from raw material suppliers and Certificates of Origin are available for each protein upon request.</p> <p>Read more about our animal-free manufacturing conditions <a href="/gmp-products/gmp-capabilities#Animal">here</a>.</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-4-im-looking-for-a-sizing-vialing-or-labelling-option-that-isnt-listed-on-the-website-can-i-request-a-custom-option4" role="button" aria-expanded="false" aria-controls="expPara"> <h5>4. I’m looking for a sizing, vialing, or labelling option that isn’t listed on the website. Can I request a custom option?</h5> </a> </div> <div class="collapse" id="expPara-4-im-looking-for-a-sizing-vialing-or-labelling-option-that-isnt-listed-on-the-website-can-i-request-a-custom-option4" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><p>Bio-Techne understands that having reagents that fit seamlessly into your process can save money and reduce manufacturing risk. Please <a href="/gmp-products/gmp-proteins#request-gmp-protein">contact our Custom Services Team</a> to discuss your needs and whether custom solutions are available. 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