GMP Proteins for Cell Therapy Manufacturing

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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>GMP Protein Manufacturing for Cell Therapy</h1></div> </div> <div class="field_block:paragraph:h1_2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>Highly consistent GMP proteins are key ancillary reagents for building your cell manufacturing program. We follow all relevant regulatory guidelines to ensure a consistent, safe, and traceable supply of animal-free bioactive proteins.</p></div> </div> <div class="field_block:paragraph:h1_2_2_text_to_media:field_call_to_action_global"> <a href="/gmp-products/gmp-proteins/sample-gmp-proteins" class="btn btn-primary" type="link"> Request a GMP Protein Sample </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/IL-7-protein-hero.png" alt="IL-7" 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="/gmp-products">GMP Products</a> </li> <li> GMP Proteins </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-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> <a href="https://www.bio-techne.com/gmp-products/gmp-proteins/sample-gmp-proteins" title="Request a GMP Protein Sample" > <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/v3_gmp-facilty-rounded-corners.png" alt="GMP 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_header_2_global"> <div><br><br><br><br><h2>GMP Quality Compliance</h2></div> </div> <div class="field_block:paragraph:2_2_media_to_text:field_lg_sngl_frmtd_text_global"> <div><p>Develop your cell therapy manufacturing process with confidence by using R&D Systems™ GMP cytokines and growth factors. Our years of expertise in protein development and manufacturing, stringent quality control, and regulatory support allow us to offer industry-leading GMP proteins for ancillary use. We often use the same clone, sequence, and expression system as our RUO and animal-free grade materials to make your switch to GMP as seamless as possible.</p></div> </div> <div class="field_block:paragraph:2_2_media_to_text:field_call_to_action_global"> <a href="/gmp-products/gmp-proteins/sample-gmp-proteins" class="btn btn-primary" type="link"> Request a GMP Protein Sample </a> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--columns paragraph--view-mode--default"> <div class="list-grid list-grid-2"> <div class="row"> <div class="col-6 column-group"><h3>Cytokines for Immune Cell Therapy</h3><figure class="responsive-figure-table"><table class="table table-bordered overflow-auto"><thead><tr><th><strong>Protein</strong></th><th><strong>Animal-Free RUO</strong></th><th><strong>GMP</strong></th><th><strong>Specialized Formats</strong></th><th><strong>GMP Source</strong></th></tr></thead><tbody><tr><td>IFN-gamma</td><td><a href="/p/proteins-enzymes/recombinant-human-ifn-gamma-animal-free-protein_afl285">AFL285</a></td><td><a href="/p/proteins-enzymes/recombinant-human-ifn-gamma-gmp-protein-cf_285-gmp">285-GMP</a><br>DMF on file</td><td> </td><td><em>E.coli</em></td></tr><tr><td>IL-1 beta</td><td><a href="/p/proteins-enzymes/recombinant-human-il-1-beta-il-1f2-animal-free-protein_afl201">AFL201</a></td><td><a href="/p/proteins-enzymes/recombinant-human-il-1-beta-il-1f2-gmp-protein-cf_201-gmp">201-GMP</a></td><td> </td><td><em>E.coli</em></td></tr><tr><td>IL-2</td><td><a href="/p/proteins-enzymes/recombinant-human-il-2-protein-animal-free_bt-002-afl">BT-002-AFL</a></td><td><a href="/p/proteins-enzymes/recombinant-human-il-2-gmp-protein-cf_bt-002-gmp">BT-002-GMP</a><br>DMF on file</td><td><a href="/reagents/proteins/ready-to-use">Liquid</a></td><td><em>E.coli</em></td></tr><tr><td>IL-3</td><td><a href="/p/proteins-enzymes/recombinant-human-il-3-animal-free-protein_afl203">AFL203</a></td><td><a href="/p/proteins-enzymes/recombinant-human-il-3-gmp-protein-cf_203-gmp">203-GMP</a></td><td> </td><td><em>E.coli</em></td></tr><tr><td>IL-4</td><td><a href="/p/proteins-enzymes/recombinant-human-il-4-protein-animal-free_bt-004-afl">BT-004-AFL</a></td><td><a href="/p/proteins-enzymes/recombinant-human-il-4-gmp-protein-cf_bt-004-gmp">BT-004-GMP</a><br>DMF on file</td><td> </td><td><em>E.coli</em></td></tr><tr><td>IL-6</td><td><a href="/p/proteins-enzymes/recombinant-human-il-6-animal-free-protein_afl206">AFL206</a></td><td><a href="/p/proteins-enzymes/recombinant-human-il-6-gmp-protein-cf_206-gmp">206-GMP</a><br>DMF on file</td><td> </td><td><em>E.coli</em></td></tr><tr><td>IL-7</td><td><a href="/p/proteins-enzymes/recombinant-human-il-7-protein-animal-free_bt-007-afl">BT-007-AFL</a></td><td><a href="/p/proteins-enzymes/recombinant-human-il-7-gmp-protein-cf_bt-007-gmp">BT-007-GMP</a><br>DMF on file</td><td><a href="/reagents/proteins/ready-to-use">Liquid</a><br><a href="/reagents/proteins/ready-to-use">Process-Sized Vials</a><br><a href="/p/proteins-enzymes/propak-recombinant-human-il-7-gmp-protein-cf_ppk-007-gmp">ProPak™ Closed-System</a></td><td><em>E.coli</em></td></tr><tr><td>IL-10</td><td> </td><td><a href="https://www.bio-techne.com/p/proteins-enzymes/recombinant-human-il-10-gmp-protein-cf_1064-gmp">1064-GMP</a><br>DMF on file</td><td> </td><td><em>E.coli</em></td></tr><tr><td>IL-15</td><td><a href="/p/proteins-enzymes/recombinant-human-il-15-protein-animal-free_bt-015-afl">BT-015-AFL </a></td><td><a href="/p/proteins-enzymes/recombinant-human-il-15-gmp-protein-cf_bt-015-gmp">BT-015-GMP</a><br>DMF on file</td><td><a href="/reagents/proteins/ready-to-use">Liquid</a><br><a href="/reagents/proteins/ready-to-use">Process-Sized Vials</a><br><a href="/p/proteins-enzymes/propak-recombinant-human-il-15-gmp-protein-cf_ppk-015-gmp">ProPak Closed-System</a></td><td><em>E.coli</em></td></tr><tr><td>IL-18</td><td> </td><td>Coming Soon</td><td> </td><td><em>E.coli</em></td></tr><tr><td>IL-21</td><td><a href="/p/proteins-enzymes/recombinant-human-il-21-protein-animal-free_bt-021-afl">BT-021-AFL</a></td><td><a href="/p/proteins-enzymes/recombinant-human-il-21-gmp-protein-cf_bt-021-gmp">BT-021-GMP</a></td><td><a href="/reagents/proteins/ready-to-use">Liquid</a></td><td><em>E.coli</em></td></tr><tr><td>TNF-alpha</td><td><a href="/p/proteins-enzymes/recombinant-human-tnf-alpha-animal-free-protein_afl210">AFL210</a></td><td><a href="/p/proteins-enzymes/recombinant-human-tnf-alpha-gmp-protein-cf_210-gmp">210-GMP</a></td><td> </td><td><em>E.coli</em></td></tr></tbody></table></figure></div> <div class="col-6 column-group"><h3>Cytokines & Growth Factors for Regenerative Medicine</h3><figure class="responsive-figure-table"><table class="table table-bordered overflow-auto"><thead><tr><th><strong>Protein</strong></th><th><strong>Animal-Free RUO</strong></th><th><strong>GMP</strong></th><th><strong>GMP Source</strong></th></tr></thead><tbody><tr><td>Activin A</td><td> </td><td><a href="/p/proteins-enzymes/recombinant-human-mouse-rat-activin-a-gmp-protein-cf_338-gmp">338-GMP</a><br>DMF on file</td><td>CHO</td></tr><tr><td>Betacellulin</td><td><a href="/p/proteins-enzymes/recombinant-human-betacellulin-protein-animal-free_bt-btc-afl">BT-BTC-AFL</a></td><td><a href="/p/proteins-enzymes/recombinant-human-betacellulin-gmp-protein-cf_bt-btc-gmp">BT-BTC-GMP</a><br>DMF on file</td><td><em>E.coli</em></td></tr><tr><td>BDNF</td><td><a href="/p/proteins-enzymes/recombinant-human-bdnf-protein-animal-free_bt-bdnf-afl">BT-BDNF-AFL</a></td><td><a href="/p/proteins-enzymes/recombinant-human-bdnf-gmp-protein-cf_bt-bdnf-gmp">BT-BDNF-GMP</a><br>DMF on file</td><td><em>E.coli</em></td></tr><tr><td>BMP-2</td><td> </td><td><a href="/p/proteins-enzymes/recombinant-human-bmp-2-gmp-protein-cf_355-gmp">355-GMP</a></td><td>CHO</td></tr><tr><td>BMP-4</td><td><a href="/p/proteins-enzymes/recombinant-human-bmp-4-animal-free-protein_afl314e">AFL314E</a></td><td><a href="/p/proteins-enzymes/recombinant-human-bmp-4-gmp-protein-cf_314e-gmp">314E-GMP</a></td><td><em>E.coli</em></td></tr><tr><td>EGF</td><td><a href="/p/proteins-enzymes/recombinant-human-egf-animal-free-protein_afl236">AFL236</a></td><td><a href="/p/proteins-enzymes/recombinant-human-egf-gmp-protein-cf_236-gmp">236-GMP</a><br>DMF on file</td><td><em>E.coli</em></td></tr><tr><td>FGF basic/FGF2</td><td><a href="/p/proteins-enzymes/recombinant-human-fgf-basic-fgf2-protein-animal-free_bt-fgfb-afl">BT-FGFB-AFL</a></td><td><a href="/p/proteins-enzymes/recombinant-human-fgf-basic-fgf2-gmp-protein-cf_bt-fgfb-gmp">BT-FGFB-GMP</a><br>DMF on file</td><td><em>E.coli</em></td></tr><tr><td>FGF7</td><td> </td><td>Coming Soon</td><td> </td></tr><tr><td>Flt-3 Ligand/FLT3L </td><td><a href="/p/proteins-enzymes/recombinant-human-flt-3-ligand-flt3l-protein-animal-free_bt-ft3l-afl">BT-FT3L-AFL</a></td><td><a href="/p/proteins-enzymes/recombinant-human-flt-3-ligand-flt3l-gmp-protein-cf_bt-ft3l-gmp">BT-FT3L-GMP</a><br>DMF on file</td><td><em>E.coli</em></td></tr><tr><td>GDF-8/Myostatin</td><td> </td><td><a href="/p/proteins-enzymes/recombinant-human-mouse-rat-gdf-8-myostatin-gmp-protein-cf_788-gmp">788-GMP</a></td><td>NS0</td></tr><tr><td>GDNF</td><td> </td><td><a href="/p/proteins-enzymes/recombinant-human-gdnf-gmp-protein-cf_212-gmp">212-GMP</a></td><td>NS0</td></tr><tr><td>GM-CSF</td><td><a href="/p/proteins-enzymes/recombinant-human-gm-csf-animal-free-protein_afl215">AFL215</a></td><td><a href="/p/proteins-enzymes/recombinant-human-gm-csf-gmp-protein-cf_215-gmp">215-GMP</a></td><td><em>E.coli</em></td></tr><tr><td>HGF</td><td> </td><td><a href="/p/proteins-enzymes/recombinant-human-hgf-ns0-expressed-gmp-protein-cf_294-gmp">294-GMP</a></td><td>NS0</td></tr><tr><td>IGF-I</td><td><a href="/p/proteins-enzymes/recombinant-human-igf-i-igf-1-animal-free-protein_afl291">AFL291</a></td><td><a href="/p/proteins-enzymes/recombinant-human-igf-i-igf-1-gmp-protein-cf_291-gmp">291-GMP</a><br>DMF on file</td><td><em>E.coli</em></td></tr><tr><td>KGF/FGF-7</td><td> </td><td><a href="/p/proteins-enzymes/recombinant-human-kgf-fgf-7-gmp-protein-cf_251-gmp">251-GMP</a></td><td><em>E.coli</em></td></tr><tr><td>LR3 IGF-I</td><td> </td><td><a href="/p/proteins-enzymes/recombinant-human-lr3-igf-i-igf-1-gmp-protein-cf_8335d-gmp">8335D-GMP</a></td><td><em>E.coli</em></td></tr><tr><td>M-CSF</td><td><a href="/p/proteins-enzymes/recombinant-human-m-csf-animal-free-protein_afl216">AFL216</a></td><td><a href="/p/proteins-enzymes/recombinant-human-m-csf-gmp-protein-cf_216-gmp">216-GMP</a></td><td><em>E.coli</em></td></tr><tr><td>Noggin Fc tag</td><td> </td><td><a href="/p/proteins-enzymes/recombinant-human-noggin-fc-chimera-gmp-protein-cf_3344-gmp">3344-GMP</a></td><td>NS0</td></tr><tr><td>PDGF-AA</td><td><a href="/p/proteins-enzymes/recombinant-human-pdgf-aa-animal-free-protein_afl221">AFL221</a></td><td><a href="/p/proteins-enzymes/recombinant-human-pdgf-aa-gmp-protein-cf_221-gmp">221-GMP</a></td><td><em>E.coli</em></td></tr><tr><td>PDGF-BB</td><td><a href="/p/proteins-enzymes/recombinant-human-pdgf-bb-animal-free-protein_afl220">AFL220</a></td><td><a href="/p/proteins-enzymes/recombinant-human-pdgf-bb-gmp-protein-cf_220-gmp">220-GMP</a></td><td><em>E.coli</em></td></tr><tr><td>SCF/c-kit Ligand</td><td><a href="/p/proteins-enzymes/recombinant-human-scf-protein-animal-free_bt-scf-afl">BT-SCF-AFL</a></td><td><a href="/p/proteins-enzymes/recombinant-human-scf-gmp-protein-cf_bt-scf-gmp">BT-SCF-GMP</a><br>DMF on file</td><td><em>E.coli</em></td></tr><tr><td>Sonic Hedgehog (C24II)<br>N-Terminus</td><td><a href="/p/proteins-enzymes/recombinant-human-sonic-hedgehog-shh-c24ii-animal-free-cf_afl1845">AFL1845</a></td><td><a href="/p/proteins-enzymes/recombinant-human-sonic-hedgehog-shh-c24ii-n-term-gmp-cf_1845-gmp">1845-GMP</a></td><td><em>E.coli</em></td></tr><tr><td>Sonic Hedgehog<br>N-Terminus</td><td> </td><td><a href="/p/proteins-enzymes/recombinant-human-sonic-hedgehog-shh-n-terminus-gmp-cf_1314-gmp">1314-GMP</a></td><td><em>E.coli</em></td></tr><tr><td>TGF-beta 1</td><td> </td><td><a href="/p/proteins-enzymes/recombinant-human-tgf-beta-1-gmp-protein-cf_240-gmp">240-GMP</a><br>DMF on file</td><td>CHO</td></tr><tr><td>Thrombopoietin</td><td> </td><td><a href="/p/proteins-enzymes/recombinant-human-thrombopoietin-gmp-protein-cf_288e-gmp">288E-GMP</a><br>DMF on file</td><td><em>E.coli</em></td></tr><tr><td>VEGF</td><td><a href="/p/proteins-enzymes/recombinant-human-vegf-165-protein-animal-free_bt-vegf-afl">BT-VEGF-AFL</a></td><td><a href="/p/proteins-enzymes/recombinant-human-vegf-165-gmp-protein-cf_bt-vegf-gmp">BT-VEGF-GMP</a><br>DMF on file</td><td><em>E.coli</em></td></tr><tr><td>Vitronectin</td><td> </td><td>Coming Soon</td><td> </td></tr><tr><td>Wnt-3a</td><td> </td><td><a href="/p/proteins-enzymes/recombinant-human-wnt-3a-gmp-protein-cf_5036-gmp">5036-GMP</a></td><td>CHO</td></tr></tbody></table></figure></div> </div> </div> </div> </div> <div> <section class="paragraph paragraph--type--full-width-banner-with-image mb-4 paragraph--view-mode--default paragraph-background-color--"> <div class="banner_background_image" data-bgimage="https://resources.bio-techne.com/bio-techne-assets/images/products/propak-hero-bg.jpg" style="background-repeat: no-repeat;"> <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>For Closed-Process Cell Therapy Manufacturing: ProPak GMP Cytokines</h2></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>GMP IL-7 and IL-15 are now available in single-use weldable bags. These 1 L process-sized protein bags reduce both variability and risk for your cell therapy, plus eliminate reconstitution and aliquoting.</p></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_call_to_action_global"> <a href="/gmp-products/closed-process-solutions" class="btn btn-primary" type="link"> Learn More About Closed-Process Solutions </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> <img src="https://resources.bio-techne.com/bio-techne-assets/images/products/propak-frontimg.png" alt="ProPak FrontImg" loading="lazy" > </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </section> </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-view-gmp-il-2-consistency-data17" role="button" aria-expanded="false" aria-controls="expPara"> <h5>View GMP IL-2 Consistency Data</h5> </a> </div> <div class="collapse" id="expPara-view-gmp-il-2-consistency-data17" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/ces-sds-maurice-il-2-graph-888x295-v2.jpg" alt="GMP IL-2 Consistency Data" loading="lazy" > </div> <br/> <div><h3>Analysis of the Activity, Lot-to-Lot Consistency, and Purity of GMP-grade Recombinant Human IL-2</h3> <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> <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-view-gmp-il-7-consistency-data25" role="button" aria-expanded="false" aria-controls="expPara"> <h5>View GMP IL-7 Consistency Data</h5> </a> </div> <div class="collapse" id="expPara-view-gmp-il-7-consistency-data25" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/ces-sds-maurice-il-7-graph-888x295-v3.jpg" alt="GMP IL-7 Consistency Data" loading="lazy" > </div> <br/> <div><h3>Analysis of the Activity, Lot-to-Lot Consistency, and Purity of GMP-grade Recombinant Human IL-7</h3> <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> <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-view-gmp-il-10-consistency-data25" role="button" aria-expanded="false" aria-controls="expPara"> <h5>View GMP IL-10 Consistency Data</h5> </a> </div> <div class="collapse" id="expPara-view-gmp-il-10-consistency-data25" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/ces-sds-maurice-il-10-graph-888x295-v2.jpg" alt="Activity, lot-to-lot consistency, and purity testing of R&D Systems GMP IL-10 protein" loading="lazy" > </div> <br/> <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 class="thin-banner banner_wrapper"> <div class="banner-dark"> <div> <div><h2>Looking for a Different Protein?</h2></div> <a href="/gmp-products/gmp-proteins#request-custom-gmp" > <button type="button" class="btn btn-primary"> Request a Custom GMP Protein </button> </a> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><h2>Animal-Free GMP Proteins for Cell Therapy Manufacturing</h2> <p>Animal-free RUO and GMP recombinant human proteins are manufactured using equipment and reagents that are certified animal-free. Our dedicated controlled-access animal-free laboratories ensure that at no point in production are these products exposed to potential contamination by animal components or byproducts.</p></div> </div> </div> <div> <div class="paragraph paragraph--type--full-page-text-with-media mb-4 paragraph--view-mode--default"> <div><h3>Transition Seamlessly from RUO to GMP</h3></div> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/graphs/gmp-transition-graphs.png" alt="GMP to RUO Transition Graphs" loading="lazy" > </div> <div><p>Both AF RUO and GMP grades of E.coli sourced proteins share the same sequence, source, formulation, activity and purity specifications, manufacturing site and personnel, and vial type – ensuring equivalent performance and process continuity as you transition to the clinic.</p></div> </div> </div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><h3>Supply Chain Continuity</h3> <p>It is critical to secure a stable supply of GMP-grade proteins for use as raw materials in ex vivo cell manufacturing. This becomes progressively more important during the transition from early- to late-stage clinical trials. We have the expertise and ability to scale up your GMP protein supply. Working with your process forecasting, we will provide supply and quality agreements to ensure the consistent supply of the GMP proteins you require.</p> <ul> <li>Risk mitigation management</li> <li>Secondary cell banking facility</li> <li>Quality-controlled change and notification process</li> </ul></div> </div> </div> <div> <div class="paragraph paragraph--type--section paragraph--view-mode--default"> <div> <div> <div class="paragraph paragraph--type--header"> <div> <div><h3>GMP Quality Policy and Regulatory Support</h3></div> </div> </div> </div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><p>We produce GMP-grade cytokines and growth factors under regulatory guidelines for ancillary materials in cell therapy manufacturing processes. This includes extensive quality control testing and comprehensive documentation of manufacturing systems and traceability of source materials. You can be confident you will receive a consistent, safe, and traceable supply of raw materials. We perform regular audits of our facilities and we welcome customer audits.</p> <p>Visit <strong><a href="/gmp-products/gmp-capabilities">GMP Capabilities</a></strong> for an overview of our GMP facility certifications world wide.</p></div> </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-regulatory-certifications-and-guidelines-for-our-gmp-manufacturing-facility19" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Regulatory Certifications and Guidelines for Our GMP Manufacturing Facility</h5> </a> </div> <div class="collapse" id="expPara-regulatory-certifications-and-guidelines-for-our-gmp-manufacturing-facility19" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><ul> <li>ISO 9001:2015, ISO 13485:2016-certified facilities including a completely animal-free facility dedicated to manufacturing GMP proteins</li> <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 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-documentation-and-traceability-for-gmp-protein-production0" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Documentation and Traceability for GMP Protein Production</h5> </a> </div> <div class="collapse" id="expPara-documentation-and-traceability-for-gmp-protein-production0" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><p>We work with preferred vendors for raw materials to mitigate risk and adhere to a strict definition of animal-free conditions. Certificates of Origin (COOs) are available upon request.</p> <ul> <li>Individual specification sheets with all testing results, reviewed by both our Quality Control (QC) and Quality Assurance (QA) departments</li> <li>Lot-specific Certificates of Analysis</li> <li>Full QA review of all batch and bottling records before any material is shipped</li> <li>Documented processes and QA control of documentation and process changes</li> <li>Personnel training programs</li> <li>Raw material testing, tracing, and vendor qualification/monitoring</li> <li>Fully validated equipment, processes, and test methods</li> <li>Equipment calibration schedules using a computerized calibration program</li> <li>Facility maintenance and safety programs</li> <li>Material review board for variances</li> <li>Stability monitoring over the shelf life of each product</li> <li>Product change notifications</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-safety-and-quality-control-testing-for-gmp-quality-management-systems20" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Safety and Quality Control Testing for GMP Quality Management Systems</h5> </a> </div> <div class="collapse" id="expPara-safety-and-quality-control-testing-for-gmp-quality-management-systems20" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><p>We pay strict attention to detail at all levels of the protein manufacturing process. Our quality management systems for GMP proteins include detailed Standard Operating Procedures (SOPs) and quality-controlled documentation of the manufacturing equipment and procedures. You can rely on our GMP proteins for building a consistent and robust cell therapy manufacturing program.</p> <ul> <li>Biological potency specification</li> <li>Defined purity specifications</li> <li>Stability testing program</li> <li>Defined endotoxin specifications</li> <li>Host cell protein content testing</li> <li>Sterility testing according to USP</li> <li>Additional testing available depending on your needs</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-gmp-protein-certificate-of-analysis-specifications0" role="button" aria-expanded="false" aria-controls="expPara"> <h5>GMP Protein Certificate of Analysis Specifications</h5> </a> </div> <div class="collapse" id="expPara-gmp-protein-certificate-of-analysis-specifications0" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><p>We provide each manufactured lot of GMP protein with a Certificate of Analysis (CofA) that documents the relevant quality systems and product specifications. Prior to CofA release, we perform a full QA review of all batch and bottling records. Here is what you can expect to find on our CofAs:</p> <ul> <li>Actual vial fill (protein mass) for accurate reconstitution</li> <li>Source information</li> <li>N-terminal sequencing of the first 10 amino acids</li> <li>Purity specification</li> <li>Bioactivity assay including benchmarking against a master lot</li> <li>Sterility testing to USP</li> <li>Endotoxin levels</li> <li>Host cell protein specification</li> <li>Host cell DNA specification</li> <li>Stability statement</li> <li>Certifications and regulatory guidelines followed</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-additional-resources21" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Additional Resources</h5> </a> </div> <div class="collapse" id="expPara-additional-resources21" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><h5>Literature</h5> <p><a href="https://resources.bio-techne.com/bio-techne-assets/images/literature/fl-key-considerations-for-cytokine-supplier-selection.pdf">Key Considerations for Cytokine Supplier Selection for Cell Therapies Article</a></p> <p><a href="https://resources.bio-techne.com/bio-techne-assets/images/literature/bio-techne-gmp-cytokines-growth-factors-therapeutic-manufacturing-update.pdf">GMP Cytokines and Growth Factors for Therapeutic Manufacturing Brochure</a></p> <h5>Website Resources</h5> <p><a href="/reagents/proteins/liquid-cytokines-workflow">Liquid Cytokines</a></p> <p><a href="/reagents/proteins">Recombinant Proteins</a></p> <p><a href="/gmp-products/gmp-capabilities">GMP Capabilities</a></p> <p><a href="/research-areas/immune-cell-therapy/t-cell-manufacturing">T Cell Manufacturing for Cell Therapy</a></p> <p><a href="/research-areas/immune-cell-therapy/nk-cells">Natural Killer (NK) Cells for Cell Therapy</a></p> <p><a href="/research-areas/stem-cells/ipsc">Induced Pluripotent Stem Cells (iPSCs)</a></p> <p><a href="/research-areas/cell-and-gene-therapy">Cell and Gene Therapy</a></p> <p><a href="/applications/bioprocessing/cell-culture-development">Bioprocessing: Cell Culture Development</a></p> <p><a href="/services/custom-protein-services">Custom Protein Services</a></p> <p><a href="/services/custom-cell-and-gene-therapy-services">Custom Services for Cell and Gene Therapy</a></p></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> <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 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><h3>State-of-the-Art GMP Protein Manufacturing Facility</h3></div> </div> <div class="field_block:paragraph:2_2_media_to_text:field_lg_sngl_frmtd_text_global"> <div><p>We're committed to meeting the increasing demands of therapeutic cell manufacturing. Our facility supports large-scale production of GMP-grade, <em>E. coli</em>-derived recombinant proteins.</p> <ul> <li>Entire facility dedicated to manufacturing GMP proteins</li> <li>Completely animal-free – No animal components are allowed in the facility</li> <li>Capacity – 61,000 sq. ft. to meet your current and future supply requirements</li> <li>Expandability – Available space to build additional capacity</li> <li>ISO 5/7/8 cleanrooms for the entire production process</li> </ul> <p><a href="/gmp-manufacturing-facility">Learn More About Our New Facility</a></p></div> </div> <div class="field_block:paragraph:2_2_media_to_text:field_call_to_action_global"> <a href="/gmp-products/gmp-facility-tour-request" class="btn btn-primary" type="link"> Request a Video Tour </a> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--card-paragraph paragraph--view-mode--default card-para-default"> <h2>GMP Protein Resources</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="/resources/literature/realize-your-protein-and-cell-potential-guide" > <div class="card-img-top text-center mb-3" style="background-repeat: no-repeat; background-color: ; height:200px; width: 100%;"> <div class="teaser-valign-container" style=""> <div class="valign"> <img src="https://resources.bio-techne.com/bio-techne-assets/images/literature/bt-realize-protein-thumbnail.png" alt="Realize your protein and cell potential brochure" loading="lazy" > </div> </div> </div> </a> <a class="card_title_link" href="/resources/literature/realize-your-protein-and-cell-potential-guide" > <h3 class="card_title_htag"></h3> </a> <div class="card_description flex-grow-1"> </div> <div class="card-bottom-link"> <div> <a href="/resources/literature/realize-your-protein-and-cell-potential-guide" > Guide: Realize Your Protein and Cell Potential </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="/resources/webinars/key-considerations-for-cytokine-supplier-selection" > <div class="card-img-top text-center mb-3" style="background-repeat: no-repeat; background-color: ; height:200px; width: 100%;"> <div class="teaser-valign-container" style=""> <div class="valign"> <img src="https://resources.bio-techne.com/bio-techne-assets/images/webinars/Webinar_Selecting-the-Right-Cytokine-Supplier-for-Cell-Therapy-thumb.png" alt="Webinar: Selecting the Right Cytokine Supplier for Cell Therapy" loading="lazy" > </div> </div> </div> </a> <a class="card_title_link" href="/resources/webinars/key-considerations-for-cytokine-supplier-selection" > <h3 class="card_title_htag"></h3> </a> <div class="card_description flex-grow-1"> </div> <div class="card-bottom-link"> <div> <a href="/resources/webinars/key-considerations-for-cytokine-supplier-selection" > Webinar: Selecting the Right Cytokine Supplier for Cell Therapy </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="/resources/literature/t-cell-therapies-ebook" > <div class="card-img-top text-center mb-3" style="background-repeat: no-repeat; background-color: ; height:200px; width: 100%;"> <div class="teaser-valign-container" style=""> <div class="valign"> <img src="https://resources.bio-techne.com/bio-techne-assets/images/literature/t-cell-based-therapies-ebook-thumbnail-500x580.png" alt="T Cell-Based Therapies eBook" loading="lazy" > </div> </div> </div> </a> <a class="card_title_link" href="/resources/literature/t-cell-therapies-ebook" > <h3 class="card_title_htag"></h3> </a> <div class="card_description flex-grow-1"> </div> <div class="card-bottom-link"> <div> <a href="/resources/literature/t-cell-therapies-ebook" > eBook: T Cell Based Therapies </a> </div> </div> </div> </div> </div> </div> </div> </div> <div> <div 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