Cell & Gene Therapy Manufacturing & Research Services

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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>Cell and Gene Therapy Manufacturing and Research Solutions</h1></div> </div> <div class="field_block:paragraph:h1_2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>Unlocking tomorrow's therapies</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> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/cgt-hero-stemcell-bmogen1000x1000.png" alt="CGT Hero Stemcell BmoGen" 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="/research-areas">Research Areas</a> </li> <li> Cell & Gene Therapy Research and Manufacturing Solutions </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--freeform mb-4 paragraph--view-mode--default"> <div><p><a href="#ict">Immune Cell Therapy</a> | <a href="#rm">Regenerative Medicine</a> | <a href="#gt">Gene Therapy</a></p></div> </div> </div> <div> <div class="paragraph paragraph--type--section paragraph--view-mode--default mb-4"> <div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><p>Cell and gene therapies are set to become the new standard of healthcare, but nevertheless remain variable, complex, and difficult to manufacture with consistency. </p> <p>As an industry, we are building collective knowledge and experience that will help to accelerate development, approval, and delivery of therapies, but we still have some bottlenecks to solve while attempting to bring cost of goods down:</p> <ul> <li>What’s the best way to minimize variability in your process?</li> <li>Can you seamlessly transition from RUO to GMP?</li> <li>How can you scale-up manufacturing from bench-top to clinic to large-scale?</li> </ul> <p>To overcome these challenges and set yourself up for regulatory approval, you need high-quality raw materials, cutting-edge manufacturing solutions, and precision analytics that empower you to accelerate development and standardize processes.</p> <p>Bio-Techne's technologies and services can be tailored to meet your needs, enabling seamless and efficient development and production of cell and gene therapies. Our collective knowledge and expertise positions us well as your collaborator and long term partner. Whether you are developing an immune cell, regenerative, or gene therapy, we are ready to shape the future of healthcare.</p> <p>Together, we can unlock tomorrow’s therapies.</p></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--freeform mb-4 paragraph--view-mode--default"> <div><p><a name="ict"></a></p></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>Immune Cell Therapy</h2></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>Demonstrating comparability and reproducibility is essential for the advancement of your immune cell therapy. Understanding your therapy’s mechanism of action and quantifying CQAs are complex and can be the source of costly clinical and regulatory setbacks.</p> <p>Our high-quality, GMP-grade raw materials coupled with precision analytics technology enable you to provide robust, reliable data to determine proof of concept, ensure regulatory approval and accelerate time to patient.</p> <p>These scalable, flexible solutions can help you adapt to an ever-changing regulatory landscape. We’re also here to help to embed flexibility into your process, so that you can easily adapt your process to meet changing requirements.</p> <p>These scalable, flexible solutions enable you to seamless move from the lab to the clinic and adapt to an ever-changing regulatory landscape:</p> <ul> <li>Animal-free RUO and GMP proteins</li> <li>Non-viral gene delivery systems</li> <li>Immune cell culture solutions</li> <li>Automated analytical instruments</li> </ul></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_call_to_action_global"> <a href="/research-areas/immune-cell-therapy" class="btn btn-primary" type="link"> Explore Immune Cell Therapy Workflow 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/research-areas/car-t-cell525x300b.png" alt="Car T Cell" loading="lazy" > </div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><p><a name="rm"></a></p></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>Regenerative Medicine</h2></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>Minimizing variability is the keystone to success when developing regenerative therapies. With consistent, scalable solutions coupled with a reliable supply of high-quality raw materials, we can help you to forge a pathway towards safe, life-changing therapies.</p> <p>We recognize the challenges you face to scale-up production - that’s why all our regenerative medicine solutions are made with scalability at their core.</p> <p>We provide tailored solutions to help you throughout the regenerative medicine development workflow, including:</p> <ul> <li>Animal-free RUO and GMP proteins</li> <li>Non-viral gene delivery systems</li> <li>Stem cell and organoid culture solutions</li> <li>RUO and GMP small molecules</li> <li>Spatial biology platforms</li> <li>Automated analytical instruments</li> </ul></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_call_to_action_global"> <a href="/research-areas/regenerative-medicine" class="btn btn-primary" type="link"> Explore Regenerative Medicine Workflow 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/research-areas/healbthy-cell525x300b.png" alt="Healthy Cell" loading="lazy" > </div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><p><a name="gt"></a></p></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>Gene Therapy</h2></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>Achieving safe and effective transgene delivery is among the greatest challenges faced by gene therapy developers. The inherent complexity of viral vectors makes them difficult to characterize with consistency throughout development and manufacturing stages.</p> <p>That’s why we provide precision analytical tools for critical quality attribute analysis to ensure safe, high quality, consistent, and efficacious therapies.</p> <p>These customizable, flexible, and fast assay and analytics systems provide the high-specificity, automation, and reliable results you need throughout the gene therapy development workflow:</p> <ul> <li>Spatial biology platforms for <em>in vivo</em> monitoring</li> <li>Automated vector analysis and characterization solutions</li> <li>Immunoassays</li> </ul></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_call_to_action_global"> <a href="/research-areas/gene-therapy" class="btn btn-primary" type="link"> Explore Gene Therapy Workflow 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/research-areas/cgt-dna525x300.png" alt="Adeno-Associated Viruses " loading="lazy" > </div> </div> </div> </div> </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--_-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>Scale Up & Out With Confidence</h2></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>Scaling up production from the benchtop to clinical manufacturing is a major hurdle to overcome for all cell and gene therapies. Producing complex cell-based therapeutics at scale is a huge challenge involving long processes and large quantities, but we aim to make this process easier for you.</p><p>To make scaling-up easier for immune cell therapy projects, we’ve partnered with Wilson Wolf to bring you <a href="/research-areas/immune-cell-therapy/scaleready">ScaleReady™</a> — a collaboration that aims to bring immune cell therapies into the clinic faster with simplified, standardized, and streamlined solutions – already used in approved CAR-T drug therapies on the market.</p><p>Scalability is at the heart of all our cell and gene therapy solutions, and can be boosted further with our comprehensive portfolio of GMP materials.  Get up to full-scale manufacturing and minimize risks with raw materials that provide industry-leading quality, consistency and reliability.</p></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_call_to_action_global"> <a href="/gmp-products/gmp-capabilities" class="btn btn-primary" type="link"> Explore Our GMP Manufacturing Capabilities </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 class="field_block:paragraph:2_2_text_to_media:field_image_caption"> <div>Explore our GMP manufacturing facility in this video</div> </div> </div> </div> </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--_-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>A Smoother Transition from RUO to GMP</h2></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>Navigating the shift from R&D to clinical manufacturing presents unique challenges, particularly when confronted with the change from RUO to GMP raw materials. To facilitate a seamless transition, we offer a host of GMP materials for cell and gene therapy, including cytokines and growth factors, which are all manufactured in our new specialized animal-free GMP manufacturing facility.</p> <p>Each GMP product stands as a direct counterpart to our RUO animal-free version, produced in accordance with ISO 9001 certifications, along with adhering to USP and European guidelines. The meticulous approach we take with our RUO and GMP materials ensures that you have a smooth transition process, empowering you with the assurance of a consistent supply and unwavering quality in your raw materials.</p></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_call_to_action_global"> <a href="/gmp-products/ruo-to-gmp" class="btn btn-primary" type="link"> Learn About Transitioning to GMP </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/research-areas/gmp-raw-materials1050x700.png" alt="GMP Raw Materials" loading="lazy" > </div> </div> </div> </div> </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--_-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>Custom Cell and Gene Therapy Solutions</h2></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>Does your cell and gene therapy manufacturing process have specific volume requirements? To ensure that your process runs as efficiently as possible, and to minimize waste, we can bottle and package bulk reagents to fit your precise process requirements for all of our RUO and GMP grade materials. Our custom solutions include:</p> <ul> <li>Custom GMP protein and antibody development</li> <li>Cell culture media manufacturing services</li> <li>Small molecules and chemistry services</li> <li>Custom immunoassay development</li> <li>Custom flow cytometry reagents</li> </ul></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_call_to_action_global"> <a href="/services/custom-cell-and-gene-therapy-services" class="btn btn-primary" type="link"> View Custom Solutions for Cell and Gene Therapy </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/research-areas/gmp-facility1050x700.png" alt="GMP Facility" loading="lazy" > </div> </div> </div> </div> </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--_-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>Improve Product Insights with Robust QC and Analytics Tools</h2></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>Getting your cell and gene therapy products through regulatory approval and onto the market requires accurate, reproducible testing of critical quality attributes.</p> <p>Our analytical products and services are manufactured to the highest quality assurance measures, empowering you to move forward with confidence, and ensure that your cell and gene therapy products meet your precise quality, purity, and performance requirements.</p> <ul> <li>Simplify and accelerate your workflow with easy-to-use, automated solutions</li> <li>Analyze multiple CQAs with a single platform</li> <li>Achieve high-sensitivity cell phenotyping throughout your workflow</li> <li>Closely monitor product efficacy and toxicity </li> </ul></div> </div> <div class="field_block:paragraph:2_2_text_to_media:field_call_to_action_global"> <a href="/research-areas/cell-and-gene-therapy/analytical-solutions" class="btn btn-primary" type="link"> Discover Analytical Solutions for Cell and Gene Therapy </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/diagnostics/cell-gene-therapy-product-insights.jpg" alt="Cell Gene Therapy Product Insights" loading="lazy" > </div> </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--freeform mb-4 paragraph--view-mode--default"> <div><h2>On-Demand Cell and Gene Therapy Educational Resources</h2> <p>We’re committed to driving forward cell and gene therapy research in every way possible, which is why we have curated a collection of on-demand educational resources to guide you through your cell and gene therapy journey. Immerse yourself in our educational articles, educational content, and application notes in our resources center.</p> <p>Dive into a wealth of wisdom through our engaging cell and gene therapy webinars which cover challenges in the field, best practices, and shine a spotlight on the latest advancements. Missed a crucial session? 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