{"id":18915,"date":"2025-05-13T15:27:16","date_gmt":"2025-05-13T15:27:16","guid":{"rendered":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/?p=18915"},"modified":"2025-05-13T19:54:56","modified_gmt":"2025-05-13T19:54:56","slug":"guide-to-cell-therapy-gmp-manufacturing-for-autologous-car-t-and-beyond","status":"publish","type":"post","link":"https:\/\/www.thermofisher.com\/blog\/behindthebench\/guide-to-cell-therapy-gmp-manufacturing-for-autologous-car-t-and-beyond\/","title":{"rendered":"Guide to Cell Therapy GMP Manufacturing for Autologous CAR-T and Beyond"},"content":{"rendered":"\r\n<p><a href=\"http:\/\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2025\/04\/CGAT-Blot.png\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-18919\" src=\"http:\/\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2025\/04\/CGAT-Blot.png\" alt=\"Cell therapy GMP manufacturing scientists at the bench\" width=\"738\" height=\"415\" srcset=\"https:\/\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2025\/04\/CGAT-Blot.png 738w, https:\/\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2025\/04\/CGAT-Blot-300x169.png 300w\" sizes=\"auto, (max-width: 738px) 100vw, 738px\" \/><\/a><\/p>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n\r\n<p><span lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\">Autologous cell therapy, using a patient&#8217;s own cells, offers significant advantages, including reduced risk of immune rejection and infection. This personalized approach can lead to better outcomes and eliminates the need for donor matching and immunosuppressive drugs. Additionally, it enhances safety by minimizing concerns about disease transmission or genetic issues from donor cells, making it a highly promising and effective treatment option.<\/span><\/p>\r\n\r\n\r\n\r\n<p>This blog will explore how developing customized solutions for process automation in accordance with GMP compliance addresses key technical bottlenecks, advances the manufacturing of, and ultimately improves patient access to, these life-saving medicines.<\/p>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-16018d1d wp-block-buttons-is-layout-flex\">\r\n<div class=\"wp-block-button has-custom-width wp-block-button__width-75 has-custom-font-size is-style-fill has-medium-font-size\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color has-text-align-center wp-element-button\" style=\"border-radius: 0px;background-color: #ee3134\" href=\"https:\/\/www.thermofisher.com\/us\/en\/home\/clinical\/cell-gene-therapy\/cell-therapy\/cell-therapy-manufacturing-solutions.html?cid=cdi_cgx_sbu_r01_co_pfo1101_pgm1629_col000000_0so_blg_il_awa_og_s00_cellmfgwfl\" target=\"_blank\" rel=\"noreferrer noopener nofollow\"><strong>Explore cell therapy manufacturing technologies<\/strong><\/a><\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-yoast-seo-table-of-contents yoast-table-of-contents\">\r\n<h2>Table of contents<\/h2>\r\n<ul>\r\n<li><a href=\"#h-what-is-autologous-car-t-cell-therapy\" data-level=\"2\">What is autologous CAR T-cell therapy?<\/a><\/li>\r\n<li><a href=\"#h-the-evolution-of-autologous-car-t-cell-therapy\" data-level=\"2\">The evolution of autologous CAR T-cell therapy<\/a><\/li>\r\n<li><a href=\"#h-fda-approved-cell-and-gene-therapies\" data-level=\"2\">FDA approved cell and gene therapies<\/a><\/li>\r\n<li><a href=\"#h-current-challenges-of-cell-therapy-gmp-manufacturing\" data-level=\"2\">Current challenges of cell therapy GMP manufacturing<\/a><\/li>\r\n<li><a href=\"#h-the-role-of-automation-in-cell-therapy-manufacturing\" data-level=\"2\">The role of automation in cell therapy manufacturing<\/a><\/li>\r\n<li><a href=\"#h-good-manufacturing-practices-gmp-in-cell-therapy\" data-level=\"2\">Good manufacturing practices (GMP) in cell therapy<\/a><\/li>\r\n<li><a href=\"#h-thermo-fisher-scientific-automated-solutions-for-gmp-cell-therapy-manufacturing\" data-level=\"2\">Thermo Fisher Scientific automated solutions for GMP cell therapy manufacturing<\/a>\r\n<ul>\r\n<li><a href=\"#h-gibco-cts-rotea-counterflow-centrifugation-system-nbsp\" data-level=\"3\">Gibco\u2122 CTS\u2122 Rotea\u2122 Counterflow Centrifugation System \u00a0<\/a><\/li>\r\n<li><a href=\"#h-gibco-cts-dynacellect-magnetic-separation-system-nbsp\" data-level=\"3\">Gibco\u2122 CTS\u2122 Dynacellect\u2122 Magnetic Separation System \u00a0<\/a><\/li>\r\n<li><a href=\"#h-gibco-cts-xenon-electroporation-system-nbsp\" data-level=\"3\">Gibco\u2122 CTS\u2122 Xenon\u2122 Electroporation System \u00a0<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<li><a href=\"#h-integrating-automation-and-gmp-for-cell-therapy-manufacturing\" data-level=\"2\">Integrating automation and GMP for cell therapy manufacturing <\/a><\/li>\r\n<li><a href=\"#h-recommended-cell-therapy-gmp-manufacturing-resources\" data-level=\"2\">Recommended cell therapy GMP manufacturing resources<\/a><\/li>\r\n<li><a href=\"#h-references\" data-level=\"2\">References<\/a><\/li>\r\n<\/ul>\r\n<\/div>\r\n\r\n\r\n\r\n<h2 id=\"h-what-is-autologous-car-t-cell-therapy\" class=\"wp-block-heading\">What is autologous CAR T-cell therapy?<\/h2>\r\n\r\n\r\n\r\n<p>Autologous CAR T-cell therapy is a type of immunotherapy that utilizes genetically modified T cells to target and fight cancer. This process involves collecting T cells from the patient&#8217;s blood through leukapheresis, genetically modifying them in a laboratory to express Chimeric Antigen Receptors (CARs), expanding the modified T cells, and then infusing them back into the patient. The engineered CARs on the T cells&#8217; surface enable them to recognize and bind to specific antigens on cancer cells, allowing for targeted and effective destruction of these cells.<\/p>\r\n\r\n\r\n\r\n<h2 id=\"h-the-evolution-of-autologous-car-t-cell-therapy\" class=\"wp-block-heading\">The evolution of autologous CAR T-cell therapy<\/h2>\r\n\r\n\r\n\r\n<p>CAR T-cell therapy has come a long way since its inception. The journey began with the first successful bone marrow transplants in the late 1960s, which laid the foundation for modern hematopoietic stem cell transplants used to treat blood cancers and disorders.<sup>1<\/sup> Over the decades, advancements in genetic engineering, stem cell research, and immunotherapy have propelled cell therapy into a new era.\u00a0\u00a0Today, CAR T cell therapy has evolved into a viable treatment option for several hematological malignancies, with multiple FDA-approved therapies and ongoing research to expand its use to solid tumors.<\/p>\r\n\r\n\r\n\r\n<h2 id=\"h-fda-approved-cell-and-gene-therapies\" class=\"wp-block-heading\">FDA approved cell and gene therapies<\/h2>\r\n\r\n\r\n\r\n<p>The launch of Kymriah in 2017, the first CAR T-cell therapy, marked a significant milestone, paving the way for FDA approval of additional CAR T-cell products and expanding the horizons of cell therapy to treat solid tumors and other conditions.<sup>2<\/sup><\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-table\">\r\n<table class=\"has-fixed-layout\">\r\n<thead>\r\n<tr>\r\n<th>Therapy type<\/th>\r\n<th>Drug name<\/th>\r\n<th>Indication<\/th>\r\n<\/tr>\r\n<\/thead>\r\n<tbody>\r\n<tr>\r\n<td>Cell therapy<\/td>\r\n<td>AMTAGVI (lifileucel)\u00a0<\/td>\r\n<td>Metastatic melanoma<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Gene therapy<\/td>\r\n<td>LENMELDY (atidarsagene autotemcel)\u00a0<\/td>\r\n<td>Metachromatic leukodystrophy<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Cell therapy<\/td>\r\n<td>TECELRA (afamitresgene autoleucel)\u00a0<\/td>\r\n<td>Advanced synovial sarcoma<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>CAR T-cell therapy<\/td>\r\n<td>AUCATZYL (obecabtagene autoleucel)\u00a0<\/td>\r\n<td>B-cell acute lymphoblastic leukemia<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Cell therapy<\/td>\r\n<td>CASGEVY (exagamglogene autotemcel [exa-cel])\u00a0<\/td>\r\n<td>Blood and immune system disorders<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Cell therapy<\/td>\r\n<td>RYONCIL (remestemcel-L-rknd)\u00a0<\/td>\r\n<td>Steroid-refractory acute graft versus host disease<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<\/figure>\r\n\r\n\r\n\r\n<p>In 2024, the FDA granted accelerated approval for afami-cel (TECELRA) for adults with unresectable or metastatic synovial carcinoma, marking the first TCR-T cell therapy for a solid tumor<sup>3<\/sup>, and Obecabtagene Autoleucel (Aucatzyl by Autolus Inc.), a CD19-directed autologous T-cell immunotherapy for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).<sup>4<\/sup><\/p>\r\n\r\n\r\n\r\n<p>The global cell and gene therapy market size was valued at USD 18.13 billion in 2023 and is projected to reach USD 97.33 billion by 2033.<sup>5<\/sup> As of Q4 2024, there are now more than 4,238 gene, cell, and RNA therapies in development.<sup>6<\/sup> The Cell and Gene Therapy (CGT) space is also shifting towards non-oncology indications like autoimmune and neurodegenerative diseases, with about 1,900 clinical trials occurring globally. (6) These advancements are driving improved patient outcomes across solid tumor indications, sickle cell disease, beta-thalassemia, and CAR-T therapies for earlier lines of treatment, including a first-line approval for high-risk large B-cell lymphoma.<sup>7<\/sup><\/p>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\r\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\"><hr class=\"wp-block-separator has-text-color has-alpha-channel-opacity has-background is-style-dots\" style=\"background-color: #ee3134;color: #ee3134\" \/><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis: 33.33%\">\r\n<figure class=\"wp-block-image size-full is-resized\"><a href=\"https:\/\/www.thermofisher.com\/us\/en\/home\/clinical\/cell-gene-therapy\/cell-gene-therapy-learning-center\/cell-therapy-brochure.html\" target=\"_blank\" rel=\"noreferrer noopener\"><img decoding=\"async\" class=\"wp-image-4492\" style=\"width: 208px;height: auto\" src=\"http:\/\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2025\/04\/Cell-Therapy-Brochure.jpg\" alt=\"Cell Therapy Brochure\" \/><\/a><\/figure>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis: 66.66%\">\r\n<h4 class=\"wp-block-heading has-text-color has-link-color wp-elements-f633decc7ff049e9751c28e64808ff4d\" style=\"color: #ee3134\">E-book download: cell therapy commercialization path<\/h4>\r\n<div class=\"glfh_linkContainer\">\u00a0<\/div>\r\n\r\n\r\n\r\n<p>This guide explains the pathway from cell therapy discovery to commercialization.<\/p>\r\n\r\n\r\n\r\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\r\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-background wp-element-button\" style=\"border-radius: 0px;background-color: #ee3134\" href=\"https:\/\/www.thermofisher.com\/us\/en\/home\/clinical\/cell-gene-therapy\/cell-gene-therapy-learning-center\/cell-therapy-brochure.html?cid=bid_clb_cts_r01_co_pfo1101_pgm1629_col000000_0so_blg_il_lgn_og_s00_cellmfgwflblg\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Download e-book<\/strong><\/a><\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n<hr class=\"wp-block-separator has-text-color has-alpha-channel-opacity has-background is-style-dots\" style=\"background-color: #ee3134;color: #ee3134\" \/><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<h2 id=\"h-current-challenges-of-cell-therapy-gmp-manufacturing\" class=\"wp-block-heading\">Current challenges of cell therapy GMP manufacturing<\/h2>\r\n\r\n\r\n\r\n<p>Despite its promise, cell therapy manufacturing faces significant challenges, particularly in adhering to Good Manufacturing Practices (GMP). Key issues include:<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>Complexity:<\/strong> The manufacturing process involves multiple complex steps, each requiring precise control to ensure product quality and consistency.<\/li>\r\n\r\n\r\n\r\n<li><strong>Cost:<\/strong> Producing autologous cell therapies is expensive, partly due to the individualized nature of the treatment and the need for specialized facilities and equipment.<\/li>\r\n\r\n\r\n\r\n<li><strong>Scalability:<\/strong> Meeting the growing demand for these therapies necessitates scalable manufacturing solutions that maintain high standards of quality.<\/li>\r\n\r\n\r\n\r\n<li><strong>Regulatory compliance:<\/strong> Ensuring compliance with stringent regulatory requirements across different regions adds another layer of complexity.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<h2 id=\"h-the-role-of-automation-in-cell-therapy-manufacturing\" class=\"wp-block-heading\">The role of automation in cell therapy manufacturing<\/h2>\r\n\r\n\r\n\r\n<p>Automation is central in addressing the challenges of cell therapy manufacturing. It can help bring several advantages:<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>Reducing manual labor and errors:<\/strong> Automation minimizes human intervention, reducing the risk of errors and contamination, which is crucial for maintaining the integrity of patient-specific therapies.<\/li>\r\n\r\n\r\n\r\n<li><strong>Enhancing scalability:<\/strong> Automated systems can handle larger volumes and more complex processes, making it feasible to produce therapies on a commercial scale.<\/li>\r\n\r\n\r\n\r\n<li><strong>Improving consistency and quality:<\/strong> Automation ensures that each batch is produced under uniform conditions, enhancing consistency and quality, which is essential for regulatory compliance and patient safety.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<h2 id=\"h-good-manufacturing-practices-gmp-in-cell-therapy\" class=\"wp-block-heading\">Good manufacturing practices (GMP) in cell therapy<\/h2>\r\n\r\n\r\n\r\n<p>GMP guidelines are designed to ensure that products are consistently produced and controlled according to quality standards. In cell therapy manufacturing, GMP compliance is critical for several reasons:<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>Ensuring product safety<\/strong>: GMP regulations mandate stringent controls to prevent contamination and ensure the safety of the final product. This includes maintaining clean facilities, using high-quality raw materials, and implementing robust quality control measures.<\/li>\r\n\r\n\r\n\r\n<li><strong>Regulatory compliance<\/strong>: Adhering to GMP is essential for obtaining regulatory approval from agencies like the FDA, ensuring that the manufacturing process meets all legal and quality requirements.<\/li>\r\n\r\n\r\n\r\n<li><strong>Building trust<\/strong>: GMP compliance builds trust with stakeholders, including patients, healthcare providers, and investors, demonstrating a commitment to quality and safety.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\r\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\"><hr class=\"wp-block-separator has-text-color has-alpha-channel-opacity has-background is-style-dots\" style=\"background-color: #ee3134;color: #ee3134\" \/><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis: 33.33%\">\r\n<figure class=\"wp-block-image size-full is-resized\"><a href=\"https:\/\/www.thermofisher.com\/us\/en\/home\/global\/forms\/webinar-process-control-car-t-cell-manufacturing.html\" target=\"_blank\" rel=\"noreferrer noopener\"><img decoding=\"async\" class=\"wp-image-4491\" style=\"width: 222px;height: auto\" src=\"http:\/\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2025\/05\/Webinar-on-laptop-view.png\" alt=\"Cell therapy manufacturing webinar\" \/><\/a><\/figure>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis: 66.66%\">\r\n<h4 class=\"wp-block-heading has-text-color has-link-color wp-elements-0c071cf667eac5563c277ea3a250deca\" style=\"color: #ee3134\">Free webinar: leveraging flexibility and automation in next-gen cell therapy manufacturing<\/h4>\r\n<div class=\"glfh_linkContainer\">\u00a0<\/div>\r\n\r\n\r\n\r\n<p>With the surge in cell therapy approvals and advancements, the pressure to scale production while maintaining quality and safety standards has never been higher. Traditional manufacturing methods simply can&#8217;t keep up with the complexities of cell therapies. This webinar explores how advanced technologies and strategies can help streamline your operations, reduce costs, and expedite time-to-market.<\/p>\r\n\r\n\r\n\r\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\r\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-background wp-element-button\" style=\"border-radius: 0px;background-color: #ee3134\" href=\"https:\/\/www.thermofisher.com\/us\/en\/home\/global\/forms\/webinar-next-gen-cell-therapy-manufacturing.html?cid=cdi_cgx_sbu_r01_co_pfo1101_pgm1629_col000000_0so_blg_il_lgn_og_s00_cellmfgwflblg\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Access webinar<\/strong><\/a><\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n<hr class=\"wp-block-separator has-text-color has-alpha-channel-opacity has-background is-style-dots\" style=\"background-color: #ee3134;color: #ee3134\" \/><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<h2 id=\"h-thermo-fisher-scientific-automated-solutions-for-gmp-cell-therapy-manufacturing\" class=\"wp-block-heading\">Thermo Fisher Scientific automated solutions for GMP cell therapy manufacturing<\/h2>\r\n\r\n\r\n\r\n<p>Thermo Fisher Scientific offers a range of automated solutions designed to streamline GMP cell therapy manufacturing. These solutions integrate seamlessly into GMP-compliant workflows, enhancing efficiency, reducing costs, and ensuring the consistent production of high-quality cell therapies.<\/p>\r\n\r\n\r\n\r\n<p>These GMP-compliant, closed automated manufacturing solutions facilitate process optimization while automating key unit operations such as cell isolation, activation, and gene editing. This allows customers to choose which unit operations to automate while still providing scalability. Gibco CTS instruments address the challenges of open manual systems by offering closed, automated systems that minimize contamination risks and reduce the need for cleanroom environments. These systems improve process consistency and reliability by reducing operator variability and hands-on time, leading to widespread adoption among process developers in the cell therapy field.<\/p>\r\n\r\n\r\n\r\n<p>These instruments, along with their supporting consumables and software products, enable GMP compliance. They can be physically integrated to remove open processes, minimizing contamination risk and offering greater control over processes. Digital integration via tools such as CTS Cellmation software improves record keeping and maintains data integrity.<\/p>\r\n\r\n\r\n\r\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\r\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\r\n<h3 id=\"h-gibco-cts-rotea-counterflow-centrifugation-system-nbsp\" class=\"wp-block-heading\"><strong>Gibco\u2122 CTS\u2122 Rotea\u2122 Counterflow Centrifugation System<\/strong>\u00a0<\/h3>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\r\n<figure data-wp-context=\"{&quot;imageId&quot;:&quot;6ade5dc788835&quot;}\" data-wp-interactive=\"core\/image\" data-wp-key=\"6ade5dc788835\" class=\"wp-block-image size-large wp-lightbox-container\"><img decoding=\"async\" data-wp-class--hide=\"state.isContentHidden\" data-wp-class--show=\"state.isContentVisible\" data-wp-init=\"callbacks.setButtonStyles\" data-wp-on--click=\"actions.showLightbox\" data-wp-on--load=\"callbacks.setButtonStyles\" data-wp-on-window--resize=\"callbacks.setButtonStyles\" class=\"wp-image-4496\" src=\"http:\/\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2025\/04\/Rotea-Product.png\" alt=\"Gibco CTS Rotea Counterflow Centrifugation System \" \/><button\n\t\t\tclass=\"lightbox-trigger\"\n\t\t\ttype=\"button\"\n\t\t\taria-haspopup=\"dialog\"\n\t\t\taria-label=\"Enlarge\"\n\t\t\tdata-wp-init=\"callbacks.initTriggerButton\"\n\t\t\tdata-wp-on--click=\"actions.showLightbox\"\n\t\t\tdata-wp-style--right=\"state.imageButtonRight\"\n\t\t\tdata-wp-style--top=\"state.imageButtonTop\"\n\t\t>\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"12\" height=\"12\" fill=\"none\" viewBox=\"0 0 12 12\">\n\t\t\t\t<path fill=\"#fff\" d=\"M2 0a2 2 0 0 0-2 2v2h1.5V2a.5.5 0 0 1 .5-.5h2V0H2Zm2 10.5H2a.5.5 0 0 1-.5-.5V8H0v2a2 2 0 0 0 2 2h2v-1.5ZM8 12v-1.5h2a.5.5 0 0 0 .5-.5V8H12v2a2 2 0 0 1-2 2H8Zm2-12a2 2 0 0 1 2 2v2h-1.5V2a.5.5 0 0 0-.5-.5H8V0h2Z\" \/>\n\t\t\t<\/svg>\n\t\t<\/button><\/figure>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-buttons has-custom-font-size has-small-font-size is-horizontal is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-769315fb wp-block-buttons-is-layout-flex\">\r\n<div class=\"wp-block-button has-custom-width wp-block-button__width-100 has-custom-font-size is-style-fill has-small-font-size\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color has-text-align-center wp-element-button\" style=\"border-radius: 0px;background-color: #ee3134\" href=\"https:\/\/www.thermofisher.com\/us\/en\/home\/clinical\/cell-gene-therapy\/cell-therapy\/cell-therapy-manufacturing-solutions\/rotea-counterflow-centrifugation-system.html?cid=bid_clb_cts_r01_co_pfo1101_pgm1629_col000000_0so_blg_il_awa_og_s00_cellmfgwflblg\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>V<\/strong>iew<strong> CTS Rotea system<\/strong><\/a><\/div>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\r\n<p><strong>Features<\/strong><\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>Closed cell processing system\u00a0<\/li>\r\n\r\n\r\n\r\n<li>Low output volume\u00a0<\/li>\r\n\r\n\r\n\r\n<li>Process flexibility\u00a0<\/li>\r\n\r\n\r\n\r\n<li>High cell recovery and viability\u00a0<\/li>\r\n<\/ul>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\r\n<p><strong>Applications<\/strong><\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>Leukopak processing<\/li>\r\n\r\n\r\n\r\n<li>PBMC separation<\/li>\r\n\r\n\r\n\r\n<li>Cell wash and concentrate<\/li>\r\n\r\n\r\n\r\n<li>Buffer exchange<\/li>\r\n\r\n\r\n\r\n<li>Platelet elutriation<\/li>\r\n\r\n\r\n\r\n<li>RBC lysis<\/li>\r\n\r\n\r\n\r\n<li>Dissociation of pluripotent stem cell spheroids<\/li>\r\n<\/ul>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n<hr class=\"wp-block-separator has-text-color has-alpha-channel-opacity has-background is-style-dots\" style=\"background-color: #ee3134;color: #ee3134\" \/><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\r\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\r\n<h3 id=\"h-gibco-cts-dynacellect-magnetic-separation-system-nbsp\" class=\"wp-block-heading\"><strong>Gibco\u2122 CTS\u2122 Dynacellect\u2122 Magnetic Separation System<\/strong>\u00a0<\/h3>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\r\n<figure data-wp-context=\"{&quot;imageId&quot;:&quot;6ade5dc789942&quot;}\" data-wp-interactive=\"core\/image\" data-wp-key=\"6ade5dc789942\" class=\"wp-block-image size-large wp-lightbox-container\"><img decoding=\"async\" data-wp-class--hide=\"state.isContentHidden\" data-wp-class--show=\"state.isContentVisible\" data-wp-init=\"callbacks.setButtonStyles\" data-wp-on--click=\"actions.showLightbox\" data-wp-on--load=\"callbacks.setButtonStyles\" data-wp-on-window--resize=\"callbacks.setButtonStyles\" class=\"wp-image-4461\" src=\"http:\/\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2025\/04\/DynaCellect-Product-Shot.png\" alt=\"Gibco CTS DynaCellect Magnetic Separation System\" \/><button\n\t\t\tclass=\"lightbox-trigger\"\n\t\t\ttype=\"button\"\n\t\t\taria-haspopup=\"dialog\"\n\t\t\taria-label=\"Enlarge\"\n\t\t\tdata-wp-init=\"callbacks.initTriggerButton\"\n\t\t\tdata-wp-on--click=\"actions.showLightbox\"\n\t\t\tdata-wp-style--right=\"state.imageButtonRight\"\n\t\t\tdata-wp-style--top=\"state.imageButtonTop\"\n\t\t>\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"12\" height=\"12\" fill=\"none\" viewBox=\"0 0 12 12\">\n\t\t\t\t<path fill=\"#fff\" d=\"M2 0a2 2 0 0 0-2 2v2h1.5V2a.5.5 0 0 1 .5-.5h2V0H2Zm2 10.5H2a.5.5 0 0 1-.5-.5V8H0v2a2 2 0 0 0 2 2h2v-1.5ZM8 12v-1.5h2a.5.5 0 0 0 .5-.5V8H12v2a2 2 0 0 1-2 2H8Zm2-12a2 2 0 0 1 2 2v2h-1.5V2a.5.5 0 0 0-.5-.5H8V0h2Z\" \/>\n\t\t\t<\/svg>\n\t\t<\/button><\/figure>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-buttons has-custom-font-size has-small-font-size is-horizontal is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-769315fb wp-block-buttons-is-layout-flex\">\r\n<div class=\"wp-block-button has-custom-width wp-block-button__width-100 has-custom-font-size is-style-fill has-small-font-size\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color has-text-align-center wp-element-button\" style=\"border-radius: 0px;background-color: #ee3134\" href=\"https:\/\/www.thermofisher.com\/us\/en\/home\/life-science\/bioproduction\/gibco-bioprocessing\/magnetic-separation-system.html?cid=bcd_cct_cth_r01_co_pfo1101_pgm1629_col000000_0so_blg_il_awa_og_s00_cellmfgwflblg\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>View CTS DynaCellect system<\/strong><\/a><\/div>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\r\n<p><strong>Features<\/strong><\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>A closed, automated isolation and bead removal system\u00a0<\/li>\r\n\r\n\r\n\r\n<li>High-throughput and scalable<\/li>\r\n\r\n\r\n\r\n<li>High cell purity, recovery, and viability\u00a0<\/li>\r\n\r\n\r\n\r\n<li>GMP-compliant\u00a0<\/li>\r\n\r\n\r\n\r\n<li>Sterile single-use kits allow seamless scaling from research to clinical manufacturing<\/li>\r\n<\/ul>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\r\n<p><strong>Applications<\/strong><\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>Cell isolation<\/li>\r\n\r\n\r\n\r\n<li>De-beading<\/li>\r\n\r\n\r\n\r\n<li>Increased throughput or scale-up<\/li>\r\n<\/ul>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n<hr class=\"wp-block-separator has-text-color has-alpha-channel-opacity has-background is-style-dots\" style=\"background-color: #ee3134;color: #ee3134\" \/><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\r\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\r\n<h3 id=\"h-gibco-cts-xenon-electroporation-system-nbsp\" class=\"wp-block-heading\"><strong>Gibco\u2122 CTS\u2122 Xenon\u2122 Electroporation System<\/strong>\u00a0<\/h3>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\r\n<figure data-wp-context=\"{&quot;imageId&quot;:&quot;6ade5dc78a7a3&quot;}\" data-wp-interactive=\"core\/image\" data-wp-key=\"6ade5dc78a7a3\" class=\"wp-block-image size-large wp-lightbox-container\"><img decoding=\"async\" data-wp-class--hide=\"state.isContentHidden\" data-wp-class--show=\"state.isContentVisible\" data-wp-init=\"callbacks.setButtonStyles\" data-wp-on--click=\"actions.showLightbox\" data-wp-on--load=\"callbacks.setButtonStyles\" data-wp-on-window--resize=\"callbacks.setButtonStyles\" class=\"wp-image-4461\" src=\"http:\/\/admin.acceleratingscience.com\/behindthebench\/wp-content\/uploads\/sites\/9\/2025\/04\/Xenon-Product.png\" alt=\"Gibco Xenon Electroporation System\" \/><button\n\t\t\tclass=\"lightbox-trigger\"\n\t\t\ttype=\"button\"\n\t\t\taria-haspopup=\"dialog\"\n\t\t\taria-label=\"Enlarge\"\n\t\t\tdata-wp-init=\"callbacks.initTriggerButton\"\n\t\t\tdata-wp-on--click=\"actions.showLightbox\"\n\t\t\tdata-wp-style--right=\"state.imageButtonRight\"\n\t\t\tdata-wp-style--top=\"state.imageButtonTop\"\n\t\t>\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"12\" height=\"12\" fill=\"none\" viewBox=\"0 0 12 12\">\n\t\t\t\t<path fill=\"#fff\" d=\"M2 0a2 2 0 0 0-2 2v2h1.5V2a.5.5 0 0 1 .5-.5h2V0H2Zm2 10.5H2a.5.5 0 0 1-.5-.5V8H0v2a2 2 0 0 0 2 2h2v-1.5ZM8 12v-1.5h2a.5.5 0 0 0 .5-.5V8H12v2a2 2 0 0 1-2 2H8Zm2-12a2 2 0 0 1 2 2v2h-1.5V2a.5.5 0 0 0-.5-.5H8V0h2Z\" \/>\n\t\t\t<\/svg>\n\t\t<\/button><\/figure>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-buttons has-custom-font-size has-small-font-size is-horizontal is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-769315fb wp-block-buttons-is-layout-flex\">\r\n<div class=\"wp-block-button has-custom-width wp-block-button__width-100 has-custom-font-size is-style-fill has-small-font-size\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color has-text-align-center wp-element-button\" style=\"border-radius: 0px;background-color: #ee3134\" href=\"https:\/\/www.thermofisher.com\/us\/en\/home\/clinical\/cell-gene-therapy\/cell-therapy\/cell-therapy-manufacturing-solutions\/xenon-electroporation-system.html?cid=bid_clb_cts_r01_co_pfo1101_pgm1629_col000000_0so_blg_il_awa_og_s00_cellmfgwflblg\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>View CTS Xenon system<\/strong><\/a><\/div>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\r\n<p><strong>Applications<\/strong><\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>Closed, modular, large-scale electroporation system\u00a0<\/li>\r\n\r\n\r\n\r\n<li>GMP-compliant\u00a0<\/li>\r\n\r\n\r\n\r\n<li>User-friendly interface\u00a0<\/li>\r\n<\/ul>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\r\n<p><strong>Applications<\/strong><\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>Non-viral transfection<\/li>\r\n\r\n\r\n\r\n<li>Electroporation of T-, NK-cells<\/li>\r\n\r\n\r\n\r\n<li>Cell therapy process development<\/li>\r\n\r\n\r\n\r\n<li>Cell therapy manufacturing<\/li>\r\n<\/ul>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n<hr class=\"wp-block-separator has-text-color has-alpha-channel-opacity has-background is-style-dots\" style=\"background-color: #ee3134;color: #ee3134\" \/><\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-embed__wrapper\">\u00a0<\/div>\r\n<div>\r\n<p><iframe loading=\"lazy\" title=\"CAR-T Cell Therapy Manufacturing Workflow\" width=\"760\" height=\"428\" src=\"https:\/\/www.youtube.com\/embed\/lx3EhUVHI-Q?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe><\/p>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-16018d1d wp-block-buttons-is-layout-flex\">\r\n<div class=\"wp-block-button has-custom-width wp-block-button__width-75 has-custom-font-size is-style-fill has-medium-font-size\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color has-text-align-center wp-element-button\" style=\"border-radius: 0px;background-color: #ee3134\" href=\"https:\/\/www.thermofisher.com\/us\/en\/home\/clinical\/cell-gene-therapy\/cell-therapy\/cell-therapy-manufacturing-solutions\/xenon-electroporation-system.html?cid=bid_clb_cts_r01_co_pfo1101_pgm1629_col000000_0so_blg_il_awa_og_s00_cellmfgwflblg\" target=\"_blank\" rel=\"noreferrer noopener nofollow\"><strong>Explore cell therapy manufacturing technologies<\/strong><\/a><\/div>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\">Integrating automation and GMP for cell therapy manufacturing<\/h2>\r\n<div class=\"glfh_linkContainer\"><a title=\"Copy link to clipboard\" href=\"https:\/\/admin.acceleratingscience.com\/life-in-the-lab\/wp-admin\/post.php?post=4178&amp;action=edit#block-ded4c07b-bd26-49db-a69e-446fe0df9a96\">\ud83d\udd17<\/a><\/div>\r\n\r\n\r\n\r\n<p>Cell therapy represents the frontier of medical science, offering great potential to treat diseases that were once considered incurable. However, the complexity and specificity of these therapies necessitate a robust framework that ensures their success. Developing a flexible and agnostic approach can significantly enhance the effectiveness and scalability of biological processes in cell and gene therapy.<\/p>\r\n\r\n\r\n\r\n<p>Below are a few tips that can help achieve a flexible, agnostic approach:<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>Implement Modular Platforms:<\/strong> Use platforms that support plug-and-play components, making it easier to test and integrate new technologies.<\/li>\r\n\r\n\r\n\r\n<li><strong>Invest in Scalable Solutions: <\/strong>Ensure that the technologies you adopt can be scaled up or down based on the requirements of the process.<\/li>\r\n\r\n\r\n\r\n<li><strong>Ensure Regulatory Compliance: <\/strong>Choosing a system that supports CFR 21 part 11 compliance should help streamline clinical translation and manufacturability. Investing in a closed modular, flexible automated system before regulatory approval can reduce risks and save time compared to manual systems during the transition to commercialization<strong>.<\/strong><\/li>\r\n\r\n\r\n\r\n<li><strong>Select Digital Integration Platforms: <\/strong>Opting for Cell therapy software solutions like <a href=\"https:\/\/www.thermofisher.com\/us\/en\/home\/clinical\/cell-gene-therapy\/cell-therapy\/cell-therapy-manufacturing-solutions\/cellmation-software-deltav-system.html?cid=cdi_cgx_sbu_r01_co_pfo1101_pgm1629_col000000_0so_blg_il_awa_og_s00_cellmfgwflblg\">Gibco\u2122 CTS\u2122 Cellmation\u2122 Software<\/a> that can seamlessly integrate with automation tools, providing real-time monitoring, data analytics, and process control.<\/li>\r\n\r\n\r\n\r\n<li><strong>Quality &amp; Regulatory Compliant Reagents:<\/strong> Plan for scaling by partnering with a reputable vendor to ensure a timely supply of high-quality reagents. Choose GMP-manufactured products that are tailored for cell and gene therapy, supporting your transition from discovery to clinical and commercial manufacturing.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>The future of autologous CAR T cell therapy lies in the seamless integration of automation and GMP compliance. Modular manufacturing solutions cater to the diverse needs of cell therapy manufacturers, whether scaling up for allogeneic or scaling down for autologous production. This adaptability enables manufacturers to continuously advance their therapies, whereas a more rigid, singular approach limits flexibility and the ability to pivot when necessary.<\/p>\r\n\r\n\r\n\r\n<p>By embracing these advancements, the industry can overcome current limitations, ensuring that innovative therapies reach more patients safely and efficiently. As technology continues to evolve, the potential for further improvements in cell therapy manufacturing is immense, promising a new era of medical breakthroughs.<\/p>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<h2 id=\"h-recommended-cell-therapy-gmp-manufacturing-resources\" class=\"wp-block-heading\">Recommended cell therapy GMP manufacturing resources<\/h2>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>Publication: <\/strong><a href=\"https:\/\/www.biorxiv.org\/content\/10.1101\/2024.06.04.596536v1.full\" target=\"_blank\" rel=\"noreferrer noopener\">Accelerating CAR T cell manufacturing with an automated next-day process<\/a>\u00a0<\/li>\r\n\r\n\r\n\r\n<li><strong>App Note: <\/strong><a href=\"https:\/\/assets.thermofisher.com\/TFS-Assets\/BID\/Application-Notes\/efficient-car-t-cell-manufacturing-instrument-workflow-app-note.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Efficient CAR T cell manufacturing using a closed and integrated instrument workflow<\/a><\/li>\r\n\r\n\r\n\r\n<li><strong>Whitepaper: <\/strong><a href=\"https:\/\/assets.thermofisher.com\/TFS-Assets\/BID\/Reference-Materials\/car-t-cell-therapy-manufacturing-automated-bioprocessing-white-paper.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Enhancing the efficiency of CAR T cell therapy manufacturing through automated bioprocessing<\/a><\/li>\r\n\r\n\r\n\r\n<li><strong>Whitepaper:<\/strong> <a href=\"https:\/\/assets.thermofisher.com\/TFS-Assets\/BID\/Reference-Materials\/autologous-car-t-cell-manufacturing-semiautomatic-closed-modular-workflow-white-paper.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Autologous CAR T cell manufacturing using a semiautomatic, closed, modular workflow<\/a><\/li>\r\n<li><strong>Publication:\u00a0<\/strong><a href=\"https:\/\/assets.thermofisher.com\/TFS-Assets\/BID\/Reference-Materials\/automated-24-hr-cart-manufacturing-process-article.pdf\">An automated 24-hour CAR-T manufacturing process<\/a><\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-16018d1d wp-block-buttons-is-layout-flex\">\r\n<div class=\"wp-block-button has-custom-width wp-block-button__width-75 has-custom-font-size is-style-fill has-medium-font-size\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color has-text-align-center wp-element-button\" style=\"border-radius: 0px;background-color: #ee3134\" href=\"https:\/\/www.thermofisher.com\/us\/en\/home\/clinical\/cell-gene-therapy\/cell-therapy\/cell-therapy-manufacturing-solutions\/cellmation-software-deltav-system.html?cid=cdi_cgx_sbu_r01_co_pfo1101_pgm1629_col000000_0so_blg_il_awa_og_s00_cellmfgwflblg\" target=\"_blank\" rel=\"noreferrer noopener nofollow\"><strong>Explore cell therapy manufacturing technologies<\/strong><\/a><\/div>\r\n<\/div>\r\n<div>\u00a0<\/div>\r\n<div>###<\/div>\r\n<div>\r\n<p class=\"selectionShareable\"><em>Intended use of the products mentioned in this article varies. For specific use statements, please refer to the product label.<\/em><\/p>\r\n<p class=\"selectionShareable\"><em>\u00a9 2025 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.<\/em><\/p>\r\n<\/div>\r\n\r\n\r\n\r\n<div class=\"wp-block-spacer\" style=\"height: 25px\" aria-hidden=\"true\">\u00a0<\/div>\r\n\r\n\r\n\r\n<h2 id=\"h-references\" class=\"wp-block-heading\">References<\/h2>\r\n\r\n\r\n\r\n<ol>\r\n<li>First Successful Bone Marrow Transplant Led to Today\u2019s Immunotherapies &#8211; Wisconsin Medical Alumni Association. <a href=\"https:\/\/wmaa.med.wisc.edu\/quarterly\/vol-20\/no-2\/golden-anniversary-bone-marrow-transplant\/\">https:\/\/wmaa.med.wisc.edu\/quarterly\/vol-20\/no-2\/golden-anniversary-bone-marrow-transplant\/<\/a> (accessed Apr 28, 2025).<\/li>\r\n<li>First-Ever CAR T-cell Therapy Approved in U.S.; <em>Cancer Discovery<\/em>, American Association for Cancer Research. <a href=\"https:\/\/aacrjournals.org\/cancerdiscovery\/article\/7\/10\/OF1\/6073\/First-Ever-CAR-T-cell-Therapy-Approved-in-U-S\">https:\/\/aacrjournals.org\/cancerdiscovery\/article\/7\/10\/OF1\/6073\/First-Ever-CAR-T-cell-Therapy-Approved-in-U-S<\/a> (accessed Apr 28, 2025).<\/li>\r\n<li>Adaptimmune Receives U.S. FDA Accelerated Approval of TECELRA\u00ae (Afamitresgene Autoleucel), the First Approved Engineered Cell Therapy for a Solid Tumor; <em>Adaptimmune (ADAP)<\/em>. <a href=\"https:\/\/www.adaptimmune.com\/investors-and-media\/news-center\/press-releases\/detail\/271\/adaptimmune-receives-u-s-fda-accelerated-approval-of\">https:\/\/www.adaptimmune.com\/investors-and-media\/news-center\/press-releases\/detail\/271\/adaptimmune-receives-u-s-fda-accelerated-approval-of<\/a> (accessed Apr 28, 2025).<\/li>\r\n<li>Autolus Therapeutics Announces FDA Approval of AUCATZYL\u00ae (Obecabtagene Autoleucel \u2013 Obe-cel) for Adults with Relapsed\/Refractory B-Cell Acute Lymphoblastic Leukemia (r\/r B-ALL); <em>Autolus Therapeutics plc<\/em>. <a href=\"https:\/\/autolus.gcs-web.com\/news-releases\/news-release-details\/autolus-therapeutics-announces-fda-approval-aucatzylr\">https:\/\/autolus.gcs-web.com\/news-releases\/news-release-details\/autolus-therapeutics-announces-fda-approval-aucatzylr<\/a> (accessed Apr 28, 2025).<\/li>\r\n<li>Mitra, S.; Lankford, C.; McBride, A. Manufacturing CAR T Cells: The Next Frontier in Cell Therapy. In <em>Cell Therapy: Current Challenges and Future Directions<\/em>; National Center for Biotechnology Information (US): Bethesda, MD, 2023. <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK600652\/\">https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK600652\/<\/a> (accessed Apr 28, 2025).<\/li>\r\n<li>2024 Cell, Gene &amp; RNA Landscape Report; <em>American Society of Gene &amp; Cell Therapy and Citeline<\/em>. <a href=\"https:\/\/www.asgct.org\/global\/documents\/asgct-citeline-q4-2024-report.aspx\">https:\/\/www.asgct.org\/global\/documents\/asgct-citeline-q4-2024-report.aspx<\/a> (accessed Apr 28, 2025).<\/li>\r\n<li>FDA D.I.S.C.O. Burst Edition: FDA Approval Yescarta (Axicabtagene Ciloleucel) for Adult Patients with Large B-Cell Lymphoma; <em>FDA<\/em>. <a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-disco-burst-edition-fda-approval-yescarta-axicabtagene-ciloleucel-adult-patients-large-b-cell\">https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-disco-burst-edition-fda-approval-yescarta-axicabtagene-ciloleucel-adult-patients-large-b-cell<\/a> (accessed Apr 28, 2025).<\/li>\r\n<li>Khang, M.; Suryaprakash, S.; Kotrappa, M.; Mulyasasmita, W.; Topp, S.; Wu, J. Manufacturing Innovation to Drive Down Cell Therapy Costs. <em>Trends Biotechnol.<\/em> <strong>2023<\/strong>, <em>41<\/em> (10), 1216\u20131219. <a href=\"https:\/\/doi.org\/10.1016\/j.tibtech.2023.04.006\">https:\/\/doi.org\/10.1016\/j.tibtech.2023.04.006<\/a>.<\/li>\r\n<\/ol>\r\n\r\n\r\n\r\n<p>&nbsp;<\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; Autologous cell therapy, using a patient&#8217;s own cells, offers significant advantages, including reduced risk of immune rejection and infection. This personalized approach can lead to better outcomes and eliminates the need for donor matching and immunosuppressive drugs. Additionally, it enhances safety by minimizing concerns about disease transmission or genetic issues from donor cells, making<\/p>\n","protected":false},"author":120,"featured_media":18919,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_monsterinsights_skip_tracking":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[54,2315,2316,1087],"tags":[],"division":[],"class_list":{"0":"post-18915","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-cancer-research","8":"category-cell-therapy","9":"category-gene-therapy","10":"category-pharmamfg","11":"entry"},"_selected_authors":"","_selected_reviewers":"","acf":[],"yoast_head":"<!-- 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