{"id":17815,"date":"2024-12-17T23:36:21","date_gmt":"2024-12-17T22:36:21","guid":{"rendered":"https:\/\/biokteca.com\/fabricacion-descentralizada-de-medicamentos-en-terapias-avanzadas\/"},"modified":"2025-03-05T10:12:23","modified_gmt":"2025-03-05T09:12:23","slug":"decentralized-manufacturing-of-advanced-therapy-medicinal-products","status":"publish","type":"post","link":"https:\/\/biokteca.com\/en\/decentralized-manufacturing-of-advanced-therapy-medicinal-products\/","title":{"rendered":"Decentralized Manufacturing of Advanced Therapy Medicinal Products"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"17815\" class=\"elementor elementor-17815 elementor-16269\">\n\t\t\t\t<div class=\"elementor-element elementor-element-723530b e-flex e-con-boxed e-con e-parent\" data-id=\"723530b\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1d8b387 elementor-widget elementor-widget-wcf--blog--post--title\" data-id=\"1d8b387\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;data-duration&quot;:0.75,&quot;fade-offset&quot;:40,&quot;delay&quot;:0.15,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\" data-widget_type=\"wcf--blog--post--title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"wcf--title\">Decentralized Manufacturing of Advanced Therapy Medicinal Products<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d15deb7 e-con-full e-flex e-con e-child\" data-id=\"d15deb7\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;data-duration&quot;:0.75,&quot;fade-offset&quot;:40,&quot;delay&quot;:0.15,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-010a8b9 e-con-full e-flex e-con e-child\" data-id=\"010a8b9\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ee37407 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"ee37407\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"50\" height=\"50\" viewBox=\"0 0 50 50\" fill=\"none\"><rect opacity=\"0.1\" width=\"50\" height=\"50\" rx=\"25\" fill=\"#8DCF9B\"><\/rect><path d=\"M24.5 24.9999C25.4889 24.9999 26.4556 24.7067 27.2779 24.1573C28.1001 23.6079 28.741 22.827 29.1194 21.9134C29.4978 20.9997 29.5969 19.9944 29.4039 19.0245C29.211 18.0546 28.7348 17.1637 28.0355 16.4644C27.3363 15.7651 26.4454 15.2889 25.4755 15.096C24.5055 14.9031 23.5002 15.0021 22.5866 15.3805C21.673 15.759 20.8921 16.3998 20.3427 17.2221C19.7932 18.0443 19.5 19.011 19.5 19.9999C19.5013 21.3256 20.0285 22.5966 20.9659 23.534C21.9033 24.4714 23.1743 24.9986 24.5 24.9999ZM24.5 16.6666C25.1593 16.6666 25.8037 16.8621 26.3519 17.2284C26.9001 17.5946 27.3273 18.1152 27.5796 18.7243C27.8319 19.3334 27.8979 20.0036 27.7693 20.6502C27.6407 21.2968 27.3232 21.8908 26.857 22.357C26.3908 22.8231 25.7969 23.1406 25.1503 23.2692C24.5037 23.3978 23.8335 23.3318 23.2244 23.0795C22.6153 22.8272 22.0947 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fill=\"#8DCF9B\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b383f2b elementor-widget elementor-widget-wcf--blog--post--meta-info\" data-id=\"b383f2b\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"wcf--blog--post--meta-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t        <ul class=\"wcf--meta-list style-2\">\r\n\t        \t\t\t\r\n\t\t\t                <li class=\"wcf--author-wrap\">\r\n                    <div class=\"wcf-author-img\">\r\n                        <img alt='' src='https:\/\/biokteca.com\/wp-content\/litespeed\/avatar\/f82114988f3144235a5373efd77c5387.jpg?ver=1776177320' class='avatar avatar-55 photo' height='55' width='55' \/>                    <\/div>\r\n                    <div class=\"wcf--author-info\">\r\n                        <div class=\"wcf--author-title label\">\r\n\t\t                    Write to                        <\/div>\r\n                        <div class=\"wcf--meta-author\">\r\n                            <a href=\"https:\/\/biokteca.com\/en\/author\/clara-caja\/\">Clara Caja<\/a>\r\n                        <\/div>\r\n                    <\/div>\r\n                <\/li>\r\n\t\t\t\t\t        <\/ul>\r\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-28e028e e-con-full e-flex e-con e-child\" data-id=\"28e028e\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f46d52d elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"f46d52d\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"50\" height=\"50\" viewBox=\"0 0 50 50\" fill=\"none\"><rect opacity=\"0.1\" width=\"50\" height=\"50\" rx=\"25\" fill=\"#8DCF9B\"><\/rect><path d=\"M30.8333 16.6667H30V15.8333C30 15.3733 29.6275 15 29.1667 15C28.7058 15 28.3333 15.3733 28.3333 15.8333V16.6667H21.6667V15.8333C21.6667 15.3733 21.2942 15 20.8333 15C20.3725 15 20 15.3733 20 15.8333V16.6667H19.1667C16.8692 16.6667 15 18.5358 15 20.8333V30.8333C15 33.1308 16.8692 35 19.1667 35H30.8333C33.1308 35 35 33.1308 35 30.8333V20.8333C35 18.5358 33.1308 16.6667 30.8333 16.6667ZM19.1667 18.3333H30.8333C32.2117 18.3333 33.3333 19.455 33.3333 20.8333V21.6667H16.6667V20.8333C16.6667 19.455 17.7883 18.3333 19.1667 18.3333ZM30.8333 33.3333H19.1667C17.7883 33.3333 16.6667 32.2117 16.6667 30.8333V23.3333H33.3333V30.8333C33.3333 32.2117 32.2117 33.3333 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    <div class=\"wcf--category-title label\">\r\n\t\t                    \t\t                    Category                        <\/div>\r\n                        <ul class=\"wcf--category-list\">\r\n\t\t\t\t\t\t\t                                <li class=\"wcf--meta-category wcf-separator\"\r\n                                    data-separator=\"|\">\r\n                                    <a class=\"wcf-btn-default btn-hover-none\" href=\"https:\/\/biokteca.com\/en\/category\/news\/\">\r\n\t\t\t\t\t\t\t\t\t\tNews                                    <\/a>\r\n                                <\/li>\r\n\t\t\t\t\t\t\t                            <\/ul>\r\n                    <\/li>\r\n\t\t\t\t\t\t\t\t\t        <\/ul>\r\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fb55d39 e-con-full e-flex e-con e-child\" data-id=\"fb55d39\" data-element_type=\"container\" 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animated-slow e-flex elementor-invisible e-con e-child\" data-id=\"7c47826\" data-element_type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeIn&quot;,&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;data-duration&quot;:0.75,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;fade-offset&quot;:40,&quot;delay&quot;:0.15,&quot;on-scroll&quot;:1,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-cb8aec0 e-con-full e-flex e-con e-child\" data-id=\"cb8aec0\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-81e50ef elementor-view-default elementor-position-top elementor-mobile-position-top elementor-widget elementor-widget-icon-box\" data-id=\"81e50ef\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon elementor-animation-\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"17\" height=\"19\" viewBox=\"0 0 17 19\" fill=\"none\"><path id=\"Vector\" d=\"M13.5353 11.8304C12.4643 11.8304 11.5055 12.3358 10.8693 13.128L6.73098 10.6975C6.85967 10.3229 6.93041 9.92007 6.93041 9.50029C6.93041 9.0806 6.85967 8.67779 6.73098 8.30317L10.869 5.87205C11.5051 6.66453 12.464 7.1701 13.5351 7.1701C15.4456 7.1701 16.9999 5.56165 16.9999 3.58451C17.0001 1.60795 15.4458 0 13.5353 0C11.6246 0 10.0701 1.60795 10.0701 3.58442C10.0701 4.0042 10.1407 4.40709 10.2695 4.7818L6.13126 7.213C5.49516 6.42094 4.53644 5.9157 3.46569 5.9157C1.55472 5.9157 0 7.52365 0 9.50021C0 11.4767 1.55472 13.0846 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class=\"default-details-social-media\">\r\n\t\t\t                <li>\r\n                    <a href=\"https:\/\/biokteca.com\/en\/decentralized-manufacturing-of-advanced-therapy-medicinal-products\/\"\r\n                       data-social=\"facebook\">\r\n                        <span class=\"wcf-social-icn \"><i aria-hidden=\"true\" class=\"share-ico binox-theme wcftheme-wcf-icon icon-wcf-facebook\"><\/i><\/span>\r\n                        <span class=\"info-s-title\"> Facebook <\/span>\r\n\t\t\t\t\t\t                            <span>\r\n                                                                                            <\/span>\r\n\t\t\t\t\t\t                    <\/a>\r\n                <\/li>\r\n\t\t\t                <li>\r\n                    <a href=\"https:\/\/biokteca.com\/en\/decentralized-manufacturing-of-advanced-therapy-medicinal-products\/\"\r\n                       data-social=\"twitter\">\r\n                        <span class=\"wcf-social-icn \"><svg 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icon-wcf-linkdin\"><\/i><\/span>\r\n                        <span class=\"info-s-title\"> Linkedin <\/span>\r\n\t\t\t\t\t\t                            <span>\r\n                                                                                            <\/span>\r\n\t\t\t\t\t\t                    <\/a>\r\n                <\/li>\r\n\t\t\t        <\/ul>\r\n\r\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c4d9b4b e-con-full e-flex e-con e-child\" data-id=\"c4d9b4b\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-7d9a514 e-con-full e-flex e-con e-child\" data-id=\"7d9a514\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-4abd5fe e-con-full e-flex e-con e-child\" data-id=\"4abd5fe\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-00b53a6 e-flex e-con-boxed e-con e-child\" data-id=\"00b53a6\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c4828d1 elementor-widget-mobile_extra__width-inherit wcf-t-animation-none elementor-widget elementor-widget-text-editor\" data-id=\"c4828d1\" data-element_type=\"widget\" data-settings=\"{&quot;on-scroll&quot;:&quot;1&quot;,&quot;data-duration&quot;:0.75,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;fade-offset&quot;:40,&quot;wcf_text_animation&quot;:&quot;none&quot;,&quot;delay&quot;:0.15,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Clara Caja. Regulatory Affairs Technician at Konexio Biotech<\/p><p>\u00a0<\/p><p>According to their own definition, advanced therapy medicinal products (ATMPs) are divided into four main categories, as established in Regulation (EC) No. 1394\/2007 and Royal Legislative Decree 1\/2015, of the 24<sup>th<\/sup> of July, which are: gene therapy medicinal products, cell therapy medicinal products, tissue engineered products and advanced therapy medicinal products combined with one or more medical devices.<\/p><p>ATMPs are regulated by Regulation (EC) No. 1394\/2007. Also, it is essential that, like all medicines, they are manufactured in accordance with Good Manufacturing Practice (GMP). Volume 4 of EudraLex (the rules governing medicines in the European Union) contains guidelines for the interpretation of the principles and guidelines of good manufacturing practice for medicinal products for human and veterinary use.<\/p><p>Volume 4 of EudraLex is divided into four parts: Part I Basic Requirements for Medicinal Products, Part II Basic Requirements for Active Substances used as Starting Materials, Part III GMP Related Documents and Part IV GMP Requirements for Advanced Therapy Medicinal Products. Therefore, Advanced Therapy Medicinal Products will be manufactured in accordance with Part IV of the CNF.<\/p><p>There are currently two main routes for the large-scale delivery of ATMPs to patients: centralised and decentralised manufacturing (<strong>Figure 1<\/strong>).<\/p><p>Centralised manufacturing is considered the traditional way of manufacturing these drugs; it consists of a single facility that carries out production and is responsible for supplying ATMPs to a large geographical region. For personalised treatment, this may occur in a specific region or may require the transportation of the patient\u2019s cells over long distances.<\/p><p>Decentralised manufacturing has emerged recently and consists of the production of ATMPs in regional centres (\u2018hubs\u2019) that are close to the treatment centres and deliver the products to their immediate environment.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ee94bfa elementor-widget elementor-widget-wcf--image\" data-id=\"ee94bfa\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-image-animation&quot;:&quot;none&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"wcf--image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wcf--image\">\r\n\t\t\t<img decoding=\"async\" width=\"1290\" height=\"562\" src=\"https:\/\/biokteca.com\/wp-content\/uploads\/2024\/12\/regulacion-medicamentos-terapias-avanzadas-mapa.webp\" class=\"attachment-full size-full wp-image-16272\" alt=\"\" srcset=\"https:\/\/biokteca.com\/wp-content\/uploads\/2024\/12\/regulacion-medicamentos-terapias-avanzadas-mapa.webp 1290w, https:\/\/biokteca.com\/wp-content\/uploads\/2024\/12\/regulacion-medicamentos-terapias-avanzadas-mapa-300x131.webp 300w, https:\/\/biokteca.com\/wp-content\/uploads\/2024\/12\/regulacion-medicamentos-terapias-avanzadas-mapa-1024x446.webp 1024w, https:\/\/biokteca.com\/wp-content\/uploads\/2024\/12\/regulacion-medicamentos-terapias-avanzadas-mapa-768x335.webp 768w\" sizes=\"(max-width: 1290px) 100vw, 1290px\" \/>\t\t<\/div>\r\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b95678b wcf-t-animation-none elementor-widget elementor-widget-text-editor\" data-id=\"b95678b\" data-element_type=\"widget\" data-settings=\"{&quot;on-scroll&quot;:&quot;1&quot;,&quot;data-duration&quot;:0.75,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;fade-offset&quot;:40,&quot;wcf_text_animation&quot;:&quot;none&quot;,&quot;delay&quot;:0.15,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Figure 1.<\/strong> A) Centralised manufacturing of ATMPs. B) Decentralised manufacturing of ATMPs. Source: <em>Roadmap of the needs and strategy of the Implementation of new Advanced Therapies. Restore horizon<\/em><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-33ef4cf wcf-t-animation-none elementor-widget elementor-widget-text-editor\" data-id=\"33ef4cf\" data-element_type=\"widget\" data-settings=\"{&quot;on-scroll&quot;:&quot;1&quot;,&quot;data-duration&quot;:0.75,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;fade-offset&quot;:40,&quot;wcf_text_animation&quot;:&quot;none&quot;,&quot;delay&quot;:0.15,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Centralised manufacturing can present some disadvantages and challenges compared to decentralised ATMP manufacturing. Conventional pharmacological manufacturing is a highly centralised process, and involves complicated supply chain logistics and cryopreservation. While this is a time-tested and economically sustainable process for traditional pharmacological drugs, it can be difficult to scale up to advanced therapy drugs, especially when it comes to autologous cell therapies.<\/p><p>Centralised cell therapy manufacturing can be time-consuming due to several factors. First, the process of isolating and expanding cells can take a significant amount of time. In addition, ensuring that patients have access to the therapy can be a time-consuming challenge, especially for those who are far from centralised manufacturing facilities. The logistics involved in transporting the therapy to these patients can mean significant obstacles and delays.<\/p><p>Decentralisation changes the manufacture of cell therapy to a more distributed process, bringing it closer to patients as it improves access and convenience. Doctors with access to a local cell and gene therapy laboratory can work with local staff to create prior approval, schedule collection, create the treatment, release it, and administer the treatment as quickly as possible. Rate-limiting factors are reduced as patient material is available locally, thus reducing logistical and transport challenges.<\/p><p>Decentralised manufacturing is the preferred model for autologous cellular products. It is applicable to both pharmaceutical approaches and to smaller biotech companies and specialised hospitals that are producing ATMPs. Each centre must be able to deliver equivalent ATMPs, regardless of location or operators, hence, the emergence of integrated and automated management systems that allow the apheresis product to pass through the multiple stages of manufacturing within a disposable single-use kit that does not open directly to the environment. The extraction of samples and the addition of reagents or media are carried out by means of sterile tube welders or aseptic access ports, thus maintaining what is known as a functionally closed system, reducing the variation caused by operators. Automated devices have become the preferred method for decentralised CAR T manufacturing. Some of these devices are CliniMACS Prodigy\u00a9 or Lonza Cocoon\u00a9.<\/p><p>As indicated in Part IV of the NCF, the certification and release of ATMP batches manufactured under a decentralised system is especially important as manufacturing in multiple locations increases the risk of product variability.<\/p><p>In particular, the batch certification and release process should ensure that each batch released at any of the sites has been manufactured and verified in accordance with the requirements for commercialization\/clinical trial authorisation and other relevant regulatory requirements, including compliance with the NCF. With this in mind, the following aspects should be considered:<\/p><p>A central facility must be identified, which must be established in the EU. The central facility is responsible for supervising the decentralised sites. The central facility must assume, at least, the two following tasks: ensure that those who participate in the certification and batch release process are adequately qualified and trained for their tasks, and perform audits to confirm that the certification and batch release process is being followed as described in the standard operating procedure (SOP).<\/p><p>A contract or technical agreement must be established between the central facility and the decentralised locations. This agreement must establish the responsibilities of each of the parties, including the responsibility of the qualified person (QP).<\/p><p>The qualified person (QP) has the ultimate responsibility for certifying that a batch of ATMPs meets the quality requirements and can be released. The QP of the central facility can trust the data from the decentralised locations, but only as long as it has been provided by qualified and trained personnel.<\/p><p>For all the above reasons, the decentralised manufacture of advanced therapy medicinal products, specifically cell therapies, represents a step towards a more inclusive healthcare system, where advanced treatments are not a privilege, but a right accessible to all.<\/p><p>\u00a0<\/p><p><strong>Bibliography<\/strong><\/p><ol><li>Regulation (EC) No. 1394\/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001\/83\/EC and Regulation (EC) No. 726\/2004.<\/li><li>Part IV of the Guidelines on specific good manufacturing practice for advanced therapy medicinal products.<\/li><li>D 4.1 Roadmap of WP4. Roadmap of the needs and strategy of the implementation of new Advanced Therapies de Restore Horizon<\/li><li>Shah, M., Krull, A., Odonnell, L., de Lima, M. J., &amp; Bezerra, E. (2023). Promises and challenges of a decentralized CAR T-cell manufacturing model.\u00a0Frontiers in transplantation,\u00a02, 1238535.<\/li><li>Decentralized manufacturing of cell and gene therapies: Overcoming challenges and identifying opportunities Harrison, Richard P. et al. <em>Cytotherapy,<\/em> Volume 19, Issue 10, 1140 &#8211; 1151<\/li><\/ol><ol start=\"6\"><li>Beyond Urban Centers: Expanding CAR-T Therapy with Decentralized Manufacturing. Boston Labs &#8211; Inspired Clinical Logistics.<\/li><\/ol>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-04dc47d elementor-widget elementor-widget-wcf--blog--post--tags\" data-id=\"04dc47d\" data-element_type=\"widget\" data-settings=\"{&quot;on-scroll&quot;:&quot;1&quot;,&quot;data-duration&quot;:0.75,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;fade-offset&quot;:40,&quot;delay&quot;:0.15,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\" data-widget_type=\"wcf--blog--post--tags.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t        <div class=\"wcf--post-tags\">\r\n\t\t\t        <\/div>\r\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Advanced Therapy Medicinal Products are regulated by Regulation (EC) No 1394\/2007.<\/p>\n","protected":false},"author":4,"featured_media":17755,"comment_status":"open","ping_status":"open","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":""},"categories":[40],"tags":[],"class_list":["post-17815","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/biokteca.com\/en\/wp-json\/wp\/v2\/posts\/17815","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/biokteca.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/biokteca.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/biokteca.com\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/biokteca.com\/en\/wp-json\/wp\/v2\/comments?post=17815"}],"version-history":[{"count":5,"href":"https:\/\/biokteca.com\/en\/wp-json\/wp\/v2\/posts\/17815\/revisions"}],"predecessor-version":[{"id":18216,"href":"https:\/\/biokteca.com\/en\/wp-json\/wp\/v2\/posts\/17815\/revisions\/18216"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/biokteca.com\/en\/wp-json\/wp\/v2\/media\/17755"}],"wp:attachment":[{"href":"https:\/\/biokteca.com\/en\/wp-json\/wp\/v2\/media?parent=17815"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/biokteca.com\/en\/wp-json\/wp\/v2\/categories?post=17815"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/biokteca.com\/en\/wp-json\/wp\/v2\/tags?post=17815"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}