{"id":28322,"date":"2023-08-01T16:42:53","date_gmt":"2023-08-01T14:42:53","guid":{"rendered":"https:\/\/fleming.events\/?post_type=articles&#038;p=28322"},"modified":"2023-08-01T18:53:20","modified_gmt":"2023-08-01T16:53:20","slug":"healing-the-future","status":"publish","type":"articles","link":"https:\/\/fleming.events\/articles\/healing-the-future\/","title":{"rendered":"Healing the Future: The Incredible Rise of Cell &amp; Gene Therapy Products\/ATMPs!"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"28322\" class=\"elementor elementor-28322\" data-elementor-post-type=\"articles\">\n\t\t\t\t\t\t<div class=\"elementor-inner\">\n\t\t\t\t<div class=\"elementor-section-wrap\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-23dd217a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"23dd217a\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7ac5906\" data-id=\"7ac5906\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-508a0a44 de_scroll_animation_no elementor-widget elementor-widget-text-editor\" data-id=\"508a0a44\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<p>In the rapidly evolving world of pharmaceuticals, advancements in science and technology are continually reshaping the landscape of healthcare. One of the hottest topics of the last year is <strong>Advanced therapy medicinal products (ATMPs)<\/strong>, more specifically <strong>Cell &amp; Gene Therapy Products<\/strong>. These medicines for human use are based on cells, tissues, and genes.\u00a0 The number of cell &amp; gene <strong>products<\/strong> has <strong>increased rapidly<\/strong> in recent years. Many Pharma companies and businesses are faced with <strong>new challenges<\/strong> in their <strong>development<\/strong> and <strong>production<\/strong>.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-41aac954 de_scroll_animation_no elementor-widget elementor-widget-heading\" data-id=\"41aac954\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-large\">Expert-Led Trainings from Industry Leaders<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e1d5424 de_scroll_animation_no elementor-widget elementor-widget-text-editor\" data-id=\"3e1d5424\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<div class=\"fl-module fl-module-rich-text fl-node-5dd7cec867c3e\" data-node=\"5dd7cec867c3e\"><div class=\"fl-module-content fl-node-content\"><div class=\"fl-rich-text\"><p><br \/>We have been organizing several trainings tackling these issues to help you stay ahead in the dynamic Pharma industry.<\/p><p>The pathways to meeting CMC requirements are not as clearly defined. <strong>Novel approaches<\/strong> must be taken to ensure the product&#8217;s identity, strength, quality, purity, or potency. The <a href=\"https:\/\/fleming.events\/cell-gene-therapy-products-cmc-quality-requirements\/\"><strong>Cell &amp; Gene Therapy Products \u2013 CMC &amp; Quality Requirements<\/strong> <strong>training<\/strong><\/a>\u00a0provides a practical &amp; in-depth understanding of <strong>CMC &amp; quality requirements<\/strong> and brings <strong>clarifications<\/strong> on global regulation, requirements, compliance &amp; quality concerns.<\/p><\/div><\/div><\/div>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18a6268a de_scroll_animation_no elementor-widget elementor-widget-heading\" data-id=\"18a6268a\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-medium\">Cutting-Edge Topics Covered:<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3545dffc de_scroll_animation_no elementor-widget elementor-widget-text-editor\" data-id=\"3545dffc\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<div class=\"fl-module fl-module-rich-text fl-node-5dd7cec86858b\" data-node=\"5dd7cec86858b\"><div class=\"fl-module-content fl-node-content\"><div class=\"fl-rich-text\"><ul><li>The ATMP regulatory framework<\/li><li>Quality raw materials &amp; starting materials criteria<\/li><li>Process development &amp; manufacturing strategy<\/li><li>Process validation requirements<\/li><li>Method validation\/qualification strategies<\/li><li>Release specifications for ATMPs<\/li><li>Analytical characterization &amp; comparability<\/li><li>Data requirements for manufacture and control<\/li><li>Gene therapy product class specificities<\/li><li>Manufacturing process changes\/ Change control<\/li><\/ul><p><br \/>Enrich your expertise and empower your career by joining us on <strong>19 \u2013 21 September 2023<\/strong> in Vienna, Austria. This training is also available as an <strong>Online Live Stream<\/strong> | 9:00 CEST \u2013 15:00 CEST.<\/p><\/div><p>If your business needs to gain a comprehensive overview of the <strong>stability<\/strong> and <strong>shelf-life<\/strong> regulatory landscape and in-depth insights into cell and gene therapy products, the <a href=\"https:\/\/fleming.events\/stability-and-shelf-life-of-cell\/\"><strong>Stability &amp; Shelf Life of Cell &amp; Gene Therapy Products training<\/strong><\/a>\u00a0is the right fit for you.<\/p><\/div><\/div>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7f97f34 de_scroll_animation_no elementor-widget elementor-widget-heading\" data-id=\"7f97f34\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-medium\">Practical Knowledge and Hands-On Experience:<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-270653db de_scroll_animation_no elementor-widget elementor-widget-text-editor\" data-id=\"270653db\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<div class=\"fl-module fl-module-rich-text fl-node-5dd7cec8683a3\" data-node=\"5dd7cec8683a3\"><div class=\"fl-module-content fl-node-content\"><div class=\"fl-rich-text\"><ul><li>Guidance and regulation for the stability of cell and gene therapies\/ ATMPs<\/li><li>Limitations of accelerated and stress stability assessment<\/li><li>Instabilities by chemical, physical, and microbiological factors<\/li><li>Analytical methodology for stability assessment<\/li><li>The role of excipients in the stability of ATMPs<\/li><li>Transport and shipping impact on stability and shelf-life<\/li><li>Importance of in-use stability studies<\/li><\/ul><p><br \/>With the increasing complexity of today\u2019s therapeutics like Biologics, Biopharmaceuticals, Biosimilars &amp; ATMPs, unique issues have emerged especially in <strong>managing immunogenicity<\/strong> in clinical practice and during drug development. The <a href=\"https:\/\/fleming.events\/immunogenicity-of-biologics-biopharmaceuticals-and-atmps\/\"><strong>Immunogenicity of Biologics, Biopharmaceuticals &amp; ATMPs course<\/strong><\/a> brings a practical &amp; in-depth understanding of immunogenicity in pre-clinical and clinical development and brings clarifications on regulation, requirements, and quality concerns.<\/p><\/div><\/div><\/div>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-15f1dfdf de_scroll_animation_no elementor-widget elementor-widget-heading\" data-id=\"15f1dfdf\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-medium\">Expert-Led Training from Industry Leaders:<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1e34e5ba de_scroll_animation_no elementor-widget elementor-widget-text-editor\" data-id=\"1e34e5ba\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\">\n\t\t\t\t<ul><li>Guidelines, regulatory &amp; quality requirements for immunogenicity<\/li><li>Immerging into the field of immunology &amp; immune reactions<\/li><li>Different factors which may impact immunogenicity<\/li><li>Analytical development \u2013 screening, confirmation &amp; neutralization assays<\/li><li>Characterization and monitoring of ADAs with appropriate analytical tools<\/li><li>Study design &amp; bioanalytical methods as characterization tools<\/li><li>Immunogenicity risk assessment, mitigation &amp; risk minimization<\/li><li>Clinical development \u2013 pitfalls &amp; challenges, strategies to avoid ADA formation<\/li><li>Clinical synopsis with special emphasis on immunogenicity<\/li><li>Case studies on mAbs, ATMPs &amp; Biosimilars<\/li><\/ul><p><br \/>Let&#8217;s unleash <strong>the full potential<\/strong> of <strong>cell and gene therapies<\/strong> and create a world where diseases are no longer insurmountable barriers to human well-being. We will be happy to meet you at one of our trainings.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t","protected":false},"featured_media":28328,"template":"","class_list":["post-28322","articles","type-articles","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Future of Healthcare: Cell &amp; Gene Therapy | Fleming<\/title>\n<meta name=\"description\" content=\"Explore the rise of Cell &amp; Gene Therapy Products with Fleming. 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