{"id":6387,"date":"2021-05-11T15:34:47","date_gmt":"2021-05-11T15:34:47","guid":{"rendered":"http:\/\/www.caltagmedsystems.co.uk\/information\/?p=6387"},"modified":"2024-06-11T15:27:01","modified_gmt":"2024-06-11T15:27:01","slug":"a-seamless-transition-from-lab-to-clinical-trials","status":"publish","type":"post","link":"https:\/\/www.caltagmedsystems.co.uk\/information\/a-seamless-transition-from-lab-to-clinical-trials\/","title":{"rendered":"A seamless transition from LAB to CLINICAL TRIALS"},"content":{"rendered":"<div class=\"article article-2 article-inverse\">\n<div class=\"text\">\n<h2><a href=\"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-content\/uploads\/From-lab-to-clinical-trials-for-newsletter.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-6405 size-full\" src=\"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-content\/uploads\/From-lab-to-clinical-trials-for-newsletter.jpg\" alt=\"\" width=\"1128\" height=\"398\" srcset=\"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-content\/uploads\/From-lab-to-clinical-trials-for-newsletter.jpg 1128w, https:\/\/www.caltagmedsystems.co.uk\/information\/wp-content\/uploads\/From-lab-to-clinical-trials-for-newsletter-300x106.jpg 300w, https:\/\/www.caltagmedsystems.co.uk\/information\/wp-content\/uploads\/From-lab-to-clinical-trials-for-newsletter-1024x361.jpg 1024w, https:\/\/www.caltagmedsystems.co.uk\/information\/wp-content\/uploads\/From-lab-to-clinical-trials-for-newsletter-768x271.jpg 768w\" sizes=\"auto, (max-width: 1128px) 100vw, 1128px\" \/><\/a><\/h2>\n<h2>CELLnTEC\u2019s Higher Certified (HC) products<\/h2>\n<p>Higher Certified (HC) culture media by CELLnTEC are used in translational bench-to-bedside research projects. They enable a seamless transition from the development of cell-based therapies into clinical trials.<\/p>\n<p>HC culture media are manufactured using upgraded ingredients and processes and are successfully being used in a range of Phase I and II clinical trials. These media are ideally suited for use during early stages like product development, protocol validation, and characterization of the cell-based product before entering clinical trials. Utilization of HC media for the early phases ensures:<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>All processes and products are finalized using the identical medium formulation that will be used during the clinical trials<\/li>\n<li>Sources of variability are eliminated<\/li>\n<li>Re-validation of protocols following a change in culture medium ingredients is not required<\/li>\n<li>All data submitted for regulatory approval are obtained using the identical products and processes that will be used clinically<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><a href=\"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-content\/uploads\/HC-products.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-6404 size-large\" src=\"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-content\/uploads\/HC-products-1024x463.jpg\" alt=\"\" width=\"750\" height=\"339\" srcset=\"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-content\/uploads\/HC-products-1024x463.jpg 1024w, https:\/\/www.caltagmedsystems.co.uk\/information\/wp-content\/uploads\/HC-products-300x136.jpg 300w, https:\/\/www.caltagmedsystems.co.uk\/information\/wp-content\/uploads\/HC-products-768x348.jpg 768w, https:\/\/www.caltagmedsystems.co.uk\/information\/wp-content\/uploads\/HC-products.jpg 1445w\" sizes=\"auto, (max-width: 750px) 100vw, 750px\" \/><\/a><\/p>\n<h2>Highlights of HC media<\/h2>\n<\/div>\n<\/div>\n<div class=\"text\">\n<p>Higher Certified (HC) culture media differ from CELLnTEC\u2019s standard research-grade media in the following ways, to meet progressing user needs with respect to the following criteria:<\/p>\n\n<table id=\"tablepress-214\" class=\"tablepress tablepress-id-214\">\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-1\">\n\t<td class=\"column-1\">COMPONENTS<\/td><td class=\"column-2\">Clinically compatible, well documented, tight tolerances.<\/td>\n<\/tr>\n<tr class=\"row-2\">\n\t<td class=\"column-1\">MANUFACTURING<\/td><td class=\"column-2\">Tight documentation, dedicated equipment, additional process certification.<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">QC PROCESS<\/td><td class=\"column-2\">Additional Quality Control testing steps for all HC media.<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">DOCUMENTATION<\/td><td class=\"column-2\">Extended information regarding component origin, manufacturing processes, chemical composition.<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">CONSISTENCY<\/td><td class=\"column-2\">Product formulation will remain consistent. No changes will be made without prior notification to the end user.<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-1\">SUPPORT<\/td><td class=\"column-2\">Additional range of services, including custom product documentation, advanced technical &amp; scientific support, support with regulatory processes, lot reservation.<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td class=\"column-1\">SERUM FREE<\/td><td class=\"column-2\">HC media are chemically defined and serum-free *.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n<p><strong>*\u00a0The Higher Certified (HC) versions are supplied without serum supplementation for those products that do require serum in their standard research versions.<\/strong><br \/>\n<strong>This enables the end-user to supplement with serum validated to deliver the desired cell behaviour and known to meet the necessary regulatory requirements.<\/strong><\/p>\n<h2>CELLnTEC\u2019s HC media portfolio<\/h2>\n\n<table id=\"tablepress-215\" class=\"tablepress tablepress-id-215\">\n<thead>\n<tr class=\"row-1\">\n\t<th class=\"column-1\">CATALOG NUMBER<\/th><th class=\"column-2\">HC PRODUCT NAME<\/th><th class=\"column-3\">APPLICATION<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\"><a href=\"https:\/\/www.caltagmedsystems.co.uk\/pricing_ordering\/search_results.php?searchwords=CnT-PR-HC\">CnT-PR-HC<\/a><\/td><td class=\"column-2\">\tCnT-Prime Epithelial Proliferation Medium, Higher Certified<\/td><td class=\"column-3\">Isolation &amp; Expansion<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\"><a href=\"https:\/\/www.caltagmedsystems.co.uk\/pricing_ordering\/search_results.php?searchtype=all&amp;searchwords=CnT-07-HC\">CnT-07-HC<\/a><\/td><td class=\"column-2\">CnT-07 Epithelial Proliferation Medium, Higher Certified<\/td><td class=\"column-3\">Isolation &amp; Expansion<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\"><a href=\"https:\/\/www.caltagmedsystems.co.uk\/pricing_ordering\/search_results.php?searchtype=all&amp;searchwords=CnT-30-HC\">CnT-30-HC<\/a><\/td><td class=\"column-2\">CnT-30 iPSC Epithelial Differentiation Medium, Higher Certified<\/td><td class=\"column-3\">Differentiation<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\"><a href=\"https:\/\/www.caltagmedsystems.co.uk\/pricing_ordering\/search_results.php?searchtype=all&amp;searchwords=CnT-40-HC\">CnT-40-HC<\/a><\/td><td class=\"column-2\">CnT-40 Melanocyte Proliferation Medium w\/o Serum, Higher Certified<\/td><td class=\"column-3\">Isolation &amp; Expansion<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-1\"><a href=\"https:\/\/www.caltagmedsystems.co.uk\/pricing_ordering\/search_results.php?searchtype=all&amp;searchwords=CnT-PR-ECM-HC\">CnT-PR-ECM-HC<\/a><\/td><td class=\"column-2\">CnT-Prime Fibroblast ECM Medium, Higher Certified<\/td><td class=\"column-3\">Differentiation<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td class=\"column-1\"><a href=\"https:\/\/www.caltagmedsystems.co.uk\/pricing_ordering\/search_results.php?searchtype=all&amp;searchwords=CnT-ENDO-HC\">CnT-ENDO-HC<\/a><\/td><td class=\"column-2\">CnT-ENDO Endothelial Proliferation Medium w\/o Serum, Higher Certified<\/td><td class=\"column-3\">Isolation &amp; Expansion<\/td>\n<\/tr>\n<tr class=\"row-8\">\n\t<td class=\"column-1\"><a href=\"https:\/\/www.caltagmedsystems.co.uk\/pricing_ordering\/search_results.php?searchtype=all&amp;searchwords=CnT-PR-F-HC\">CnT-PR-F-HC<\/a><\/td><td class=\"column-2\">CnT-Prime Fibroblast Proliferation Medium w\/o Serum, Higher Certified<\/td><td class=\"column-3\">Isolation &amp; Expansion<\/td>\n<\/tr>\n<tr class=\"row-9\">\n\t<td class=\"column-1\"><a href=\"https:\/\/www.caltagmedsystems.co.uk\/pricing_ordering\/search_results.php?searchtype=all&amp;searchwords=CnT-PR-KM-HC\">CnT-PR-KM-HC<\/a><\/td><td class=\"column-2\">CnT-Prime Keratinocyte\/Melanocyte Co-Culture Medium, Higher Certified<\/td><td class=\"column-3\">Co-Culture<\/td>\n<\/tr>\n<tr class=\"row-10\">\n\t<td class=\"column-1\"><a href=\"https:\/\/www.caltagmedsystems.co.uk\/pricing_ordering\/search_results.php?searchtype=all&amp;searchwords=+CnT-ISO-50-HC\"> CnT-ISO-50-HC<\/a><\/td><td class=\"column-2\">CnT-IsoBoost, Isolation Boosting Supplement, Higher Certified<\/td><td class=\"column-3\">\tIsolation<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n<p>For more information and quotes contact techsupport@caltagmedsystems.co.uk<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>CELLnTEC\u2019s Higher Certified (HC) products Higher Certified (HC) culture media by CELLnTEC are used in translational bench-to-bedside research projects. They enable a seamless transition from the development of cell-based therapies into clinical trials. HC culture media are manufactured using upgraded<\/p>\n","protected":false},"author":13,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[743],"class_list":["post-6387","post","type-post","status-publish","format-standard","hentry","category-general-information","tag-cellntec"],"_links":{"self":[{"href":"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-json\/wp\/v2\/posts\/6387","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-json\/wp\/v2\/comments?post=6387"}],"version-history":[{"count":13,"href":"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-json\/wp\/v2\/posts\/6387\/revisions"}],"predecessor-version":[{"id":6410,"href":"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-json\/wp\/v2\/posts\/6387\/revisions\/6410"}],"wp:attachment":[{"href":"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-json\/wp\/v2\/media?parent=6387"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-json\/wp\/v2\/categories?post=6387"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.caltagmedsystems.co.uk\/information\/wp-json\/wp\/v2\/tags?post=6387"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}