{"id":2797,"date":"2021-11-04T16:16:57","date_gmt":"2021-11-04T16:16:57","guid":{"rendered":"https:\/\/www.almacgroup.com\/diagnostics\/?page_id=2797"},"modified":"2025-02-21T11:21:12","modified_gmt":"2025-02-21T11:21:12","slug":"cdx-manufacturing","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/diagnostics\/clinical-trial-solutions\/cdx-manufacturing\/","title":{"rendered":"CDx Manufacturing"},"content":{"rendered":"\n<p>Almac Diagnostics Services\u2019 Manufacturing Team has experience in the manufacture of <strong>ssPMA lab developed tests<\/strong> and <strong>IVD kits<\/strong>. The team regularly engage with the <strong>FDA<\/strong> to support pre-submissions, conduct process validation studies, and prepare manufacturing processes for <strong>PMA submissions<\/strong>. In addition, the team also provide support to obtain <strong>IDE approvals<\/strong> and are instrumental in supporting <strong>CE-marking of Clinical Trial Assays<\/strong>.<\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\" id=\"h-almac-cdx-manufacturing-capabilities\"><strong>Almac CDx Manufacturing Capabilities<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"537\" height=\"482\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/image-red.png\" alt=\"\" class=\"wp-image-2798 lazyload\" data-srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/image-red.png 537w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/image-red-300x269.png 300w\" data-sizes=\"(max-width: 537px) 100vw, 537px\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 537px; --smush-placeholder-aspect-ratio: 537\/482;\" \/><noscript><img decoding=\"async\" width=\"537\" height=\"482\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/image-red.png\" alt=\"\" class=\"wp-image-2798\" srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/image-red.png 537w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/image-red-300x269.png 300w\" sizes=\"(max-width: 537px) 100vw, 537px\" \/><\/noscript><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\" id=\"h-packaging-and-design\"><strong>Packaging and Design<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Bespoke packaging &amp; label design service managed by a specialist team<\/li>\n\n\n\n<li>Labels design to comply with 21CFR 801\/809 and ISO15223<\/li>\n\n\n\n<li>Label material validation<\/li>\n\n\n\n<li>Technical consultation for component selection<\/li>\n\n\n\n<li>Inventory and temperature-controlled solutions for stock<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\" id=\"h-reagent-preparation\"><strong>Reagent Preparation<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Dedicated suite for the preparation of reagents and control samples<\/li>\n\n\n\n<li>Environmentally monitored facilities<\/li>\n\n\n\n<li>Robust QC procedures<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\" id=\"h-quality-control\"><strong>Quality Control<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Development and validation of QC test methods<\/li>\n\n\n\n<li>Validation of the Manufacturing Process<\/li>\n\n\n\n<li>Dedicated equipment lines<\/li>\n\n\n\n<li>Sampling and component testing<\/li>\n\n\n\n<li>Manufacturing process surveillance<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\" id=\"h-kit-production\"><strong>Kit Production<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Set up and assembly of dedicated production lines for a range of IVD kits and batch sizes<\/li>\n\n\n\n<li>Inventory management system for stock monitoring<\/li>\n\n\n\n<li>Temperature controlled facilities and warehouse<\/li>\n\n\n\n<li>Controlled production processes and robust staff training<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\" id=\"h-logistics-and-distribution\"><strong>Logistics and Distribution<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Dedicated logistics team to provide solutions for IVD kit distribution&nbsp;<\/li>\n\n\n\n<li>Approved couriers and worldwide delivery capabilities<\/li>\n\n\n\n<li>Bespoke distribution strategy per product<\/li>\n\n\n\n<li>Partners with global distributors<\/li>\n\n\n\n<li>Cold chain specialists<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\" id=\"h-regulatory-compliance\"><strong>Regulatory Compliance<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>GMP compliant and ISO13485 accredited facility<\/li>\n\n\n\n<li>Independent quality and regulatory personnel<\/li>\n\n\n\n<li>Facilitation of customer \/ regulatory audits<\/li>\n\n\n\n<li>Regulatory compliant labelling<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Almac Diagnostics Services\u2019 Manufacturing Team has experience in the manufacture of ssPMA lab developed tests and IVD kits. The team regularly engage with the FDA to support pre-submissions, conduct process validation studies, and prepare manufacturing processes for PMA submissions. In addition, the team also provide support to obtain IDE approvals and are instrumental in supporting [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":8,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-2797","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.3.1 (Yoast SEO v26.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CDx Manufacturing - Diagnostic Services<\/title>\n<meta name=\"description\" content=\"Streamline your clinical trials with Almac&#039;s CDx Manufacturing services. Benefit from our expertise in companion diagnostic development and manufacturing\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/clinical-trial-solutions\/cdx-manufacturing\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CDx Manufacturing\" \/>\n<meta property=\"og:description\" content=\"Streamline your clinical trials with Almac&#039;s CDx Manufacturing services. 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