{"id":9328,"date":"2021-03-02T09:44:21","date_gmt":"2021-03-02T17:44:21","guid":{"rendered":"https:\/\/www.qad.com\/blog\/?p=9328"},"modified":"2021-03-02T09:45:53","modified_gmt":"2021-03-02T17:45:53","slug":"cmos-are-you-ready-for-cgt-manufacturing","status":"publish","type":"post","link":"https:\/\/www.qad.com\/blog\/2021\/03\/cmos-are-you-ready-for-cgt-manufacturing","title":{"rendered":"CMOs: Are You Ready for CGT Manufacturing?"},"content":{"rendered":"<p>[vc_row][vc_column][vc_single_image image=&#8221;9329&#8243; img_size=&#8221;full&#8221;][vc_column_text]<span style=\"font-weight: 400;\">It\u2019s no surprise that demand continues to build and funding continues to flow in for <\/span><a target=\"_blank\" href=\"https:\/\/www.cellandgene.com\/doc\/the-rise-of-gene-cell-therapy-and-the-resulting-need-for-in-house-production-facilities-a-guide-0001\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">production of cell and gene therapies<\/span><\/a><span style=\"font-weight: 400;\"> (CGT). Many new CGT products are game changers &#8212; potential cures for diseases, not just treatments.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Meeting the Demand for CGT Manufacturing<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">With growing demand, there\u2019s a <\/span><span style=\"font-weight: 400;\">need for more suitable CGT manufacturing facilities. But production of cell and gene therapies is complex. It\u2019s costly. The manufacturing process is different from that of traditional small molecule medicines. <\/span><span style=\"font-weight: 400;\">With traditional biologics, approximately 35% of the manufacturing process is outsourced, but w<\/span><span style=\"font-weight: 400;\">ith CGTs, the industry <\/span><a target=\"_blank\" href=\"https:\/\/www.cellandgene.com\/doc\/scaling-cell-and-gene-therapy-manufacturing-operations-0001\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">outsources 65%<\/span><\/a><span style=\"font-weight: 400;\"> or more of their manufacturing processes. <\/span><span style=\"font-weight: 400;\">Big biopharma doesn\u2019t have the production-ready infrastructure in place. <\/span><span style=\"font-weight: 400;\">The biopharmaceutical community needs smaller, more agile CMOs now, more than ever.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Producing cell and gene therapies is a great opportunity for contract manufacturing organizations (CMOs) to grow their businesses while stepping up to support the industry. <\/span><span style=\"font-weight: 400;\">But as of July 2020, only <\/span><a target=\"_blank\" href=\"https:\/\/www.pharmaceutical-technology.com\/comment\/cell-and-gene-therapies-viral-vectors\/?utm_source=Army%20Technology&amp;utm_medium=website&amp;utm_campaign=Must%20Read&amp;utm_content=Image\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">152 CMOs had the capability to produce<\/span><\/a><span style=\"font-weight: 400;\"> cell or gene therapies for global distribution in a market that is <\/span><a target=\"_blank\" href=\"https:\/\/www.businesswire.com\/news\/home\/20210107005499\/en\/Global-Cell-and-Gene-Therapy-Market-Report-2020-Market-to-Recover-and-Grow-at-a-CAGR-of-24.1-in-2023---Forecast-to-2030---ResearchAndMarkets.com\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">expected to <\/span><span style=\"font-weight: 400;\">reach $13.23 billion<\/span><\/a><span style=\"font-weight: 400;\"> in 2023 at a CAGR of 24.10%.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">With the great need to produce <\/span><span style=\"font-weight: 400;\">the biologic compounds that represent the future of medicine, that represent for CMOs, <\/span><span style=\"font-weight: 400;\">perhaps, the business opportunity of a lifetime, why aren\u2019t CMO companies moving faster to fill the need?<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Before they invest time and money in CGT manufacturing, CMOs need to make some foundational decisions that will affect their future efficiency, potential for growth and risk management capabilities. Those decisions can be summed up in three questions:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">How can CMOs manage the fast growth of cell and gene therapeutics without compromising quality?<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">What Critical Quality Attributes (CQAs) should be measured and reported?<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">What manufacturing-at-scale issues need to be addressed to deliver personalized treatments directly to the patient?<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The answers to these questions about barriers to entry will affect how fast CMOs step up to the new CGT manufacturing paradigms. To help, we offer a whitepaper entitled \u201c<\/span><a target=\"_blank\" href=\"https:\/\/www.qad.com\/documents\/white-papers\/cell-and-gene-therapy.pdf\" rel=\"noopener noreferrer\"><b>Cell and Gene Therapy Manufacturing: A Startup Guide for CMOs<\/b><\/a><span style=\"font-weight: 400;\">\u201d that provides guidelines for moving into CGT manufacturing with confidence.\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Building a Strong CGT Manufacturing Strategy<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Building a strong infrastructure is one element of building a strong CGT manufacturing strategy. As a CMO grows and builds a manufacturing base, it\u2019s important to implement an ERP (Enterprise Resource Planning) system. An ERP platform integrates core business processes into a single system so you operate as a connected business. An integrated core establishes a strong foundation so you can accelerate growth and minimize risk.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">But with CGT manufacturing, it\u2019s not just build it once and it\u2019s done. The evolution of CGT manufacturing will continue. Personalized CGT products will require consistent re-engineering of process configurations. The ERP solution you choose should be flexible enough to accommodate almost unlimited changes to both your manufacturing process and supply chain and still maintain your strong integrated core.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">An ERP solution well-suited to <\/span><a target=\"_blank\" href=\"https:\/\/www.qad.com\/documents\/brochures\/qad-contract-mfg-life-sciences-brochure.pdf\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">CMO manufacturing<\/span><\/a><span style=\"font-weight: 400;\"> of CGTs should be in the cloud for flexibility and its vendor should be knowledgeable of regulatory and industry requirements. It\u2019s also important to partner with an ERP supplier who understands the CGT space &#8212; who understands the needs of CMOs because they\u2019ve worked with them for decades.<\/span><\/p>\n<p style=\"text-align: center;\"><span style=\"font-weight: 400;\">&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/span><\/p>\n<p><strong>As you prepare for CGT manufacturing, QAD offers a self-diagnostic tool to help you identify how your organization measures up in terms of a strong and flexible infrastructure<\/strong><span style=\"font-weight: 400;\"><strong>. Try our<\/strong> <\/span><a target=\"_blank\" href=\"https:\/\/www.qad.com\/adaptive-manufacturing-enterprise\/diagnostic\" rel=\"noopener noreferrer\"><b>Adaptive Manufacturing Enterprise Maturity Model Diagnostic<\/b><\/a><span style=\"font-weight: 400;\">.<\/span>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_single_image image=&#8221;9329&#8243; img_size=&#8221;full&#8221;][vc_column_text]It\u2019s no surprise that demand continues to build and funding continues to flow in for production of cell and gene therapies (CGT). Many new CGT products are game changers &#8212; potential cures for diseases, not just treatments. Meeting the Demand for CGT Manufacturing With growing demand, there\u2019s a need for more suitable CGT [&hellip;]<\/p>\n","protected":false},"author":108,"featured_media":9329,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[182,199],"tags":[1421,773,1309,1448,1543,9,436,296,1544,697,1422,511,24,295],"class_list":["post-9328","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-featured","category-manufacturing-trends","tag-adaptable-erp","tag-adaptive-erp","tag-adaptive-manufacturing-enterprise","tag-adaptive-manufacturing-enterprise-diagnostic","tag-biopharmaceutical-cgt-manufacturing","tag-cloud-erp","tag-cloud-erp-manufacturing","tag-cmo","tag-contract-manufacturing-erp","tag-disruption","tag-erp-for-manufacturing","tag-life-sciences-erp","tag-manufacturing","tag-pharma"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CMOs: Are You Ready for CGT Manufacturing? 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