{"id":11826,"date":"2024-11-08T13:39:25","date_gmt":"2024-11-08T05:39:25","guid":{"rendered":"https:\/\/flcube.com\/?p=11826"},"modified":"2024-11-08T13:39:28","modified_gmt":"2024-11-08T05:39:28","slug":"cde-releases-technical-guidelines-for-pilot-registration-and-phased-manufacturing-of-adcs","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=11826","title":{"rendered":"CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs"},"content":{"rendered":"\n

The Center for Drug Evaluation (CDE) has issued the \u201cTechnical Requirements for Pilot Registration and Application of Phased Manufacturing of Antibody Drug Conjugates (ADC).\u201d This document complements the \u201cPilot Work Plan for Phased Manufacturing of Biological Products\u201d released last month and aims to guide the pilot work of phased manufacturing for ADCs, including small molecules, stock solutions, or formulations.<\/p>\n\n\n\n

ADC Production and Quality Control<\/strong>
The document highlights that ADCs are produced by conjugating small molecules with conventional biological products, which introduces unique challenges in terms of structure, production, and other aspects. Due to the high volume of materials used in the ADC production process, there is a risk of introducing exogenous factors or toxic chemical materials, which necessitates a comprehensive quality control strategy based on risk assessment.<\/p>\n\n\n\n

Quality Attributes and Lifecycle Research<\/strong>
The quality attributes of intermediate products, such as small molecules and raw materials, in the upstream production processes can impact the key quality attributes of subsequent processes or ADC raw materials\/formulations. Therefore, it is essential to conduct research and verification across the entire production chain and lifecycle for phased manufacturing of ADC products.<\/p>\n\n\n\n

Risks in ADC Phased Manufacturing<\/strong>
Compared to non-phased manufacturing, the phased manufacturing of ADCs may introduce new risks during the transportation and handover process of intermediate products. The applicant\/marketing authorization holder (MAH) should focus on quality control, acceptance standards, and change research of intermediate products during transportation. Close attention must be paid to quality changes that may affect safety and effectiveness, such as protein polymer levels and payload detachment levels.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The Center for Drug Evaluation (CDE) has issued the \u201cTechnical Requirements for Pilot Registration and…<\/p>\n","protected":false},"author":1,"featured_media":11827,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11,4],"tags":[35],"class_list":["post-11826","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","category-policy-regulatory","tag-adc-xdc"],"yoast_head":"\nCDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Center for Drug Evaluation (CDE) has issued the \u201cTechnical Requirements for Pilot Registration and Application of Phased Manufacturing of Antibody Drug Conjugates (ADC).\u201d This document complements the \u201cPilot Work Plan for Phased Manufacturing of Biological Products\u201d released last month and aims to guide the pilot work of phased manufacturing for ADCs, including small molecules, stock solutions, or formulations.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=11826\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=11826\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2024-11-08T05:39:25+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-08T05:39:28+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/44947794f370599e32b50f59acd5e11f.png\" \/>\n\t<meta property=\"og:image:width\" content=\"817\" \/>\n\t<meta property=\"og:image:height\" content=\"492\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11826#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11826\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs\",\"datePublished\":\"2024-11-08T05:39:25+00:00\",\"dateModified\":\"2024-11-08T05:39:28+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11826\"},\"wordCount\":273,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11826#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/44947794f370599e32b50f59acd5e11f.png\",\"keywords\":[\"ADC \\\/ XDC\"],\"articleSection\":[\"Company\",\"Drug\",\"Policy \\\/ Regulatory\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=11826#respond\"]}],\"copyrightYear\":\"2024\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11826\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=11826\",\"name\":\"CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11826#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11826#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/44947794f370599e32b50f59acd5e11f.png\",\"datePublished\":\"2024-11-08T05:39:25+00:00\",\"dateModified\":\"2024-11-08T05:39:28+00:00\",\"description\":\"The Center for Drug Evaluation (CDE) has issued the \u201cTechnical Requirements for Pilot Registration and Application of Phased Manufacturing of Antibody Drug Conjugates (ADC).\u201d This document complements the \u201cPilot Work Plan for Phased Manufacturing of Biological Products\u201d released last month and aims to guide the pilot work of phased manufacturing for ADCs, including small molecules, stock solutions, or formulations.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11826#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=11826\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11826#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/44947794f370599e32b50f59acd5e11f.png\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/44947794f370599e32b50f59acd5e11f.png\",\"width\":817,\"height\":492,\"caption\":\"CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=11826#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs - Insight, China's Pharmaceutical Industry","description":"The Center for Drug Evaluation (CDE) has issued the \u201cTechnical Requirements for Pilot Registration and Application of Phased Manufacturing of Antibody Drug Conjugates (ADC).\u201d This document complements the \u201cPilot Work Plan for Phased Manufacturing of Biological Products\u201d released last month and aims to guide the pilot work of phased manufacturing for ADCs, including small molecules, stock solutions, or formulations.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=11826","og_locale":"en_US","og_type":"article","og_title":"CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs","og_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","og_url":"https:\/\/flcube.com\/?p=11826","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2024-11-08T05:39:25+00:00","article_modified_time":"2024-11-08T05:39:28+00:00","og_image":[{"width":817,"height":492,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/44947794f370599e32b50f59acd5e11f.png","type":"image\/png"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=11826#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=11826"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs","datePublished":"2024-11-08T05:39:25+00:00","dateModified":"2024-11-08T05:39:28+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=11826"},"wordCount":273,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=11826#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/44947794f370599e32b50f59acd5e11f.png","keywords":["ADC \/ XDC"],"articleSection":["Company","Drug","Policy \/ Regulatory"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=11826#respond"]}],"copyrightYear":"2024","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=11826","url":"https:\/\/flcube.com\/?p=11826","name":"CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=11826#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=11826#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/44947794f370599e32b50f59acd5e11f.png","datePublished":"2024-11-08T05:39:25+00:00","dateModified":"2024-11-08T05:39:28+00:00","description":"The Center for Drug Evaluation (CDE) has issued the \u201cTechnical Requirements for Pilot Registration and Application of Phased Manufacturing of Antibody Drug Conjugates (ADC).\u201d This document complements the \u201cPilot Work Plan for Phased Manufacturing of Biological Products\u201d released last month and aims to guide the pilot work of phased manufacturing for ADCs, including small molecules, stock solutions, or formulations.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=11826#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=11826"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=11826#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/44947794f370599e32b50f59acd5e11f.png","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/44947794f370599e32b50f59acd5e11f.png","width":817,"height":492,"caption":"CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=11826#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/44947794f370599e32b50f59acd5e11f.png","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/11826","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=11826"}],"version-history":[{"count":2,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/11826\/revisions"}],"predecessor-version":[{"id":11883,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/11826\/revisions\/11883"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/11827"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=11826"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=11826"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=11826"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}