{"id":2623,"date":"2023-03-20T13:46:39","date_gmt":"2023-03-20T05:46:39","guid":{"rendered":"https:\/\/www.cellauto.com\/cellauto\/?p=2623"},"modified":"2023-03-20T13:50:54","modified_gmt":"2023-03-20T05:50:54","slug":"%e8%a7%a3%e8%af%bb-fda%e8%8d%af%e5%93%81%e5%ae%a1%e8%af%84%e5%92%8c%e7%a0%94%e7%a9%b6%e4%b8%ad%e5%bf%83%e5%8f%91%e5%b8%83%e3%80%8a%e8%8d%af%e5%93%81%e7%94%9f%e4%ba%a7%e4%b8%ad%e7%9a%84%e4%ba%ba","status":"publish","type":"post","link":"https:\/\/www.cellauto.com\/cellauto\/2023\/03\/20\/2623\/","title":{"rendered":"\u89e3\u8bfb | FDA\u836f\u54c1\u5ba1\u8bc4\u548c\u7814\u7a76\u4e2d\u5fc3\u53d1\u5e03\u300a\u836f\u54c1\u751f\u4ea7\u4e2d\u7684\u4eba\u5de5\u667a\u80fd\u300b\u8ba8\u8bba\u7a3f"},"content":{"rendered":"\n<p>2023\u5e743\u67082\u65e5\uff0cFDA\u836f\u54c1\u5ba1\u8bc4\u548c\u7814\u7a76\u4e2d\u5fc3\u53d1\u5e03\u4e86\u300aArtificial Intelligence in Drug Manufacturing\u300b\u8ba8\u8bba\u6587\u4ef6\uff0c\u4f9b\u516c\u4f17\u57282023\u5e745\u67081\u65e5\u524d\u63d0\u51fa\u610f\u89c1\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" loading=\"lazy\" width=\"793\" height=\"1024\" src=\"https:\/\/www.cellauto.com\/cellauto\/wp-content\/uploads\/2023\/03\/\u5fae\u4fe1\u56fe\u7247_20230320133419-793x1024.png\" alt=\"\" class=\"wp-image-2624\" srcset=\"https:\/\/www.cellauto.com\/cellauto\/wp-content\/uploads\/2023\/03\/\u5fae\u4fe1\u56fe\u7247_20230320133419-793x1024.png 793w, https:\/\/www.cellauto.com\/cellauto\/wp-content\/uploads\/2023\/03\/\u5fae\u4fe1\u56fe\u7247_20230320133419-232x300.png 232w, https:\/\/www.cellauto.com\/cellauto\/wp-content\/uploads\/2023\/03\/\u5fae\u4fe1\u56fe\u7247_20230320133419-768x992.png 768w, https:\/\/www.cellauto.com\/cellauto\/wp-content\/uploads\/2023\/03\/\u5fae\u4fe1\u56fe\u7247_20230320133419-113x146.png 113w, https:\/\/www.cellauto.com\/cellauto\/wp-content\/uploads\/2023\/03\/\u5fae\u4fe1\u56fe\u7247_20230320133419-39x50.png 39w, https:\/\/www.cellauto.com\/cellauto\/wp-content\/uploads\/2023\/03\/\u5fae\u4fe1\u56fe\u7247_20230320133419-58x75.png 58w, https:\/\/www.cellauto.com\/cellauto\/wp-content\/uploads\/2023\/03\/\u5fae\u4fe1\u56fe\u7247_20230320133419.png 932w\" sizes=\"(max-width: 793px) 100vw, 793px\" \/><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>FRAME\u4f18\u5148\u8003\u8651\u7684\u56db\u79cd\u6280\u672f<\/strong><\/p>\n\n\n\n<p>\u5148\u8fdb\u7684\u751f\u4ea7\u6280\u672f\u6709\u53ef\u80fd\u63d0\u9ad8\u751f\u4ea7\u8fc7\u7a0b\u548c\u4f9b\u5e94\u94fe\u7684\u53ef\u9760\u6027\u548c\u7a33\u5065\u6027\uff0c\u5e76\u589e\u52a0\u7f8e\u56fd\u516c\u4f17\u53ca\u65f6\u83b7\u5f97\u4f18\u8d28\u836f\u54c1\u7684\u673a\u4f1a\u3002\u836f\u54c1\u5ba1\u8bc4\u548c\u7814\u7a76\u4e2d\u5fc3 (CDER) \u5efa\u7acb\u4e86\u5148\u8fdb\u751f\u4ea7\u8bc4\u4f30\u76d1\u7ba1\u6846\u67b6 (Regulatory Advanced Manufacturing Evaluation\uff0cFRAME) \u8ba1\u5212\uff0c\u4ee5\u652f\u6301\u91c7\u7528\u53ef\u4ee5\u4e3a\u60a3\u8005\u5e26\u6765\u76ca\u5904\u7684\u5148\u8fdb\u751f\u4ea7\u6280\u672f\u3002<\/p>\n\n\n\n<p>\u7f8e\u56fd\u56fd\u5bb6\u79d1\u5b66\u9662\u3001\u5de5\u7a0b\u9662\u548c\u533b\u5b66\u9662 (NASEM) \u53d1\u5e03\u4e86\u4e00\u4efd\u62a5\u544a\uff0c\u786e\u5b9aCDER\u53ef\u80fd\u9047\u5230\u7684\u5177\u6709\u63a8\u8fdb\u5236\u836f\u751f\u4ea7\u6f5c\u529b\u7684\u521b\u65b0\u3002\u6839\u636e\u8fd9\u4efd\u62a5\u544a\u4ee5\u53ca\u901a\u8fc7\u65b0\u5174\u6280\u672f\u8ba1\u5212\u4e0e\u5229\u76ca\u76f8\u5173\u8005\u7684\u63a5\u89e6\uff0cFRAME\u8ba1\u5212\u4f18\u5148\u8003\u8651\u56db\u79cd\u6280\u672f\uff1a<\/p>\n\n\n\n<p><strong>\u7aef\u5230\u7aef\u8fde\u7eed\u751f\u4ea7<\/strong>(End-to-End Continuous Manufacturing, E2E CM)\uff1a\u4e00\u4e2a\u5b8c\u5168\u96c6\u6210\u7684\u8fc7\u7a0b\uff0c\u539f\u6750\u6599\u4e0d\u65ad\u88ab\u8f93\u5165\u548c\u8f6c\u5316\uff0c\u836f\u54c1\u6210\u54c1\u4e0d\u65ad\u88ab\u751f\u4ea7\u51fa\u6765\u3002<\/p>\n\n\n\n<p><strong>\u6df1\u5733\u8d5b\u52a8\u667a\u9020\u79d1\u6280\u6709\u9650\u516c\u53f8\uff08\u540e\u7b80\u79f0\u8d5b\u52a8\u667a\u9020\uff09\u81ea\u4e3b\u7814\u53d1\u7684CELLAUTO Matrix Platform\u8d5b\u52a8\u5168\u81ea\u52a8\u7ec6\u80de\u667a\u9020\u7cfb\u7edf\uff0c\u4ee5\u751f\u4ea7\u7269\u6599\u81ea\u52a8\u5206\u914d\u3001\u4f20\u8f93\u4e3a\u5165\u53e3\uff0c\u5168\u6d41\u7a0b\u5c01\u95ed\u751f\u4ea7\uff0c\u4ee5\u6210\u54c1\u7ec6\u80de\u5236\u5242\u5206\u88c5\u4e3a\u51fa\u53e3\uff0c\u5b9e\u73b0\u4e86\u7aef\u5230\u7aef\u7684\u8fde\u7eed\u751f\u4ea7\u3002<\/strong><\/p>\n\n\n\n<p><strong>\u5206\u5e03\u5f0f\u751f\u4ea7<\/strong>&nbsp;(Distributed Manufacturing\uff0cDM)\uff1a\u4e00\u4e2a\u5206\u6563\u7684\u751f\u4ea7\u5e73\u53f0\uff0c\u5176\u751f\u4ea7\u5355\u5143\u53ef\u4ee5\u90e8\u7f72\u5230\u591a\u4e2a\u4f4d\u7f6e\u3002<\/p>\n\n\n\n<p><strong>CELLAUTO Matrix Platform\u8d5b\u52a8\u5168\u81ea\u52a8\u7ec6\u80de\u667a\u9020\u7cfb\u7edf\u901a\u8fc7\u53ef\u652f\u6491\u7684\u529f\u80fd\u6027\u5e73\u53f0\uff0c\u5b9e\u73b0\u5206\u5e03\u5f0f\u751f\u4ea7\u3002\u5168\u6d41\u7a0b\u81ea\u52a8\u5b8c\u6210\u7ec6\u80de\u6d17\u6da4\u3001\u7ec6\u80de\u914d\u5236\u3001 \u57f9\u517b\u6269\u589e\u3001\u7ec6\u80de\u6536\u83b7\u3001\u7ec6\u80de\u6d53\u7f29\u3001\u5236\u5242\u5206\u88c5\u3002<\/strong><\/p>\n\n\n\n<p><strong>\u5373\u65f6\u62a4\u7406\u751f\u4ea7<\/strong>(Point-of-Care Manufacturing, POC)\uff1a\u4e00\u4e2aDM\u5e73\u53f0\uff0c\u5176\u751f\u4ea7\u5355\u5143\u9760\u8fd1\u60a3\u8005\u62a4\u7406\uff0c\u4f8b\u5982\uff0c\u5728\u533b\u7597\u673a\u6784\u3002<\/p>\n\n\n\n<p><strong>\u8d5b\u52a8\u667a\u9020\u7075\u6d3b\u7684\u7ec6\u80de\u751f\u4ea7\u5e73\u53f0\uff0c\u65e2\u6709\u652f\u6301I\/II\/III\u4e34\u5e8a\u8bd5\u9a8c\u3001\u4ea7\u54c1\u4e0a\u5e02\u540e\u5927\u89c4\u6a21\u751f\u4ea7\u7684\u5f02\u4f53\u95f4\u5145\u8d28\u5e72\u7ec6\u80de\u7684\u5927\u6279\u91cf\u751f\u4ea7\u5e73\u53f0\u53ca\u901a\u7528\u578b\u514d\u75ab\u7ec6\u80de\u7684\u5927\u6279\u91cf\u751f\u4ea7\u5e73\u53f0\uff0c\u53c8\u6709\u9002\u7528\u573a\u666f\u4e3a\u7ec6\u80de\u50a8\u5b58\u3001\u533b\u9662\u201c\u5e8a\u8fb9\u5f0f\u201d\u751f\u4ea7\u3001\u5b9e\u9a8c\u5ba4\u3001I\u4e34\u5e8a\u8bd5\u9a8c\u3001CAR-T\u3001IPS\u751f\u4ea7\u7684\u81ea\u4f53\u53ca\u5c0f\u6279\u91cf\u751f\u4ea7\u5e73\u53f0\u3002<\/strong><\/p>\n\n\n\n<p><strong>\u4eba\u5de5\u667a\u80fd\uff1a<\/strong>\u53ef\u4ee5\u611f\u77e5\u73af\u5883\u3001\u89e3\u91ca\u6570\u636e\u548c\u51b3\u5b9a\u884c\u52a8\u7684\u8f6f\u4ef6\u548c\u786c\u4ef6\u7cfb\u7edf\u3002<\/p>\n\n\n\n<p><strong>\u8d5b\u52a8\u667a\u9020\u975e\u4fb5\u5165\u6027\u7ec6\u80de\u8d28\u91cf\u5728\u7ebf\u76d1\u6d4b\u548c\u5206\u6790\u5e73\u53f0\uff0c\u901a\u8fc7\u6d77\u91cf\u7ec6\u80de\u7279\u5f81\u3001\u7ec6\u80de\u529f\u80fd\u548c\u4e34\u5e8a\u6cbb\u7597\u6548\u679c\u6570\u636e\uff0c\u8fdb\u884c\u7ec6\u80de\u8d28\u91cf\u56de\u6eaf\u5206\u6790\uff0c\u9a71\u52a8\u4e34\u5e8a\u65b9\u6848\u4f18\u5316\u3001\u751f\u4ea7\u5de5\u827a\u4f18\u5316\u3002<\/strong><\/p>\n\n\n\n<p><strong>GMP\u751f\u4ea7\u81ea\u52a8\u5316\u8f6f\u4ef6\uff0c\u901a\u8fc7\u4eba\u673a\u6599\u6cd5\u73af\u7684\u6570\u5b57\u5316\u7ba1\u7406\uff0c\u5b9e\u73b0\u7269\u6599\u8017\u6750\u7528\u91cf\u9884\u6d4b\u53ca\u89c4\u5212\uff0c\u751f\u4ea7\u667a\u80fd\u5907\u6599\uff0c\u5de5\u4e1a\u5927\u8111\u6307\u6325\u81ea\u52a8\u5316\u5236\u5907\u4e0e\u8d28\u68c0\uff0c\u5de5\u4e1a\u5927\u8111\u8f85\u52a9\u8d28\u91cf\u4e8b\u4ef6\u9884\u8b66\u8bca\u65ad\uff0c\u667a\u80fd\u4eea\u5668\u8bbe\u5907\u4e92\u8054\u4e92\u901a\u7b49\u3002<\/strong><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><strong><a href=\"https:\/\/mp.weixin.qq.com\/s\/wfpQnRpxQzl1epliPCFONA\">\u70b9\u51fb\u67e5\u770b\u8ba8\u8bba\u7a3f\u539f\u6587<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>2023\u5e743\u67082\u65e5\uff0cFDA\u836f\u54c1\u5ba1\u8bc4\u548c\u7814\u7a76\u4e2d\u5fc3\u53d1\u5e03\u4e86\u300aArtifi<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":1,"featured_media":2625,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/posts\/2623"}],"collection":[{"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/comments?post=2623"}],"version-history":[{"count":3,"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/posts\/2623\/revisions"}],"predecessor-version":[{"id":2628,"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/posts\/2623\/revisions\/2628"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/media\/2625"}],"wp:attachment":[{"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/media?parent=2623"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/categories?post=2623"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/tags?post=2623"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}