{"id":1475,"date":"2023-02-18T10:34:00","date_gmt":"2023-02-18T02:34:00","guid":{"rendered":"https:\/\/vcro.online\/wordpress4\/?p=1475"},"modified":"2024-08-29T11:41:37","modified_gmt":"2024-08-29T03:41:37","slug":"fda%e5%b0%8d%e6%96%bccar-t%e7%b4%b0%e8%83%9e%e6%b2%bb%e7%99%82%e7%94%a2%e5%93%81%e5%9c%a8%e6%97%a9%e6%9c%9find%e6%99%82%e4%b9%8bcmc%e5%af%a9%e6%9f%a5%e8%80%83%e9%87%8f-iv","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/tw\/?p=1475","title":{"rendered":"FDA\u5c0d\u65bcCAR T\u7d30\u80de\u6cbb\u7642\u7522\u54c1\u5728\u65e9\u671fIND\u6642\u4e4bCMC\u5be9\u67e5\u8003\u91cf-IV"},"content":{"rendered":"\n<p>\u5728\u7f8e\u570bFDA\u65bc2022\u5e74\u4e09\u6708\u767c\u5e03CAR-T\u7d30\u80de\u7522\u54c1\u7684\u7522\u696d\u6307\u5f15\u8349\u6848\uff08Consideration for the Development of Chimeric Antigen Receptor [CAR] T Cell Products: Draft Guidance for Industry 1\uff09\u4e2d\uff0c\u95dc\u65bc\u7d30\u80de\u7522\u54c1\u5728\u55ae\u4e00\u5834\u6240\u6216\u591a\u5834\u6240\u88fd\u9020\u7684\u554f\u984c\uff0cFDA\u7684\u5efa\u8b70\u5982\u4e0b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u55ae\u4e00\u5834\u6240\u96d6\u53ef\u6e1b\u5c11\u56e0\u5834\u5730\u8a2d\u65bd\u4e0d\u540c\u5c0e\u81f4\u7684\u7522\u54c1\u5dee\u7570\u6027\uff0c\u4f46\u9808\u8003\u91cf\u7684\u662f\u7d30\u80de\u8d77\u59cb\u7269\u3001\u6700\u7d42CAR T\u7522\u54c1\u3001\u6216\u6e2c\u8a66\u6aa2\u54c1\u5728\u51b7\u51cd\u4fdd\u5b58\u6216\u7269\u6d41\u904e\u7a0b\u7684\u554f\u984c\u3002<\/li>\n\n\n\n<li>\u591a\u5834\u6240\u88fd\u9020\u9808\u8003\u91cf\u56e0\u5834\u5730\u8a2d\u65bd\u4e0d\u540c\u5c0e\u81f4\u7684\u7522\u54c1\u5dee\u7570\u6027\uff0c\u56e0\u6b64\u5c0d\u4e0d\u540c\u88fd\u9020\u5834\u6240\u6240\u4e4b\u7522\u54c1\u9032\u884c\u6bd4\u8f03\u6027\u8a66\u9a57\u662f\u5fc5\u9808\u7684\uff08\u5efa\u8b70\u5148\u6307\u5b9a\u4e00\u500b\u53c3\u8003\u88fd\u9020\u5834\u6240\uff0c\u5176\u4ed6\u88fd\u9020\u5ee0\u6240\u518d\u548c\u53c3\u8003\u5834\u6240\u6bd4\u8f03\uff09\u3002\u5728IND\u968e\u6bb5\uff0c\u88fd\u9020\u5ee0\u6240\u5fc5\u9808\u7b26\u5408CGMP\u4e4b\u898f\u7bc4\uff0c\u53e6\u5916FDA\u4e5f\u5efa\u8b70\u76e1\u53ef\u80fd\u6240\u6709\u5834\u6240\u4f9d\u5faa\u76f8\u540c\u4e4bSOPs\u3001\u8a13\u7df4\u3001\u76f8\u95dc\u8a66\u5291\u3001\u8207\u88fd\u9020\u8a2d\u65bd\uff1b\u82e5\u6709\u4e0d\u540c\uff0c\u61c9\u8aaa\u660e\u4e0d\u540c\u4e4b\u8655\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u591a\u5834\u6240\u88fd\u9020\u4e5f\u9808\u8003\u91cf\u5404\u5834\u6240\u4f7f\u7528\u7684\u5206\u6790\u65b9\u6cd5\u3002FDA\u5efa\u8b70\u4f7f\u7528\u5206\u6790\u65b9\u6cd5\u8f49\u79fb\u8a08\u5283\uff08assay transfer protocol\uff09\u4ee5\u78ba\u4fdd\u975e\u85e5\u5178\u5206\u6790\u65b9\u6cd5\u5728\u4e0d\u540c\u5834\u6240\u9593\u4e4b\u518d\u73fe\u6027\u3002\u95dc\u65bc\u85e5\u5178\u5206\u6790\u65b9\u6cd5\uff0c\u96d6\u4e0d\u9808\u8b49\u660e\u5834\u6240\u9593\u4e4b\u518d\u73fe\u6027\uff0c\u4f46\u4ecd\u61c9\u9a57\u8b49\u5404\u5834\u6240\u7686\u53ef\u57f7\u884c\u6b32\u4f7f\u7528\u4e4b\u85e5\u5178\u5206\u6790\u65b9\u6cd5\u3002<\/p>\n\n\n\n<p>\u5ef6\u4f38\u95b1\u8b80\uff1a<\/p>\n\n\n\n<p>1. 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