{"id":1507,"date":"2023-02-08T11:00:00","date_gmt":"2023-02-08T03:00:00","guid":{"rendered":"https:\/\/vcro.online\/cn\/?p=1507"},"modified":"2024-07-12T13:32:13","modified_gmt":"2024-07-12T05:32:13","slug":"fda%e5%af%b9%e4%ba%8ecar-t%e7%bb%86%e8%83%9e%e6%b2%bb%e7%96%97%e4%ba%a7%e5%93%81%e5%9c%a8%e6%97%a9%e6%9c%9find%e6%97%b6%e4%b9%8bcmc%e5%ae%a1%e6%9f%a5%e8%80%83%e8%99%91-iv","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/cn\/?p=1507","title":{"rendered":"FDA\u5bf9\u4e8eCAR T\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u5728\u65e9\u671fIND\u65f6\u4e4bCMC\u5ba1\u67e5\u8003\u8651-IV"},"content":{"rendered":"\n<p>\u5728\u7f8e\u56fdFDA\u4e8e2022\u5e74\u4e09\u6708\u53d1\u5e03CAR-T\u7ec6\u80de\u4ea7\u54c1\u7684\u4ea7\u4e1a\u6307\u5f15\u8349\u6848\uff08Consideration for the Development of Chimeric Antigen Receptor [CAR] T Cell Products: Draft Guidance for Industry 1\uff09\u4e2d\uff0c\u5173\u4e8e\u7ec6\u80de\u4ea7\u54c1\u5728\u5355\u4e00\u573a\u6240\u6216\u591a\u573a\u6240\u5236\u9020\u7684\u95ee\u9898\uff0cFDA\u7684\u5efa\u8bae\u5982\u4e0b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5355\u4e00\u573a\u6240\u867d\u53ef\u51cf\u5c11\u56e0\u573a\u5730\u8bbe\u65bd\u4e0d\u540c\u5bfc\u81f4\u7684\u4ea7\u54c1\u5dee\u5f02\u6027\uff0c\u4f46\u987b\u8003\u8651\u7684\u662f\u7ec6\u80de\u8d77\u59cb\u7269\u3001\u6700\u7ec8CAR T\u4ea7\u54c1\u3001\u6216\u6d4b\u8bd5\u68c0\u54c1\u5728\u51b7\u51bb\u4fdd\u5b58\u6216\u7269\u6d41\u8fc7\u7a0b\u7684\u95ee\u9898\u3002<\/li>\n\n\n\n<li>\u591a\u573a\u6240\u5236\u9020\u987b\u8003\u8651\u56e0\u573a\u5730\u8bbe\u65bd\u4e0d\u540c\u5bfc\u81f4\u7684\u4ea7\u54c1\u5dee\u5f02\u6027\uff0c\u56e0\u6b64\u5bf9\u4e0d\u540c\u5236\u9020\u573a\u6240\u6240\u4e4b\u4ea7\u54c1\u8fdb\u884c\u6bd4\u8f83\u6027\u8bd5\u9a8c\u662f\u5fc5\u987b\u7684\uff08\u5efa\u8bae\u5148\u6307\u5b9a\u4e00\u4e2a\u53c2\u8003\u5236\u9020\u573a\u6240\uff0c\u5176\u4ed6\u5236\u9020\u5382\u6240\u518d\u548c\u53c2\u8003\u573a\u6240\u6bd4\u8f83\uff09\u3002\u5728IND\u9636\u6bb5\uff0c\u5236\u9020\u5382\u6240\u5fc5\u987b\u7b26\u5408CGMP\u4e4b\u89c4\u8303\uff0c\u53e6\u5916FDA\u4e5f\u5efa\u8bae\u5c3d\u53ef\u80fd\u6240\u6709\u573a\u6240\u4f9d\u5faa\u76f8\u540c\u4e4bSOPs\u3001\u8bad\u7ec3\u3001\u76f8\u5173\u8bd5\u5242\u3001\u4e0e\u5236\u9020\u8bbe\u65bd\uff1b\u82e5\u6709\u4e0d\u540c\uff0c\u5e94\u8bf4\u660e\u4e0d\u540c\u4e4b\u5904\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u591a\u573a\u6240\u5236\u9020\u4e5f\u987b\u8003\u8651\u5404\u573a\u6240\u4f7f\u7528\u7684\u5206\u6790\u65b9\u6cd5\u3002FDA\u5efa\u8bae\u4f7f\u7528\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u8ba1\u5212\uff08assay transfer protocol\uff09\u4ee5\u786e\u4fdd\u975e\u836f\u5178\u5206\u6790\u65b9\u6cd5\u5728\u4e0d\u540c\u573a\u6240\u95f4\u4e4b\u518d\u73b0\u6027\u3002\u5173\u4e8e\u836f\u5178\u5206\u6790\u65b9\u6cd5\uff0c\u867d\u4e0d\u987b\u8bc1\u660e\u573a\u6240\u95f4\u4e4b\u518d\u73b0\u6027\uff0c\u4f46\u4ecd\u5e94\u9a8c\u8bc1\u5404\u573a\u6240\u7686\u53ef\u6267\u884c\u6b32\u4f7f\u7528\u4e4b\u836f\u5178\u5206\u6790\u65b9\u6cd5\u3002<\/p>\n\n\n\n<p>\u5ef6\u4f38\u9605\u8bfb\uff1a<\/p>\n\n\n\n<p>1. 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