{"id":1485,"date":"2022-11-18T10:36:00","date_gmt":"2022-11-18T02:36:00","guid":{"rendered":"https:\/\/vcro.online\/wordpress4\/?p=1485"},"modified":"2024-08-29T15:02:47","modified_gmt":"2024-08-29T07:02:47","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-i","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/tw\/?p=1485","title":{"rendered":"FDA\u5c0d\u65bcCAR T\u7d30\u80de\u6cbb\u7642\u7522\u54c1\u5728\u65e9\u671fIND\u6642\u4e4bCMC\u5be9\u67e5\u8003\u91cf-I"},"content":{"rendered":"\n<p>\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for the Development of Chimeric Antigen Receptor [CAR] T Cell Products: Draft Guidance for Industry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\u3002\u8a72\u6307\u5f15\u5ef6\u7e8c2020\u5e74\u767c\u5e03\u7684\u4eba\u985e\u57fa\u56e0\u6cbb\u7642IND\u7533\u8acb\u7522\u696d\u6307\u5f15 2\uff0c\u4e26\u9032\u4e00\u6b65\u91dd\u5c0dCAR T\u7d30\u80de\u7522\u54c1\u63d0\u51faFDA\u5728\u7522\u54c1\u767c\u5c55\u3001CMC\u3001\u81e8\u5e8a\u524d\u3001\u8207\u81e8\u5e8a\u8a66\u9a57\u8a2d\u8a08\u4e0a\u7684\u5efa\u8b70\u8207\u8003\u91cf\u3002\u9664\u4e86CAR T\u7d30\u80de\u7522\u54c1\u5916\uff0c\u8a31\u591a\u672c\u6307\u5f15\u4e4b\u5efa\u8b70\u8207\u8003\u91cf\u4e5f\u540c\u6a23\u9069\u7528\u5728\u5176\u4ed6\u57fa\u56e0\u6539\u9020\u514d\u75ab\u7d30\u80de\u7522\u54c1\uff08\u5982CAR NK cells\u6216TCR-modified T cells\uff09\u3002<\/p>\n\n\n\n<p>FDA\u5728CMC\u4e0a\u7684\u8003\u91cf\u7684\u91cd\u9ede\u4ecd\u6700\u4e3b\u8981\u570d\u7e5e\u5728\u7522\u54c1\u7684\u5b89\u5168\u6027\u8207\u88fd\u7a0b\u63a7\u5236\uff0c\u9664\u4e86\u4ee5\u4e0b\u5728\u672c\u6307\u5f15\u8349\u6848\u4e2d\u63d0\u5230\u4e4b\u5efa\u8b70\uff0c\u4e5f\u53ef\u53c3\u80032020\u5e74\u7684CMC\u7522\u696d\u6307\u5f15 2\u4e2d\u5c0d\u4eba\u985e\u57fa\u56e0\u6cbb\u7642\u7522\u54c1\u4e4b\u4e00\u822c\u6027\u5efa\u8b70\u3002<\/p>\n\n\n\n<p>\u95dc\u65bc\u8f09\u9ad4\u8207\u7d30\u80de\u8d77\u59cb\u7269\uff0cFDA\u5c0d\u65bc\u65e9\u671fIND\u4e4bCMC\u5be9\u67e5\u8003\u91cf\u91cd\u9ede\u5982\u4e0b\uff1a<\/p>\n\n\n\n<p>1. \u57fa\u56e0\u8f09\u9ad4\uff08Vector\uff09<\/p>\n\n\n\n<p>\u5efa\u8b70\u63d0\u4f9b\u8f09\u9ad4\u4e4b\u7d50\u69cb\u3001\u751f\u7269\u7279\u6027\u3001\u88fd\u9020\u904e\u7a0b\u8207\u6e2c\u8a66\u3001\u8207\u8f09\u9ad4\u5b89\u5b9a\u6027\u7b49\u8cc7\u8a0a\u3002\u8f09\u9ad4\u7684\u6279\u6b21\u653e\u884c\u6aa2\u6e2c\u5fc5\u9808\u5305\u542b\u5b89\u5168\u6027\u3001\u9451\u5225\u3001\u7d14\u5ea6\u3001\u8207\u6548\u50f9\u7b49\u6e2c\u5b9a\u3002\u6b64\u5916\uff0c\u8f09\u9ad4\u6fc3\u5ea6\u7684\u6e2c\u5b9a\u4e5f\u5efa\u8b70\u5305\u542b\u5728\u6279\u6b21\u653e\u884c\u6aa2\u6e2c\u4e2d\u3002\u8f09\u9ad4\u7684\u5b89\u5168\u6027\u61c9\u5305\u542b\u5fae\u751f\u7269\u8207\u5916\u4f86\u75c5\u539f\u6e2c\u8a66\u3002<\/p>\n\n\n\n<p>2. \u7d30\u80de\u8d77\u59cb\u7269\uff08Cellular starting material\uff09<\/p>\n\n\n\n<p>\u7121\u8ad6\u662f\u81ea\u9ad4\u6216\u7570\u9ad4\u7d30\u80de\uff0c\u5efa\u8b70\u63d0\u4f9b\u5305\u542b\u7d30\u80de\u6536\u96c6\u3001\u767d\u8840\u7403\u5206\u96e2\u8853\uff08leukapheresis\uff09\u3001\u76f8\u95dc\u4e4b\u7d30\u80de\u8655\u7406\u8207\u51b7\u51cd\u4fdd\u5b58\u65b9\u5f0f\u3001\u904b\u9001\u3001\u904e\u7a0b\u7ba1\u63a7\u8207\u5141\u6536\u6a19\u6e96\u7b49\u8cc7\u8a0a\u3002\u5efa\u8b70\u5728\u9032\u884cCAR T\u7d30\u80de\u88fd\u9020\u524d\uff0c\u5c0d\u767d\u8840\u7403\u5206\u96e2\u8853\u5f97\u5230\u4e4b\u8d77\u59cb\u7269\u9032\u884c\u5fae\u751f\u7269\u6c59\u67d3\u7684\u6aa2\u6e2c\uff08\u6216\u662f\u4fdd\u7559\u6a23\u54c1\uff0c\u4ee5\u9632\u6700\u7d42\u7522\u54c1\u7121\u83cc\u8a66\u9a57\u5931\u6557\u6642\u53ef\u9032\u884c\u4e8b\u5f8c\u5206\u6790\uff09\u3002<\/p>\n\n\n\n<p>\u81ea\u9ad4\u7d30\u80de\u8d77\u59cb\u7269\u4e0d\u9700\u6350\u8d08\u8005\u5408\u9069\u6027\u4e4b\u7be9\u9078\u6216\u6e2c\u8a66 [21 CFR 1271.90(a)(1)]\uff1b\u7570\u9ad4\u7d30\u80de\u8d77\u59cb\u7269\u5247\u9700\u4f9d\u716721 CFR Part 1271, Subpart C\u4e4b\u8981\u6c42\uff0c\u8a02\u5b9a\u6350\u8d08\u8005\u5408\u9069\u6027\u689d\u4ef6\u8207\u7be9\u9078\u548c\u6e2c\u8a66\u4e4b\u65b9\u6cd5\u3002<\/p>\n\n\n\n<p>\u5ef6\u4f38\u95b1\u8b80\uff1a<\/p>\n\n\n\n<p>1. U.S. FDA. Consideration for the Development of Chimeric Antigen Receptor [CAR] T Cell Products: Draft Guidance for Industry. March 2022.<\/p>\n\n\n\n<p>2. U.S. FDA. Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry, January 2020.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u570bFDA\u65bc2022\u5e74\u4e09\u6708\u767c\u5e03CAR-T\u7d30\u80de\u7522\u54c1\u7684\u7522\u696d\u6307\u5f15\u8349\u6848\uff08Consideration for the D [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[22,20,21,19],"class_list":["post-1485","post","type-post","status-publish","format-standard","hentry","category-7","tag-vcro","tag-20","tag-21","tag-19"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>FDA\u5c0d\u65bcCAR T\u7d30\u80de\u6cbb\u7642\u7522\u54c1\u5728\u65e9\u671fIND\u6642\u4e4bCMC\u5be9\u67e5\u8003\u91cf-I - VCRO \u81e8\u5e8a<\/title>\r\n<meta name=\"description\" content=\"FDA\u5c0d\u65bcCAR T\u7d30\u80de\u6cbb\u7642\u7522\u54c1\u5728\u65e9\u671fIND\u6642\u4e4bCMC\u5be9\u67e5\u8003\u91cf-I VCRO \u7dad\u5dde\u5feb\u8a0a - 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