{"id":82918,"date":"2022-11-01T08:00:00","date_gmt":"2022-11-01T01:00:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2022110108000082918"},"modified":"2022-11-01T22:12:15","modified_gmt":"2022-11-01T14:12:15","slug":"i-peace%e4%b8%8e%e7%be%8e%e5%9b%bd%e5%8a%a0%e5%b7%9e%e5%86%8d%e7%94%9f%e5%8c%bb%e5%ad%a6%e7%a0%94%e7%a9%b6%e6%89%80cirm%e5%bb%ba%e7%ab%8b%e5%90%88%e4%bd%9c%e4%bc%99%e4%bc%b4%e5%85%b3%e7%b3%bb","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2022110108000082918","title":{"rendered":"I Peace\u4e0e\u7f8e\u56fd\u52a0\u5dde\u518d\u751f\u533b\u5b66\u7814\u7a76\u6240(CIRM)\u5efa\u7acb\u5408\u4f5c\u4f19\u4f34\u5173\u7cfb"},"content":{"rendered":"<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/1213422\/I_Peace_Inc_Logo_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><p><span class=\"legendSpanClass\">\u7f8e\u56fd\u52a0\u5229\u798f\u5c3c\u4e9a\u5dde\u5e15\u6d1b\u963f\u5c14\u6258<\/span><span class=\"legendSpanClass\">2022\u5e7411\u67081\u65e5<\/span> \/\u7f8e\u901a\u793e\/ &#8212; 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21 CFR 210\/211\uff0c\u7f8e\u56fd\u5173\u4e8e\u836f\u54c1\u5236\u9020\uff0c\u52a0\u5de5\uff0c\u5305\u88c5\u6216\u50a8\u5b58\u4ee5\u53ca\u6210\u54c1\u836f\u54c1\u7684\u89c4\u5b9a; 21 CFR 1271\uff0c\u7f8e\u56fd\u4eba\u7c7b\u7ec6\u80de\u548c\u7ec4\u7ec7\u4ea7\u54c1\u6cd5\u89c4\u3002 \u8be5\u8bbe\u65bd\u8fd8\u4e8e2020\u5e74\u83b7\u5f97\u65e5\u672c\u539a\u751f\u52b3\u52a8\u7701\u9881\u53d1\u7684\u751f\u4ea7\u7279\u5b9a\u7ec6\u80de\u4ea7\u54c1\u7684\u8bb8\u53ef\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u56fd\u52a0\u5229\u798f\u5c3c\u4e9a\u5dde\u5e15\u6d1b\u963f\u5c14\u62582022\u5e7411\u67081\u65e5 \/\u7f8e\u901a\u793e\/ &#8212; I Peace (https:\/\/ipeace.com\/zh-hans\/) \u5ba3\u5e03\u5c06\u4e0e\u7f8e\u56fd\u52a0\u5dde\u518d\u751f\u533b\u5b66\u7814\u7a76\u6240(CIRM)\u5408\u4f5c\uff0c\u53c2\u52a0\u5176\u884c\u4e1a\u8d44\u6e90\u5408\u4f5c\u4f19\u4f34\u8ba1\u5212\uff0c\u4e3a\u5411CIRM\u8d44\u52a9\u7684\u5404\u79cd\u7814\u7a76\u9879\u76ee\u63d0\u4f9b\u7b26\u5408\u4f18\u826f\u751f\u4ea7\u89c4\u8303(GMP)\u8981\u6c42\u7684\u8bf1\u5bfc\u6027\u591a\u80fd\u5e72\u7ec6\u80de(iPS\u7ec6\u80de)\u94fa\u8def\u3002\u8fc7\u53bb\u6570\u5e74\uff0cI Peace\u81f4\u529b\u4e3a\u5404\u7c7b\u578b\u7684\u7ec6\u80de\u7597\u6cd5\u5f00\u53d1\u5546\u4ee5\u53ca\u5236\u836f\u516c\u53f8\u63d0\u4f9bGMP-iPS\u7ec6\u80de,\u56e0\u6b64\u6df1\u83b7CIRM\u7684\u80af\u5b9a\u5e76\u4e14\u88ab\u9080\u7ea6\u6210\u4e3a\u5408\u4f5c\u4f19\u4f34\uff0c\u9019\u8db3\u4ee5\u53cd\u6620\u51faI Peace\u7684\u9ad8\u8d28\u91cf\u7ec6\u80de\u4ea7\u54c1\u548c\u914d\u5957\u670d\u52a1\u3002 I Peace\u51ed\u501f\u5176\u4e13\u5229\u6280\u672f\u4ee5\u53ca\u6df1\u539a\u7684iPSC\u4e13\u4e1a\u77e5\u8bc6\uff0c\u63d0\u4f9b\u8d28\u91cf\u4f18\u5f02\u3001\u7279\u5f81\u660e\u786e\u7684iPSC\u4ea7\u54c1\u7ebf\uff0c\u5e76\u4e3aCIRM\u5728\u518d\u751f\u533b\u5b66\u4ea7\u54c1\u5f00\u53d1\u4e0a\u7684\u53d1\u73b0\u63a2\u6c42\u9636\u6bb5\u7814\u7a76\u9879\u76ee\u63d0\u4f9b\u4eceGMP-iPS\u7ec6\u80de\u884d\u751f\u7684\u7814\u7a76\u7ea7iPS\u7ec6\u80de\uff0c\u518d\u8005;I Peace\u5bf9\u4e8eCIRM\u83b7\u5956\u8005\u4e5f\u80fd\u8fdb\u4e00\u6b65\u63d0\u4f9b\u8f6c\u5316\u4e34\u5e8a\u5b9e\u9a8c\u9636\u6bb5\u9879\u76ee\u7684GMP iPS\u7ec6\u80de\u5236\u9020\u670d\u52a1.\u5728\u52a0\u5229\u798f\u5c3c\u4e9a\u5dde55\u4ebf\u7f8e\u5143\u7684\u62e8\u6b3e\u8d44\u52a9\u4e0b\uff0cCIRM\u5df2\u8d44\u52a982\u9879\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5e76\u652f\u6301\u8d85\u8fc7152\u9879\u6b63\u5728\u5b9e\u65bd\u7684\u518d\u751f\u533b\u5b66\u7814\u7a76\uff0c\u8fd9\u4e9b\u9879\u76ee\u6db5\u76d6\u4e86\u4ece\u53d1\u73b0\u5019\u9009\u5230III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5404\u4e2a\u9636\u6bb5\u3002 I Peace\u7ec6\u80de\u5236\u9020\u8bbe\u65bd\u88ab\u8ba4\u8bc1\u4e3a\u7b26\u5408cGMP\u6807\u51c6\uff0c\u5e76\u88ab\u5217\u5165FDA&quot;\u836f\u7269\u673a\u6784\u5f53\u524d\u6ce8\u518c\u7f51\u7ad9&quot;\u3002 \u6839\u636e\u63d0\u4ea4\u7ed9FDA\u7684\u8be6\u7ec6\u4fe1\u606f\uff0c\u8be5\u6ce8\u518c\u627f\u8ba4I Peace\u7684\u7ec6\u80de\u5236\u9020\u8bbe\u65bd\u9002\u5408\u836f\u7269\u5236\u9020\u3002 \u4e34\u5e8a\u7ea7iPSC\u751f\u4ea7\u7684\u5168\u9762\u8be6\u7ec6\u4fe1\u606f\u5df2\u5728FDA\u836f\u7269\u4e3b\u6587\u4ef6\uff08DMF\uff09\u4e2d\u6ce8\u518c\u3002 \u8bbe\u65bd\u6ce8\u518c\u4ee5\u53caDMF\u6ce8\u518c\u548cGMP\u8ba4\u8bc1\u4e3a\u5e0c\u671b\u5728\u7f8e\u56fd\uff0c\u65e5\u672c\u548c\u5176\u4ed6\u5168\u7403\u5e02\u573a\u4f7f\u7528\u6211\u4eec\u7684iPSC\u8fdb\u884c\u4e34\u5e8a\u548c\u5546\u4e1a\u7528\u9014\u7684\u5ba2\u6237\u63d0\u4f9b\u4e86\u5b89\u5fc3\u4fe1\u7528\u7684\u4fdd\u8bc1\u3002 I Peace\u5728FDA\u836f\u7269\u4f01\u4e1a\u5f53\u524d\u6ce8\u518c\u7f51\u7ad9\u4e0a\u7684\u6e05\u5355\u53ef\u4ee5\u5e2e\u52a9\u6211\u4eec\u7684\u5ba2\u6237\u901a\u8fc7\u7b80\u5355\u5730\u53c2\u8003FDA\u673a\u6784\u6807\u8bc6\u7801\uff08FEI\uff09\u6765\u786e\u8ba4\u83b7\u5f97FDA\u6279\u51c6\u7684\u4fe1\u606f\u3002 \u76ee\u524d\u7684\u8bbe\u65bd\u88ab\u7b2c\u4e09\u65b9\u8ba4\u8bc1\u4e3a\u7b26\u5408GMP\u6807\u51c6\uff0c\u76ee\u524d\u7684GMP\u8ba4\u8bc1\u6d89\u53ca\uff1aICH-Q7\uff0c\u4e00\u79cd\u751f\u4ea7\u6d3b\u6027\u836f\u7269\u6210\u5206\u7684\u5168\u7403\u6307\u5357; 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