{"id":14657,"date":"2020-12-02T14:40:18","date_gmt":"2020-12-02T06:40:18","guid":{"rendered":"https:\/\/www.cmp-micro.com\/ch\/?p=14657"},"modified":"2024-07-12T11:13:22","modified_gmt":"2024-07-12T03:13:22","slug":"20201202lonza","status":"publish","type":"post","link":"https:\/\/www.cmp-micro.com\/ch\/20201202lonza\/","title":{"rendered":"\u7d30\u80de\u548c\u57fa\u56e0\u6cbb\u7642\u7522\u54c1\u7684\u5167\u6bd2\u7d20\u6aa2\u6e2c"},"content":{"rendered":"<p><strong>\u7d30\u80de\u548c\u57fa\u56e0\u6cbb\u7642\u7522\u54c1\u7684\u5167\u6bd2\u7d20\u6aa2\u6e2c<\/strong><\/p>\n<p><strong>Endotoxin Testing for Cell and Gene Therapy Products<\/strong><\/p>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\"size-medium wp-image-14656\" src=\"https:\/\/www.cmp-micro.com\/ch\/wp-content\/uploads\/Engineered-skin-substitute-300x225.jpg\" alt=\"\" width=\"300\" height=\"225\" srcset=\"https:\/\/www.cmp-micro.com\/ch\/wp-content\/uploads\/Engineered-skin-substitute-300x225.jpg 300w, https:\/\/www.cmp-micro.com\/ch\/wp-content\/uploads\/Engineered-skin-substitute-768x576.jpg 768w, https:\/\/www.cmp-micro.com\/ch\/wp-content\/uploads\/Engineered-skin-substitute.jpg 1024w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>\u7d30\u80de\u548c\u57fa\u56e0\u7642\u6cd5\u70ba\u71b1\u9580\u8a71\u984c\uff0c\u4f46\u60a8\u662f\u5426\u4e86\u89e3\u9019\u4e9b\u7522\u54c1\u7684\u5167\u6bd2\u7d20\u6aa2\u6e2c\u8981\u6c42\uff1f\u4ee5\u53ca\u60a8\u7684\u5ba2\u6236\u662f\u5426\u610f\u8b58\u5230\u9019\u4e9b\uff1f<\/p>\n<p>&nbsp;<\/p>\n<p><strong>ATMP <\/strong><strong>\u88fd\u9020\u5546\u61c9\u9032\u884c\u5167\u6bd2\u7d20\u6aa2\u6e2c<\/strong><\/p>\n<p>\u7d30\u80de\u548c\u57fa\u56e0\u6cbb\u7642 (<a href=\"https:\/\/bioscience.lonza.com\/cell-and-gene-therapy\">Cell and gene therapy<\/a>)\u00a0\u7522\u54c1\uff0c\u4e5f\u7a31\u70ba\u201c\u65b0\u8208\u91ab\u7642\u7522\u54c1\u201d\uff08Advanced-Therapy Medicinal Products, ATMPs\uff09\uff0c\u63d0\u4f9b\u4e86\u6cbb\u7642\u75be\u75c5\u7684\u65b0\u65b9\u6cd5\uff0c\u4e26\u70ba\u5168\u7403\u60a3\u8005\u5e36\u4f86\u4e86\u5e0c\u671b\u3002\u70ba\u4e86\u78ba\u4fdd\u9019\u4e9b\u60a3\u8005\u53d7\u5230\u4fdd\u8b77\uff0c\u5167\u6bd2\u7d20\u6aa2\u6e2c\u662f\u9019\u4e9b\u7522\u54c1\u5b89\u5168\u6027\u6aa2\u6e2c\u7684\u4e00\u90e8\u5206\u3002\u5982\u679c\u60a8\u662f\u4f86\u81ea\u5b78\u8853\u6216\u7814\u7a76\u80cc\u666f\u7684ATMP\u88fd\u9020\u5546\uff0c\u60a8\u53ef\u80fd\u4e0d\u719f\u6089\u5167\u6bd2\u7d20\u6aa2\u6e2c\u8981\u6c42\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u91dd\u5c0dATMP\u7684\u76f8\u95dc\u898f\u7bc4\u5747\u6307\u51fa\u5167\u6bd2\u7d20\u6aa2\u6e2c\u4e4b\u91cd\u8981\u6027<\/strong><\/p>\n<p>\u5df2\u6709\u8a31\u591a\u76e3\u7ba1\u6a5f\u69cb\u63d0\u51faATMP\u7684\u76f8\u95dc\u6307\u5357\uff0c\u5305\u542b\uff1a<\/p>\n<ul>\n<li>\u300a\u6b50\u6d32\u85e5\u5178\u300b\uff08EP\uff09\u63d0\u51fa\u6709\u95dcATMP\u539f\u6599\uff08\u7b2c2.12\u7ae0\uff09\u548c\u57fa\u56e0\u8f49\u79fb\u91ab\u85e5\u7522\u54c1\uff08\u7b2c5.14\u7ae0\uff09\u7684\u898f\u7bc4\u3002<\/li>\n<li>\u6b50\u6d32\u91ab\u7642\u6a5f\u69cb (EMA) \u63d0\u51fa\u201c\u4eba\u9ad4\u7d30\u80de\u7684\u91ab\u7642\u7522\u54c1\u6307\u5357 (Guideline on human cell-based medicinal products)\u201d\u3002<\/li>\n<li>EMA\u8349\u6848\u63d0\u51fa\u201c\u81e8\u5e8a\u8a66\u9a57\u7814\u7a76\u4e2d\u7684\u65b0\u8208\u91ab\u7642\u7522\u54c1\u7684\u975e\u81e8\u5e8a\u548c\u81e8\u5e8a\u8981\u6c42 (Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials)\u201d\u3002<\/li>\n<li>\u7f8e\u570b\u98df\u85e5\u7f72 (FDA) \u63d0\u51fa\u201c\u4eba\u985e\u57fa\u56e0\u7642\u6cd5\u7814\u7a76\u6027\u65b0\u85e5\u61c9\u7528\u7684\u5316\u5b78\u3001\u88fd\u9020\u548c\u63a7\u5236\u8cc7\u8a0a\u2013\u5de5\u696d\u6307\u5357 (Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) \u2013 Guidance for Industry\uff09\u201d\u3002<\/li>\n<\/ul>\n<p>\u4ee5\u4e0a\u9019\u4e9b\u76e3\u7ba1\u6587\u4ef6\u5747\u6307\u51fa\u5167\u6bd2\u7d20\u6aa2\u6e2c\u7684\u91cd\u8981\u6027\u3002\u6709\u95dc\u57f7\u884c\u5167\u6bd2\u7d20\u6aa2\u6e2c\u7684\u8a73\u7d30\u8cc7\u8a0a\uff08\u4f8b\u5982\uff0c\u9700\u8981\u9032\u884c\u54ea\u4e9b\u9a57\u8b49\uff0c\u6216\u5fc5\u9808\u4f7f\u7528\u54ea\u4e9b\u5c0d\u7167\u7b49\uff09\uff0c\u5247\u9700\u53c3\u7167\u201c\u7d30\u83cc\u5167\u6bd2\u7d20\u6aa2\u6e2c\u201d\u7ae0\u7bc0\uff08EP\u7ae0\u7bc02.6.14\u548cUSP &lt; 85&gt;\uff09\u3002\u4e5f\u61c9\u53c3\u8003EP\u7b2c5.1.10\u7ae0\u548cUSP &lt;1085&gt;\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u61c9\u91dd\u5c0dATMP\u751f\u7522\u904e\u7a0b\u9032\u884c\u5167\u6bd2\u7d20\u6aa2\u6e2c<\/strong><\/p>\n<p>ATMP\u88fd\u9020\u5546\u901a\u5e38\u77e5\u6089\u6700\u7d42\u7522\u54c1\u6709\u5f37\u5236\u898f\u7bc4\u7684\u6aa2\u6e2c\u8981\u6c42\uff0c\u6210\u54c1\u5728\u4ea4\u4ed8\u7d66\u60a3\u8005\u4e4b\u524d\u5fc5\u9808\u7b26\u5408\u5167\u6bd2\u7d20\u6aa2\u6e2c\u9a57\u6536\u6a19\u6e96\uff0c\u901a\u5e38\u5fc5\u9808\u8b49\u660e \u2264 5 EU \/ kg\u75c5\u4eba\u9ad4\u91cd\uff0c\u800c\u5c0d\u65bc\u810a\u9ad3\u9798\u5167\u6ce8\u5c04\u898f\u5b9a\u66f4\u70ba\u56b4\u683c\uff0c\u61c9 \u2264 0.2 EU \/ kg\u75c5\u4eba\u9ad4\u91cd\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u76e3\u7ba1\u6a5f\u69cb\u660e\u78ba\u898f\u7bc4\uff0c\u61c9\u5728\u7d30\u80de\u548c\u57fa\u56e0\u7642\u6cd5\u7522\u54c1\u7684\u751f\u7522\u904e\u7a0b\u4e2d\u9032\u884c\u984d\u5916\u7684\u6aa2\u6e2c\u3002\u751f\u7522\u904e\u7a0b\u5305\u542b\u539f\u6599RNA\u548cDNA\u8f09\u9ad4(Vectors)\u3001\u8cea\u9ad4 (Plasmids) \u6216\u4eba\u5de5\u67d3\u8272\u9ad4DNA (Artificial chromosome DNA) \u7b49\u7b49\uff0c\u4ee5\u53ca\u751f\u7522\u904e\u7a0b\u4e2d\u6240\u4f7f\u7528\u4e4b\u7528\u5177\u3001\u8017\u6750\u90fd\u61c9\u7b26\u5408\u4f4e\u5167\u6bd2\u7d20\u542b\u91cf\uff0c\u4ee5\u78ba\u4fdd\u88fd\u9020\u51fa\u5408\u4e4e\u898f\u7bc4\u7684\u6700\u7d42\u7522\u54c1\u3002<\/p>\n<p>\u76ee\u524dATMP\u91dd\u5c0d\u5167\u6bd2\u7d20\u6aa2\u6e2c\u4e3b\u8981\u8a0e\u8ad6\u5169\u500b\u7279\u5b9a\u4e3b\u984c\u3002\u9996\u5148\uff0c\u9808\u4f7f\u7528\u7d93\u8b49\u660e\u9069\u5408\u5167\u6bd2\u7d20\u6aa2\u6e2c\u7684\u8017\u6750\u7528\u54c1\uff0c\u5176\u5167\u6bd2\u7d20\u542b\u91cf\u5fc5\u9808\u4f4e\u65bc\u5075\u6e2c\u6975\u9650\uff0c\u5c24\u5176\u61c9\u6ce8\u610f\u6a19\u793a\u201c\u7121\u71b1\u539f\u201d\u6216\u201c\u7121\u5167\u6bd2\u7d20\u201d\u7684\u7269\u54c1\u53ef\u80fd\u4e26\u975e\u4f4e\u65bc\u5075\u6e2c\u6975\u9650\u3002\u5176\u6b21\uff0c\u9700\u8981\u9a57\u8b49\u6a23\u672c\u5132\u5b58\u689d\u4ef6\uff0c\u8b49\u660e\u78ba\u5be6\u53ef\u4ee5\u5728\u9078\u5b9a\u7684\u689d\u4ef6\uff08\u5132\u5b58\u6642\u9593\u3001\u6eab\u5ea6\u548c\u5bb9\u5668\uff09\u4e0b\u5132\u5b58\u6a23\u54c1\uff0c\u800c\u4e0d\u6703\u5f71\u97ff\u5167\u6bd2\u7d20\u7684\u542b\u91cf\u3002\u5426\u5247\uff0c\u53ef\u80fd\u9020\u6210\u5047\u9670\u6027\u6216\u4f4e\u5167\u6bd2\u7d20\u7d50\u679c\uff0c\u9032\u800c\u5f71\u97ff\u60a3\u8005\u5b89\u5168\u3002<\/p>\n<p>\u5982\u679c\u60a8\u5c0d\u7d30\u80de\u6216\u57fa\u56e0\u6cbb\u7642\u7522\u54c1\u7684\u5167\u6bd2\u7d20\u6aa2\u6e2c\u6709\u4efb\u4f55\u7591\u554f\uff0c\u8acb\u96a8\u6642\u8207Lonza\u53f0\u7063\u552f\u4e00\u4ee3\u7406\u5546-\u555f\u65b0\u751f\u6280 \u806f\u7e6b\uff0c\u6211\u5011\u5f88\u9ad8\u8208\u8207\u60a8\u8a0e\u8ad6\uff01<\/p>\n<p>&nbsp;<\/p>\n<p>\u95dc\u9375\u5b57\uff1aLonza\u3001Lonza\u4ee3\u7406\u5546\u3001\u5167\u6bd2\u7d20\u3001Endotoxin\u3001\u5167\u6bd2\u7d20\u6aa2\u6e2c\u3001Cell Therapy\u3001\u7d30\u80de\u6cbb\u7642\u3001\u57fa\u56e0\u6cbb\u7642\u3001ATMP\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u8cc7\u6599\u4f86\u6e90\uff1a<a href=\"https:\/\/bioscience.lonza.com\/lonza_bs\/TW\/en\/bioscience-blog\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/bioscience.lonza.com\/lonza_bs\/TW\/en\/bioscience-blog<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7d30\u80de\u548c\u57fa\u56e0\u6cbb\u7642\u7522\u54c1\u7684\u5167\u6bd2\u7d20\u6aa2\u6e2c Endotoxin Testing for Cell and Gene The &#8230; <a class=\"more-link\" href=\"https:\/\/www.cmp-micro.com\/ch\/20201202lonza\/\">Continue reading<\/a><\/p>\n","protected":false},"author":5,"featured_media":14656,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_angie_page":false,"page_builder":"","footnotes":""},"categories":[44,590],"tags":[453,450,449,414,448,418,415,452,451],"class_list":{"0":"post-14657","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","6":"hentry","7":"category-hot-news","8":"category-cell-related","9":"tag-atmp","10":"tag-cell-therapy","11":"tag-endotoxin","12":"tag-lonza","14":"tag-418","15":"tag-415","16":"tag-452","17":"tag-451"},"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 4.9.8 - aioseo.com -->\n\t<meta name=\"description\" content=\"\u7d30\u80de\u548c\u57fa\u56e0\u6cbb\u7642\u7522\u54c1\u7684\u5167\u6bd2\u7d20\u6aa2\u6e2c Endotoxin Testing for Cell and Gene The\" \/>\n\t<meta name=\"robots\" content=\"max-image-preview:large\" \/>\n\t<meta name=\"author\" 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