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https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-2--300x54.png 300w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-2--1030x186.png 1030w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-2--768x139.png 768w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-2--1536x278.png 1536w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-2--1500x271.png 1500w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-2--705x127.png 705w\" sizes=\"auto, (max-width: 1782px) 100vw, 1782px\" \/><br \/>\n<strong>\u6ce8\u5c04\u7528\u65e0\u83cc\u5236\u5242\uff1a<\/strong><\/p>\n<p>\u00b7 5\u652f\uff08\u74f6\uff09\u68c0\u67e5\u7684\u4f9b\u8bd5\u54c1\u4e2d\u5982\u68c0\u51fa\u5fae\u7ec6\u53ef\u89c1\u5f02\u7269\uff0c\u6bcf\u652f\uff08\u74f6\uff09\u4e2d\u68c0\u51fa\u5fae\u7ec6\u53ef\u89c1\u5f02\u7269\u7684\u6570\u91cf\u5e94\u7b26\u5408\u4e0b\u8868\u4e2d\u7684\u89c4\u5b9a\uff1b<\/p>\n<p>\u00b7 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https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-3-1500x236.png 1500w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-3-705x111.png 705w\" sizes=\"auto, (max-width: 2480px) 100vw, 2480px\" \/><strong>\u65e0\u83cc\u539f\u6599\u836f\uff1a<\/strong><\/p>\n<p>\u00b7 5\u4efd\u68c0\u67e5\u7684\u4f9b\u8bd5\u54c1\u4e2d\u5982\u68c0\u51fa\u5fae\u7ec6\u53ef\u89c1\u5f02\u7269\uff0c\u6bcf\u4efd\u4f9b\u8bd5\u54c1\u4e2d\u68c0\u51fa\u5fae\u7ec6\u53ef\u89c1\u5f02\u7269\u7684\u6570\u91cf\u5e94\u7b26\u5408\u76f8\u5e94\u6ce8\u5c04\u7528\u65e0\u83cc\u5236\u5242\u7684\u89c4\u5b9a\uff1b<\/p>\n<p>\u00b7 \u5982\u67091\u4efd\u8d85\u51fa\u9650\u5ea6\u89c4\u5b9a\uff0c\u53e6\u53d610\u4efd\u540c\u6cd5\u590d\u8bd5\uff0c\u5747\u5e94\u4e0d\u8d85\u51fa\u9650\u5ea6\u89c4\u5b9a\u3002<\/p>\n<p><strong>3.2\u00a0 \u5e38\u89c1\u7684\u706f\u68c0\u65b9\u5f0f\u6709\u54ea\u4e9b\uff1f<\/strong><\/p>\n<p>\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u5e94\u91c7\u7528\u7ecf\u8fc7\u786e\u8ba4\u7684\u65b9\u6cd5\u5bf9\u6ce8\u5c04\u5242\u8fdb\u884c100%\u706f\u68c0\u5e76\u5254\u9664\u4e0d\u5408\u683c\u54c1\uff0c\u5e76\u5e94\u5728\u6700\u6613\u68c0\u6d4b\u5230\u53ef\u89c1\u5f02\u7269\u7684\u5de5\u5e8f\u8fdb\u884c\u68c0\u67e5\uff0c\u4f8b\u5982\uff1a\u4e00\u822c\u5e94\u5728\u8d34\u6807\u7b7e\u524d\u8fdb\u884c\u53ef\u89c1\u5f02\u7269\u68c0\u67e5\uff0c\u4ee5\u907f\u514d\u6807\u7b7e\u7684\u5f71\u54cd\u3002\u5f53\u524d\uff0c\u5e38\u7528\u7684\u53ef\u89c1\u5f02\u7269\u68c0\u67e5\u65b9\u6cd5\u5305\u62ec\u4eba\u5de5\u706f\u68c0\u3001\u534a\u81ea\u52a8\u5316\u68c0\u67e5\u4e0e\u81ea\u52a8\u5316\u68c0\u67e5\u3002\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b\uff08China Pharmacopeia, ChP\uff09\u4e2d\u6536\u8f7d\u4e86\u706f\u68c0\u6cd5\u4e0e\u5149\u6563\u5c04\u6cd5\uff0c\u5176\u4e2d\u5149\u6563\u5c04\u6cd5\u5c5e\u4e8e\u81ea\u52a8\u5316\u68c0\u67e5\u8303\u7574\uff1b\u6b27\u6d32\u836f\u5178\uff08European Pharmacopoeia, EP\uff09\uff0c\u65e5\u672c\u836f\u5178\uff08Japanese Pharmacopoeia, JP\uff09\u5747\u4ec5\u6536\u8f7d\u4e86\u706f\u68c0\u6cd5\u3002<\/p>\n<p><strong>3.2.1 \u4eba\u5de5\u706f\u68c0<\/strong><\/p>\n<p>\u4eba\u5de5\u706f\u68c0\u662f\u901a\u8fc7<strong>\u4eba\u773c\u89c6\u529b\u76f4\u63a5\u5206\u8fa8\u5f02\u7269<\/strong>\uff0c\u662f\u76ee\u524d\u53ef\u89c1\u5f02\u7269\u68c0\u67e5<strong>\u6700\u5e38\u89c1\u4e5f\u662f\u6700\u4e3b\u8981<\/strong>\u7684\u65b9\u6cd5\uff0c\u5404\u56fd\u836f\u5178\u5747\u6709\u6536\u8f7d\u3002\u4eba\u5de5\u706f\u68c0\u7684\u5173\u952e\u53c2\u6570\u4e3b\u8981\u5305\u62ec\uff1a<\/p>\n<p><strong>\u2460\u80cc\u666f\u548c\u5bf9\u6bd4\uff0c<\/strong>\u91c7\u7528\u9ed1\u8272\u6216\u767d\u8272\u7684\u7eaf\u8272\u80cc\u666f\u677f\u63d0\u4f9b\u5bf9\u6bd4\uff0c\u4ee5\u6700\u5927\u5316\u4ea7\u54c1\u5185\u5bb9\u7269\u7684\u53ef\u89c1\u6027\u3002<\/p>\n<p><strong>\u2461\u5149\u7167\u5ea6\u4e0e\u68c0\u67e5\u65f6\u95f4\uff0c<\/strong>\u9700\u7ed3\u5408\u5305\u88c5\u5bb9\u5668\u989c\u8272\u4e0e\u4ea7\u54c1\u7279\u6027\u7b49\u9009\u62e9\u5408\u9002\u7684\u5149\u7167\u5ea6\uff0c\u5e76\u4fdd\u8bc1\u6bcf\u4e2a\u5bb9\u5668\u90fd\u6709\u8db3\u591f\u7684\u68c0\u67e5\u65f6\u95f4\uff1b<\/p>\n<p><strong>\u2462\u9700\u4ed4\u7ec6\u65cb\u8f6c\u6216\u5012\u7f6e\u5185\u5bb9\u7269\uff0c<\/strong>\u786e\u4fdd\u5bb9\u5668\u548c\u74f6\u585e\u5185\u8868\u9762\u7684\u53ef\u89c1\u5f02\u7269\u5f97\u5230\u5145\u5206\u68c0\u67e5\uff0c\u6eb6\u6db2\u578b\u6ce8\u5c04\u5242\u8fd8\u5e94\u5c3d\u91cf\u907f\u514d\u5f15\u5165\u6c14\u6ce1\uff0c\u4ee5\u51cf\u5c11\u68c0\u6d4b\u8bef\u5dee\u3002<br \/>\n<img loading=\"lazy\" decoding=\"async\" class=\" wp-image-7817 aligncenter\" src=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-4.png\" alt=\"\" width=\"656\" height=\"468\" srcset=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-4.png 824w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-4-300x214.png 300w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-4-768x548.png 768w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-4-260x185.png 260w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-4-705x503.png 705w\" sizes=\"auto, (max-width: 656px) 100vw, 656px\" \/>A.\u5e26\u6709\u906e\u5149\u677f\u7684\u65e5\u5149\u706f\u5149\u6e90\uff08\u5149\u7167\u5ea6\u53ef\u57281000\uff5e4000lx\u8303\u56f4\u5185\u8c03\u8282\uff09\uff1b<\/p>\n<p>B.\u4e0d\u53cd\u5149\u7684\u9ed1\u8272\u80cc\u666f\uff1b<\/p>\n<p>C.\u4e0d\u53cd\u5149\u7684\u767d\u8272\u80cc\u666f\u548c\u5e95\u90e8\uff08\u4f9b\u68c0\u67e5\u6709\u8272\u5f02\u7269\uff09\uff1b<\/p>\n<p>D.\u53cd\u5149\u7684\u767d\u8272\u80cc\u666f\uff08\u6307\u906e\u5149\u677f\u5185\u4fa7\uff09\u3002<\/p>\n<p style=\"text-align: center;\">\u56fe1 \u706f\u68c0\u6cd5\u793a\u610f<\/p>\n<p><strong>3.2.2 \u534a\u81ea\u52a8\u706f\u68c0\u673a<\/strong><\/p>\n<p>\u534a\u81ea\u52a8\u5316\u68c0\u67e5\u6280\u672f\u5c06\u81ea\u52a8\u5316\u5bb9\u5668\u5904\u7406\u6280\u672f\u4e0e\u4eba\u5de5\u706f\u68c0\u7ed3\u5408\uff0c\u5728\u673a\u68b0\u652f\u6301\u4e0b\uff0c\u5bb9\u5668\u53ef\u4ee5\u5728\u68c0\u67e5\u8005\u9762\u524d<strong>\u4ee5\u6052\u5b9a\u901f\u5ea6\u4e0a\u4e0b\u7ffb\u8f6c\u6216\u65cb\u8f6c<\/strong>\uff0c\u505c\u6b62\u540e\u68c0\u67e5\u8005<strong>\u901a\u8fc7\u653e\u5927\u955c\u89c2\u5bdf<\/strong>\u5bb9\u5668\u4e2d\u7684\u53ef\u89c1\u5f02\u7269\uff0c\u673a\u68b0\u6216\u624b\u52a8\u5254\u9664\u4e0d\u5408\u683c\u54c1\u3002\u534a\u81ea\u52a8\u5316\u68c0\u67e5\u6280\u672f\u4e0e\u4eba\u5de5\u706f\u68c0\u5de5\u4f5c\u539f\u7406\u76f8\u540c\uff0c\u5173\u952e\u53c2\u6570\u76f8\u4f3c\uff0c\u4f46\u68c0\u67e5\u901f\u5ea6\u9700\u7ecf\u8fc7\u786e\u8ba4\uff0c\u5de5\u4f5c\u6548\u7387\u660e\u663e\u63d0\u9ad8\u3002<\/p>\n<p><strong>3.2.3 \u5168\u81ea\u52a8\u706f\u68c0\u673a<\/strong><\/p>\n<p>\u81ea\u52a8\u5316\u68c0\u67e5\u6280\u672f\u91c7\u7528\u4e0e\u534a\u81ea\u52a8\u5316\u68c0\u6d4b\u6280\u672f\u76f8\u4f3c\u7684\u81ea\u52a8\u5316\u5bb9\u5668\u5904\u7406\u6280\u672f\uff0c\u68c0\u6d4b\u6280\u672f\u7531\u201c\u4eba\u5de5\u68c0\u67e5\u201d\u53d1\u5c55\u4e3a<strong>\u201c\u81ea\u52a8\u5316\u68c0\u67e5\u201d<\/strong>\u3002\u5e38\u89c1\u7684\u81ea\u52a8\u5316\u68c0\u67e5\u6280\u672f\u4e3b\u8981\u5305\u62ec\u9ad8\u901f\u5de5\u4e1a\u76f8\u673a\u3001\u53ef\u89c1\u5149\u4e8c\u6781\u7ba1\u9635\u5217\u3001\uff38\u2043\u5c04\u7ebf\u3001\u8fd1\u573a\u96f7\u8fbe\u3001\u7d2b\u5916\u548c\u8fd1\u7ea2\u5916\u5149\u8c31\u7b49\uff0c\u901a\u8fc7<strong>\u4e0d\u540c\u6ce2\u957f\u548c\u4f20\u611f\u5668<\/strong>\u68c0\u6d4b\u53ef\u89c1\u5f02\u7269\uff0c\u5e76<strong>\u81ea\u52a8\u5254\u9664<\/strong>\u3002ChP\u4e2d\u7684\u5149\u6563\u5c04\u6cd5\uff08\u7b2c\u4e8c\u6cd5\uff09\u5373\u5229\u7528\u6ce8\u5c04\u5242\u4e2d\u7684\u53ef\u89c1\u5f02\u7269\u4f7f\u5165\u5c04\u5149\u53d1\u751f\u6563\u5c04\u7684\u539f\u7406\uff0c\u901a\u8fc7\u68c0\u6d4b\u5149\u6563\u5c04\u80fd\u91cf\uff0c\u8fbe\u5230\u68c0\u67e5\u6ce8\u5c04\u5242\u4e2d\u53ef\u89c1\u5f02\u7269\u7684\u76ee\u7684\u3002\u4e0e\u4eba\u5de5\u706f\u68c0\u548c\u534a\u81ea\u52a8\u5316\u68c0\u67e5\u6280\u672f\u76f8\u6bd4\uff0c\u81ea\u52a8\u5316\u68c0\u67e5\u6280\u672f\u4e0d\u4ec5\u63d0\u9ad8\u4e86\u5de5\u4f5c\u6548\u7387\uff0c\u964d\u4f4e\u4e86\u68c0\u67e5\u53d8\u5f02\u6027\uff0c<strong>\u8fd8\u63d0\u9ad8\u4e86\u7075\u654f\u5ea6\u548c\u53ef\u9760\u6027<\/strong>\uff0c\u751a\u81f3<strong>\u53ef\u4ee5\u68c0\u6d4b\u5230\u6bd4\u76ee\u68c0\u9608\u503c\u4e0b\u9650\u66f4\u5c0f\u7684\u53ef\u89c1\u5f02\u7269<\/strong>\u3002<\/p>\n<p><strong>3.3\u00a0 \u4eba\u5de5\u706f\u68c0\u7684\u6d41\u7a0b\u548c\u6807\u51c6<\/strong><\/p>\n<p>\u53ef\u89c1\u5f02\u7269\u662f\u6ce8\u5c04\u5242\u4e00\u9879<strong>\u91cd\u8981\u7684\u8d28\u91cf\u63a7\u5236\u6307\u6807<\/strong>\uff0c\u56fd\u5185\u5916\u836f\u54c1\u5ba1\u8bc4\u53ca\u76d1\u7ba1\u673a\u6784\u90fd<strong>\u9ad8\u5ea6\u5173\u6ce8<\/strong>\u6ce8\u5c04\u5242\u4e2d\u53ef\u89c1\u5f02\u7269\u7684\u68c0\u67e5\u548c\u63a7\u5236\u3002\u56fd\u5185\u5916\u836f\u5178\u5747\u89c4\u5b9a\u6ce8\u5c04\u5242\u5e94\u5bf9\u53ef\u89c1\u5f02\u7269\u8fdb\u884c\u68c0\u67e5\uff0c\u5e76\u5236\u5b9a\u4e86\u53ef\u89c1\u5f02\u7269\u68c0\u67e5\u65b9\u6cd5\u901a\u5219\uff0c\u5305\u62ec<strong>\u68c0\u67e5\u65b9\u6cd5\u548c\u7ed3\u679c\u5224\u5b9a\u6807\u51c6<\/strong>\u3002<\/p>\n<p>ChP\u89c4\u5b9a\u6ce8\u5c04\u5242\u4e0d\u5f97\u68c0\u51fa\u660e\u663e\u53ef\u89c1\u5f02\u7269\uff0c\u5bf9\u4e8e\u70b9\u72b6\u7269\u30012 mm\u4ee5\u4e0b\u7684\u77ed\u7ea4\u7ef4\u548c\u5757\u72b6\u7269\u7b49\u5fae\u7ec6\u53ef\u89c1\u5f02\u7269\u4e5f\u6839\u636e<strong>\u4e0d\u540c\u7c7b\u578b\u836f\u7269\u548c\u4e0d\u540c\u7ed9\u836f\u9014\u5f84<\/strong>\u5236\u5b9a\u4e86\u76f8\u5e94\u7684\u53ef\u63a5\u53d7\u6807\u51c6\u3002\u7f8e\u56fd\u836f\u5178\uff08United States Pharmacopeia, USP\uff09\u89c4\u5b9a\u6ce8\u5c04\u5242\u5e94\u57fa\u672c\u4e0d\u542b\u53ef\u89c1\u5f02\u7269\uff0cEP\u548cJP\u5bf9\u6ce8\u5c04\u5242\u4e2d\u53ef\u89c1\u5f02\u7269\u7684\u8981\u6c42\u4e0eUSP\u76f8\u4f3c\u3002\u540c\u65f6\u5404\u56fd\u836f\u5178\u548c\u76f8\u5173\u6280\u672f\u8981\u6c42\u5747\u660e\u786e\u6ce8\u5c04\u5242\u751f\u4ea7\u8fc7\u7a0b\u4e2d<strong>\u5e94\u5bf9\u53ef\u89c1\u5f02\u7269\u8fdb\u884c100%\u68c0\u67e5\u5e76\u540c\u65f6\u5254\u9664\u4e0d\u5408\u683c\u4ea7\u54c1<\/strong>\u3002\u7f8e\u56fdFDA\u4e8e2021\u5e7412\u6708\u53d1\u5e03\u4e86\u300a\u6ce8\u5c04\u5242\u53ef\u89c1\u5f02\u7269\u68c0\u67e5\u884c\u4e1a\u6307\u5357\uff08\u8349\u6848\uff09\u300b\uff0c\u4ee5\u4e0b\u7b80\u79f0FDA\u6307\u5357\u8349\u6848\uff0c\u7cfb\u7edf\u9610\u8ff0\u4e86<strong>\u57fa\u4e8e\u98ce\u9669\u8bc4\u4f30\u4e0e\u751f\u547d\u5468\u671f\u7ba1\u7406\u7684\u6574\u4f53\u53ef\u89c1\u5f02\u7269\u68c0\u67e5\u548c\u63a7\u5236\u7b56\u7565<\/strong>\uff0c\u540c\u65f6\u63d0\u51fa\u5e94\u5728\u4e25\u683c\u786e\u4fdd\u6ce8\u5c04\u5242\u751f\u4ea7\u7b26\u5408GMP\u8981\u6c42\u7684\u57fa\u7840\u4e0a\uff0c\u5efa\u7acb\u6574\u4f53\u7684\u63a7\u5236\u7b56\u7565\u3002<\/p>\n<p style=\"text-align: left;\">\u8868\uff11 \u5404\u56fd\u836f\u5178\u6ce8\u5c04\u5242\u4e2d\u53ef\u89c1\u5f02\u7269\u706f\u68c0\u6cd5\u6bd4\u8f83<br \/>\n<img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-7818 aligncenter\" src=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-5.png\" alt=\"\" width=\"2578\" height=\"928\" srcset=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-5.png 2578w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-5-300x108.png 300w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-5-1030x371.png 1030w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-5-768x276.png 768w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-5-1536x553.png 1536w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-5-2048x737.png 2048w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-5-1500x540.png 1500w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-5-705x254.png 705w\" sizes=\"auto, (max-width: 2578px) 100vw, 2578px\" \/><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-7819 aligncenter\" src=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-6.jpg\" alt=\"\" width=\"1280\" height=\"855\" srcset=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-6.jpg 1280w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-6-300x200.jpg 300w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-6-1030x688.jpg 1030w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-6-768x513.jpg 768w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1209-6-705x471.jpg 705w\" sizes=\"auto, (max-width: 1280px) 100vw, 1280px\" \/><strong>\u9f0e\u5eb7\u751f\u7269\u62e5\u67093\u6761\u5236\u5242\u704c\u88c5\u7ebf<\/strong>\uff0c\u5305\u542b1\u6761\u5c0f\u5bb9\u91cf\u6ce8\u5c04\u5242\u7ebf\u30011\u6761\u51bb\u5e72\u7c89\u9488\u5242\u7ebf\u548c1\u6761\u9884\u704c\u5c01\u6ce8\u5c04\u5242\u7ebf\uff0c\u5168\u90e8\u91c7\u7528\u9694\u79bb\u5668\u6280\u672f\uff0c\u5176\u4e2d\u5c0f\u5bb9\u91cf\u6ce8\u5c04\u5242\u7ebf\u5df22022\u5e741\u6708\u901a\u8fc7GMP\u73b0\u573a\u6838\u67e5\uff0c\u6210\u4e3a\u56fd\u5185\u5148\u8fdb\u7684\u5177\u6709\u5546\u4e1a\u5316\u751f\u4ea7\u80fd\u529b\u7684CDMO\u4f01\u4e1a\u3002\u76ee\u524d\u751f\u4ea7\u7ebf\u6ee1\u8db3\u4e2d\u56fdNMPA\u3001\u6b27\u76dfEMA\u3001\u7f8e\u56fdFDA\u548cPIC\/S GMP\u7684\u8981\u6c42\u6765\u751f\u4ea7\u6db2\u4f53\u65e0\u83cc\u4ea7\u54c1\u3002\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u6211\u4eec\u7684\u751f\u4ea7\u64cd\u4f5c\u4ee5\u53ca\u8bbe\u5907\u8bbe\u65bd\u76d1\u6d4b\u90fd\u662f\u201c7x24hrs \u201d\uff0c\u706f\u68c0\u8fc7\u7a0b\u91c7\u75282\u6b21100%\u4eba\u5de5\u706f\u68c0\uff0c\u4e4b\u540e\u8fdb\u884cAQL\u53d6\u6837\uff0c\u786e\u4fdd\u706f\u68c0\u8fc7\u7a0b\u7684\u6709\u6548\u6027\u3002<\/p>\n<p>1. <strong>\u5c0f\u5bb9\u91cf\u6ce8\u5c04\u5242<\/strong>\uff082mL\u30016mL\u300110 mL\u300115 mL\u300120 mL\u300150mL\uff09\uff1a\u91c7\u7528\u5148\u8fdb\u7684\u8fdb\u53e3\u751f\u4ea7\u7ebf\uff0c\u5177\u5907100%\u5728\u7ebf\u79f0\u91cd\u529f\u80fd\u3002<\/p>\n<p>2. <strong>\u51bb\u5e72\u7c89\u9488\u5242<\/strong>\uff082mL\u30016mL\u300110mL\u300120mL\uff09\uff1a\u914d\u5907\u5168\u81ea\u52a8\u8054\u52a8\u7ebf\u548c25\u5e73\u65b9\u7c73\u51bb\u5e72\u673a\uff0c\u5177\u5907100%\u5728\u7ebf\u79f0\u91cd\u529f\u80fd\u3002<\/p>\n<p>3.<strong>\u9884\u704c\u5c01\u6ce8\u5c04\u5242<\/strong>\uff081mL\u30012.25mL\uff09\uff1a\u914d\u5907\u81ea\u52a8\u62c6\u5305\u673a\u5668\u548cPFS\u704c\u88c5\u673a\uff0c\u5177\u5907\u673a\u68b0\u81c2\u81ea\u52a8\u53d6\u6837\u79f0\u91cd\u529f\u80fd\u3002<\/p>\n<p>\u53c2\u8003\u6587\u732e\uff1a<\/p>\n<p>[1] \u5f20\u82b8,\u738b\u4e9a\u654f.\u6ce8\u5c04\u7528\u51bb\u5e72\u5236\u5242\u65b0\u836f\u7533\u62a5\u4e2d\u7684\u836f\u5b66\u5e38\u89c1\u95ee\u9898\u548c\u57fa\u672c\u8003\u8651[J].\u836f\u7269\u8bc4\u4ef7\u7814\u7a76, 2023, 46(9):1848-1853.<\/p>\n<p>[2] \u6ce8\u5c04\u5242\u53ef\u89c1\u5f02\u7269\u4ea7\u751f\u7684\u539f\u56e0\u548c\u68c0\u67e5\u65b9\u6cd5<\/p>\n<p>(https:\/\/www.ouryao.com\/blog-719835-47381.html\uff09<\/p>\n<p>[3] \u6ce8\u5c04\u5242\u53ef\u89c1\u5f02\u7269\u63a7\u5236\u6307\u5bfc\u539f\u5219 \u9644\u4ef6 1\uff1a\u6ce8\u5c04\u5242\u53ef\u89c1\u5f02\u7269\u63a7\u5236\u6307\u5bfc\u539f\u5219\uff08\u65b0\u589e\uff09\u516c\u793a\u7a3f\uff08\u7b2c\u4e00\u6b21\uff09<\/p>\n<p>[4] \u4e2d\u56fd\u836f\u51782020 \u7248 \u4e09\u90e8\u901a\u5219 0904 \u53ef\u89c1\u5f02\u7269\u68c0\u67e5\u6cd5<\/p>\n<p>[5] \u9646\u4ed5\u534e,\u674e\u6749,\u848b\u660e\u8273,\u7b49.\u6ce8\u5c04\u5242\u7c7b\u836f\u54c1\u751f\u4ea7\u98ce\u9669\u9632\u63a7\u68c0\u67e5\u7684\u5206\u6790\u4e0e\u6539\u8fdb\u5bf9\u7b56[J].\u4e2d\u56fd\u533b\u836f\u5de5\u4e1a\u6742\u5fd7, 2022, 53(10):1516-1521.DOI:10.16522\/j.cnki.cjph.2022.10.020<\/p>\n<p>[6] \u674e\u8d8a,\u8463\u6b66\u519b,\u5f20\u8000,\u7b49.\u7f8e\u56fdFDA\u300a\u6ce8\u5c04\u5242\u53ef\u89c1\u5f02\u7269\u68c0\u67e5\u884c\u4e1a\u6307\u5357(\u8349\u6848)\u300b\u4ecb\u7ecd\u4e0e\u89e3\u8bfb[J].\u4e2d\u56fd\u65b0\u836f\u6742\u5fd7, 2023, 32(13):1309-1314.<\/p>\n<p>[7] \u6768\u534e,\u738b\u6709\u82b3.\u5236\u836f\u5de5\u827a\u9879\u76ee\u8d28\u91cf\u63a7\u5236\u5b58\u5728\u7684\u95ee\u9898\u53ca\u5b8c\u5584\u63aa\u65bd[J].\u4e2d\u6587\u79d1\u6280\u671f\u520a\u6570\u636e\u5e93(\u5f15\u6587\u7248)\u533b\u836f\u536b\u751f, 2022(4):3.<\/p>\n<p><strong>\u5173\u4e8e\u9f0e\u5eb7\u751f\u7269<\/strong><\/p>\n<p>\u9f0e\u5eb7\u751f\u7269\u662f\u4e00\u5bb6\u5168\u7403\u9886\u5148\u7684CDMO\u516c\u53f8\uff0c\u7387\u5148\u5f15\u8fdb\u4e86\u5168\u7403\u9996\u4e2a\u6a21\u5757\u5316\u751f\u7269\u5236\u836f\u5de5\u5382KUBio\uff0c\u8d4b\u80fd\u751f\u7269\u5236\u54c1\u4ece\u7ec6\u80de\u682a\u5f00\u53d1\u5230\u5546\u4e1a\u5316\u751f\u4ea7\u7684\u5168\u8fc7\u7a0b\u3002\u6211\u4eec\u4f4d\u4e8e\u4e0a\u6d77\u7684\u521b\u65b0\u4e2d\u5fc3\u805a\u7126\u9ad8\u6548\u7684\u7ec6\u80de\u682a\u5f00\u53d1\u548c\u5148\u8fdb\u7684\u6280\u672f\u5f00\u53d1\uff0c\u4e0e\u62e5\u6709\u591a\u56fd\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u548c\u65b0\u836f\u4e0a\u5e02\u6210\u529f\u7ecf\u9a8c\u7684\u6b66\u6c49\u5236\u9020\u5de5\u5382\u76f8\u7ed3\u5408\uff0c\u9f0e\u5eb7\u751f\u7269\u6b63\u5728\u4e3a\u5168\u7403\u751f\u7269\u533b\u836f\u5ba2\u6237\u63d0\u4f9b\u4e00\u7ad9\u5f0f\u7684CMC\u89e3\u51b3\u65b9\u6848\u3002\u5728\u9f0e\u5eb7\u751f\u7269,\u6211\u4eec\u6709\u4e00\u4e2a\u5171\u540c\u7684\u76ee\u6807, \u81f4\u529b\u4e8e\u63d0\u9ad8\u524d\u6cbf\u751f\u7269\u533b\u836f\u5bf9\u5168\u7403\u60a3\u8005\u7684\u53ef\u53ca\u6027\uff0c\u5c65\u884c\u6211\u4eec\u5bf9\u4eba\u7c7b\u5065\u5eb7\u7684\u627f\u8bfa\u3002\u5982\u9700\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95ee: <a href=\"http:\/\/www.chimebiologics.com\" target=\"_blank\" rel=\"noopener\">www.chimebiologics.com<\/a>\u3002<\/p>\n<p><\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2d3l4o-9301d0cdc14489efa114080353995aa9\">\n.flex_column.av-2d3l4o-9301d0cdc14489efa114080353995aa9{\n-webkit-border-radius:0px 0px 0px 0px;\n-moz-border-radius:0px 0px 0px 0px;\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class='flex_column av-2d3l4o-9301d0cdc14489efa114080353995aa9 av_one_third  avia-builder-el-2  el_after_av_two_third  el_before_av_two_third  flex_column_div av-zero-column-padding '     ><\/div><\/p>\n<div class='flex_column 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