{"id":42700,"date":"2025-10-30T08:58:36","date_gmt":"2025-10-30T07:58:36","guid":{"rendered":"https:\/\/kymos.com\/news\/oligoxplorer%ef%bc%9a%e6%88%91%e4%bb%ac%e7%9a%84%e5%af%a1%e6%a0%b8%e8%8b%b7%e9%85%b8%e7%96%97%e6%b3%95-cmc-%e5%b9%b3%e5%8f%b0\/"},"modified":"2026-07-07T12:41:19","modified_gmt":"2026-07-07T10:41:19","slug":"oligoxplorer%ef%bc%9a%e6%88%91%e4%bb%ac%e7%9a%84%e5%af%a1%e6%a0%b8%e8%8b%b7%e9%85%b8%e7%96%97%e6%b3%95-cmc-%e5%b9%b3%e5%8f%b0","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/oligoxplorer%ef%bc%9a%e6%88%91%e4%bb%ac%e7%9a%84%e5%af%a1%e6%a0%b8%e8%8b%b7%e9%85%b8%e7%96%97%e6%b3%95-cmc-%e5%b9%b3%e5%8f%b0\/","title":{"rendered":"OligoXplorer\uff1a\u6211\u4eec\u7684\u5be1\u6838\u82f7\u9178\u7597\u6cd5 CMC \u5e73\u53f0"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" 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14pt;\"><strong>\u57fa\u4e8e\u5be1\u6838\u82f7\u9178\u7684\u7597\u6cd5<\/strong>\u5df2\u6210\u4e3a\u73b0\u4ee3\u533b\u5b66\u4e2d\u6700\u5177\u524d\u666f\u7684\u836f\u7269\u7c7b\u522b\u4e4b\u4e00\u3002\u5b83\u4eec\u5728\u57fa\u56e0\u5c42\u9762\u9776\u5411\u75be\u75c5\u7684\u80fd\u529b\u662f\u65e0\u4e0e\u4f17\u4e0d\u540c\u7684\uff0c\u4f46<strong>\u5176\u5316\u5b66\u7279\u6027\u4e5f\u5e26\u6765\u4e86\u4e00\u7cfb\u5217\u65b0\u7684\u5206\u6790\u6311\u6218<\/strong>\u3002\u5e8f\u5217\u3001\u957f\u5ea6\u6216\u9aa8\u67b6\u7684\u6bcf\u4e00\u5904\u4fee\u6539\u90fd\u53ef\u80fd\u5f71\u54cd\u6d3b\u6027\u3001\u5b89\u5168\u6027\u548c\u7a33\u5b9a\u6027\u3002\u56e0\u6b64\uff0c<strong>\u53ef\u9760\u7684\u8868\u5f81\u65b9\u6cd5<\/strong>\u5bf9\u4e8e<strong>\u5f00\u53d1\u4eba\u5458\u548c\u76d1\u7ba1\u673a\u6784\u786e\u4fdd\u4ea7\u54c1\u6574\u4e2a\u751f\u547d\u5468\u671f\u7684\u8d28\u91cf\u548c\u4e00\u81f4\u6027\u81f3\u5173\u91cd\u8981<\/strong>\u3002  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u4e3a\u4e86\u6ee1\u8db3\u8fd9\u4e00\u9700\u6c42\uff0c<strong>Kymos \u610f\u5927\u5229\u5f00\u53d1\u4e86 OligoXplorer<\/strong>\uff0c\u8fd9\u662f\u4e00\u4e2a\u7814\u53d1\u9879\u76ee\uff0c\u65e8\u5728\u4e3a\u57fa\u4e8e\u5be1\u6838\u82f7\u9178\u7597\u6cd5\u7684 <strong>CMC \u8868\u5f81\u521b\u5efa\u4e00\u4e2a\u5168\u9762\u7684\u5206\u6790\u5e73\u53f0<\/strong>\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8be5\u9879\u76ee\u662f\u4e0e <strong>\u5361\u7f8e\u65e5\u8bfa\u5927\u5b66 (UNICAM)<\/strong> \u751f\u7269\u79d1\u5b66\u4e0e\u517d\u533b\u5b66\u9662\u5408\u4f5c\u5f00\u5c55\u7684\uff0c\u5e76\u7531 <strong>\u9a6c\u5c14\u51ef\u5927\u533a<\/strong> \u5728\u5176\u521b\u65b0\u8ba1\u5212 (PR Marche FESR 2021\/2027) \u4e0b\u5171\u540c\u8d44\u52a9\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u9664\u4e86\u79d1\u5b66\u8303\u7574\u4e4b\u5916\uff0cOligoXplorer \u8fd8\u6807\u5fd7\u7740 Kymos \u96c6\u56e2\u7684\u4e00\u4e2a\u91cd\u8981\u91cc\u7a0b\u7891\uff1a\u5b83<strong>\u5de9\u56fa\u4e86\u6211\u4eec\u5728 TIDES \u9886\u57df\u7684\u7ecf\u9a8c\uff0c\u5e76\u901a\u8fc7\u5be1\u6838\u82f7\u9178\u7684 CMC \u6d4b\u8bd5\u6269\u5c55\u4e86\u6211\u4eec\u7684\u4e1a\u52a1\u7ec4\u5408<\/strong>\u3002<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u4e86\u89e3\u5206\u6790\u6311\u6218<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>\u5be1\u6838\u82f7\u9178\u4ecb\u4e8e\u5c0f\u5206\u5b50\u548c\u751f\u7269\u5236\u54c1\u4e4b\u95f4<\/strong>\uff0c\u5bf9\u4e8e\u4f20\u7edf\u7684\u5316\u5b66\u65b9\u6cd5\u6765\u8bf4\u592a\u5927\uff0c\u800c\u5bf9\u4e8e\u5927\u591a\u6570\u751f\u7269\u6d4b\u5b9a\u6765\u8bf4\u53c8\u592a\u5c0f\u3002\u5b83\u4eec\u5e9e\u5927\u7684\u4f53\u79ef\u3001\u9ad8\u6781\u6027\u4ee5\u53ca\u5f62\u6210\u4e8c\u7ea7\u7ed3\u6784\u7684\u503e\u5411\uff0c\u4f7f\u5176<strong>\u96be\u4ee5\u5206\u79bb\u3001\u5b9a\u91cf\u548c\u6d4b\u5e8f<\/strong>\u3002\u5982\u524d\u6240\u8ff0\uff0c<strong>\u5e8f\u5217\u957f\u5ea6\u6216\u5176\u5316\u5b66\u6027\u8d28\u7684\u5fae\u5c0f\u53d8\u5316\u90fd\u4f1a\u5f71\u54cd\u6548\u529b\u3001\u7279\u5f02\u6027\u548c\u7a33\u5b9a\u6027<\/strong>\u3002  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u51fa\u4e8e\u8fd9\u4e2a\u539f\u56e0\uff0c<strong>\u76d1\u7ba1\u673a\u6784\u671f\u671b\u83b7\u5f97\u5168\u9762\u7684 CMC \u8d44\u6599\u5305<\/strong>\uff0c\u8fd9\u4e9b\u8d44\u6599\u5305\u5efa\u7acb\u5728\u6b63\u4ea4\u5206\u6790\u65b9\u6cd5\u4e4b\u4e0a\uff0c<strong>\u4ee5\u786e\u8ba4\u5e8f\u5217\u8eab\u4efd\u3001\u5b9a\u91cf\u542b\u91cf\u5e76\u8868\u5f81\u6742\u8d28<\/strong>\uff1b\u6240\u6709\u8fd9\u4e9b\u90fd\u9700\u5728\u7ecf\u8fc7\u9a8c\u8bc1\u4e14\u53ef\u91cd\u590d\u7684\u6761\u4ef6\u4e0b\u8fdb\u884c\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">OligoXplorer \u7684\u6784\u601d\u6b63\u662f\u4e3a\u4e86\u5e94\u5bf9\u8fd9\u4e9b\u6311\u6218\uff1a<strong>\u63a2\u7d22\u3001\u5f00\u53d1\u548c\u9a8c\u8bc1\u80fd\u591f\u652f\u6301\u5be1\u6838\u82f7\u9178\u8868\u5f81\u5404\u4e2a\u9636\u6bb5\u7684\u65b9\u6cd5<\/strong>\uff0c\u4ece\u65e9\u671f\u5f00\u53d1\u5230 GMP \u653e\u884c\u6d4b\u8bd5\u3002<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u4e09\u5927\u4e3b\u8981\u5206\u6790\u9886\u57df<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\u8be5\u9879\u76ee\u4e13\u6ce8\u4e8e\u4e09\u4e2a\u4e3b\u8981\u5206\u6790\u9886\u57df\uff1a<strong>\u6d4b\u5e8f\u3001\u542b\u91cf\u6d4b\u5b9a\u548c\u76f8\u5173\u7269\u8d28<\/strong>\u3002\u6bcf\u4e2a\u9886\u57df\u90fd\u6db5\u76d6\u4e86\u5be1\u6838\u82f7\u9178\u63a7\u5236\u4e2d\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027 (CQA)\u3002 <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u6d4b\u5e8f\uff1a\u786e\u8ba4\u5206\u5b50\u8eab\u4efd<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\u786e\u5b9a\u5be1\u6838\u82f7\u9178\u643a\u5e26<strong>\u6b63\u786e\u7684\u5e8f\u5217\u662f\u786e\u4fdd\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u7b2c\u4e00\u6b65<\/strong>\u3002<\/span><br \/>\n<span style=\"font-size: 14pt;\">\u6211\u4eec\u5728\u610f\u5927\u5229\u7684\u56e2\u961f\u5df2\u7ecf\u5efa\u7acb\u5e76\u5b8c\u5584\u4e86 <strong>LC-MS \u548c HR-MS \u5de5\u4f5c\u6d41\u7a0b\uff0c\u80fd\u591f\u786e\u8ba4\u5e8f\u5217\u8eab\u4efd<\/strong>\u5e76\u63ed\u793a\u7ec6\u5fae\u7684\u53d8\u4f53\uff0c\u5982\u77ed\u4f53\u3001\u957f\u4f53\u6216\u5316\u5b66\u4fee\u9970\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8272\u8c31\u5206\u7ea7\u6709\u52a9\u4e8e\u5728\u8d28\u8c31\u5206\u6790\u4e4b\u524d\u5206\u79bb\u8fd9\u4e9b\u53d8\u4f53\uff0c\u4ece\u800c\u63d0\u9ad8\u5206\u8fa8\u7387\u548c\u53ef\u9760\u6027\u3002\u5176\u6210\u679c\u662f<strong>\u4e00\u5957\u80fd\u591f\u63d0\u4f9b\u6e05\u6670\u3001\u9ad8\u8d28\u91cf\u8eab\u4efd\u6570\u636e\u7684\u65b9\u6cd5\uff0c\u9002\u7528\u4e8e\u5e38\u89c4 CMC \u6d4b\u8bd5<\/strong>\u3002 <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u542b\u91cf\u6d4b\u5b9a\uff1a\u6d4b\u91cf\u542b\u91cf\u548c\u5f3a\u5ea6<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>\u5be1\u6838\u82f7\u9178\u7684\u5b9a\u91cf<\/strong>\u540c\u6837\u5177\u6709\u6311\u6218\u6027\uff0c\u800c\u51c6\u786e\u5730\u8fdb\u884c\u5b9a\u91cf\u5bf9\u4e8e<strong>\u6548\u529b\u548c\u5242\u91cf\u7684\u53ef\u91cd\u590d\u6027\u81f3\u5173\u91cd\u8981<\/strong>\u3002\u5b83\u4eec\u7684\u7406\u5316\u6027\u8d28\u4f1a\u5f71\u54cd\u56de\u6536\u7387\u548c\u54cd\u5e94\uff0c\u5c24\u5176\u662f\u5728\u5e38\u89c4\u6d4b\u8bd5\u671f\u95f4\u3002 <\/span><br \/>\n<span style=\"font-size: 14pt;\">\u4e3a\u4e86\u514b\u670d\u8fd9\u4e00\u56f0\u96be\uff0c<strong>Kymos \u610f\u5927\u5229\u5f00\u53d1\u5e76\u9a8c\u8bc1\u4e86\u7528\u4e8e\u7cbe\u786e\u91cf\u5316\u7684 LC-UV \u548c LC-MS \u65b9\u6cd5<\/strong>\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u65b9\u6cd5\u9a8c\u8bc1\u6db5\u76d6\u4e86\u7ebf\u6027\u3001\u7cbe\u5bc6\u5ea6\u548c\u7a33\u5065\u6027\uff0c\u800c\u8272\u8c31\u4f18\u5316\u6709\u52a9\u4e8e\u5c06\u4e3b\u5cf0\u4e0e\u964d\u89e3\u6216\u6742\u8d28\u4fe1\u53f7\u5206\u79bb\u3002\u5176\u7ed3\u679c\u662f\u83b7\u5f97\u4e86\u4e00\u79cd<strong>\u7ecf\u8fc7\u9a8c\u8bc1\u3001\u7b26\u5408\u7528\u9014\u7684\u542b\u91cf\u6d4b\u5b9a\u65b9\u6cd5\uff0c\u53ef\u7528\u4e8e GMP \u73af\u5883\u4e2d\u7684\u6279\u6b21\u653e\u884c\u548c\u7a33\u5b9a\u6027\u7814\u7a76\u9879\u76ee<\/strong>\u3002 <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u76f8\u5173\u7269\u8d28\uff1a\u786e\u4fdd\u7eaf\u5ea6\u548c\u4ea7\u54c1\u5b8c\u6574\u6027<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\u5373\u4f7f\u662f\u5fae\u5c0f\u7684<strong>\u6742\u8d28\u4e5f\u4f1a\u5f71\u54cd\u6cbb\u7597\u6548\u679c<\/strong>\u3002\u5728\u5408\u6210\u8fc7\u7a0b\u4e2d\uff0c\u5be1\u6838\u82f7\u9178\u4f1a\u4ea7\u751f\u4e00\u7cfb\u5217\u622a\u77ed\u6216\u5ef6\u957f\u7684\u7269\u79cd (n\u20131, n+1)\uff0c\u6216\u901a\u8fc7\u6c27\u5316\u6216\u8131\u560c\u5464\u4ea7\u751f\u5316\u5b66\u6742\u8d28\u3002<strong>\u8bc6\u522b\u5e76\u91cf\u5316\u8fd9\u4e9b\u7269\u8d28\u5bf9\u4e8e\u4ea7\u54c1\u5b89\u5168\u548c\u76d1\u7ba1\u5408\u89c4\u81f3\u5173\u91cd\u8981<\/strong>\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u901a\u8fc7 <em>OligoXplorer<\/em>\uff0c\u6211\u4eec\u7684\u610f\u5927\u5229\u56e2\u961f\u5efa\u7acb\u4e86 <strong>LC-UV \u548c LC-MS 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