{"id":42383,"date":"2021-06-22T10:41:51","date_gmt":"2021-06-22T08:41:51","guid":{"rendered":"https:\/\/kymos.com\/%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae\/"},"modified":"2026-07-08T23:34:46","modified_gmt":"2026-07-08T21:34:46","slug":"%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae","status":"publish","type":"page","link":"https:\/\/kymos.com\/zh-hans\/%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae\/","title":{"rendered":"\u670d\u52a1"},"content":{"rendered":"

\u751f\u7269\u5206\u6790\u4e0e CMC \u670d\u52a1<\/h1><\/div>

\u5728\u4ea7\u54c1\u7814\u53d1\u548c\u8d28\u91cf\u63a7\u5236\u7684\u6bcf\u4e2a\u9636\u6bb5\u63d0\u4f9b\u5168\u9762\u7684\u751f\u7269\u5206\u6790\u548c CMC \u6d4b\u8bd5\u89e3\u51b3\u65b9\u6848\u3002<\/p>\n<\/div><\/div><\/div>

\u4e34\u5e8a\u524d\u4e0e\u4e34\u5e8a\u751f\u7269\u5206\u6790<\/strong><\/h4><\/div>

\u65e8\u5728\u786e\u4fdd\u7b26\u5408 GLP \u548c GCP \u6807\u51c6\u7684\u5168\u9762\u4e34\u5e8a\u524d\u548c\u4e34\u5e8a\u670d\u52a1\u3002<\/p>\n<\/div>

\u67e5\u770b\u8be6\u60c5<\/span><\/i><\/a><\/div><\/div><\/div>

CMC \u670d\u52a1\u4e0e\u8d28\u91cf\u63a7\u5236<\/strong><\/h4><\/div>

\u7531\u901a\u8fc7 GMP \u8ba4\u8bc1\u5e76\u7ecf FDA\u3001EMA \u548c ANVISA \u68c0\u67e5\u7684\u5b9e\u9a8c\u5ba4\u63d0\u4f9b\u53ef\u9760\u7684 CMC \u548c\u8d28\u91cf\u63a7\u5236\u89e3\u51b3\u65b9\u6848\u3002<\/p>\n<\/div>

\u67e5\u770b\u8be6\u60c5<\/span><\/i><\/a><\/div><\/div><\/div>
<\/div><\/div><\/div><\/div>

\u5206\u5b50<\/p>\n<\/div>

<\/div><\/div>

\u57fa\u4e8e\u5206\u5b50\u89c4\u683c\u7684 CRO \u670d\u52a1<\/h2><\/h2><\/div><\/div><\/div>

\u6211\u4eec\u662f\u5c0f\u5206\u5b50\u3001\u751f\u7269\u5236\u54c1\u3001TIDES\uff08\u5be1\u6838\u82f7\u9178\u548c\u591a\u80bd\uff09\u4ee5\u53ca\u7ec6\u80de\u548c\u57fa\u56e0\u7597\u6cd5\u5206\u6790\u65b9\u9762\u7684\u4e13\u5bb6\u3002<\/p>\n<\/div><\/div><\/div>

<\/span><\/div>

\u5c0f\u5206\u5b50<\/h3><\/div>

\u7ecf\u8fc7 GLP \u8ba4\u8bc1\u7684\u5c0f\u5206\u5b50\u751f\u7269\u5206\u6790\u548c\u7ecf\u8fc7 GMP \u8ba4\u8bc1\u7684\u8d28\u91cf\u63a7\u5236\u3002<\/p>\n<\/div>

\u67e5\u770b\u8be6\u60c5<\/span><\/i><\/a><\/div><\/div><\/div>
<\/span><\/div>

\u751f\u7269\u5236\u54c1\u548c\u751f\u7269\u7c7b\u4f3c\u836f<\/h3><\/div>

\u9488\u5bf9\u86cb\u767d\u8d28\u3001\u6fc0\u7d20\u3001\u9176\u3001\u751f\u7269\u7c7b\u4f3c\u836f\u548c ADC \u7684\u751f\u7269\u5206\u6790\u53ca\u8d28\u91cf\u63a7\u5236\u670d\u52a1\u3002<\/p>\n<\/div>

\u67e5\u770b\u8be6\u60c5<\/span><\/i><\/a><\/div><\/div><\/div>
<\/span><\/div>

TIDES\uff08\u5be1\u6838\u82f7\u9178\u548c\u591a\u80bd\uff09<\/h3><\/div>

\u9488\u5bf9 TIDES\uff08\u5be1\u6838\u82f7\u9178\u548c\u591a\u80bd\uff09\u7684 GMP \u548c GLP \u8ba4\u8bc1\u751f\u7269\u5206\u6790\u53ca\u8d28\u91cf\u63a7\u5236\u670d\u52a1<\/p>\n<\/div>

\u67e5\u770b\u8be6\u60c5<\/span><\/i><\/a><\/div><\/div><\/div>
<\/span><\/div>

\u7ec6\u80de\u4e0e\u57fa\u56e0\u6cbb\u7597<\/h3><\/div>

\u7ecf GLP \u548c GMP \u8ba4\u8bc1\u7684\u6838\u9178\u3001\u75c5\u6bd2\u8f7d\u4f53\u548c\u8102\u8d28\u7eb3\u7c73\u9897\u7c92\u7684\u8d28\u91cf\u63a7\u5236\u4e0e\u751f\u7269\u5206\u6790\u3002<\/p>\n<\/div>

\u67e5\u770b\u8be6\u60c5<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\n

\u670d\u52a1<\/p>\n<\/div>

<\/div><\/div>

\u901a\u8fc7 GMP \u548c GLP \u8ba4\u8bc1\u3002\u7ecf FDA\u3001EMA \u548c ANVISA \u68c0\u67e5\u7684\u5b9e\u9a8c\u5ba4\u3002<\/h2><\/div>

\u51ed\u501f 20 \u591a\u5e74\u7684\u7ecf\u9a8c\uff0cKymos \u96c6\u56e2\u63d0\u4f9b\u4ee5\u4e0b\u670d\u52a1\uff1a<\/p>\n<\/div><\/div><\/div>

\"pre-clinical-bioanalysis-b\"<\/div><\/div>
\u751f\u7269\u5206\u6790\u670d\u52a1<\/span><\/a><\/div>

\u4e34\u5e8a\u524d\u4e0e\u4e34\u5e8a\u751f\u7269\u5206\u6790<\/h1><\/div>

\u6211\u4eec\u7684\u5168\u9762\u670d\u52a1\u5305\u62ec\u5c0f\u5206\u5b50\u3001\u751f\u7269\u5236\u5242\u548c\u5148\u8fdb\u7597\u6cd5\u7684\u751f\u7269\u5206\u6790\u3001\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u3001\u751f\u7269\u6807\u5fd7\u7269\u5206\u6790\u3001PK \u8bc4\u4f30\u3001\u751f\u7269\u5206\u5e03\u548c\u514d\u75ab\u539f\u6027\uff0c\u5e76\u7531 LC-MS\/MS \u548c Meso QuickPlex SQ \u7b49\u5148\u8fdb\u5e73\u53f0\u63d0\u4f9b\u652f\u6301\u3002<\/p>\n<\/div>

\u63a2\u7d22\u4e34\u5e8a\u524d\u4e0e\u4e34\u5e8a\u751f\u7269\u5206\u6790<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div>
CMC \u670d\u52a1<\/span><\/a><\/div>

CMC \u5206\u6790\u4e0e\u8d28\u91cf\u63a7\u5236<\/h1><\/div>

\u6211\u4eec\u7684\u670d\u52a1\u5305\u62ec\u65b9\u6cd5\u5f00\u53d1\u4e0e\u9a8c\u8bc1\u3001\u8d28\u91cf\u63a7\u5236\u3001\u7a33\u5b9a\u6027\u7814\u7a76\u3001\u751f\u7269\u7c7b\u4f3c\u836f\u53ef\u6bd4\u6027\u7814\u7a76\u4ee5\u53ca\u6279\u6b21\u653e\u884c\uff0c\u5e76\u7531\u5148\u8fdb\u7684\u5206\u6790\u6280\u672f\u548c\u5de5\u827a\u63d0\u4f9b\u652f\u6301\u3002<\/p>\n<\/div>

\u63a2\u7d22 CMC \u5206\u6790\u4e0e\u8d28\u91cf\u63a7\u5236<\/span><\/i><\/a><\/div><\/div><\/div>
\"cmc-services-b\"<\/div><\/div><\/div><\/div>

\u751f\u7269\u5206\u6790<\/p>\n<\/div>

<\/div><\/div>

\u751f\u7269\u5206\u6790\u4e13\u5bb6\uff1a\u7cbe\u51c6\u4e0e\u77e5\u8bc6<\/h2><\/div>

Kymos \u96c6\u56e2\u5904\u4e8e\u751f\u7269\u5206\u6790\u7684\u524d\u6cbf\uff0c\u4e3a\u836f\u7269\u5f00\u53d1\u7684\u6bcf\u4e2a\u9636\u6bb5\u63d0\u4f9b\u7cbe\u51c6\u53ef\u9760\u7684\u6d4b\u8bd5\u89e3\u51b3\u65b9\u6848\u3002\u51ed\u501f 20 \u591a\u5e74\u7684\u4e13\u4e1a\u77e5\u8bc6\uff0c\u6211\u4eec\u4e13\u6ce8\u4e8e\u5c0f\u5206\u5b50\u3001\u751f\u7269\u5236\u5242\u548c\u6838\u9178\u7684\u751f\u7269\u5206\u6790\uff0c\u786e\u4fdd\u7b26\u5408\u884c\u4e1a\u6700\u9ad8\u6807\u51c6\u3002\u6211\u4eec\u7684\u5c16\u7aef\u6280\u672f\u548c\u6df1\u539a\u7684\u79d1\u5b66\u77e5\u8bc6\u4f7f\u6211\u4eec\u80fd\u591f\u652f\u6301\u5ba2\u6237\uff0c\u5e76\u63d0\u4f9b\u65e8\u5728\u7f29\u77ed\u5176\u4e0a\u5e02\u65f6\u95f4\u7684\u9ad8\u8d28\u91cf\u5b9a\u5236\u670d\u52a1\uff1a <\/p>\n<\/div>