{"id":42716,"date":"2026-06-23T12:50:40","date_gmt":"2026-06-23T10:50:40","guid":{"rendered":"https:\/\/kymos.com\/news\/%e5%8f%8c%e7%89%b9%e5%bc%82%e6%80%a7%e6%8a%97%e4%bd%93%ef%bc%9a%e8%8d%af%e4%bb%a3%e5%8a%a8%e5%8a%9b%e5%ad%a6%e5%92%8c%e5%85%8d%e7%96%ab%e5%8e%9f%e6%80%a7%e7%a0%94%e7%a9%b6%e4%b8%ad%e7%9a%84%e6%8c%91\/"},"modified":"2026-06-23T12:50:40","modified_gmt":"2026-06-23T10:50:40","slug":"%e5%8f%8c%e7%89%b9%e5%bc%82%e6%80%a7%e6%8a%97%e4%bd%93%ef%bc%9a%e8%8d%af%e4%bb%a3%e5%8a%a8%e5%8a%9b%e5%ad%a6%e5%92%8c%e5%85%8d%e7%96%ab%e5%8e%9f%e6%80%a7%e7%a0%94%e7%a9%b6%e4%b8%ad%e7%9a%84%e6%8c%91","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/%e5%8f%8c%e7%89%b9%e5%bc%82%e6%80%a7%e6%8a%97%e4%bd%93%ef%bc%9a%e8%8d%af%e4%bb%a3%e5%8a%a8%e5%8a%9b%e5%ad%a6%e5%92%8c%e5%85%8d%e7%96%ab%e5%8e%9f%e6%80%a7%e7%a0%94%e7%a9%b6%e4%b8%ad%e7%9a%84%e6%8c%91\/","title":{"rendered":"\u53cc\u7279\u5f02\u6027\u6297\u4f53\uff1a\u836f\u4ee3\u52a8\u529b\u5b66\u548c\u514d\u75ab\u539f\u6027\u7814\u7a76\u4e2d\u7684\u6311\u6218"},"content":{"rendered":"

\u4ec0\u4e48\u662f\u53cc\u7279\u5f02\u6027\u6297\u4f53\uff1f<\/h2>\n

\u53cc\u7279\u5f02\u6027\u6297\u4f53 (BsAbs<\/strong>) \u662f\u7ecf\u5de5\u7a0b\u5316\u6539\u9020\u7684\u6297\u4f53\uff0c\u5177\u6709\u540c\u65f6\u7ed3\u5408\u4e24\u4e2a\u9776\u70b9<\/strong>\uff08\u6297\u539f\u6216\u8868\u4f4d\uff09\u7684\u72ec\u7279\u80fd\u529b\uff0c\u8868\u73b0\u51fa\u5353\u8d8a\u7684\u7597\u6548\u3001\u7279\u5f02\u6027\u548c\u5b89\u5168\u6027\u3002\u6b63\u5728\u5f00\u53d1\u7684 BsAbs \u7684\u9002\u7528\u8303\u56f4\u6db5\u76d6\u7ec6\u80de\u95f4\u6865\u63a5\u3001\u90bb\u8fd1\u6548\u5e94\u3001\u53cc\u9776\u70b9\u6291\u5236\u4ee5\u53ca\u4f9d\u8d56\u4e8e\u4e24\u79cd\u6297\u539f\u7c7b\u578b\u7684\u7ec6\u80de\u9776\u5411\u3002<\/strong> \u5b83\u4eec\u5df2\u6210\u4e3a\u764c\u75c7\u6cbb\u7597\u9886\u57df\u5173\u6ce8\u7684\u7126\u70b9\uff1b\u5c3d\u7ba1\u5982\u6b64\uff0c\u8fd1\u5e74\u6765\uff0c\u66f4\u591a\u7684 BsAbs \u4e5f\u5df2\u5728\u5176\u4ed6\u6cbb\u7597\u9886\u57df\u63a8\u51fa\u3002 <\/span><\/p>\n

\u6297\u4f53\u7531\u53ef\u7ed3\u6676\u7247\u6bb5\u533a (Fc)<\/strong>\uff08\u4e0e\u7ec6\u80de\u53d7\u4f53\u548c\u8865\u4f53\u76f8\u4e92\u4f5c\u7528\u7684\u6052\u5b9a\u533a\uff09\u548c\u6297\u539f\u7ed3\u5408\u7247\u6bb5\u533a (Fab)<\/strong>\uff08\u5305\u542b\u53ef\u53d8\u91cd\u94fe\u548c\u53ef\u53d8\u8f7b\u94fe\uff1b\u8be5\u533a\u57df\u662f\u8bc6\u522b\u9776\u70b9\u7684\u533a\u57df\uff09\u7ec4\u6210\u3002<\/span><\/p>\n

BsAbs \u7ecf\u5de5\u7a0b\u5316\u6539\u9020\uff0c\u5728 Fab \u533a\u57df\u62e5\u6709\u4e24\u6761\u4e0d\u540c\u7684\u81c2<\/strong>\uff0c\u5177\u6709\u5404\u81ea\u4e0d\u540c\u7684\u53ef\u53d8\u8f7b\u94fe\u548c\u91cd\u94fe\uff0c\u6bcf\u6761\u81c2\u90fd\u80fd\u8bc6\u522b\u7279\u5b9a\u7684\u9776\u70b9\uff0c\u4ece\u800c\u4f7f\u5176\u80fd\u591f\u540c\u65f6\u7ed3\u5408\u4e24\u79cd\u6297\u539f<\/strong>\u3002\u5728\u5de5\u7a0b\u5316\u6539\u9020 BsAbs \u65f6\uff0c\u4e00\u4e2a\u4e3b\u8981\u7684\u8003\u8651\u56e0\u7d20\u662f\u786e\u4fdd Fab \u533a\u57df\u4e24\u6761\u4e0d\u540c\u7684\u91cd\u94fe\u548c\u8f7b\u94fe\u6b63\u786e\u7ec4\u88c5\u3002\u6b64\u5916\uff0c\u5bf9 BsAbs Fc \u533a\u7684\u6539\u9020\u53ef\u4fc3\u8fdb\u5e76\u589e\u5f3a\u5176\u7a33\u5b9a\u6027\uff0c\u6539\u53d8\u514d\u75ab\u529f\u80fd\uff0c\u5e76\u5ef6\u957f\u5176\u534a\u8870\u671f\u3002 <\/span><\/p>\n

\u5728 BsAbs \u7684\u5f00\u53d1\u8fc7\u7a0b\u4e2d\uff0c\u9009\u62e9\u6700\u4f73\u5019\u9009\u836f\u7269\u81f3\u5173\u91cd\u8981\u3002<\/strong> \u8fd9\u79cd\u9009\u62e9\u57fa\u4e8e\u7406\u5316\u6027\u8d28\u3001\u683c\u5f0f\u3001\u7279\u5f02\u6027\u3001\u836f\u4ee3\u52a8\u529b\u5b66 (PK) \u548c\u9884\u671f\u7684\u6cbb\u7597\u6548\u679c\u3002<\/span><\/p>\n

BsAbs \u5f00\u53d1\u4e2d\u901a\u5e38\u8003\u8651\u54ea\u4e9b\u53c2\u6570\uff1f<\/h2>\n

\u4e3a\u786e\u4fdd\u5b89\u5168\u6027\u3001\u8d28\u91cf\u548c\u7597\u6548\uff0c\u5206\u6790\u7a0b\u5e8f\u5fc5\u987b\u8bc4\u4f30\u56db\u4e2a\u4e3b\u8981\u7c7b\u522b\u7684\u82e5\u5e72\u5173\u952e\u8d28\u91cf\u5c5e\u6027 (CQAs)\uff1a<\/span><\/p>\n

    \n
  • \n

    \u5b89\u5168\u6027\uff1a<\/b>\u5185\u6bd2\u7d20\u3001\u652f\u539f\u4f53\u3001\u514d\u75ab\u539f\u6027\uff08ADA\u3001NAb\uff09\u3001\u75c5\u539f\u4f53\u5b58\u5728\u3002<\/span><\/p>\n<\/li>\n

  • \n

    \u8d28\u91cf\uff1a<\/b>\u7cd6\u57fa\u5316\u3001\u805a\u96c6\u3001\u5bbf\u4e3b\u7ec6\u80de\u86cb\u767d (HCP)\u3001\u5bbf\u4e3b\u7ec6\u80de DNA (HCDNA)\u3002<\/span><\/p>\n<\/li>\n

  • \n

    \u9274\u5b9a\u4e0e\u7eaf\u5ea6\uff1a<\/b>\u5927\u5c0f\u3001\u6c28\u57fa\u9178\u5e8f\u5217\u3001\u805a\u7cd6\u5206\u6790\uff08ELISA\u3001LC-MS\u3001SEC-HPLC\u3001SDS-PAGE\uff09\u3002<\/span><\/p>\n<\/li>\n

  • \n

    \u6548\u529b\uff1a<\/b>\u9776\u70b9\u7ed3\u5408\uff08ELISA\u3001SPR\uff09\u3001\u7ec6\u80de\u53cd\u5e94\u548c\u7ec6\u80de\u6bd2\u6027\uff08\u7ec6\u80de\u5206\u6790\u3001ADCC\uff09\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n

    BsAbs \u5f00\u53d1\u4e2d\u7684\u4e34\u5e8a\u524d\u548c\u4e34\u5e8a\u8003\u8651\u56e0\u7d20<\/h2>\n

    \u836f\u4ee3\u52a8\u529b\u5b66 (PK)<\/h3>\n

     <\/p>\n

    BsAbs \u5e26\u6765\u4e86\u72ec\u7279\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u6311\u6218<\/strong>\uff0c\u5f71\u54cd\u7740\u5bf9 PK \u6982\u51b5\u3001\u7ed9\u836f\u65b9\u6848\u3001\u534a\u8870\u671f\u548c\u6e05\u9664\u7387\u7684\u8bc4\u4f30\u3002\u7531\u4e8e BsAbs \u5728\u80c3\u80a0\u9053\u4e2d\u7684\u7a33\u5b9a\u6027\u8f83\u4f4e\u4e14\u80a0\u58c1\u6e17\u900f\u6027\u8f83\u5dee\uff0c\u56e0\u6b64\u5b83\u4eec\u4e0d\u9002\u5408\u4f5c\u4e3a\u53e3\u670d\u5019\u9009\u836f\u7269\u3002\u76f8\u53cd\uff0cBsAbs \u53ef\u4ee5\u901a\u8fc7\u9759\u8109\u6ce8\u5c04 (IV)\u3001\u8179\u8154\u6ce8\u5c04 (IP) \u6216\u76ae\u4e0b\u6ce8\u5c04 (SC) \u7ed9\u836f\u3002<\/strong> <\/span><\/p>\n

    \u5b83\u4eec\u7684\u5206\u5b50\u5927\u5c0f\u548c\u5176\u4ed6\u7406\u5316\u6027\u8d28\u76f4\u63a5\u5f71\u54cd\u5176\u5206\u5e03\u548c\u7ec4\u7ec7\u6e17\u900f\u3002<\/strong> BsAbs \u7684 Fc \u533a\u57df\u8d1f\u8d23\u7ef4\u6301\u548c\u589e\u5f3a\u5168\u8eab\u5b58\u5728\uff0c\u4ece\u800c\u51cf\u5c11\u9891\u7e41\u7ed9\u836f\u7684\u9700\u6c42\u3002<\/span><\/p>\n

    \u7531\u4e8e PK \u6982\u51b5\u548c\u7ebf\u6027\u53ef\u80fd\u4e0e\u4f20\u7edf\u7684\u5355\u514b\u9686\u6297\u4f53 (mAbs) \u4e0d\u540c\uff0c\u56e0\u6b64 PK \u751f\u7269\u5206\u6790\u7814\u7a76\u5fc5\u987b\u51c6\u786e\u786e\u5b9a\u9700\u8981\u6d4b\u91cf\u54ea\u79cd\u6216\u54ea\u4e9b\u5206\u6790\u7269\uff0c\u65e0\u8bba\u662f\u603b\u6297\u4f53\u3001\u5355\u4e2a\u6d3b\u6027\u81c2\u8fd8\u662f\u7ed3\u5408\u590d\u5408\u7269\uff0c\u8fd9\u4e00\u70b9\u81f3\u5173\u91cd\u8981\u3002<\/strong><\/span><\/p>\n

    \u836f\u6548\u5b66 (PD)<\/h3>\n

     <\/p>\n

    \u4f5c\u4e3a\u5b89\u5168\u6027\u8bc4\u4f30\u7684\u4e00\u90e8\u5206\uff0c\u53ef\u4ee5\u6d4b\u91cf\u7279\u5b9a\u7684\u751f\u7269\u6807\u5fd7\u7269\u548c\u7ec6\u80de\u56e0\u5b50\u3002<\/strong> \u8fd9\u662f\u5242\u91cf\u9012\u589e\u9636\u6bb5\u7684\u5173\u952e\u6b65\u9aa4\uff0c\u56e0\u4e3a\u589e\u52a0\u5242\u91cf\u53ef\u80fd\u4f1a\u5f15\u8d77\u7ec6\u80de\u56e0\u5b50\u91ca\u653e\u7efc\u5408\u5f81 (CRS)\u3002<\/span><\/p>\n

    \u514d\u75ab\u539f\u6027\u98ce\u9669<\/h3>\n

     <\/p>\n

    \u4e0e\u4f20\u7edf mAbs \u7684\u6807\u51c6 ADA \u5206\u6790\u76f8\u6bd4\uff0c\u8bc4\u4f30\u6297\u836f\u7269\u6297\u4f53 (ADA) \u7684\u6311\u6218\u6027\u8981\u5927\u5f97\u591a\u3002<\/strong> \u4f20\u7edf\u7684\u591a\u5c42\u7ea7\u65b9\u6cd5\u5fc5\u987b\u5728\u786e\u8ba4\u9636\u6bb5\u63a5\u53d7\u989d\u5916\u7684\u8868\u5f81\u6b65\u9aa4\uff0c\u4ee5\u7ed8\u5236\u9488\u5bf9\u53cc\u7279\u5f02\u6027\u5206\u5b50\u6bcf\u4e2a\u5355\u72ec\u529f\u80fd\u57df\u7684\u53cd\u5e94\u56fe\u8c31\u3002<\/strong><\/span><\/p>\n

    \u5408\u89c4\u6846\u67b6<\/h2>\n

    \u5f00\u53d1\u7a33\u5065\u7684\u751f\u7269\u5206\u6790\u65b9\u6cd5\u9700\u8981\u4e25\u683c\u9075\u5b88\u56fd\u9645\u76d1\u7ba1\u6846\u67b6\u3002\u5173\u952e\u6307\u5357\u5305\u62ec\uff1a <\/span><\/p>\n

      \n
    • \n

      ICH M10\uff1a<\/b>\u751f\u7269\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5357\u3002<\/span><\/p>\n<\/li>\n

    • \n

      EMA \u6307\u5357\uff1a<\/b>\u6cbb\u7597\u6027\u86cb\u767d\u8d28\u836f\u4ee3\u52a8\u529b\u5b66\u4e34\u5e8a\u7814\u7a76\u6307\u5357\uff0c\u5305\u62ec\u7279\u522b\u5f3a\u8c03\u4ea7\u54c1\u76f8\u5173\u6742\u8d28\u7684\u8be6\u7ec6\u8868\u5f81\uff08\u4f8b\u5982 2017 \u5e74\u6307\u5357\u7684\u7b2c 7.4 \u8282\uff09\u3002<\/span><\/p>\n<\/li>\n

    • \n

      FDA \u6307\u5357\uff1a<\/b>\u53cc\u7279\u5f02\u6027\u6297\u4f53\u5f00\u53d1\u9879\u76ee\u884c\u4e1a\u6307\u5357 (2021) \u548c 2019 \u5e74\u6307\u5357\u6846\u67b6\uff08\u5305\u62ec\u7b2c IV.A.3 \u8282\uff09\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n

      BsAbs PK \u548c\u514d\u75ab\u539f\u6027\u6311\u6218\uff1aKymos \u7ecf\u9a8c<\/h2>\n

      \u8bda\u7136\uff0c\u7531\u4e8e BsAbs \u7684\u7ed3\u6784\u590d\u6742\u6027\u548c\u53cc\u9776\u70b9\u7ed3\u5408\u7279\u6027\uff0c\u4e0e\u4f20\u7edf\u7684\u5355\u514b\u9686\u6297\u4f53\u76f8\u6bd4\uff0c\u5b83\u4eec\u5e26\u6765\u4e86\u989d\u5916\u7684\u5206\u6790\u6311\u6218\u3002<\/span><\/p>\n

      \u6839\u636e\u6211\u4eec\u7684\u7ecf\u9a8c\uff0c\u5728\u65b9\u6cd5\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u9700\u8981\u7279\u522b\u6ce8\u610f<\/strong>\u3002\u91cd\u8981\u7684\u662f\u8981\u5f7b\u5e95\u8bc4\u4f30\u6f5c\u5728\u7684\u9776\u70b9\u5e72\u6270<\/strong>\u3002\u6b64\u5916\uff0c\u9009\u62e9\u6700\u5408\u9002\u7684\u5206\u6790\u683c\u5f0f<\/strong>\u3001\u4ed4\u7ec6\u8868\u5f81\u5173\u952e\u8bd5\u5242<\/strong>\u5e76\u786e\u4fdd\u5728\u6240\u9700\u751f\u7269\u57fa\u8d28\u4e2d\u5177\u6709\u8db3\u591f\u7684\u5206\u6790\u6027\u80fd<\/strong>\u4e5f\u81f3\u5173\u91cd\u8981\u3002 <\/span><\/p>\n

      \u901a\u8fc7\u6211\u4eec\u7684 BsAb \u9879\u76ee\uff0c\u6211\u4eec\u5728\u5e94\u5bf9\u4e0e\u8fd9\u4e9b\u5206\u5b50\u76f8\u5173\u7684\u5e38\u89c1\u6311\u6218\u65b9\u9762\u79ef\u7d2f\u4e86\u5b9d\u8d35\u7684\u7ecf\u9a8c\u3002\u901a\u8fc7\u5168\u9762\u4e14\u6ce8\u91cd\u7ec6\u8282\u7684\u5206\u6790\u65b9\u6cd5\u5f00\u53d1\u4e0e\u4f18\u5316\uff0c\u6211\u4eec\u76f8\u4fe1\u53ef\u4ee5\u5efa\u7acb\u7a33\u5065\u53ef\u9760\u7684 PK \u548c ADA \u5206\u6790<\/strong>\u3002\u8fd9\u4e3a\u6210\u529f\u5f00\u53d1\u53ef\u5e94\u7528\u4e8e\u4e34\u5e8a\u524d\u548c\u4e34\u5e8a\u9879\u76ee\u7684\u5176\u4ed6 BsAbs \u5206\u6790\u65b9\u6cd5\u94fa\u5e73\u4e86\u9053\u8def\u3002 <\/span><\/p>\n

      Kymos \u96c6\u56e2\u5982\u4f55\u534f\u52a9 BsAbs \u7684\u5f00\u53d1\uff1f<\/h2>\n

      Kymos \u96c6\u56e2\u63d0\u4f9b\u4e00\u6574\u5957\u5206\u6790\u80fd\u529b\uff0c\u4ee5\u652f\u6301\u590d\u6742\u751f\u7269\u5236\u54c1\u7684\u751f\u7269\u5206\u6790\u548c CMC \u8981\u6c42\uff1a<\/span><\/p>\n

        \n
      • \n

        CMC \u548c\u7406\u5316\u6027\u8d28\uff1a<\/b>\u6297\u4f53\u8868\u5f81\u3001\u5206\u5b50\u5927\u5c0f\u3001\u5e8f\u5217\u6d4b\u5b9a\u548c\u5fae\u751f\u7269\u68c0\u6d4b\u3002<\/span><\/p>\n<\/li>\n

      • \n

        \u529f\u80fd\u548c\u6548\u529b\u6d4b\u8bd5\uff1a<\/b>\u901a\u8fc7 ELISA \u6216 SPR \u8fdb\u884c\u9776\u70b9\u7ed3\u5408\u548c\u86cb\u767d\u8d28\u76f8\u4e92\u4f5c\u7528\uff0c\u4ee5\u53ca\u7ec6\u80de\u6bd2\u6027\u548c\u57fa\u4e8e\u7ec6\u80de\u7684\u6548\u529b\u5206\u6790\u3002<\/span><\/p>\n<\/li>\n

      • \n

        \u4e34\u5e8a\u524d\u548c\u4e34\u5e8a\u751f\u7269\u5206\u6790\uff1a<\/b>\u901a\u8fc7\u914d\u4f53\u7ed3\u5408\u5206\u6790 (LBA) \u8fdb\u884c\u836f\u4ee3\u52a8\u529b\u5b66\u6c34\u5e73\u8bc4\u4f30\u3002<\/span><\/p>\n<\/li>\n

      • \n

        PD \u548c\u751f\u7269\u6807\u5fd7\u7269\uff1a<\/b>\u7528\u4e8e\u8ffd\u8e2a\u4e0d\u540c\u7ec6\u80de\u56e0\u5b50\u3001\u56e0\u5b50\u548c\u767d\u7ec6\u80de\u4ecb\u7d20\u7684\u591a\u91cd\u68c0\u6d4b\u80fd\u529b\u3002<\/span><\/p>\n<\/li>\n

      • \n

        \u9ad8\u7ea7\u514d\u75ab\u539f\u6027\uff1a<\/b>\u603b\u7ed3\u5408 ADA \u5206\u6790\u3001\u8be6\u7ec6\u7684\u7ed3\u6784\u57df\u8868\u5f81\u548c\u4e2d\u548c\u6297\u4f53 (NAb) \u68c0\u6d4b\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n

        \u53cc\u7279\u5f02\u6027\u6297\u4f53\u7684\u4e00\u7ad9\u5f0f\u89e3\u51b3\u65b9\u6848<\/h2>\n

        \u6211\u4eec\u901a\u8fc7\u5408\u5e76\u6211\u4eec\u4e13\u4e1a\u7684\u4e34\u5e8a\u524d\u548c\u4e34\u5e8a CRO \u80fd\u529b\uff0c\u4e3a\u5ba2\u6237\u7684\u9879\u76ee\u63d0\u4f9b\u5168\u5305\u5f0f\u534f\u52a9<\/strong>\uff0c\u5728\u7edf\u4e00\u7684\u76d1\u7ba1\u6846\u67b6\u4e0b\u6db5\u76d6 PK\u3001\u514d\u75ab\u539f\u6027\u3001\u751f\u7269\u6807\u5fd7\u7269\u548c\u5f7b\u5e95\u7684\u7ed3\u6784\u8868\u5f81\u3002<\/span><\/p>\n

        \u7ed3\u8bba<\/h2>\n

        \u6cbb\u7597\u6027\u6297\u4f53\u7684\u5f00\u53d1\u6b63\u901a\u8fc7 BsAbs \u7684\u5de5\u7a0b\u5316\u6539\u9020\u6765\u514b\u670d\u4f20\u7edf\u5355\u514b\u9686\u6297\u4f53 (mAbs) \u7684\u5c40\u9650\u6027\u3002\u5b83\u4eec\u7684\u53cc\u9776\u70b9\u4f5c\u7528\u673a\u5236\u4f7f\u5176\u80fd\u591f\u6709\u6548\u5730\u4f5c\u7528\u4e8e\u590d\u6742\u7684\u75be\u75c5\u901a\u8def\u3002\u7136\u800c\uff0c\u8fd9\u4e00\u72ec\u7279\u7279\u5f81\u53ca\u5176\u590d\u6742\u7684\u7ed3\u6784\u67b6\u6784\uff0c\u5f3a\u8c03\u4e86\u5bf9\u7597\u6548\u548c\u5b89\u5168\u6027\u5c5e\u6027\u8fdb\u884c\u5f7b\u5e95\u3001\u53ef\u9760\u8c03\u67e5\u7684\u7edd\u5bf9\u5fc5\u8981\u6027\u3002\u968f\u7740\u9488\u5bf9\u66f4\u591a\u4e34\u5e8a\u75c5\u75c7\u7684\u65b0\u5de5\u7a0b\u7b56\u7565\u4e0d\u65ad\u6d8c\u73b0\uff0c\u8fd9\u4e00\u4e0d\u65ad\u53d1\u5c55\u7684\u9886\u57df\u5728\u5f00\u53d1\u7684\u6bcf\u4e2a\u9636\u6bb5\u90fd\u9700\u8981\u7a33\u5065\u7684\u5206\u6790\u652f\u6301\u548c\u5148\u8fdb\u7684\u6280\u672f\u3002 <\/span><\/p>\n

        \u53c2\u8003\u6587\u732e<\/h2>\n
          \n
        • \n

          Tetsuya Wakabayashi, Taichi Kuramochi (2025) \u53cc\u7279\u5f02\u6027\u6297\u4f53\u7684\u53d1\u73b0\u4e0e\u5f00\u53d1\u3002Protein Expr Purif.<\/i> 2025 Dec:236:106787. doi: 10.1016\/j.pep.2025.106787. Epub 2025 Aug 5.<\/span><\/p>\n<\/li>\n

        • \n

          Ding Y, Andrien B, Sarkar M and Aimone M (2024). \u53cc\u7279\u5f02\u6027\u6297\u4f53\u7684\u5de5\u827a\u5f00\u53d1\u3001\u5236\u9020\u548c\u4e34\u5e8a\u652f\u6301\uff1a\u5316\u5b66\u3001\u5236\u9020\u548c\u63a7\u5236\u65b9\u9762\u7684\u8003\u8651\u3002BioProcess International<\/i> 22(11\u201312). <\/span><\/p>\n<\/li>\n

        • \n

          \u7f8e\u56fd\u536b\u751f\u4e0e\u516c\u4f17\u670d\u52a1\u90e8\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u7269\u8bc4\u4f30\u4e0e\u7814\u7a76\u4e2d\u5fc3 (CDER) (2021)\u3002\u53cc\u7279\u5f02\u6027\u6297\u4f53\u5f00\u53d1\u9879\u76ee\u884c\u4e1a\u6307\u5357\u3002\u7f8e\u56fd\u751f\u7269\u5236\u54c1\u8bc4\u4f30\u4e0e\u7814\u7a76\u4e2d\u5fc3 (CBER) \u836f\u7269\u8d28\u91cf\/CMC\u3002 <\/span><\/p>\n<\/li>\n

        • \n

          Choi et al. (2024). \u5df2\u83b7\u6279\u53cc\u7279\u5f02\u6027\u6297\u4f53\u7684\u4f5c\u7528\u673a\u5236\u548c\u836f\u4ee3\u52a8\u529b\u5b66\u3002Biomol Ther (Seoul)<\/i> 2024 Oct 25;32(6):708\u2013722. doi: 10.4062\/biomolther.2024.146. <\/span><\/p>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"

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