{"id":53521,"date":"2018-09-28T01:00:00","date_gmt":"2018-09-30T01:45:57","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/%e5%b9%b2%e8%b4%a7%e4%b8%8b%e6%b8%b8%e7%ba%af%e5%8c%96%e5%b7%a5%e8%89%ba%e5%b9%b3%e5%8f%b0%e6%96%b9%e6%b3%95%e7%9a%84%e6%af%94%e8%be%83\/"},"modified":"2018-09-30T09:46:00","modified_gmt":"2018-09-30T01:46:00","slug":"%e5%b9%b2%e8%b4%a7%e4%b8%8b%e6%b8%b8%e7%ba%af%e5%8c%96%e5%b7%a5%e8%89%ba%e5%b9%b3%e5%8f%b0%e6%96%b9%e6%b3%95%e7%9a%84%e6%af%94%e8%be%83","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/53521\/","title":{"rendered":"\u5e72\u8d27|\u4e0b\u6e38\u7eaf\u5316\u5de5\u827a\u5e73\u53f0\u65b9\u6cd5\u7684\u6bd4\u8f83"},"content":{"rendered":"
\n

\u672c\u7bc7\u6587\u7ae0\u4e3b\u8981\u4ecb\u7ecd\u4e86\u5173\u4e8e\u6297\u4f53\u4e0b\u6e38\u7eaf\u5316\u5de5\u827a\u5f00\u53d1\u7684\u5e73\u53f0\u65b9\u6cd5\u3002\u4e00\u4e2a\u597d\u7684\u5e73\u53f0\u662f\u7531\u4e00\u4e2a\u4e2a\u5b9a\u4e49\u826f\u597d\u7684\u64cd\u4f5c\u5355\u5143\u6a21\u5757\u7ec4\u6210\uff0c\u800c\u5927\u90e8\u5206\u7684\u64cd\u4f5c\u5355\u5143\u90fd\u662f\u9884\u5148\u5b9a\u4e49\u597d\u7684\uff0c\u6211\u4eec\u9700\u8981\u5f00\u53d1\u7684\u53ea\u662f\u6bcf\u4e2a\u64cd\u4f5c\u5355\u5143\u4e2d\u7684\u5173\u952e\u5143\u7d20\u3002<\/span><\/p>\n

\u5173\u952e\u56e0\u7d20\u7684\u8003\u91cf\u662f\u8861\u91cf\u4e00\u4e2a\u5de5\u827a\u597d\u574f\u7684\u91cd\u8981\u6307\u6807\u3002\u9996\u5148\uff0c\u6211\u4eec\u9700\u8003\u8651\u7684\u56e0\u7d20\u662f\u7eaf\u5ea6\uff08\u4f8b\u5982\uff1aHCP\uff0c\u6b8b\u4f59DNA\uff0c\u6b8b\u4f59Protein A\uff0c\u7ec6\u83cc\u5185\u6bd2\u7d20\u7b49\uff09\u548c\u6742\u8d28\uff08\u4f8b\u5982\uff1a\u9ad8\u805a\u7269\uff0c\u4f4e\u805a\u7269\u7b49\uff09\u3002\u5176\u6b21\uff0c\u6574\u4e2a\u5de5\u5e8f\u4e2d\uff0c\u9664\u75c5\u6bd2\u7684\u80fd\u529b\u662f\u786e\u4fdd\u4ea7\u54c1\u5b89\u5168\u6027\u7684\u91cd\u8981\u4fdd\u969c\u3002\u518d\u6b21\uff0c\u6211\u4eec\u8fd8\u9700\u8981\u8003\u8651\u8fc7\u7a0b\u5f00\u53d1\u7684\u901f\u5ea6\uff0c\u5373\u4e00\u4e2a\u4ea7\u54c1\u4ece\u7814\u53d1\u5230\u8fdb\u5165\u4e34\u5e8a\u6240\u9700\u7684\u65f6\u95f4\u3002\u540c\u65f6\uff0c\u5de5\u827a\u8fd8\u5fc5\u987b\u6ee1\u8db3\u4e00\u4e9b\u6807\u51c6\u51c6\u5219\uff0c\u5305\u62ec\u6536\u7387\u3001\u4ea7\u91cf\u3001\u7a33\u5065\u6027\u3001\u53ef\u9760\u6027\u3001\u7a33\u5b9a\u6027\u7b49\u3002\u56e0\u6b64\uff0c\u4e00\u4e2a\u7075\u6d3b\u7684\u3001\u901a\u7528\u7684mAbs\u5e73\u53f0\u65b9\u6cd5\u7684\u5efa\u7acb\u5c24\u5176\u91cd\u8981\uff0c\u4e00\u65b9\u9762\u53ef\u4ee5\u5927\u5927\u7f29\u77ed\u65f6\u95f4\u6210\u672c\uff0c\u4e00\u65b9\u9762\u53ef\u4ee5\u751f\u4ea7\u51fa\u9ad8\u7eaf\u5ea6\u3001\u9ad8\u8d28\u91cf\u3001\u5b89\u5168\u6709\u4fdd\u969c\u7684\u4ea7\u54c1\u3002<\/span><\/p>\n

\u4e0b\u9762\uff0c\u6211\u4eec\u4ece\u4e00\u5f20\u6d41\u7a0b\u56fe\uff08Fig. 1\u548cFig. 2\uff09\u6765\u7b80\u5355\u4ecb\u7ecd\u548c\u6bd4\u8f83\u4e00\u4e0bAmgen\u548cGenentech\u53d1\u8868\u7684\u4e0b\u6e38\u5de5\u827a\u5e73\u53f0\u65b9\u6cd5\uff08\u6570\u636e\u4e3b\u8981\u6765\u6e90\u4e8e\u53c2\u8003\u6587\u732e\u6240\u5217\u56db\u7bc7\u6587\u732e\uff09\u3002<\/span><\/p>\n

\"\u5e72\u8d27|\u4e0b\u6e38\u7eaf\u5316\u5de5\u827a\u5e73\u53f0\u65b9\u6cd5\u7684\u6bd4\u8f83\"<\/span><\/p>\n

Fig. 1 Platform downstream process of mAbs of Amgen<\/span><\/p>\n

\"\u5e72\u8d27|\u4e0b\u6e38\u7eaf\u5316\u5de5\u827a\u5e73\u53f0\u65b9\u6cd5\u7684\u6bd4\u8f83\"<\/span><\/p>\n

Fig. 2 Platform downstream process of mAbs of Genentech<\/span>
<\/p>\n

\u6839\u636eFig.1 \u548cFig.2 \u6211\u4eec\u4e0d\u96be\u770b\u51fa\uff0cAmgen\u548cGenentech\u7684\u4e0b\u6e38\u7eaf\u5316\u5e73\u53f0\u65b9\u6cd5\u7684\u6846\u67b6\u57fa\u672c\u4e0a\u662f\u4e00\u81f4\u7684\u3002\u7b2c\u4e00\u6b65\uff0c\u7ec6\u80de\u6536\u83b7\u6db2\u7684\u6f84\u6e05\u5904\u7406\uff1b\u7b2c\u4e8c\u6b65\uff0c\u521d\u7eaf\u2014\u2014\u4eb2\u548c\u5c42\u6790\uff1b\u7b2c\u4e09\u6b65\uff0c\u75c5\u6bd2\u706d\u6d3b\uff1b\u7b2c\u56db\u6b65\uff0c\u7cbe\u7eaf\u2014\u2014\u9634\u9633\u79bb\u5b50\u5c42\u6790\uff1b\u7b2c\u4e94\u6b65\uff0c\u9664\u75c5\u6bd2\u8fc7\u6ee4\uff1b(\u8fd9\u91cc\u9700\u6ce8\u610f\u7684\u662fGenentech\u5c06\u9664\u75c5\u6bd2\u8fc7\u6ee4\u5de5\u5e8f\u653e\u5728\u4e86\u9634\u9633\u79bb\u5b50\u4e24\u6b65\u5c42\u6790\u4e2d\u95f4\u3002\u7b14\u8005\u8ba4\u4e3a\u987a\u5e8f\u7684\u4e0d\u540c\u5bf9\u6837\u54c1\u7eaf\u5ea6\u7684\u5f71\u54cd\u4e0d\u662f\u5f88\u5927\uff0c\u5de5\u5e8f\u7684\u5148\u540e\u53ef\u80fd\u53ea\u662f\u4e3a\u4e86\u65b9\u4fbf\u64cd\u4f5c\u3002)\u7b2c\u516d\u6b65\uff0c\u8d85\u6ee4\u900f\u6790\u3002\u8fd96\u6b65\u5373\u53ef\u770b\u4f5c\u662f5\u4e2a\u9884\u5148\u5b9a\u4e49\u597d\u7684\u64cd\u4f5c\u5355\u5143\uff0c\u6bcf\u4e00\u4e2a\u6297\u4f53\u4e4b\u95f4\u65e2\u6709\u76f8\u4f3c\u6027\u53c8\u5177\u6709\u5176\u81ea\u8eab\u7684\u7279\u5f02\u6027\uff0c\u6240\u4ee5\u8fd9\u5c31\u9700\u8981\u6211\u4eec\u5728\u8fd9\u4e9b\u9884\u5b9a\u4e49\u597d\u7684\u64cd\u4f5c\u5355\u5143\u91cc\u63a2\u7a76\u5e76\u786e\u5b9a\u4e00\u4e9b\u5173\u952e\u56e0\u7d20\uff0c\u4e3a\u6bcf\u4e00\u4e2a\u5355\u6297\u5206\u5b50\u90fd\u91cf\u8eab\u5b9a\u505a\u4e00\u4e2a\u6700\u4f73\u201c\u5c45\u4f4f\u5730\u201d\uff0c\u8fd9\u4e5f\u5c31\u610f\u5473\u7740\u4e00\u4e2a\u597d\u7684\u5e73\u53f0\u65b9\u6cd5\u5fc5\u987b\u5728\u5177\u6709\u4e00\u5b9a\u901a\u7528\u6027\u7684\u540c\u65f6\u4e5f\u5177\u5907\u8f83\u597d\u7684\u7075\u6d3b\u6027\u3002<\/span><\/p>\n

\u4e0b\u9762\u6211\u4eec\u5c06\u7ee7\u7eed\u53bb\u63a2\u7a76Amgen\u548cGenentech\u4ed6\u4eec\u5728\u6bcf\u4e00\u4e2a\u64cd\u4f5c\u6a21\u5757\u4e2d\u90fd\u63a2\u7a76\u4e86\u54ea\u4e9b\u5173\u952e\u56e0\u7d20\u53ca\u6bcf\u4e00\u4e2a\u6a21\u5757\u5b58\u5728\u7684\u610f\u4e49\u662f\u4ec0\u4e48\u3002<\/span><\/p>\n

\u7b2c\u4e00\u6b65\uff0c\u7ec6\u80de\u6536\u83b7\u6db2\u7684\u6f84\u6e05\u3002\u4e3b\u8981\u662f\u79bb\u5fc3\u3001\u6df1\u5c42\u8fc7\u6ee4\u3002\u6df1\u5c42\u8fc7\u6ee4\u5668\u4e3b\u8981\u91c7\u7528\u7684\u662f\u4e00\u79cd\u591a\u5b54\u4ecb\u8d28\uff0c\u4ece\u800c\u53ef\u4ee5\u53bb\u9664\u4e00\u4e9b\u7ec6\u80de\u788e\u7247\u548cHCP\u3002\u6df1\u5c42\u8fc7\u6ee4\u5668\u901a\u5e38\u4e0d\u4f1a\u6709\u7edd\u5bf9\u7684\u5b54\u9699\u5927\u5c0f\u8bc4\u5b9a\uff0c\u6240\u4ee5\u901a\u5e38\u6211\u4eec\u4f1a\u5728\u5176\u540e\u9762\u63a5\u4e00\u4e2a0.45\u03bcm\u62160.2\u03bcm\u7684\u8fc7\u6ee4\u5668\u6765\u53bb\u9664\u4e00\u4e9b\u56fa\u4f53\u5fae\u7c92\u3002\u8fd9\u4e00\u6b65\u64cd\u4f5c\u51e0\u4e4e\u9002\u7528\u4e8e\u6240\u6709\u7684mAbs\u3002<\/span><\/p>\n

\u7b2c\u4e8c\u6b65\uff0c\u521d\u7eaf\u2014\u2014\u4eb2\u548c\u5c42\u6790\u3002\u4eb2\u548c\u5c42\u6790\u4e3b\u8981\u7528\u4e8e\u6355\u83b7\u6297\u4f53\uff0c\u4f7f\u91d1\u9ec4\u8272\u8461\u8404\u7403\u83ccA\u86cb\u767d\u5728pH\u4e3a\u4e2d\u6027\u6216\u78b1\u6027\u6761\u4ef6\u4e0b\u4e0eIgG\u5206\u5b50\u7684Fc\u6bb5\u7279\u5f02\u6027\u7ed3\u5408\uff0c\u5728pH\u4e3a\u9178\u6027\u6761\u4ef6\u4e0b\u53ef\u4ee5\u89e3\u79bb\u88ab\u6d17\u8131\u4e0b\u6765\u3002\u8be5\u6b65\u9aa4\u53ef\u4ee5\u4f7f\u6837\u54c1\u7eaf\u5ea6\u8fbe\u523099%\uff0c\u8fd8\u53ef\u4ee5\u53bb\u966490%\u4ee5\u4e0a\u7684HCP\u548cDNA\uff0c\u4f18\u5316\u8f83\u597d\u7684\u5de5\u827a\u8fd8\u53ef\u4ee5\u53bb\u96646log\u4ee5\u4e0a\u7684\u75c5\u6bd2\u548c\u5c11\u91cf\u805a\u4f53\u3002\u4f46\u8be5\u6b65\u9aa4\u4e0d\u80fd\u53bb\u9664Fc\u7247\u6bb5\u3001\u5927\u91cf\u7684\u805a\u4f53\u548c\u8131\u843d\u7684Protein A\u3002Amgen\u548cGenentech\u5728\u4eb2\u548c\u5c42\u6790\u8fd9\u4e00\u6b65\u6240\u63a2\u7a76\u7684\u7684\u76f8\u5173\u64cd\u4f5c\u53c2\u6570\u5982Table 1\u548cTable 2\u6240\u793a\u3002<\/span><\/p>\n

Table 1 The Operational parameters for Protein A chromatography of Amgen<\/span><\/p>\n

\"\u5e72\u8d27|\u4e0b\u6e38\u7eaf\u5316\u5de5\u827a\u5e73\u53f0\u65b9\u6cd5\u7684\u6bd4\u8f83\"<\/p>\n

Table 2 The Operational parameters for Protein A chromatography of Genentech<\/span><\/p>\n

\"\u5e72\u8d27|\u4e0b\u6e38\u7eaf\u5316\u5de5\u827a\u5e73\u53f0\u65b9\u6cd5\u7684\u6bd4\u8f83\"<\/p>\n

   \u7b2c\u4e09\u6b65\uff0c\u75c5\u6bd2\u706d\u6d3b\u3002FDA\u7684Q5A\u6307\u5bfc\u6587\u4ef637\u8981\u6c42\u5fc5\u987b\u4f7f\u7528\u4e24\u79cd\u4e13\u95e8\u7528\u4e8e\u75c5\u6bd2\u51cf\u5c11\u7684\u65b9\u6cd5\u505a\u6b63\u4ea4\u5b9e\u9a8c\u8bc1\u660e\u54fa\u4e73\u52a8\u7269\u7ec6\u80de\u57f9\u517b\u4ea7\u7269\u7684\u5b89\u5168\u6027\u3002\u4f4epH\u5b75\u80b2\uff08pH<3.8\uff09\u5df2\u7ecf\u88ab\u8bc1\u660e\u662f\u4e00\u79cd\u6709\u6548\u75c5\u6bd2\u706d\u6d3b\u7684\u65b9\u6cd5\u3002Genentech\u5728\u4f4epH\u706d\u6d3b\u8fd9\u4e00\u6b65\u4e2d\u4e3b\u8981\u8003\u8651\u5230\u4ee5\u4e0b\u4e3b\u8981\u53c2\u6570\uff1apH\u3001\u5b75\u80b2\u65f6\u95f4\u3001\u5b75\u80b2\u6e29\u5ea6\u3001\u8c03\u9178buffer\u3001\u86cb\u767d\u6d53\u5ea6\u3001\u542b\u76d0\uff08NaCl\uff09\u91cf\u3001\u86cb\u767d\u7b49\u7535\u70b9\u7b49\u3002<\/span><\/p>\n

\u7b2c\u56db\u6b65\uff0c\u7cbe\u7eaf\u2014\u2014CEX\u3001AEX\u3002CEX\u91c7\u7528\u7684\u662f\u7ed3\u5408\u6a21\u5f0f\uff0c\u86cb\u767d\u5728pH<pI\u6761\u4ef6\u4e0b\u5e26\u6b63\u7535\uff0c\u4e0e\u9633\u79bb\u5b50\u4ea4\u6362\u5242\u7ed3\u5408\uff0c\u6700\u540e\u7528\u4e00\u5b9a\u76d0\u68af\u5ea6\u5c06\u76ee\u7684\u86cb\u767d\u6d17\u8131\u4e0b\u6765\uff0c\u5176\u4e3b\u8981\u53bb\u9664\u805a\u4f53\u3001\u6297\u4f53\u7247\u6bb5\u3001\u6b8b\u7559Protein A\u3001\u90e8\u5206HCP\u3002AEX\u91c7\u7528\u7684\u662f\u6d41\u7a7f\u6a21\u5f0f\uff0c\u86cb\u767d\u5728pH<pI\u6761\u4ef6\u4e0b\u5e26\u6b63\u7535\uff0c\u4e0e\u9634\u79bb\u5b50\u4ea4\u6362\u5242\u4e0d\u7ed3\u5408\uff0c\u76f4\u63a5\u6d41\u7a7f\uff1b\u800c\u5927\u90e8\u5206HCP\u7684pI< pH\uff0c\u5e26\u8d1f\u7535\uff0c\u4e0e\u9634\u79bb\u5b50\u4ea4\u6362\u5242\u7ed3\u5408\uff1b\u5728\u6b64\u6761\u4ef6\u4e0b\u6b8b\u4f59DNA\u3001\u7ec6\u83cc\u5185\u6bd2\u7d20\u4e5f\u80fd\u7ed3\u5408\u5728\u67f1\u5b50\u4e0a\uff1b\u56e0\u6b64\uff0cAEX\u4e3b\u8981\u53bb\u9664\u6b8b\u7559DNA\u3001HCP\u548c\u75c5\u6bd2\uff08>4log\uff09\u3002Amgen\u8ba4\u4e3a\uff0c\u7cbe\u7eaf\u8272\u8c31\u6cd5\u7684\u9009\u62e9\u53d6\u51b3\u4e8e\u9700\u8981\u6e05\u9664\u7684\u6742\u8d28\u6027\u8d28\u3002\u6839\u636e\u6742\u8d28\u7684\u6027\u8d28\u9009\u62e9\u6b63\u786e\u7684\u8272\u8c31\u65b9\u6cd5\uff08\u89c1Fig. 3\uff09\uff0c\u4f1a\u8fbe\u5230\u4e8b\u534a\u529f\u500d\u7684\u6548\u679c\u3002Genentech\u5728\u91c7\u7528CEX\u4e3b\u8981\u8003\u8651\u7684\u53c2\u6570\u5982Table 3\u6240\u793a\uff1b\u91c7\u7528AEX\u4e3b\u8981\u7814\u7a76\u4e86\u7ed3\u5408\u548c\u6d41\u7a7f\u4e24\u4e2a\u6a21\u5f0f\uff0c\u5176\u6d41\u7a7f\u6a21\u5f0f\u7684\u6761\u4ef6\u4e3apH\u4f4e\u4e8epI 0.5-1\u4e2a\u5355\u4f4d\uff0c\u7535\u5bfc<7.5 ms\/cm\uff1b\u76f8\u5173\u5b9e\u9a8c\u6570\u636e\u8868\u660e\uff1a\u7535\u5bfc\u8d8a\u4f4e\uff0cHCP\u6e05\u9664\u7387\u8d8a\u9ad8\uff1b\u800cpH\u8d8a\u9ad8\uff0c\u7535\u5bfc\u8d8a\u9ad8\uff0c\u90fd\u4f1a\u4f7f\u86cb\u767d\u8d8b\u5411\u4e8e\u7ed3\u5408\u67f1\u5b50\uff1b1M NaCl\u901a\u5e38\u7528\u4e8e\u9633\u67f1\u7684\u91cd\u751f\u3002<\/span><\/p>\n

\"\u5e72\u8d27|\u4e0b\u6e38\u7eaf\u5316\u5de5\u827a\u5e73\u53f0\u65b9\u6cd5\u7684\u6bd4\u8f83\"<\/span><\/p>\n

Fig. 3 Modes of chromatography employed for clearing specific kinds if contaminants<\/span><\/p>\n

Table 3 The Operational parameters for CEX of Genentech<\/span><\/p>\n

\"\u5e72\u8d27|\u4e0b\u6e38\u7eaf\u5316\u5de5\u827a\u5e73\u53f0\u65b9\u6cd5\u7684\u6bd4\u8f83\"<\/p>\n

   \u7b2c\u4e94\u6b65\uff0c\u9664\u75c5\u6bd2\u8fc7\u6ee4\u3002\u8be5\u6b65\u9aa4\u901a\u5e38\u662f\u7528\u6765\u8bc1\u660e\u75c5\u6bd2\u6709\u6548\u53bb\u9664\u7684\u7b2c\u4e8c\u4e2a\u65b9\u6cd5\u3002\u75c5\u6bd2\u8fc7\u6ee4\u5668\u6839\u636e\u5176\u5b54\u9699\u5927\u5c0f\u5206\u4e3a\u9006\u8f6c\u5f55\u75c5\u6bd2\uff08<50nm\uff09\u4ee5\u53ca\u7ec6\u5c0f\u75c5\u6bd2\uff08<20nm\uff09\u7ea7\u8fc7\u6ee4\u5668\u3002\u6839\u636e\u86cb\u767d\u91cf\uff0c\u9009\u62e9\u5408\u9002\u7684\u6ee4\u5668\uff0c\u5728\u6052\u538b\u6a21\u5f0f\u4e0b\u64cd\u4f5c\u3002<\/span>
<\/p>\n

\u7b2c\u516d\u6b65\uff0c\u8d85\u6ee4\u900f\u6790\u3002\u901a\u8fc7\u8be5\u6b65\u9aa4\u662f\u5c06\u6837\u54c1\u7f6e\u6362\u5230\u6700\u7ec8\u7684\u5236\u5242Buffer\u4e2d\uff0c\u6700\u7ec8\u5f62\u6210\u539f\u6db2\u4ee5\u4fbf\u51bb\u5b58\u6216\u5236\u6210\u6700\u7ec8\u7684\u6210\u54c1\u3002\u8be5\u6b65\u9aa4\u4e3b\u8981\u4f1a\u8003\u8651\u5230\u7684\u53c2\u6570\u6709\u8d85\u6ee4\u819c\u5305\u7684\u7c7b\u578b\u3001\u8de8\u819c\u538b\u529b\u3001\u900f\u6790\u500d\u6570\u3001\u6837\u54c1\u6d53\u5ea6\u7b49\u3002<\/span><\/p>\n

\u4ee5\u4e0a\u5373\u662f\u5173\u4e8eAmgen\u548cGenentech\u4e0b\u6e38\u7eaf\u5316\u5de5\u827a\u7684\u4e00\u4e2a\u5e73\u53f0\u65b9\u6cd5\u7684\u5168\u90e8\u5206\u4eab\u3002\u4e00\u4e2a\u597d\u7684\u5e73\u53f0\u65b9\u6cd5\u7684\u5efa\u7acb\u5fc5\u987b\u5728\u4fdd\u8bc1\u4ea7\u54c1\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u7684\u524d\u63d0\u4e0b\uff0c\u5177\u5907\u4e00\u5b9a\u7684\u901a\u7528\u6027\u3001\u7075\u6d3b\u6027\u3001\u7b80\u5355\u6027\u3001\u5ec9\u4ef7\u6027\u7b49\u3002\u5728\u6b64\u57fa\u7840\u4e0a\uff0c\u6211\u4eec\u624d\u80fd\u771f\u6b63\u505a\u5230\u505a\u597d\u6bcf\u4e00\u4e2a\u6297\u4f53\u3002<\/span><\/p>\n

\u53c2\u8003\u6587\u732e<\/span><\/p>\n

1.Abhinav A. Shukla , Brian Hubbard, Tim Tressel, Sam Guhan, Duncan Low. Downstream processing of monoclonal antibodies\u2014Applicationof platform approaches. Journal of Chromatography B, 848 (2007) 28\u201339<\/span><\/p>\n

2.Benedicte Lebreton, Gregory S. Blank, Stefanie Sze-Khoo. Purification Strategies to Process 5 g\/L Titers of Monoclonal Antibodies. BioPharm International Volume 2009 Supplement, Issue 2.<\/span><\/p>\n

3.Robert L. Fahrner , Heather L. Knudsen , Carol D.Basey. Industrial Purification of Pharmaceutical Antibodies: Development, Operation, and Validation of Chromatography Processes. Biotechnology and Genetic Engineering Reviews 18(2001) 301.<\/span><\/p>\n

4.Yuan Xu. Bracketed Generic Inactivation of rodent Retroviruses by Low pH treatment for Monoclonal Antibodies and Recombinant Proteins. Biotechnology and Bioengineering, 2003,82(3)\uff0c321-329.<\/span><\/p>\n

\u57f9\u8bad\u63a8\u8350<\/span><\/strong><\/p>\n

\u7b26\u5408 \u201cFDA\u8d28\u91cf\u91cf\u5ea6\u8349\u6848\u201d\u7684\u4ea7\u54c1\u8d28\u91cf\u5e74\u5ea6\u56de\u987e\u7814\u8ba8\u4f1a<\/strong><\/a>
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“\u65b0\u836f\u5f00\u53d1\u4e2d\u7684\u9879\u76ee\u7ba1\u7406\u548c\u6cd5\u89c4\u6ce8\u518c\u7b56\u7565”(\u6b66\u6c49\uff09\u6280\u672f\u4ea4\u6d41\u4f1a<\/span><\/a><\/span><\/strong><\/span><\/p>\n

\u7b2c\u4e8c\u671f\u201c\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836fGMP\u5236\u5ea6\u8981\u70b9\u89e3\u6790\u53ca\u5e94\u7528\u5b9e\u65bd<\/a><\/span><\/strong><\/span><\/p>\n

\u3010\u6b63\u5728\u62db\u751f\u3011\uff089\u6708\u6d4e\u5357\uff09\u5236\u836f\u4f01\u4e1a\u9a8c\u8bc1\u7ba1\u7406\u9ad8\u7ea7\u7814\u4fee\u73ed\uff08\u7b2c\u516d\u671f\uff09<\/a><\/span><\/strong><\/span>
<\/span><\/p>\n

\u7814\u53d1\u8d28\u91cf\u7ba1\u7406\u8fd0\u884c\u96be\u70b9\u5b9e\u65bd\u53ca\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836f\u7269GMP\u5b9e\u65bd\u5173\u952e\u70b9\u63a7\u5236\u201d\u9ad8\u7ea7\u7814\u4fee\u73ed<\/a><\/span><\/strong><\/span><\/p>\n

\u8bc6\u522b\u5fae\u4fe1\u4e8c\u7ef4\u7801\uff0c\u6dfb\u52a0\u751f\u7269\u5236\u54c1\u5708\u5c0f\u7f16\uff0c\u7b26\u5408\u6761\u4ef6\u8005\u5373\u53ef\u52a0\u5165\u751f\u7269\u5236\u54c1\u5fae\u4fe1\u7fa4\uff01<\/strong>
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\u8bf7\u6ce8\u660e\uff1a\u59d3\u540d+\u7814\u7a76\u65b9\u5411\uff01<\/strong><\/span><\/p>\n

\"\u5e72\u8d27|\u4e0b\u6e38\u7eaf\u5316\u5de5\u827a\u5e73\u53f0\u65b9\u6cd5\u7684\u6bd4\u8f83\"\"\u5e72\u8d27|\u4e0b\u6e38\u7eaf\u5316\u5de5\u827a\u5e73\u53f0\u65b9\u6cd5\u7684\u6bd4\u8f83\"<\/p>\n

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\u7248\u6743\u4e3a\u751f\u7269\u5236\u54c1\u5708\u6240\u6709\u3002\u6b22\u8fce\u4e2a\u4eba\u8f6c\u53d1\u5206\u4eab\u3002\u5176\u4ed6\u4efb\u4f55\u5a92\u4f53\u3001\u7f51\u7ad9\u5982\u9700\u8f6c\u8f7d\u6216\u5f15\u7528\u672c\u7f51\u7248\u6743\u6240\u6709\u5185\u5bb9\u987b\u83b7\u5f97\u6388\u6743\u4e14\u5728\u9192\u76ee\u4f4d\u7f6e\u5904\u6ce8\u660e\u201c\u8f6c\u81ea\uff1a\u751f\u7269\u5236\u54c1\u5708\u201d\u3002<\/span><\/p>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"

\u672c\u7bc7\u6587\u7ae0\u4e3b\u8981\u4ecb\u7ecd\u4e86\u5173\u4e8e\u6297\u4f53\u4e0b\u6e38\u7eaf\u5316\u5de5\u827a\u5f00\u53d1\u7684\u5e73\u53f0\u65b9\u6cd5\u3002\u4e00\u4e2a\u597d\u7684\u5e73\u53f0\u662f\u7531\u4e00\u4e2a\u4e2a\u5b9a\u4e49\u826f\u597d\u7684\u64cd\u4f5c\u5355\u5143\u6a21\u5757\u7ec4\u6210\uff0c\u800c\u5927\u90e8 […]<\/p>\n","protected":false},"author":1,"featured_media":53522,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/53521"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=53521"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/53521\/revisions"}],"predecessor-version":[{"id":53531,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/53521\/revisions\/53531"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/53522"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=53521"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=53521"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=53521"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}