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Development and Validation of Quantitative Real-Time PCR for the Detection of Residual CHO Host Cell DNA and Optimization of Sample Pretreatment Method in Biopharmaceutical Products

机译:生物药物产品中残留CHO宿主细胞DNA检测实时定量PCR的开发与验证以及样品前处理方法的优化

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摘要

BackgroundThe presence of residual DNA carried by biological products in the body may lead to an increased oncogenicity, infectivity, and immunomodulatory risk. Therefore, current agencies including WHO, EU, and the FDA limited the accepted amounts of residual DNA (less than 10 ng or 100 pg/dose). Among the methods of detecting residual DNA, qPCR is considered to be the most practical for residual DNA quantitation due to its sensitivity, accuracy, precision, and time-saving.
机译:背景技术生物制品携带的残留DNA可能会导致体内致癌性,感染性和免疫调节风险增加。因此,包括WHO,EU和FDA在内的当前机构限制了可接受的残留DNA量(少于10μng或100μpg/剂量)。在检测残留DNA的方法中,qPCR被认为是最实用的残留DNA定量方法,因为它具有灵敏性,准确性,准确性和省时性。

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