Establishing acceptable limits of residual DNA.
Establishing acceptable limits of residual DNA.
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DOI：
10.5731/pdajpst.2013.00910
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发表时间：
2013-03-01
影响因子：
--
通讯作者：
Yang, Harry
中科院分区：
文献类型：
--
作者：
Yang, Harry
生物制品可能含有宿主细胞底物中的残留DNA。因此，这种残留的DNA可能编码或藏匿癌基因和感染剂，并传播给产品接受者，导致可能的致癌或感染事件。世界卫生组织和美国食品和药物管理局的指南建议，最终产品剂量中残留DNA的含量和大小限制为10 ng/剂和200个碱基对。本文讨论了使用一种基于风险的方法建立可接受的残留DNA限量，该方法可能不同于当前的法规规范。还对目前用于DNA安全性评估的方法进行了综述和比较。LAY摘要：从细胞等生物来源生产的药物可能含有DNA。目前尚不清楚DNA对产品接受者的健康风险有多大，但通常可以通过降低DNA水平来设计制造过程，将风险降至最低。本文介绍了计算健康风险的新方法。
Biological products can contain residual DNA from host cell substrates. It is therefore possible that such residual DNA could encode or harbor oncogenes and infectious agents, and transmit to product recipients, leading to possible oncogenic or infective events. The World Health Organization and U.S. Food and Drug Administration guidelines recommend that 10 ng/dose and 200 base pairs be the limits of content and size of residual DNA in the final product dose. This paper discusses establishment of acceptable limits of residual DNA using a risk-based approach that may differ from the current regulatory specifications. Methods currently in use for DNA safety assessment are also reviewed and compared.LAY ABSTRACT: Medicines produced from biological sources like cells can contain DNA. It is not clear what health risk the DNA can pose in the product recipients, but often manufacturing can be designed to minimize the risk by reducing the levels of DNA. This article describes new methods for calculating the health risks.