摘要
生物制品中残留DNA可能具有感染性和致癌性，因此生物制品的纯化过程需要验证，尽可能将产品中残留DNA的水平降到最低。厂家有必：要显示DNA去除过程，并有适当定量分析方法检测残留DNA的含量。当前DNA定量分析所采用的最普遍方法是定量PCR（quantitative real time polymerase chain reaction，Q-PCR）。此文就残留DNA的感染性、致癌性、免疫原性等潜在风险以及残留DNA分析技术的最新进展做一综述。
The residual DNA （rDNA） in biological products may be potentially infections or oneogenic, so purification processes need to be validated for confirming its clearance. It is necessary for manufacturers to show clearance of DNA throughout production processes and to confirm rDNA levels in the final products using an appropriately specific and quantitative analytical method. The most common methodology for rDNA quantitation used currently is a quantitative realtime polymerase chain reaction. In this paper, potential risks of infectivity, oneogenieity, and immunogenicity of rDNA and recent progress in rDNA analysis techniques are reviewed.
出处
《国际生物制品学杂志》
CAS
2013年第1期30-34,共5页
International Journal of Biologicals
关键词
生物制品
残留DNA
聚合酶链反应
Biological products
Residual DNA
Polymerase chain reaction
