Petricciani J C, Regan P J
World Health Organization, Geneva, Switzerland.
Dev Biol Stand. 1987;68:43-9.
Based on a number of assumptions about oncogene size, frequency, biological integrity, and in vitro as well as in vivo transformation efficiency, estimates are made of the risk that the residual cellular DNA (rcDNA) contaminant in a biological product will cause a neoplastic transformation event. Using a statistical Poisson distribution approach, the probability of such an event is calculated to be at most 10(-6) assuming optimal in vitro conditions with 100 oncogene copies per cell and a 10 pg contaminant. More realistic assumptions using in vivo data suggest that the probability of a transformation event is at most 10(-9) assuming 100 oncogene copies per cell and a contaminant of 1 ng. Imperfections of the model and specific considerations of the human in vivo case are discussed.
基于对癌基因大小、频率、生物学完整性以及体外和体内转化效率的若干假设，对生物制品中残留细胞DNA（rcDNA）污染物导致肿瘤转化事件的风险进行了估计。使用统计泊松分布方法，假设在体外最佳条件下每个细胞有100个癌基因拷贝且污染物为10 pg，计算出此类事件的概率至多为10^(-6)。使用体内数据的更现实假设表明，假设每个细胞有100个癌基因拷贝且污染物为1 ng，转化事件的概率至多为10^(-9)。讨论了模型的不完善之处以及人体体内情况的具体考量。
