Horaud F
Institut Pasteur, Paris, France.
Biologicals. 1995 Sep;23(3):225-8. doi: 10.1006/biol.1995.0037.
The acceptability of viral vaccines manufactured in culture of continuous cell lines opened the way to a new technology of vaccine preparation. The large scale cultivation of continuous cell lines contributed greatly to the improvement of the safety and the consistency of viral vaccines. Experimental studies concerning residual cellular DNA and its oncogenic potential showed clearly that this material is not able to induce tumours. The small amounts of cellular DNA present in the final product, and the deleterious effect of the vaccine manufacturing process on the integrity and biological activity of DNA, both contribute to regarding residual cellular DNA as an issue of no practical importance. There is no evidence that limits on the concentration of residual cellular DNA in the final product is scientifically justified.
在连续细胞系培养物中生产的病毒疫苗的可接受性为疫苗制备的新技术开辟了道路。连续细胞系的大规模培养极大地促进了病毒疫苗安全性和一致性的提高。关于残留细胞DNA及其致癌潜力的实验研究清楚地表明，这种物质不能诱发肿瘤。最终产品中存在的少量细胞DNA以及疫苗生产过程对DNA完整性和生物活性的有害影响，都使得残留细胞DNA被视为一个没有实际重要性的问题。没有证据表明对最终产品中残留细胞DNA浓度的限制在科学上是合理的。
