Wierenga D E, Cogan J, Petricciani J C
Pharmaceutical Research and Manufacturers of America, Washington, DC, USA.
Biologicals. 1995 Sep;23(3):221-4. doi: 10.1006/biol.1995.0036.
For decades, developers and regulators of vaccines and other biological products have been concerned about the theoretical risk to patients posed by contaminants derived from the cell substrates used to produce those products. The present study addresses the issue of how risky DNA may be as a residual impurity by injecting both normal and immunosuppressed monkeys with 10(8) genome equivalents of DNA from a human tumor cell line. After more than eight years of observation, none of the animals shows evidence of neoplastic disease. The results of this study along with clinical experiences with already approved products derived from continuous cell lines suggest that he benefits of using such cells for the production of biologicals far outweigh any theoretical risks associated with DNA.
几十年来，疫苗及其他生物制品的研发者和监管者一直担心用于生产这些制品的细胞基质所产生的污染物会给患者带来理论上的风险。本研究通过给正常和免疫抑制的猴子注射来自一种人类肿瘤细胞系的10⁸个基因组当量的DNA，探讨了DNA作为残留杂质可能存在多大风险的问题。经过八年多的观察，没有一只动物出现肿瘤疾病的迹象。这项研究的结果以及来自已获批准的连续细胞系制品的临床经验表明，使用此类细胞生产生物制品的益处远远超过与DNA相关的任何理论风险。
