In regenerative medical products for clinical applications, a major concern is the risk of ruminant-derived materials developing transmissible spongiform encephalopathy (TSE) in the manufacturing process. Because of the risk of TSE causing prion disease, the raw materials derived from ruminants should be compliant with the “Standard for Biological Raw Materials” to ensure the quality and safety of pharmaceutical products. We therefore tested whether plasmid DNA could withstand four chemical reagents (Gdn-HCl, Gdn-SCN, TCA, or SDS), having referred to the report by Tateishi et al. [1], which describes how Creutzfeldt–Jakob disease pathogens can be inactivated by chemical reagents capable of producing a 7-log reduction in prion inactivation. We observed that plasmid DNA was mixed with chemical reagents and that the functionality of plasmid DNA was equivalent for both chemical and non-chemical treatment. The potency of plasmid DNA was monitored by the existence of DNA fragments and the function by which GFP proteins were produced by HEK293-cell transfected plasmid DNA. The existence of DNA fragments was detected in plasmid DNA treated by chemical reagents, except when undergoing TCA treatment. Additionally, when HEK293 cells were transfected with the plasmid DNA after chemical treatment, GFP protein was produced. These results indicate that plasmid DNA can withstand the chemical treatments for blocking prion transmission.

在用于临床的再生医疗产品中，主要关注的问题是反刍动物衍生材料在生产过程中发展为传染性海绵状脑病（TSE）的风险。由于TSE可能引起病毒疾病，因此反刍动物的原料应符合“生物原料标准”，以确保药品的质量和安全性。因此，在参考Tateishi等人的报告后，我们测试了质粒DNA是否可以承受四种化学试剂（Gdn-HCl，Gdn-SCN，TCA或SDS）。[1]，它描述了如何通过能够使in病毒灭活减少7个对数的化学试剂灭活Creutzfeldt–Jakob病原体。我们观察到质粒DNA与化学试剂混合在一起，并且质粒DNA的功能对于化学和非化学处理都是等效的。通过DNA片段的存在以及通过HEK293细胞转染的质粒DNA产生GFP蛋白的功能来监测质粒DNA的效力。用化学试剂处理过的质粒DNA中检测到DNA片段的存在，但进行TCA处理时除外。另外，当化学处理后用质粒DNA转染HEK293细胞时，产生了GFP蛋白。这些结果表明质粒DNA可以耐受阻断blocking病毒传播的化学处理。通过DNA片段的存在以及HEK293细胞转染的质粒DNA产生GFP蛋白的功能来监测质粒DNA的效力。用化学试剂处理过的质粒DNA中检测到DNA片段的存在，但进行TCA处理时除外。另外，当化学处理后用质粒DNA转染HEK293细胞时，产生了GFP蛋白。这些结果表明质粒DNA可以耐受阻断blocking病毒传播的化学处理。通过DNA片段的存在以及HEK293细胞转染的质粒DNA产生GFP蛋白的功能来监测质粒DNA的效力。用化学试剂处理过的质粒DNA中检测到DNA片段的存在，但进行TCA处理时除外。另外，当化学处理后用质粒DNA转染HEK293细胞时，产生了GFP蛋白。这些结果表明质粒DNA可以耐受阻断blocking病毒传播的化学处理。