Chang Jen-Ting, Chou Yu-Chi, Lin Meng-Shiue, Wang Shih-Rong
Division of Biotechnology, Animal Technology Institute Taiwan, Chunan, Miaoli, ROC.
Jpn J Vet Res. 2010 Nov;58(3-4):179-83.
By selecting pseudorabies virus (PrV) as a model virus, this study assessed the feasibility of applying viral inactivation strategies to manufacturing medicinal products from the milk of transgenic sows. The efficacy of heat, acidic/alkaline and detergent treatments was also evaluated with respect to their ability to inactivate PrV in milk samples. Experimental results indicate that PrV was inactivated obviously at least 7.125 log10 for 30 min at 60 degrees C. At alkaline values of pH 10 and acidic value of pH 4, PrV infectivity was reduced to 3.625 log10 and exceeded 5 log10, respectively. Moreover, PrV virus was inactivated efficiently (> 3.875 log10) by using 0.25-1% of Triton X-100 treatment and without a loss of biological activity of the recombinant human coagulation factor IX (rhFIX).
of this study demonstrate the effectiveness of the proposed detergent inactivation method for PrV inactivation of rhFIX production from transgenic products, especially in milk materials.
本研究选择伪狂犬病病毒(PrV)作为模型病毒,评估了将病毒灭活策略应用于从转基因母猪乳汁生产药用产品的可行性。还针对热、酸/碱和去污剂处理对牛奶样品中PrV的灭活能力进行了评估。实验结果表明,在60℃下处理30分钟,PrV明显被灭活至少7.125 log10。在pH值为10的碱性条件和pH值为4的酸性条件下,PrV的感染力分别降至3.625 log10和超过5 log10。此外,使用0.25 - 1%的 Triton X - 100处理可有效灭活PrV病毒(> 3.875 log10),且重组人凝血因子IX(rhFIX)的生物活性未损失。
本研究证明了所提出的去污剂灭活方法对从转基因产品,特别是牛奶原料中生产rhFIX时PrV灭活的有效性。