McCormick Lisa, Maheshwari Gargi
Fermentation and Cell Culture, Bioprocess R&D, Merck Research Laboratories, Merck and Co., Inc., P.O. Box 4, WP17-201, West Point, PA 19486, USA.
Antiviral Res. 2004 Oct;64(1):27-33. doi: 10.1016/j.antiviral.2004.04.008.
Throughout the pharmaceutical industry, adenovirus-based products are being developed for human use as vaccine vectors and gene therapy delivery vehicles. The implementation of effective decontamination procedures is critical to the successful manufacture of these products to minimize the risk of personnel exposure and prevent product cross-contamination in the manufacturing facility. In this investigation, we have conducted small-scale decontamination studies to determine the efficacy of Virkon S on the inactivation of adenovirus types 5 and 6 in suspension. Virkon S is a commercially available oxidative disinfectant used against a variety of bacteria, spores, fungi, and viruses. A cytotoxicity-based endpoint dilution assay was used to quantify adenovirus potency before and after Virkon S treatment. We show that the level of organic content in the inactivation sample matrix has a significant impact on Virkon S activity. The potency of adenovirus types 5 and 6 was reduced by greater than six logs upon a five minute exposure to the appropriate concentration of Virkon S. Based on these results, we propose that Virkon S liquid decontamination procedures for adenovirus types 5 and 6 use 0.9% Virkon S for contact times greater than five minutes.
在整个制药行业,基于腺病毒的产品正被开发用于人类,作为疫苗载体和基因治疗递送工具。实施有效的去污程序对于这些产品的成功生产至关重要,以将人员暴露风险降至最低,并防止生产设施中的产品交叉污染。在本研究中,我们进行了小规模去污研究,以确定Virkon S对悬浮液中5型和6型腺病毒的灭活效果。Virkon S是一种市售的氧化性消毒剂,可用于对抗多种细菌、孢子、真菌和病毒。基于细胞毒性的终点稀释测定法用于量化Virkon S处理前后腺病毒的效价。我们表明,灭活样品基质中的有机含量水平对Virkon S的活性有显著影响。5型和6型腺病毒在暴露于适当浓度的Virkon S五分钟后,效价降低了超过6个对数。基于这些结果,我们建议针对5型和6型腺病毒的Virkon S液体去污程序使用0.9%的Virkon S,接触时间超过五分钟。