Triton X‐100 detergent treatment is a robust enveloped virus inactivation unit operation included in biopharmaceutical manufacturing processes. However, the European Commission officially placed Triton X‐100 on the Annex XIV authorization list in 2017 because a degradation product of Triton X‐100, 4‐(1,1,3,3‐tetramethylbutyl) phenol (also known as 4‐tert‐octylphenol), is considered to have harmful endocrine disrupting activities. As a result, the use of Triton X‐100 in the European Economic Area (EEA) would not be allowed unless an ECHA issued authorization was granted after the sunset date of January 4, 2021. This has prompted biopharmaceutical manufacturers to search for novel, environment‐friendly alternative detergents for enveloped virus inactivation. In this study, we report the identification of such a novel detergent, Simulsol SL 11W. Simulsol SL 11W is an undecyl glycoside surfactant produced from glucose and C11 fatty alcohol. We report here that Simulsol SL 11W was able to effectively inactive enveloped viruses, such as xenotropic murine leukemia virus (XMuLV) and pseudorabies virus (PRV). By using XMuLV as a representative enveloped virus, the influence of various parameters on the effectiveness of virus inactivation was evaluated. Virus inactivation by Simulsol SL 11W was effective across different clarified bioreactor harvests at broad concentrations, pH, and temperature ranges. Simulsol SL 11W concentration, temperature of inactivation, and treatment time were identified as critical process parameters for virus inactivation. Removal of Simulsol SL 11W was readily achieved by Protein A chromatography and product quality was not affected by detergent treatment. Taken together, these results have shown the potential of Simulsol SL 11W as a desirable alternative to Triton X‐100 for enveloped virus inactivation that could be readily implemented into biopharmaceutical manufacturing processes.

中文翻译：

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用于病毒灭活的 Triton X-100 替代品的鉴定和表征。

Triton X-100 去污剂处理是一种强大的包膜病毒灭活单元操作，包括在生物制药制造过程中。然而，欧盟委员会于 2017 年将 Triton X-100 正式列入附件 XIV 授权清单，因为 Triton X-100, 4-(1,1,3,3-四甲基丁基)苯酚（也称为 4-tert -辛基苯酚），被认为具有有害的内分泌干扰活动。因此，除非在 2021 年 1 月 4 日日落日期之后获得 ECHA 颁发的授权，否则不允许在欧洲经济区 (EEA) 使用 Triton X-100。这促使生物制药制造商寻找新的、用于包膜病毒灭活的环保替代洗涤剂。在这项研究中，我们报告了这种新型洗涤剂 Simulsol SL 11W 的鉴定。Simulsol SL 11W 是一种十一烷基糖苷表面活性剂，由葡萄糖和 C11 脂肪醇制成。我们在此报告 Simulsol SL 11W 能够有效灭活包膜病毒，例如异嗜性鼠白血病病毒 (XMuLV) 和伪狂犬病病毒 (PRV)。以XMuLV为代表的包膜病毒，评估了各种参数对病毒灭活效果的影响。Simulsol SL 11W 的病毒灭活在不同浓度、pH 值和温度范围内的不同澄清生物反应器收获中均有效。Simulsol SL 11W 浓度、灭活温度和处理时间被确定为病毒灭活的关键工艺参数。Simulsol SL 11W 很容易通过蛋白 A 色谱去除，产品质量不受洗涤剂处理的影响。