Vaishali Sharma, Lynn Manchester, Melissa Holstein, Xuankuo Xu, Sanchayita Ghose, Caryn L. Heldt
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引用次数: 0
摘要
背景可持续和有效的病毒灭活策略对于确保生物制品的安全和质量至关重要。欧盟2021年禁止Triton X-100在生物制造中用于病毒灭活,这促使该领域寻找同样有效的可持续替代品。我们的目标是通过比较Triton X-100与糖苷和胺氧化物的抗病毒功效,确保生态友好的表面活性剂介导的病毒灭活的有效性,从而提高生物制药生产的可持续性。结果观察表面活性剂对疱疹病毒、SuHV、HSV和逆转录病毒XMuLV的抗病毒作用。与Triton X-100相比,表面活性剂表现出同等或更好的失活效果。疱疹病毒的灭活与所有表面活性剂相似。对于XMuLV,具有较长烷基链的表面活性剂在1倍CMC时达到最大对数降低值(LRV),优于Triton X-100,后者需要2倍CMC才能达到相同的效果。具有庞大头基团的表面活性剂,如LAPAO,对XMuLV的效果较低。在离子强度为2 M的盐浓度下,Triton X-100和TDAO对疱疹病毒的抗病毒作用下降。在0.5倍CMC时,表面活性剂的失活变化,表明表面活性剂的特性影响其在低于CMC时的抗病毒性能。结论盐的加入通过降低表面活性剂的CMC来增强表面活性剂的抗病毒作用,同时保持病毒灭活的一致性。在测试的表面活性剂中,尾部较长的葡萄糖苷n-壬基-β- d -葡萄糖苷(NG)表现出最强的活性,可以作为生物加工过程中病毒灭活的环保表面活性剂。对于NG,病毒灭活与所有测试变量无关。
Impact of Eco-Friendly Surfactant Structure and Class on Enveloped Virus Inactivation
Background
Sustainable and effective strategies for virus inactivation are crucial for ensuring the safety and quality of biological products. The European Union's (EU) 2021 ban on Triton X-100 for viral inactivation in biomanufacturing has pushed the field to find sustainable alternatives with equal effectiveness. We aim to increase the sustainability of biopharmaceutical production by ensuring the effectiveness of eco-friendly surfactant-mediated virus inactivation by comparing the antiviral efficacy of Triton X-100 to glucosides and amine oxides.
Results
Surfactants were evaluated for antiviral efficacy against herpes viruses, SuHV and HSV, and the retrovirus XMuLV. The surfactants demonstrated equivalent or superior inactivation efficacy compared to Triton X-100. Herpes viruses were inactivated similarly with all surfactants. For XMuLV, surfactants with longer alkyl chains achieved maximum log reduction values (LRV) at 1x CMC, outperforming Triton X-100, which required 2x CMC for comparable efficacy. Surfactants with bulky headgroups, such as LAPAO, showed lower efficacy against XMuLV. At a salt concentration of 2 M ionic strength, the antiviral efficacy of Triton X-100 and TDAO decreased for the herpes viruses. Variability in inactivation was observed among the surfactants at 0.5x CMC, indicating that surfactant characteristics influence their antiviral performance below CMC.
Conclusions
Adding salt enhanced the antiviral efficacy of surfactants by lowering their CMC while maintaining consistent virus inactivation. Among the surfactants tested, the glucoside with a longer tail, n-nonyl-β-D-glucoside (NG), emerged as the most robust and could function as an eco-friendly surfactant for virus inactivation in bioprocessing. For NG, virus inactivation was independent of all variables tested.
Biotechnology JournalBiochemistry, Genetics and Molecular Biology-Molecular Medicine
CiteScore
8.90
自引率
2.10%
发文量
123
审稿时长
1.5 months
期刊介绍:
Biotechnology Journal (2019 Journal Citation Reports: 3.543) is fully comprehensive in its scope and publishes strictly peer-reviewed papers covering novel aspects and methods in all areas of biotechnology. Some issues are devoted to a special topic, providing the latest information on the most crucial areas of research and technological advances.
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