Abstract：
The session provided an update on the application and mechanistic understanding of intensified unit operations (e.g., mixed mode depth filters, mixed mode AEX) since the last conference in 2019. One of the key gaps identified in the 2019 Viral Clearance Symposium session on the topic was for more investigation required to achieve a clear understanding of the molecular mechanisms of virus removal and the relevance of different moleculés interactions including resin, virus, and product. Further investigation into worst-case conditions for these unit operations is also warranted. One of the key outcomes from that 2019 discussion was also that multimodal anion exchangers can have robust and effective virus removal, depending on process and impurities-an observation that was recapitulated with more specific case studies and evidenced by broader application of these chromatographic resins in late-stage regulatory filings.
摘要：
会议提供了对强化单元操作的应用和机械理解的更新(例如，混合模式深度过滤器，混合模式AEX）自2019年上一次会议以来。在2019年病毒清除研讨会上确定的关键差距之一是需要进行更多的调查，以明确了解病毒清除的分子机制以及包括树脂在内的不同分子相互作用的相关性。病毒,和产品。还需要对这些单元操作的最坏情况进行进一步调查。2019年讨论的关键成果之一是，多峰阴离子交换剂可以强大而有效地去除病毒，取决于过程和杂质-通过更具体的案例研究概括了这一观察结果，并通过这些色谱树脂在后期监管备案中的广泛应用得到了证明。
