Continued insights into virus clearance validation across continuous capture chromatography,Biotechnology and Bioengineering

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Continued insights into virus clearance validation across continuous capture chromatography
Biotechnology and Bioengineering ( IF 3.5 ) Pub Date : 2021-01-09 , DOI: 10.1002/bit.27674
James M Angelo ₁ , Kevin Potter ₁ , Thomas Müller-Späth ₂ , Xuankuo Xu ₁ , Zheng Jian Li ₁ , Sanchayita Ghose ₁

Affiliation

Multi-column capture chromatography (MCC) has gained increased attention lately due to the significant economic and process-related advantages it offers compared to traditional batch mode chromatography. However, for wide adoption of this technology in the clinical and commercial space, it requires scalable models for viral validation. In this study, additional viral validation studies were conducted under cGLP guidelines to assess retro-(X-MuLV) and parvo-virus (minute virus of mice) clearance across twin-column continuous capture chromatography (CaptureSMB) to supplement work previously performed. A surrogate model was validated using standard batch mode chromatography equipment based on flow path modifications to mimic the loading strategy employed in CaptureSMB. In addition, aged resin was used in this surrogate format to assess the impact of resin lifetime on viral clearance during continuous capture operation. The impact of column loading was also explored to shed light on the viral clearance mechanisms of protein A chromatography in overloading conditions. The proposed approach greatly simplifies MCC virus validation studies, and provides a robust strategy for regulatory filing of continuous biomanufacturing processes.

中文翻译：

继续深入了解连续捕获色谱中的病毒清除验证

与传统的批处理模式色谱相比，多柱捕获色谱 (MCC) 近来受到越来越多的关注，因为它具有显着的经济和工艺相关优势。然而，为了在临床和商业领域广泛采用这项技术，它需要可扩展的病毒验证模型。在这项研究中，根据 cGLP 指南进行了额外的病毒验证研究，以评估逆转录病毒（X-MuLV）和细小病毒（小鼠微小病毒）在双柱连续捕获色谱 (CaptureSMB) 中的清除率，以补充之前进行的工作。使用基于流路修改的标准批处理模式色谱设备验证替代模型，以模拟 CaptureSMB 中采用的加载策略。此外，在这种替代形式中使用老化的树脂来评估树脂寿命对连续捕获操作期间病毒清除的影响。还探讨了柱加载的影响，以阐明超载条件下蛋白 A 层析的病毒清除机制。所提出的方法极大地简化了 MCC 病毒验证研究，并为连续生物制造过程的监管备案提供了强有力的策略。

更新日期：2021-01-09

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