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首页> 外文期刊>Biotechnology Progress >Prediction of Viral Filtration Performance of Monoclonal Antibodies Based on Biophysical Properties of Feed
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Prediction of Viral Filtration Performance of Monoclonal Antibodies Based on Biophysical Properties of Feed

机译：基于饲料生物物理特性的单克隆抗体病毒过滤性能预测

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Controlling viral contamination is an important issue in the process development of monoclonal antibodies (MAbs) produced from mammalian cell lines. Virus filtration (VF) has been demonstrated to be a robust and effective clearance step which can provide >= 4 logs of reduction via size exclusion. The minimization of VF area by increasing flux and filter loading is critical to achieving cost targets as VFs are single use and often represent up to 10% of total purification costs. The research presented in this publication describes a development strategy focused on biophysical attributes of product streams that are directly applicable to VF process performance. This article summarizes a case study where biophysical tools (high-pressure size exclusion chromatography, dynamic light scattering, and absolute size exclusion chromatography) were applied to a specific MAb program to illustrate how changes in feed composition (pH, sodium chloride concentration, and buffer salt type) can change biophysical properties which correlate with VF performance. The approach was subsequently refined and expanded over the course of development of three MAbs where performance metrics (i.e., loading and flux) were evaluated for two specific virus filters (Viresolve Pro and Planova 20N) during both unspiked control runs and virus clearance experiments. The analyses of feed attributes can be applied to a decision tree to guide the recommendation of a VF filter and operating conditions for use in future MAb program development. The understanding of the biophysical properties of the feed can be correlated to virus filter performance to significantly reduce the mass of product, time, and costs associated with virus filter step development. (C) 2015 American Institute of Chemical Engineers
机译：控制病毒污染是从哺乳动物细胞系生产单克隆抗体（MAb）的过程开发中的重要问题。病毒过滤（VF）已被证明是一种强大而有效的清除步骤，可通过尺寸排阻提供> = 4的减少对数。通过增加通量和过滤器负荷来最小化VF面积对于实现成本目标至关重要，因为VF是一次性使用的，通常占总净化成本的10％。该出版物中提出的研究描述了一种开发策略，该策略侧重于直接适用于VF过程性能的产品流的生物物理属性。本文总结了一个案例研究，其中将生物物理工具（高压尺寸排阻色谱，动态光散射和绝对尺寸排阻色谱）应用于特定的MAb程序，以说明饲料成分（pH，氯化钠浓度和缓冲液）的变化盐类型）可以改变与VF性能相关的生物物理特性。随后在开发三种MAb的过程中对方法进行了完善和扩展，在未加标的对照运行和病毒清除实验期间，对两种特定的病毒过滤器（Viresolve Pro和Planova 20N）评估了性能指标（即负载和通量）。提要属性的分析可以应用于决策树，以指导VF过滤器的推荐和操作条件，以用于将来的MAb程序开发。对饲料的生物物理特性的了解可以与病毒过滤器的性能相关联，以显着减少与病毒过滤器步骤开发相关的产品质量，时间和成本。 （C）2015美国化学工程师学会

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