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首页> 外文会议>Conference on single-use technologies II: bridging polymer science to biotechnology applications >VIRUS REDUCTION FILTRATION IN CONTINUOUS BIOPROCESSING: CRITICAL FLUX CONCEPT FOR VIRUS BREAKTHROUGH
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VIRUS REDUCTION FILTRATION IN CONTINUOUS BIOPROCESSING: CRITICAL FLUX CONCEPT FOR VIRUS BREAKTHROUGH

机译：连续生物处理中的病毒减少过滤：通过病毒的临界通量概念

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Virus reduction filtration is an integral component of virus clearance strategy in modern biologics production processes. Continuous bioprocessing and process intensification are the buzz words in biopharmaceutical industry due to benefits of cost savings from higher productivity, operational flexibility and better product quality. A typical batch process operates virus reduction filters at constant pressure to maximize the throughput within one shift of process time constraint. However, continuous bioprocessing would demand constant low flux virus reduction operation over extended duration to address the complications of frequent filter switching. Due to relaxation of process time constraint, continuous bioprocessing allows better utilization of filter capacity (L/m~2). However, there is limited understanding around the virus breakthrough mechanism and associated critical process parameters. This poses an interesting question how to define end point for virus reduction filtration while utilizing most of the filter capacity for low fouling feed. What is the effect of flux, differential pressure and total viral particle load on virus clearance performance of commercially available viral filters? Is there a critical flux for viral reduction filters below which they are susceptible to significant virus breakthrough (LRV ＜4) and if yes, how sensitive it is to filter's property and other process parameters? This study explores the effect of flux, differential pressure and total viral particle load on viral clearance performance of three commercially available filters. These filters are selected to cover the wide range of filter permeability and membrane material. The viral clearance study was performed both in the presence and absence of products.
机译：减少病毒过滤是现代生物制剂生产过程中清除病毒策略不可或缺的组成部分。由于更高的生产率，操作灵活性和更好的产品质量节省了成本，因此连续生物加工和过程强化是生物制药行业的流行语。典型的批处理过程在恒定压力下运行病毒减少过滤器，以在处理时间限制的一班之内最大程度地提高吞吐量。然而，连续的生物处理将需要在延长的持续时间内进行恒定的低通量病毒还原操作，以解决频繁更换过滤器的复杂性。由于放宽了处理时间限制，连续生物处理可以更好地利用过滤器容量（L / m〜2）。但是，对病毒突破机制和相关的关键过程参数的了解有限。这提出了一个有趣的问题，即如何在将大部分过滤能力用于低污染饲料的同时，为减少病毒的过滤定义终点。通量，压差和总病毒颗粒负载对市售病毒过滤器的病毒清除性能有何影响？对于病毒减少过滤器，是否有一个临界通量，在该通量以下，它们容易受到病毒的重大突破（LRV ＜4）;如果是，对过滤器的性能和其他工艺参数有多敏感？这项研究探讨了通量，压差和总病毒颗粒负荷对三种市售滤池的病毒清除性能的影响。选择这些过滤器以覆盖广泛的过滤器渗透性和膜材料。在有无产品的情况下均进行了病毒清除研究。

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