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首页> 外文会议>Conference on single-use technologies II: bridging polymer science to biotechnology applications >EVALUATION OF AMBR® 250 PERFUSION BIOREACTOR SYSTEM AS A MODEL FOR HIGH-THROUGHPUT PERFUSION CELL CULTURE PROCESS DEVELOPMENT
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EVALUATION OF AMBR® 250 PERFUSION BIOREACTOR SYSTEM AS A MODEL FOR HIGH-THROUGHPUT PERFUSION CELL CULTURE PROCESS DEVELOPMENT

机译：作为高通量灌注细胞培养过程开发模型的AMBR®250灌注生物反应器系统的评估

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摘要

The efficient development and delivery of high-quality therapeutic products necessitates the need for high-throughput process development (HTPD) tools. In recent years, fed-batch process development timelines have been significantly reduced as industry has implemented fully automated mini bioreactor systems such as the ambr® 250 HT. More recently, as continuous processing for biologics has gained traction, driven by novel technology and economic pressure to significantly improve monoclonal antibody (mAb) production over the standard fed-batch process, more efficient, cost effective, and environmentally sustainable mAb processes are expected. Traditionally, perfusion process development work requires a combination of deep-well plates and small-scale stirred tank bioreactor (STR), both of which are labor intensive and time consuming. The established ambr®250 HT platform has recently been integrated with perfusion capabilities to enable rapid continuous perfusion process development (PD). In this work, we present the results from our assessment of the automated disposable perfusion bioreactor system for high throughput upstream PD activities, including clone selection and process optimization. In addition, several high stress conditions were also examined here to identify optimal operation ranges for the current system. The studies conclude that ambr® 250 perfusion reactor is able to generate process performance and product quality profiles equivalent to bench-top bioreactors for a high cell density perfusion process.
机译：有效开发和交付高质量治疗产品需要高通量过程开发（HTPD）工具。近年来，随着行业实施全自动微型生物反应器系统（例如ambr®250 HT），分批补料工艺的开发时间已大大缩短。最近，随着生物技术的连续处理在新技术和经济压力的推动下得到发展，与标准的分批补料工艺相比，单克隆抗体（mAb）的生产得到了显着提高，因此人们期望有更高效率，成本效益和环境可持续性的mAb工艺。传统上，灌注过程的开发工作需要将深孔板和小型搅拌釜生物反应器（STR）结合使用，这两种方法都是劳动密集型且耗时的。已建立的ambr®250HT平台最近已与灌注功能集成在一起，以实现快速连续的灌注过程开发（PD）。在这项工作中，我们提出了对自动化一次性灌注生物反应器系统进行评估的结果，该系统用于高通量上游PD活动，包括克隆选择和工艺优化。此外，这里还检查了几种高应力条件，以确定当前系统的最佳运行范围。研究得出的结论是，ambr®250灌注反应器能够产生与台式生物反应器相当的过程性能和产品质量曲线，适用于高细胞密度灌注过程。

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