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Evaluating Integrated Analytics for Single-use Mini Bioreactors

机译:评估单使用迷你生物反应器的综合分析

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In the past decade, single-use automated micro bioreactors have been widely adopted in biopharma facilities for scaling-down mammalian and microbial cell processes for production of biologics. Using these types of small-scale bioreactors has been proven to significantly increase speed and throughput of cell line and process development4 with results that are more reproducible than using shake flasks as scale down models. Whilst the use of automated scale-down bioreactors does increase throughput in clone or strain screening, as well as testing of culture conditions and process parameters, it also leads to a rise in the number of samples that need to be taken and analyzed. Key assays typically run by bioprocess scientists include: off-line pH checks, viable cell density (VCD), viability, and metabolites including glucose, lactate, glutamine, and glutamate. These measurements can be used for process control and monitoring, to calculate feed additions and determine optimum time for harvest. Currently, Sartorius Stedim Biotech estimates that from the hundreds of ambr 15 automated microscale bioreactor systems installed, over four million samples are generated globally every day and Figure 1 highlights areas where manual operations have traditionally caused bottlenecks in the overall workflow when running these assays.
机译:在过去的十年中,单使用自动微生物生物反应器已广泛采用Biopharma设施,用于扩大哺乳动物和用于生产生物学的微生物细胞工艺。已经证明,使用这些类型的小规模生物反应器可以显着提高细胞系和过程开发的速度和吞吐量,结果比使用摇瓶作为缩放模型更可重复。虽然使用自动缩小的生物反应器确实增加了克隆或菌株筛选的产量,以及培养条件和工艺参数的测试,它也导致需要采取和分析的样品数量的增加。通常由生物过程科学家经营的关键测定包括:离线pH检查,可行的细胞密度(VCD),活力和代谢物,包括葡萄糖,乳酸,谷氨酰胺和谷氨酸。这些测量可用于过程控制和监测,以计算进料添加并确定收获的最佳时间。目前,Sartorius Stim Biotech估计,从数百个AMBR 15自动微尺度生物反应器系统,每天都在全球生成超过400万个样本,并且图1突出了在运行这些测定时传统上导致整个工作流程中的瓶颈的区域。

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