This work aims to evaluate the benefits of the continuous process in biopharmaceutical manufacturing of monoclonal antibodies (mAbs). An integrated continuous process is designed and built using a process simulator and compared with a fed-batch process production line. The comparisons are based on cost of goods (COG/g) calculation and sensitivity analysis. The fed-batch process results in operating COG/g of $99/g in mAbs production, whereas the continuous process accounts for $51/g. Because of the smaller footprint and fewer storage tanks required in the continuous process, the facility cost reduced by 66%, compared to the fed-batch process. In continuous production, there is a better utilization of the primary capture resin, which leads to a reduction in consumables cost by 68%. Sensitivity analysis is used to evaluate the process in different manufacturing scales (50–1200 kg/yr), upstream titers (1.5–5.5 g/L), and downstream yield (70%–80%). Cost savings can be observed through the entire range.

中文翻译：

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分批和连续单克隆抗体生产的比较及经济性分析

这项工作旨在评估连续过程在生物制药生产单克隆抗体（mAb）中的益处。使用过程模拟器设计和构建集成的连续过程，并与分批补料生产线进行比较。比较是基于商品成本（COG / g）计算和敏感性分析。补料分批工艺产生的单克隆抗体生产中的运营COG / g为$ 99 / g，而连续工艺的成本为$ 51 / g。由于连续过程所需的占地面积较小且所需的储罐较少，因此与分批进料过程相比，设备成本降低了66％。在连续生产中，可以更好地利用初级捕集树脂，从而将耗材成本降低68％。敏感性分析用于评估不同制造规模（50–1200 kg /年），上游效价（1.5–5.5 g / L）和下游产量（70％–80％）的过程。可以在整个范围内节省成本。