Continuous processing offers a promising approach to revolutionize biotherapeutics manufacturing as reflected in recent years. The current study offers a comparative economic assessment of batch and continuous processing for the production of biotherapeutic products. Granulocyte‐colony stimulating factor (GCSF), a protein expressed in E. coli, and an IgG1 monoclonal antibody, were chosen as representatives of microbial and mammalian derived products for this assessment. Economic indicators—cost of goods (COGs), net present value (NPV), and payback time have been estimated for the assessment. For the case of GCSF, conversion from batch to integrated continuous manufacturing induced a $COGs/g reduction of 83% and 73% at clinical and commercial scales, respectively. For the case of mAb therapeutic, a 68% and 35% reduction in $COGs/g on translation from batch to continuous process was projected for clinical and commercial scales, respectively. Upstream mAb titer was also found to have a significant impact on the process economics. With increasing mAb titer, the $COG/g decreases in both operating modes. With titer increasing from 2 to 8 g/L, the $COG/g of batch process was reduced by 53%, and that of the continuous process was reduced by 63%. Cost savings in both the cases were attributed to increased productivity, efficient equipment and facility utilization, smaller facility footprint, and reduction in utilization of consumables like resin media and buffers actualized by the continuous processing platform. The current study quantifies the economic benefits associated with continuous processing and highlights its potential in reducing the manufacturing cost of biotherapeutics.

中文翻译：

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生物治疗药物生产连续加工的经济评估

正如近年来所反映的那样，连续加工为彻底改变生物疗法制造提供了一种有前途的方法。目前的研究提供了生物治疗产品生产的批量和连续加工的比较经济评估。粒细胞集落刺激因子 (GCSF)，一种在大肠杆菌中表达的蛋白质。大肠杆菌和 IgG1 单克隆抗体被选为微生物和哺乳动物衍生产品的代表进行本次评估。经济指标——商品成本 (COG)、净现值 (NPV) 和投资回收期已为评估进行了估算。对于 GCSF，从批量生产到集成连续生产的转换导致临床和商业规模的 COGs/g 分别降低了 83% 和 73%。对于 mAb 治疗药物，预计临床和商业规模从批次到连续过程的转化成本 COGs/g 分别降低 68% 和 35%。还发现上游 mAb 滴度对工艺经济性有显着影响。随着 mAb 滴度的增加，两种操作模式下的 $COG/g 都会降低。随着滴度从 2 g/L 增加到 8 g/L，批处理的 $COG/g 降低了 53%，连续过程的减少了63%。这两种情况下的成本节约都归因于生产力的提高、设备和设施的高效利用、设施占地面积的减少以及连续处理平台实现的树脂介质和缓冲液等耗材的利用率降低。目前的研究量化了与连续加工相关的经济效益，并强调了其在降低生物治疗药物制造成本方面的潜力。