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Comparison between Batch and Continuous Monoclonal Antibody Production and Economic Analysis

Author:
Yang, Ou, Prabhu, Siddharth, Ierapetritou, Marianthi
Source:
Industrial & engineering chemistry process design and development 2019 v.58 no.15 pp. 5851-5863
ISSN:
1520-5045
Subject:
antibody formation, biopharmaceuticals, cost effectiveness, manufacturing, monoclonal antibodies, process design, tanks
Abstract:
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.
Agid:
6373322