The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing Adam C. Fisher, Mark-Henry Kamga,

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The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing Adam C. Fisher, Mark-Henry Kamga, Cyrus Agarabi, Kurt Brorson, Sau L. Lee, Seongkyu Yoon Trends in Biotechnology Volume 37, Issue 3, Pages 253-267 (March 2019) DOI: 10.1016/j.tibtech.2018.08.008 Copyright © 2018 Elsevier Ltd Terms and Conditions

Figure 1 Perfusion Setup. In perfusion bioreactor processes, a pump adds media containing nutrients into the bioreactor while another pump flows a mixture of cells and spent media from the bioreactor through a cell retention device. The retention device separates the cells from spent media. The spent media are harvested while the cells are returned to the bioreactor. Trends in Biotechnology 2019 37, 253-267DOI: (10.1016/j.tibtech.2018.08.008) Copyright © 2018 Elsevier Ltd Terms and Conditions

Figure 2 Downstream Processing Steps. Traditional downstream biomanufacturing processes include a combination of filtration, chromatography, and eventually formulation. The bulk of cells is usually removed by an initial centrifugation. Depending on the product, two or three chromatography processes might be required before a final viral filtration/sterile filtration step to obtain the product of interest. Trends in Biotechnology 2019 37, 253-267DOI: (10.1016/j.tibtech.2018.08.008) Copyright © 2018 Elsevier Ltd Terms and Conditions

Figure 3 PCC and SMB Chromatography. Two important continuous chromatography processes gaining steam are the three-column PCC and SMB. In PCC, flow-through from a column is reloaded into subsequent columns to improve process yield. However, each column still undergoes the load–wash–elute–equilibrate cycle. In SMB, the inlet to each column is periodically ‘moved’, permitting continuous loading, elution, and harvesting, and resulting in lower buffer and resin use. PCC, periodic countercurrent chromatography; SMB, simulated moving bed. Trends in Biotechnology 2019 37, 253-267DOI: (10.1016/j.tibtech.2018.08.008) Copyright © 2018 Elsevier Ltd Terms and Conditions