Single‐Use Continuous Downstream Processing for Biopharmaceutical Products

• Published in: Single‐Use Technology in Biopharmaceutical Manufacture pp. 279 - 283
• Main Authors: Bisschops, Marc, Manser, Britta, Glenz, Martin
• Format: Book Chapter
• Language: English
• Published: Hoboken, NJ, USA John Wiley & Sons, Inc 05.08.2019
• Subjects: biopharmaceutical products; clinical manufacturing; commercial manufacturing; continuous multi‐column chromatography; continuous perfusion bioreactor; fed‐batch processes; single‐use continuous downstream processing
• ISBN: 1119477832; 9781119477839
• DOI: 10.1002/9781119477891.ch24

This chapter illustrates how continuous multicolumn chromatography is one of the key technologies to enable higher specific productivity through continuous downstream processing. It discusses the concept of multicolumn chromatography including scale‐up to clinical and commercial manufacturing. The increased specific productivity of continuous multi‐column chromatography makes it a very attractive technology for medium and high titers as often observed in modern fed‐batch processes. On the other hand, however, linking a continuous capture chromatography process to a continuous perfusion bioreactor also seems to be an obvious combination to establish a fully integrated continuous biomanufacturing platform. For clinical manufacturing and/or manufacturing of smaller amounts of (niche) products, the added value of continuous chromatography is predominantly delivered through the increased specific productivity, which enables significant savings in relatively expensive affinity adsorbent. In addition to this, the single‐use design of the entire flow path allows rapid changeover and reduces risks that would otherwise impact facility utilization.