November 1-5, 2015
Affinity chromatography is a powerful purification tool in pharmaceutical industry for capturing therapeutic proteins, in particular monoclonal antibodies (mAbs) and mAb fragments, from cell culture harvest. During the last years the resin utilization and productivity of affinity chromatography significantly improved due to the newly introduced multi-column continuous processes. The process setup was optimized to a twin-column continuous capture technology, known as CaptureSMB which requires less equipment hardware, has a less overall complexity and performs comparable if not better than other multi-column setups.
This presentation outlines the CaptureSMB concept and focuses on the scale-up from bench-top to twin-column pilot scale. Especially, the focus is on the requirements for the equipment design, process automation and regulatory aspects due to the implementation of the continuous processing. Furthermore, future trends how the EcoPrime Twin technology will enable the integrated continuous downstream processing
Kathleen Mihlbachler, Thomas Muller-Spath, Lars Auman, Michael Bavand, Rick Langone, and Gerard Gach, "EcoPrime twin – Scale-up of CaptureSMB to the process scale" in "Integrated Continuous Biomanufacturing II", Chetan Goudar, Amgen Inc. Suzanne Farid, University College London Christopher Hwang, Genzyme-Sanofi Karol Lacki, Novo Nordisk Eds, ECI Symposium Series, (2015). http://dc.engconfintl.org/biomanufact_ii/116