Evaluating the Economic and Operational Feasibility of Continuous Processes for Monoclonal Antibodies

Abstract

© 2015 Wiley-VCH Verlag GmbH & Co. KGaA. All rights reserved. Interest in continuous processing in the biotech industry has increased recently with the latest advances in perfusion cell culture technologies and the emergence of semicontinuous chromatography. Continuous manufacturing technologies have long been perceived to be more complex to implement and validate in the biotech sector. However, more recent continuous systems aim to overcome these obstacles with the promise of higher productivities and lower failure rates. This presentation will evaluate the potential of integrated batch and continuous processes via a series of case studies based on the commercial manufacture of monoclonal antibodies (mAb). The operational, economic, and environmental feasibility of these technologies is evaluated using a prototype dynamic decision-support tool built at University College London encompassing process economics, discrete-event simulation, and uncertainty analysis so as to enable a holistic assessment. The first case study compares fed-batch culture to two perfusion technologies: spin-filter perfusion and an emerging perfusion technology utilizing alternating tangential flow perfusion reactors. The second case study presents an integrated experimental and modeling approach to evaluate the potential of semicontinuous chromatography for the capture of mAbs in both clinical and commercial manufacture. The final case study provides a wide-ranging overview of the performance of continuous processing relative to the current batch platform for the mAb sector.