Computer-Aided Design and Evaluation of Batch and Continuous Multi-Mode Biopharmaceutical Manufacturing Processes

Abstract

This paper describes a dynamic decision-support tool that can design and analyse multimode biopharmaceutical manufacturing processes by performing deterministic and stochastic analysis using Monte Carlo simulation data generated by a discrete-event simulation tool. The visualisation and optimisation of multi-mode processes becomes increasingly complex with the requirement to track batches and sub-batches and predict the optimal manufacturing process, with respect to equipment fit, time pressures and cost. The tools ability to capture multi-mode processes was facilitated by the design of a pre-calculation module to screen sizing strategies and the addition of a new hierarchal layer into the discrete-event engine and supporting database. The simulation tool's methodology and ability to optimise a number of different configurations of multi-mode manufacturing processes are demonstrated in a case study comparing batch and continuous cell culture manufacturing strategies for the commercial production of monoclonal antibodies.