Multi-stage and multi-objective decision-support tool for biopharmaceutical drug product manufacturing: equipment technology evaluation

Abstract The emergence of single use technology (SUT) for equipment promises to be a revolutionary change in biopharmaceutical production. SUT equipment reduces non-value adding working time and provides operational flexibility. However, there are increased process risks such as possible contamination with leachable compounds or supply dependencies, as well as required redesign efforts. This work provides a multi-stage approach for decision-support for optimal equipment technology applied in a case study for a sterile filling line. Three design stages are identified. The first two stages explore the design landscape using the economic performance to show the general trends of favorable regions for equipment technology and the sensitivity to process parameters according to their relative importance. The last stage is more detailed but incorporates additional assessment indicators such as environmental impact and risks of process downtime. From an economic perspective SUT options are more favorable for short term and small-scale production, such as the case for preparing drugs for clinical trials. Traditional stainless-steel options had a significant economic advantage at large scale and long term production. The ranking of favorable options varied as other assessment factors, namely life-cycle CO2 emissions as well as risks in contamination and supply delay, were included in the analysis. The proposed methodology offers an agile decision-making tool, accounts for uncertainties across various design phases, and offers a systematic exploration of the available design landscape.