Online Decision-Support Tool “TECHoice” for the Equipment Technology Choice in Sterile Filling Processes of Biopharmaceuticals

Abstract

In biopharmaceutical manufacturing, a new single-use technology using disposable equipment is available for reducing the work of change-over operations compared to conventional multi-use technology that use stainless steel equipment. The choice of equipment technologies has been researched and evaluation models have been developed, however, software that can extend model exposure to reach industrial users is yet to be developed. In this work, we develop and demonstrate a prototype of an online decision-support tool for the multi-objective evaluation of equipment technologies in sterile filling of biopharmaceutical manufacturing processes. Multi-objective evaluation models of equipment technologies and equipment technology alternative generation algorithms are implemented in the tool to support users in choosing their preferred technology according to their input of specific production scenarios. The use of the tool for analysis and decision-support was demonstrated using four production scenarios in drug product manufacturing. The online feature of the tool allows users easy access within academic and industrial settings to explore different production scenarios especially at early design phases. The tool allows users to investigate the certainty of the decision by providing a sensitivity analysis function. Further enrichment of the functionalities and enhancement of the user interface could be implemented in future developments.