Economic Evaluation of Batch and Continuous Manufacturing Technologies for Solid Drug Products during Clinical Development

Abstract This work presents a model-based economic evaluation of batch and continuous manufacturing technologies for the solid drug products. The intended phase of applications is during clinical development where process/technology needs to be specified along with the development of formulation. The research was conducted in the three steps: (I) generation of alternatives and recognition of uncertainty, (II) creation of the evaluation models, and (III) interpretation of the evaluation results. As a case study, net present values of the process alternatives using either batch or continuous technology were calculated using industrial data, which were compared considering process uncertainty. Monte Carlo simulation was applied to obtain the difference of net present value between the two alternatives as a probability distribution, which could support more informed decision-making.