Methodology for economic and technical comparison of continuous and batch processes to enhance early stage decision-making

This chapter presents a fast, semi-quantitative approach to a technical-economic comparison between different process options at the early conceptualization stage. The comparison is aimed to support "go or no go" decisions in selecting the right product design and manufacturing process to progress to detailed evaluation and design/implementation. The key to develop early-stage technical and economic drivers for continuous pharmaceutical manufacturing is the availability of information and data. The presented methodology combines known approaches and tools to rationally evaluate and predict the technical feasibility, the potential risks, uncertainties and the economical profile in the early conceptual stage. Using weighting factors and score-based evaluation methods coupled with a thorough risk assessment, sensitivity and uncertainty analysis, the proposed methodology provides semi-quantitative metrics between different processing options. As the proposed methodology is based on known procedures, the evaluation process can be improved iteratively as better data becomes available.