Abstract

Leading pharmaceutical companies are implementing Process Analytical Technology (PAT). PAT is defined as a system for designing, analyzing, and controlling the manufacturing process through the real-time measurement of critical processes and critical quality parameters. The economic analysis and cost-effectiveness of PAT has not been evaluated in-depth and is the subject of this research. The knowledge gained is being used to develop a Business Case Model for PAT analysis, justification, and implementation, following pharmaceutical industry requirements including the cost model, benefit estimates, and the economic evaluation based on the Net Present Value (NPV), Internal Rate of Return (IRR), and Return on Investment (ROI) methods. The template developed may be adapted by each company according to its cost structure and manufacturing processes. A literature review was performed on Business Cases, PAT, and other economic aspects, and ten manufacturing experts were interviewed. A comparison between the different proposed structures of the cost-benefits and business case model was made selecting the relevant elements. The template was structured with the source data of the associated costs, capital investment, and estimated cash flows. The PAT Business Case template allows to evaluate different scenarios, costs, and benefits, of a proposed project.