Drug Product Production for a Highly Variable Supply Chain

Efficient mass production of drug products is crucial for providing innovative treatments for reducing blood pressure. Batch production has traditionally been the preferred method in the pharmaceutical industry, but hybrid manufacturing offers economic advantages. This project presents a comprehensive economic evaluation of batch and hybrid manufacturing of a high-volume small molecule drug product called Albatol. The production facility was designed from the ground up, considering both low and high demands ranging from 160 million to 1.6 billion tablets per year. The production process was evaluated at the unit-operation level, including granulation, drying, milling, blending, compression, and coating. The estimated cost of the manufacturing facility, including the net present value (NPV), the return of investment (ROI), and the internal rate of return (IRR) of the plant, was calculated based on free raw materials with a selling price of $0.03 per tablet. The analysis revealed that hybrid manufacturing is more profitable than batch production. For a cost of conversion of three cents per tablet with the low demand of 160 million tablets per year, the hybrid process had an IRR of 8.3% and an ROI of 3.11%, while the batch process had an IRR of 3.93% and an ROI of 0.83%. At a high demand of 1.6 billion tablets per year, the hybrid process had an IRR of 108% and an ROI of 146%, while the batch process had an IRR of 97.0% and an ROI of 127%. The results suggest that hybrid manufacturing is a more profitable and viable option for producing Albatol at a large scale.