Production of a Life-Saving Pharmaceutical
Date of Defense
Date of Graduation
Chemical and Paper Engineering
The objective of this project was to optimize an outdated chromatography process that gave poor separation of various impurities of a compound that was used as an intermediate for medicine production as well as a life-saving medicine itself. The demand for this medicine is very low, on the order of a few kilograms every couple of years. The low frequency at which this process is run translates to little experience regarding it. Several vendors were contacted to provide new perspectives and possible solutions to the problems being faced with its production. Factors that could be manipulated include the size of the separation column and the scale of it compared to the original process. Another set of factors were the properties of the packing material that are used in the separation. The particle size of the silica used to pack chromatography columns can be varied to give new results. Also, the packing method can be improved to improve the separation. Packing can potentially be more efficient by the use of pre-loaded cartridges.
A costing tool was created to organize the costs of these proposed scenarios to differentiate the outcomes. These gave an outline down to the unit cost of the individual components, as well as the manpower required and the operational costs.
The proposed process will be more than likely more expensive than the current. The specific details of the expected financial differences are not public information but the net present value of the new proposed process using a MAR of 20% was negative. This is because this process itself will not generate the profit this product will ultimately provide. However, there is a trade-off to make the process more compliant with regulation. The main goal is to find equipment and design a new process that will produce better quality product as well as a process that will be overall safer.
Gubow, Lindsay, "Production of a Life-Saving Pharmaceutical" (2020). Honors Theses. 3255.