The group’s research is focused on developing analytical methods capable of monitoring manufacturing processes in situ as they occur and providing this information to engineers to optimize the process. This systematic approach has been called Process Analytical Technology (PAT). The group’s motto is: “We have moved to manufacturing”, providing real time monitoring of pharmaceutical processes through near infrared and Raman spectroscopy.
In most manufacturing processes, chemists work in a distant laboratory and wait for a sample from the production area to arrive. Chemists analyze a sample from a process that has already occurred. The result serves to determine whether the product meets specifications, but cannot be used to improve the process. The group’s goal is to move to manufacturing, contributing to the advancement of PAT.
Quality Control depends on how samples are obtained from a process. The Theory of Sampling (TOS) which emanates from the mining and geochemical industries has been a guiding light in the group’s research. Methods have been developed to differentiate between sampling and analytical errors, in collaboration with Kim Esbensen (https://kheconsult.com/)
The transfer of knowledge to industry requires investments. The approval of a new method in industry often requires a capital investment and a Business Case. The Business Case presents a cost/benefit model which is essential for making decisions. The understanding of the Business Case for the methods developed is essential to facilitate their implementation in commercial manufacturing. The study of Business Cases for PAT and continuous manufacturing has been started in collaboration with Dr. Mayra Méndez (https://www.uprm.edu/inin/faculty/) from the industrial engineering program. The team is also working Dr Moraima De Hoyos and the Center for Business and Economic Development at UPRM (https://www.uprm.edu/cnde/es/inicio-2/), to map and understand the Puerto Rico’s pharmaceutical ecosystem.