Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
After the implementation of initiatives such as PAT and QbD, there has been a drive towards efficient manufacturing in the pharmaceutical industry. The concept of "mini-manufacturing" of drugs, as opposed to mass production of drugs, has shown promise in this area. We describe one such "mini-manufacturing" process, "drug-on-demand," which uses drop-on-demand printhead technology to deposit active pharmaceutical ingredients (API) onto edible substrates. This method also allows for the layering of different APIs and the creation of personalized dosage forms, in which the amount of API can be varied depending on the patient. In this work, we focus on the automation and control strategy for the drug-on-demand pilot facility done as part of the Engineering Research Center for Structured Organic Particulate Systems. A proper control strategy is necessary so that the system can run at optimal setpoints and adjust in real-time, allowing for an efficient manufacturing process and a precise on-spec drug product. The control strategy for our “drug-on-demand” setup allows us to execute an automated, optimized, and controlled print cycle while closely monitoring drop size, drug morphology, and drop deposition pattern.We summarize our achievements and current research in this area.
Professional Development Hours
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