Scientists have developed a system that uses continuous flow technology, instead of a batch-by-batch approach, to produce pharmaceutical compounds, and they used it to manufacture a chemotherapy drug that's currently under evaluation in clinical trials. Most pharmaceutical compounds are made in massive batches, yet small-volume continuous (SVC) manufacturing systems - currently used to produce numerous commodity chemicals - offer a number of advantages, such as improved safety and yield. As well, these systems can be used to conveniently produce pharmaceutical ingredients on site, when needed. Yet, while a number of SVC manufacturing systems have successfully produced pharmaceutical compounds in laboratories, few adhere to "current good manufacturing practices," such that they are commercially scalable. Here, Kevin P. Cole and colleagues developed a SVC manufacturing system that does adhere to such standards. The system allows for concurrent mixing of ingredients, and is equipped with fully automated filters that required no manual work, eliminating the risk of exposing operators to toxins. In this approach, a number of different techniques are used to separate layers of ingredients and effectively clean compartments after each use. The team demonstrated the effectiveness of their system by producing the chemotherapy agent prexasertib, currently being assessed in a phase two trial as a chemotherapy agent, in aqueous form. The system yielded 24 kilograms of the compound over the course of three days, the authors report.
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Science