Drug manufacturers are building a new kind of production line that runs continuously, like a refinery, rather than in stop-start batches. The problem is that modern targeted medicines are chemically complex, highly potent, and needed in smaller quantities than traditional blockbuster drugs. Existing batch manufacturing is inefficient for these compounds—it wastes reagents and solvents, struggles with rapid switchovers between products, and cannot easily scale up from lab to commercial production. This project aims to develop a flexible, modular continuous manufacturing platform that can handle complex chemistries while minimising waste and maintaining high throughput. If successful, the technology would allow a single production line to be quickly reconfigured for different drugs, reducing manufacturing costs and environmental impact. It would also speed up the transition from clinical trials to market, because the same continuous process used for small-scale testing could be scaled directly to commercial volumes. The work is applied and industry-focused, with the explicit goal of establishing ARCINOVA as a world leader in continuous modular manufacturing for new chemical entities.
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The nature of small molecule drug substance manufacturing demand is changing in response to the development of new and more targeted pharmaceutical treatments. Small molecule drug substances are becoming generally more complex in nature, more potent, and as a consequence the drug substance requirements for a candidate drug, both through the clinical development phase, and at commercial launch, has reduced significantly. The future emphasis for drug substance manufacture will be on new manufacturing technologies which can be can be introduced to handle increasing complex chemistries, where manufacturing inventories need to be kept low, where product purity needs to be maximized, where manufacturing throughput and efficiency are maintained at high level, where the technology can be aligned with the ethical and economic desire to minimize reagent, catalyst, and solvent usage as part of a GREEN and where the manufacturing technologies can be rapidly switched over to cope with low batch numbers, but increasing numbers of discreet manufacturing stages. There is therefore a clear, and as yet unmet need, for the implementation of a flexible modular manufacturing technology platform which can facilitate the above. Our vision for this project is the development of a continuous, modular manufacturing technology platform which will enable ARCINOVA to be a leading player in the development, scaleup and manufacture of new small molecule drugs. The project will focus on the development of new innovative continuous manufacturing technologies which can be rapidly transferred from proof of concept to a commercial scale asset. Initially a number of key technology areas will be chosen for development. These areas will be chosen on the basis of expected technical need from ARCINOVA, and on the basis of demonstrated expertise from the academic partner (University of Nottingham). The project outcome will enable the consortium to demonstrate operating feasibility of world first innovative continuous production tools, and will establish ARCINOVA as a world leader in defining continuous modular manufacturing technology for the support of new chemical entities (NCEs) development, scale up and manufacture
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