I-Corps: Miniaturized, End-to-End Pharmaceutical Manufacturing Platform

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The broader/commercial impact of this I-Corps project is a miniaturized, on-demand pharmaceutical manufacturing platform that is scalable and efficient to deploy, highly automated, and fast on product release. The project's aim is to reduce manufacturing and inventory cost and in turn overcome drug shortages. Broadly speaking, the current global pharmaceutical industry is prone to supply chain disruptions, drug shortages, and drug price hikes. One major contributing factor are legacy factories and processes which are limited to intermittent and slow production. Moreover, the outdated infrastructure has weaknesses in terms of product yield and environmental impact. Given the pressure of meeting demand for clinical trial supplies, uncertainties over approvals, and other resource constraints, drug development activities have often only been a series of process scale-ups with less emphasis on innovating on the next-gen manufacturing processes, which can be fundamentally better in all aspects in the long term. Consequently, this project is a significant push towards a more flexible, economical, greener, and, ultimately, more sustainable drug manufacturing infrastructure.This I-Corps project explores the commercial potential of a microfluidic-based, continuous-flow pharmaceutical manufacturing device. It represents a paradigm shift from conventional, labor-intensive, batch drug manufacturing processes. Microfluidics (MFDs) are fabricated microchannels which are up to a thousand times smaller than a conventional batch reactor for the same throughput. In turn, MFDs offer up to a thousand times increase in the surface area to volume ratio, allowing for extremely rapid heat and mass transfer and a suite of other advantages; Since the process is continuous, the system can be spatially integrated with state-of-the-art analytical sensors and computer-based controllers, by which the product quality can be assured not only by process design, but also by advanced process control. From a synthesis and purification perspective, MFDs allow for precise handling of previously inaccessible, but highly efficient, pressurized, and often exothermic pathways. This results in greener and safer processes with higher throughput and less waste. On the formulation side, MFDs provide homogeneous crystallization environments, leading to monodisperse crystal size distributions, which leads to superior reproducibility in key product quality such as shape and size.