Continuous Manufacturing Process for Visceral Leishmaniasis Drug

This project aims to demonstrate the feasibility of a safe and cost-effective manufacturing process for an oxaborole compound developed as a treatment against visceral leishmaniasis. This compound has been under Phase I clinical investigation since 2020. The team’s goal was to conduct process development and optimization using continuous flow technology, with the aim of reducing the cost of regulatory starting materials. The team has successfully shown the scalability and suitability of the manufacturing process, with batch production up to a 1kg scale under non-Good Manufacturing Practice (GMP) conditions, improved yield, and reduced production costs of active pharmaceutical ingredients. Based on these results, the team plans to undertake further commercial process development and pilotscale GMP manufacturing to facilitate investigational medicinal products supply for Phase III studies.