Advancing the establishment of Capacity for Vaccine Product Development through the Manufacture of OCV-S for Clinical Development in Africa

Covid-19 has highlighted the urgent need to establish vaccine development and manufacturing capacity at scale in Africa By focusing on the development and commercialisation of an oral cholera vaccine (OCV) in partnership with IVI this project will deliver much needed capability for the manufacture of clinical trial material (CTM) in Africa. OCV will be Biovac’s first fully manufactured and WHO PQ’d product. The overall aim is to receive a technology transfer package for a simplified OCV from IVI at small scale, follow a stepwise scale up of the process, manufacture CTM, perform clinical studies, achieve licensure in South Africa with SAHPRA and then progress to achieve WHO PQ in order to be a supplier of OCV to Gavi/Unicef. Thereafter, the process will be transferred to a new large-scale facility (yet to be built). This proposal covers the first 3 stages of a multi-stage project and includes: - Stage 1: Lab demonstration of the IVI technology - Stage 2: Readiness of API facility for process scale-up - Stage3: Process scale Up The remaining stages to follow include: - Stage 4: GMP manufacture of Clinical Trial material - Stage 5: Clinical Trials, licensure and WHO PQ - Stage 6: Transfer the process to a new manufacturing facility