Application of analytical characterization tools in process and formulation development of low cost vaccines using the ULTRA manufacturing platform

In 2016, an estimated 19.5 million infants worldwide did not receive routine life-saving vaccinations according to the World Health Organization (WHO)1. Two major limitations in improving global vaccination coverage include the costs associated with vaccine manufacturing and the challenges associated with maintaining a consistent supply. The aim of the ‘ULTRA’ project (Ultra Low-cost TRansferable Automated Platform for Vaccine Manufacturing) is to standardize the development and production of new protein subunit vaccine candidates at globally affordable costs by creating a generic, low-cost, integrated, and automated vaccine manufacturing platform. In a collaborative effort between MIT, UCL, and KU (Figure 1), state-of-the-art analytical tools will be utilized to provide well-characterized vaccine bulk and drug product facilitating process changes and reduced QC costs. Please click Additional Files below to see the full abstract