Novel Analytical Methods to Support mRNA Vaccine Manufacturing

mRNA therapeutics currently have a market value of >$40 billion, which is estimated to grow to over $100 billion by 2026. In one of the greatest scientific accomplishments of our generation, mRNA technology has demonstrated the ability to change the timeline for developing and delivering a new vaccine from years to months. The potential of mRNA technology for rapid vaccine development has recently been highlighted by the successful development and approval of two mRNA vaccines for COVID-19. Importantly, this RNA-based approach holds promise for treatments beyond vaccines and infectious diseases to diverse biologics as treatments for cancer, metabolic disorders, cardiovascular conditions, and autoimmune diseases.

Current analytical methods to characterise mRNA vaccines/therapeutics is limited and the development of methods for the analysis of mRNA therapeutics including mRNA vaccines is challenging because the manufacturing process results in the production of many closely related impurities that can be difficult to resolve and identify. This project aims to develop and optimise novel spectroscopic methods that can be used for developing faster, quantitative and more informative methods for the characterization of mRNA vaccines. These tools are essential for improving current mRNA manufacturing methods.