Novel Analytical Methods to Support mRNA Vaccine Manufacturing

mRNA疗法目前的市场价值为400亿美元，预计到2026年将增长到1000亿美元以上。作为我们这一代最伟大的科学成就之一，mRNA技术已经证明了将开发和交付新疫苗的时间从几年缩短到几个月的能力。最近，两种针对COVID-19的mRNA疫苗的成功开发和批准，突显了mRNA技术在快速疫苗开发方面的潜力。重要的是，这种基于rna的方法有望治疗疫苗和传染病以外的各种生物制剂，如癌症、代谢紊乱、心血管疾病和自身免疫性疾病的治疗。目前表征mRNA疫苗/治疗剂的分析方法有限，包括mRNA疫苗在内的mRNA治疗剂的分析方法的开发具有挑战性，因为制造过程会产生许多密切相关的杂质，难以解决和识别。该项目旨在开发和优化新的光谱方法，可用于开发更快，定量和更多信息的方法来表征mRNA疫苗。这些工具对于改进当前的mRNA制造方法至关重要。

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.