10109570Scaling a novel nanoparticle vaccine adjuvant for clinical developmentClosedLaunchpadInnovate UKAilseVax Ltd is a vaccine-focussed company developing new innovations in vaccine design and formulation. AilseVax is a spinout micro-company from Queen's University Belfast trading in Belfast. Up to this point, AilseVax has been focussed on the generation of novel cancer vaccines. In the lead up to this current application, AilseVax has developed an exciting new nanoparticle adjuvant that has the potential to be used broadly in the vaccine field; an adjuvant is a component used in many vaccines that helps create a stronger immune response. Our new adjuvant can not only be used in cancer vaccines, but also larger global markets such as infectious diseases. This is because our novel adjuvant nanoparticle can be simply added to vaccine formulations, irrespective of the disease or type of vaccine. Our preclinical studies have demonstrated that our nanoparticle adjuvant can elicit enhanced vaccine-induced immunogenicity, generating stronger immune activation than standard adjuvants. In this project, we aim to optimise the manufacturing and scaling up of our nanoparticle prototype and confirm that nanoparticles produced by an optimised, scalable process can maintain their adjuvant effects. To help us achieve this aim, AilseVax will work the Centre for Process Innovation (CPI), a UK catapult with expertise and cutting-edge technologies that it applies to advance next generation therapeutic modalities. CPI will develop a methodology for generating the nanoparticle adjuvant using a scalable and pharmaceutically-relevant manufacturing process. The AilseVax team will analyse the physiochemical properties of the nanoparticles CPI generate and assess their adjuvant effects in a number of vaccine formulations. The outcomes from this project will be a scalable manufacturing process for the novel nanoparticle adjuvant. Achievement of this outcome will remove a major commercialisation barrier to the technology, allowing the late preclinical and clinical development of the technology in vaccine formulations under development by AilseVax and downstream commercial partners.