10087303Novel OMV vaccine platform for quick response to Disease XClosedSmall Business Research InitiativeInnovate UKAbera's vaccine platform enables display of multiple antigens on Outer Membrane Vesicles (OMVs) through covalent-based coupling. These OMV nanoparticles possess inherent adjuvant activity, which elicits robust humoral and cellular immune responses. The primary objective of this project is to expedite the development of a rapid responsive platform for development of vaccines against outbreaks of Disease X. These vaccines are characterized by their exceptional efficiency, rapid development process, cost-effective production, streamlined logistics without the need for cold chain, and swift interruption of disease transmission. Our aim is to establish a production process to stockpile OMVs, enabling their prompt coupling to antigens during times of pandemics. This approach will accelerate vaccine development and ensure equitable access to vaccines, particularly in LMICs and ODA countries. Leveraging straightforward and robust technologies, production will be cost-effective and easily transferable across global regions. Notably, the compatibility of these vaccines with needle-free intranasal administration offers a unique advantage in combatting airborne disease outbreaks, where curbing transmission is of paramount importance. OMVs exhibit inherent stability, even under elevated temperatures. To further enhance stability and improve vaccine accessibility by eliminating the need for cold chain storage and distribution, we intend to implement lyophilisation. Our plan involves producing relevant batches of OMVs at a suitable process scale to demonstrate consistency and stability in stockpiles. Additionally, we will develop an analytical package to assess the capacity and consistency of antigen coupling in batches subjected to extended storage. Furthermore, we will evaluate the induction of appropriate immune responses. Moreover, we plan to establish a regulatory strategy for fast approval of a new vaccine based on the platform in case of a pandemic outbreak. In conclusion, Abera's vaccine platform, with its OMV-based technology, promises to revolutionize vaccine development. By establishing a production process for OMV stockpiles and ensuring their consistency and stability, we can swiftly respond to outbreaks, while also enabling widespread and equitable access to vaccines, even in resource-constrained settings. Through these efforts, we aim to create a comprehensive regulatory framework that expedites the approval of new vaccines during pandemics.