The Covid-19 pandemic continues to take a huge toll - an estimated 6.3m people have died including 178,000 in the UK. Globally 1.6bn students have missed school, 250m people will be pushed into extreme poverty and economic losses are estimated at £12tr. History shows that epidemic and pandemic threats constantly emerge, whilst SARS-CoV-2 continues to mutate as it becomes endemic. It is clear that major losses could be prevented by sustained domestic investment in public health. Work undertaken within Vax-Hub1 on responsive technologies and accelerated quality control methods enabled rapid development and manufacture of the ChAdOx1 vectored vaccine against SARS-CoV-2 (licensed for emergency use in December 2020 via a non-profit partnership with AstraZeneca). Over 2.9bn doses have now been released in 180 countries. The UK had a leading role during the pandemic and the proposed Hub builds on this success to advance novel research on a broader range of technologies. Working closely with stakeholders, Vax-Hub will enable the UK to be better prepared for the next pandemic. This investment into The Future Vaccine Manufacturing Hub will enable our vision to make the UK the global centre for vaccine discovery, development and manufacture. The Vaccine Manufacturing Hub brings together a world-class multidisciplinary team with decades of cumulative experience in all aspects of vaccine design and manufacturing research. This Hub will bring academia, industry, not-for-profit organizations and policy makers together to propose radical change in vaccine development and manufacturing technologies, building on a technological innovation culture. The Hub will enhance future vaccine manufacturing through (i) de-risked manufacture of new vaccines by strategically innovating for a selected range of the most promising platform technologies (established and novel/disruptive); (ii) developing manufacturing options that improve the product quality and so immunogenicity; (iii) streamlined manufacturing process development with novel responsive solutions and advanced digitalisation strategies; (iii) a focus on enhancing stability and needle-free administration routes so they become a reality within the lifetime of the Hub. The proposed Hub would be the natural location for early-stage research before projects are transferred to a GMP manufacturing facility. The work focuses on development of improved vaccine platforms which can be flexible enough to be used for multiple product manufacture. These improved vaccine technologies are used as case studies to test rapid and responsive development tools to create a whole process mimicking vaccine manufacture, which could be easily and quickly deployed in case of epidemic/pandemic scenario. Finally the research focuses on standard and novel adjuvants to make mucosal delivery a reality, thus allowing alternative route to injection for mass administration. The Hub will establish the UK as the global centre for end-to-end vaccine research and manufacture. Additionally, vaccines should be considered a national security priority, as it is evident that diseases do not respect international boundaries, thus this work into capacity building and rapid response is a significant advantage. The impact of this Hub will be felt internationally, as the UK reaffirms its leadership in Global Health and works to ensure that the outputs of this Hub reach the global community and the most vulnerable, especially children.

This application requests funds to continue and develop the EngD in Formulation Engineering which has been supported by EPSRC since 2001. The EngD was developed in response to the needs of the modern process industries. Classical process engineering is concerned with processing materials, such as petrochemicals, which can be described in thermodynamic terms. However, modern process engineering is increasingly concerned with production of materials whose structure (micro- to nano- scale) and chemistry is complex and a function of the processing it has received. For optimal performance the process must be designed concurrently with the product, as to extract commercial value requires reliable and rapid scale-up. Examples include: foods, pharmaceuticals, paints, catalysts and fuel cell electrodes, structured ceramics, thin films, cosmetics, detergents and agrochemicals. In all of these, material formulation and microstructure controls the physical and chemical properties that are essential to its function. The Centre exploits the fact that the science within these industry sectors is common and built around designing processes to generate microstructure:(i) To optimise molecular delivery: for example, there is commonality between food, personal care and pharmaceuticals; in all of these sectors molecular delivery of actives is critical (in foods, to the stomach and GI tract, to the skin in personal care, throughout the body for the pharmaceutical industry);(ii) To control structure in-process: for example, fuel cell elements and catalysts require a structure which allows efficient passage of critical molecules over wide ranges of temperature and pressure; identical issues are faced in the manufacture of structured ceramics for investment casting;(iii) Using processes with appropriate scale and defined scale-up rules: the need is to create processes which can efficiently manufacture these products with minimal waste and changeover losses.The research issues that affect widely different industry sectors are thus the same: the need is to understand the processing that results in optimal nano- to microstructure and thus optimal effect. Products are either structured solids, soft solids or structured liquids, with properties that are highly process-dependent. To make these products efficiently requires combined understanding of their chemistry, processing and materials science. Research in this area has direct industrial benefits because of the sensitivity of the products to their processes of manufacture, and is of significant value to the UK as demonstrated by our current industry base, which includes a significant number of FMCG (Fast Moving Consumer Goods) companies in which product innovation is especially rapid and consumer focused. The need for, and the added value of, the EngD Centre is thus to bring together different industries and industry sectors to form a coherent underpinning research programme in Formulation Engineering. We have letters of support from 19 companies including (i) large companies who have already shown their support through multiple REs (including Unilever, P+G, Rolls Royce, Imerys, Johnson Matthey, Cadbury and Boots), (ii) companies new to the Centre who have been attracted by our research skills and industry base (including Bayer, Akzo Nobel, BASF, Fonterra (NZ), Bristol Myers Squibb and Pepsico).