Novel T cell-based vaccine potency assay to accelerate and improve development and manufacturing

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Researchers are continuously innovating to improve healthcare through new and improved medical diagnostics, devices and therapeutics, including new vaccines. Indeed, vaccine development is increasingly attempting to address difficult-to-treat diseases such as cancer, allergy and microbial infections. The recent Covid-19 pandemic has served to widely illustrate the importance of more rapid and improved vaccine development.This project will use the latest knowledge of T-cell responses, and their associated receptor mechanisms and structures to develop a novel, reproducible way of testing manufactured vaccines. Lowering costs and improving the quality control of the manufacturing processes and throughput speed, will benefit vaccine development. More specifically, vaccines need to induce a T-cell immune response for therapeutic effect or prophylaxis. With vaccine development and manufacture, one of the most problematic issues is that of potency assays for vaccine QC (Quality Control) release and stability testing. Traditionally, animal assays or patient samples are used to determine vaccine potency; however, these assays are time-consuming, costly, show higher variability and have ethical considerations.Standardised cell-based potency assays are typically more reliable with a lower failure rate and can significantly reduce costs. Moreover, cell-based assays are also ethically more acceptable (NC3R initiative), not requiring animals, and preferred by the regulatory authorities for QC release testing.Since vaccine potency assays are very specific, depending on the target antigens, the project also aims to demonstrate a platform application, which means that the assay format can be modified for different vaccine antigens, whether tumour-associated, microbial , or tolerance-inducing. Generally, the cost reductions and shortened development times resulting from using such assays will lead to the development of more vaccines for rarer diseases, which might otherwise be considered uneconomic and which are important for Low-and-Middle-Income Countries (LMICs). This project will focus on the assay to support a new vaccine (OVM-100) from the applicant targeting Human Papilloma Virus (HPV) associated diseases such as cervical cancer. This disease is especially prevalent in LMICs where this treatment is desperately needed.This approach has not been developed to date as the initial development is costly compared to existing animal assays. Overall, the project aims to deliver a cheaper (30%), more reliable (15% decrease failure rate), rapid (2-3 days vs 3-4 weeks), flexible and robust technology. Patentable inventions will be protected with the intention to make the technology available globally.