10101620AAV Formulation Consortium - Improving AAV stability through optimised formulations and development of an analytical toolbox for stability characterisationClosedCollaborative R&DInnovate UKThe development of gene therapies holds immense significance for medical innovation. Yet, the realization of their full therapeutic impact hinges on the urgent need for technological advancements that can further improve drug product (DP) quality and efficacy. Formulation, the penultimate operation prior to final fill, is crucial for robust stability that can impact product shelf-life, therapeutic delivery and potency. However, the complexity and resource investment required, coupled with a lack of comprehensive understanding of formulation science and best-practice for stability characterisation to ensure appropriate product quality control, have hindered progress. To overcome and address formulation and stability characterisation challenges, the Cell and Gene Therapy Catapult (CGTC) established a consortium leveraging expertise of key industry stakeholders, including a therapy developer (Ikarovec), specialist chemicals company (Croda), and academic research institution (UCL), each contributing their expertise, capabilities, and assets to deliver tangible solutions that will benefit the wider cell and gene therapy (CGT) industry. Following industry assessment, this project's activities represent novelty, depth and scale beyond what is currently being performed and will be foundational for future consortium activities aiming to benefit manufacturers across the industry.