Despite exponential growth and interest in exosome-based therapeutics, there is no standardised commercial-scale method for exosome-manufacture globally, and no registered exosome therapeutics. VivaZome Therapeutics (VZT) via a CRC-P project with partners Cytiva, University of Queensland (UQ), Australia National University (ANU), La Trobe University and SeerPharma is building expertise within Australia to manufacture therapeutic exosomes. In this project, VZT will establish (1), a purpose-built, pilot ISO-8 cleanroom-facility for optimising exosome-manufacture, ready for technology transfer to a GMP manufacturing facility for production of exosome batches for non-clinical toxicology and preclinical studies and (2), a dedicated exosome-analytics laboratory (PC2) to provide stage-appropriate analytics for in-process control and product quality assurance. Quality management implementation from SeerPharma will ensure that both the manufacturing cleanroom and analytics laboratory operate according to recognised standards for laboratories (ISO-17025), FDA and OECD standards for GLP and current best Quality Management practices for the development of biotechnological products. The translational aspect of this project will focus on development and testing of novel customised-exosomes with enhanced anti-inflammatory and targeting function, tailored to treat neurological conditions; using robust preclinical-models of traumatic brain injury and retinal degeneration. The translational projects will adhere to the ARRIVE guidelines (animal research: reporting on in vivo experiments) and standards set by the International Society for Extracellular Vesicles (ISEV) for collection, processing, testing, quality control, and manufacture of exosomes. Through this project, VZT aims to close the gap of preclinical research and increase product manufacture reproducibility by establishing and using every available scientific, clinical and industrial quality standard.