Scientific Approach

The BIO-COMET work plan has been divided into 8 work packages, WPs. WP1 focuses on the development, refinement, and qualification of an automated and controlled bioreactor-based tissue manufacturing system. In WP2 the regulatory criteria and the compliance strategy required to undertake clinical trials using the bioreactor and related control instrumentation will be defined. Robust non-invasive methods to establish product release criteria for functional cartilage grafts will be developed and validated in WP3. WP4 will test the full manufacturing process, including bioreactor performance and tissue transport, and the subsequent production of the grafts needed for the animal study and the clinical trial in full compliance with regulatory issues. WP5 will focus on assessing the feasibility and safety of the bioreactor-generated grafts in a pre-clinical study, defining the surgical procedure and generating the pre-clinical data of the investigational medicinal product essential for a clinical trial. WP6 will concentrate on the definition, documentation, approval and implementation of the clinical study, working in close collaboration with WP2 and all documents necessary for compliance with regulatory issues will be reviewed before submission to the national authorities. WP7 will address the regulatory, financial, and marketing issues required to commercialise the bioreactor and cartilage graft. WP8 will ensure the coordination, management and dissemination of all the project activities.