1st October 2015 – 31st March 2016
Advanced technology now makes it possible to manufacture implants customised to the patient in terms of geometry and incorporating the patient’s own cells. At present, the means of manufacture with the most promise is 3D bioprinting, in which cells and biomaterials are co-deposited to make the viable implant with the required texture, dimensions and porosity working from Computer Aided Design (CAD) and Manufacture (CAM) data and subsequently manufactured close to the patient.
The existing regulatory framework has ways of dealing with exemptions under ‘Hospital exemption’ or ‘specials’ arrangements but there is a strong case for developing a robust regulatory approach for these personalised combination products, especially in the context of distributed manufacture.
This study aims to identify the possible modes of operating a commercial-scale distributed business for bioprinting implants containing living cells. In doing so, it will determine the extent to which the existing non-routine arrangements could be used for commercialisation of personalised Advanced Therapy Medicinal Products (ATMPs) (scaffold/cell combinations) and to identify needs in relation to the development of a more appropriate framework for regulation of customised products.