Policy briefing: Trends in customization and personalization of advanced therapies

This briefing looks at the potential for 'customization' and 'personalization' in the clinical translation of therapies based on gene editing, induced pluripotent stem cells (iPSCs) and 3D bioprinting. Customization and personalization involve tailoring some part of a product or process to a specific situation and context, which in medicine is often done to meet the requirements of an individual patient. While scope for personalized 'one-off' therapies remains limited, a variety of forms of 'mass customization', at the level of both therapeutic products and manufacturing processes, could complement mass-produced cell and gene therapies. Future policy developments need to evaluate whether to support one or several forms of manufacturing within the UK healthcare sector, as each requires different forms of support, skill sets from the workforce and logistical and regulatory hurdles to viability.