The unprecedented growth of the industry, alongside the need to develop scalable manufacturing strategies, has led to a number of challenges that need to be addressed urgently. Previously, patient numbers were so small that processes were highly manual and required numerous skilled operators. However, the recent success of early gene therapy trials means upscaling now needs to be considered right from the start. Safe and scalable gene therapies require access to manufacturing capacity that employs state-of-the-art technologies for efficient, robust and scalable production, which creates a series of questions and considerations that must be considered earlier, rather than later, in the therapy development process.