Developmental allogeneic cell therapeutic products are varied and diverse with indications ranging from cancer to GvHD. With the manufacturing and economic challenges of autologous cell-based products, emerging technologies are accelerating development of off the shelf allogeneic cell therapeutic products, which may provide some advantages over autologous patient-specific therapies. Allogeneic therapies can be manufactured with testing/quality control in advance of patient treatment need and are often amenable to manufacturing scale up rather than costly scale out often required by autologous products. In this session, unique developmental challenges for early, mid- and late-phase products will be conveyed. Additionally, challenges from the regulator perspective specific to allogeneic products and lessons learned from a recently approved product will draw focus to issues important to regulatory agencies.