We have developed a scalable and comprehensive process for GMP manufacturing of ILCs from a human GMP-grade iPSC line for cell therapy in human insulin-dependent diabetes. The product candidate is characterized by a high beta cell and endocrine cell fraction and has been optimized for low-to-absent unwanted cell content. Functional studies in diabetic rodents show robust normalization of key diabetes disease parameters upon implantation of ILCs under the kidney capsule or in Theracyte encapsulation devices, such as glucose tolerance, random fed glucose levels and circulating human C-peptide. Long-term studies demonstrate no loss of function over extended periods of time, with glucose-lowering activity on a per-beta-cell basis within the same range as observed with human donor islets. Recently, Evotec entered a collaboration with Sernova Corp., which has developed the proprietary Cell Pouch^TM device. Following implantation, the Cell Pouch^TM develops a vascularized environment to support engraftment and function of therapeutic cells. The device is currently in clinical trials with human donor islets (ClinicalTrials.gov Identifier: NCT03513939). When tested in combination with the Sernova Cell Pouch^TM pre-implanted in diabetic NSG mice, our ILCs showed excellent function, indicating that the Cell Pouch^TM provides a beneficial environment not only for human donor islets but also for iPSC-derived ILCs. iPSC-derived ILC manufacturing scale-up and tech transfer activities to Evotec’s GMP cell manufacturing team are well underway in preparation for human clinical trial evaluation.