Seraxis has developed a novel human multipotent immortal stem cell line, SR1423, and manufacturing process that generates cell clusters with hallmarks of functional, endocrine pancreatic phenotypes. These cell clusters, termed Synthetic Replacement Endocrine (SRE) clusters, contain cell types that recapitulate native islet function in vitro and potently control blood glucose in different animal models of insulin-dependent diabetes. Detailed characterization reveals significant distinctions between SRE, native islets and SC-beta cells. SRE clusters are manufactured following GMP requirements in closed vessels with large-scale formats and are being developed for near-term clinical studies. The Seraxis path to the clinic includes in-house development of quality systems, achievement of consistency and purity milestones and demonstration of stability adequate for lot release, distribution and patient care.