Evotec’s scalable GMP manufacturing process has been designed to produce induced pluripotent stem cell (iPSC)-derived islet-like clusters (ILCs) with high insulin-producing beta cell content as well as glucagon and somatostatin (produced by alpha cells and delta cells, respectively), similar to human isletsThe ILCs are cryopreserved during manufacturing, enabling storage of mass volumes and cost efficient on-demand worldwide delivery as requiredResults from a type 1 diabetes (T1D) preclinical mo
First iPSC-derived commercially viable off-the-shelf islet combination product is advancing towards regulatory filing in 2024 for anticipated clinical trial authorization to treat patients with Type 1 Diabetes (T1D) and severe hypoglycemiaiPSC islet-like cluster manufacturing scale-up and tech transfer activities are well under way in preparation for first human clinical evaluationT1D preclinical models with iPSC derived islet clusters transplanted in Sernova’s Cell Pouch has now demonstrated co