Genprex selected Andelyn Biosciences to support manufacturing scale-up for its diabetes gene therapy program, which uses an AAV vector delivered via the pancreatic duct. Under the agreement, Andelyn will transition the program through process optimization, scale-up, IND-enabling work and clinical-stage manufacturing. The planned manufacturing activities include analytical qualification, potency assay development and cGMP drug product manufacturing intended to support forthcoming clinical trials. Genprex’s approach aims to convert pancreatic alpha cells into beta-like cells in type 1 diabetes and to replenish or rejuvenate insulin-producing beta cells in type 2 diabetes. The partnership underscores how gene-therapy developers are increasingly outsourcing the last-mile manufacturing and quality systems needed for IND transition—an area where timelines and scale readiness often determine whether promising biology reaches patients.