The partnership moves the manufacturing of Genprex’s diabetes program out of academic labs and into a facility compliant with current Good Manufacturing Practices (cGMP). This transition is vital for scaling the production of the company’s AAV vector, which delivers Pdx1 and MafA genes to the pancreas to address both Type 1 and Type 2 diabetes. By securing professional manufacturing infrastructure, Genprex aims to ensure the potency, purity, and stability required for essential toxicology studies and future multi-center human trials.
Genprex Shifts Diabetes Gene Therapy to Industrial-Scale Manufacturing
Austin-based Genprex has tapped a major U.S. contract development and manufacturing organization to transition its diabetes gene therapy from small-batch research to clinical-grade production. This move marks a pivotal step in moving the company's AAV-based therapeutic candidate toward regulatory approval and upcoming human clinical trials.
Ryan Confer, President and CEO of Genprex, noted that the collaboration addresses the safety and efficacy standards needed to advance the program. The technical roadmap includes optimizing bioreactor capacity and implementing rigorous quality control protocols. Beyond current AAV efforts, the company is also exploring non-viral lipid nanoparticle delivery systems, which could eventually allow for patient re-dosing. The current therapy works by transforming alpha cells into insulin-producing beta-like cells, a process that has shown success in restoring glucose levels in non-human primate models.
Comments (0)
No comments yet. Be the first!