#Genprex #Andelyn Biosciences #diabetes gene therapy

Andelyn Biosciences Collaborates with Genprex to Scale Diabetes Gene Therapy Manufacturing

In a significant development for diabetes treatment, Andelyn Biosciences, a recognized leader in contract development and manufacturing, has announced its partnership with Genprex, Inc. This collaboration aims to significantly expand manufacturing capabilities for Genprex's innovative diabetes gene therapy program.

The diabetes gene therapy candidate being developed by Genprex targets the Pdx1 and MafA genes, utilizing an AAV vector to directly deliver these critical genes to the pancreas via the pancreatic duct. This approach holds promise as a potential therapy for both Type 1 and Type 2 diabetes, conditions that affect millions worldwide.

As part of the agreement, Andelyn will facilitate the transition of Genprex's adeno-associated virus (AAV)-based therapy to a larger scale in a compliant manner. This includes optimizing processes, enhancing scale-up operations, and ensuring compliance for IND-enabling and clinical-stage manufacturing, essential steps in clinical trial preparations.

Advanced Manufacturing Support

Central to this collaboration is Andelyn's state-of-the-art Curator® Cell and Gene Therapy Platform, which provides robust support for AAV process development, technology transfers, and analytical developments. Manufacturing activities will range from process optimization to analytical qualification and potency assay development—all conducted within a cGMP-compliant facility.

Both leaders expressed enthusiasm regarding the venture, highlighting its importance in advancing diabetes treatment methodologies. As Matt Niloff, Chief Commercial Officer at Andelyn, stated,