Forge Biologics Partners with Fractyl Health on AAV Manufacturing for Metabolic Gene Therapy

• Forge Biologics has entered a manufacturing agreement with Fractyl Health to advance its Rejuva pancreatic gene therapy platform.

• The partnership includes AAV process development, cGMP manufacturing, and analytical services delivered from Forge’s Ohio-based facility.

Forge Biologics, a manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, has announced an agreement with Fractyl Health to support the development and production of its Rejuva* pancreatic gene therapy platform. The therapy is being developed to address obesity and type 2 diabetes (T2D).

Under the agreement, Forge will provide process development, current Good Manufacturing Practice (cGMP) manufacturing, and analytical development services for Fractyl’s gene therapy candidates. The collaboration will leverage Forge’s proprietary FUEL platform, including Ignition Cells and the pEMBR 2.0 adenovirus helper plasmid.

All manufacturing activities will be conducted at Forge’s 200,000 square foot gene therapy facility, known as the Hearth, located in Columbus, Ohio.

“We are proud to support Fractyl in advancing a new class of metabolic disease therapies,” said John Maslowski, President and CEO of Forge. “Their mission to break the cycle of chronic disease management for patients is one we are honoured and excited to help enable.”

The partnership is expected to help scale the manufacturing of Fractyl’s adeno-associated virus (AAV)-based therapy, with the goal of reaching broader patient populations. The agreement supports the companies’ shared aim of enabling more efficient delivery of genetic medicines through scalable CDMO and contract manufacturing services.