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Biotechnology Daily

Forge Biologics Inks AAV Development and cGMP Manufacturing Deal with Fractyl Health

Forge Biologics, a member of the Ajinomoto Bio-Pharma Services group, signed an AAV development and manufacturing agreement to help advance Fractyl Health’s Rejuva* pancreatic gene therapy platform for the…

News Team 1 min read
Forge Biologics Inks AAV Development and cGMP Manufacturing Deal with Fractyl Health

From the Biotech Insider archive. This article dates from May 14, 2025 and is preserved as first published.

Forge Biologics, a member of the Ajinomoto Bio-Pharma Services group, signed an AAV development and manufacturing agreement to help advance Fractyl Health’s Rejuva* pancreatic gene therapy platform for the treatment of patients with obesity and type 2 diabetes.

“We developed our FUEL™ platform to provide developers like Fractyl with a more efficient and scalable manufacturing solution to help reach broader patient populations,” said John Maslowski, president and CEO of Forge. “We are proud to support Fractyl in advancing a new class of metabolic disease therapies.”

“We are proud to support Fractyl in advancing a new class of metabolic disease therapies.

Forge’s expertise in large-scale, efficient AAV manufacturing is invaluable as we move forward in our mission to develop scalable treatments that aim to prevent and reverse obesity and metabolic disease,” said Harith Rajagopalan MD, PhD, co-founder and CEO of Fractyl Health.

Through this relationship, Forge officials say the company will provide Fractyl process development, cGMP manufacturing, and analytical development services. Fractyl will also leverage Forge’s FUEL™ platform, including its proprietary HEK293 suspension Ignition Cells™ and pEMBR™ 2.0 adenovirus helper plasmid. All development and manufacturing activities will occur at the Hearth, Forge’s 200,000 ft2 gene therapy manufacturing facility in Columbus, OH.

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