Forge Biologics, a member of Ajinomoto Bio-Pharma Services and a manufacturer of genetic medicines, has launched the FUEL manufacturing platform to provide AAV gene therapy developers a more efficient and accelerated foundation for manufacturing as they advance new programs and target a broader range of diseases.
 
The FUEL (Foundation for Unleashing Excellence in Life-Changing Therapies) platform introduces several new technical advancements. One of these advancements is Forge’s pEMBR 2.0 Ad helper plasmid, which is one of the smallest commercially available at 8.9kb. It offers an enhanced safety profile and increased manufacturing efficiency. The platform also features new modified rep/cap plasmids, where a client-specific capsid sequence is incorporated into Forge’s proprietary backbone plasmid. Forge’s trusted suspension Ignition cell line, identified as HEK293, remains a vital component of the platform. These proprietary technologies, combined with Forge’s proven manufacturing processes and unique optimization packages, provide a faster, potentially safer, and more efficient foundation for AAV production.
 
“As a CDMO, we prioritize continuous innovation to deliver effective solutions for our groundbreaking clients who are focused on advancing their programs from the discovery phase to first-in-human clinical trials and beyond,” said John Maslowski, President & CEO of Forge. “The FUEL platform represents years of extensive R&D on our innovative technologies and builds upon our well-established manufacturing processes with a deep understanding of the need for product-specific flexibility with numerous optimization packages.”
 
“I’m incredibly proud of our team’s exceptional collaboration that has brought us to this point with the FUEL platform and the productivity gains we’re seeing,” said David Dismuke, Ph.D., Chief Technical Officer of Forge. “From molecular development’s research for our new pEMBR 2.0 Ad helper design, to our process development team’s repeatable high-titer manufacturing processes, Forge remains focused on driving manufacturing excellence for our clients and the industry as it continues to expand and reach broader patient populations.”
 
Forge will launch the FUEL platform and highlight its key benefits during a company presentation on October 8, 2024, during the Alliance for Regenerative Medicine’s Cell & Gene Meeting on the Mesa conference in Phoenix, Arizona.