Forge Biologics, a key player in Ajinomoto Bio-Pharma Services and a leading manufacturer of genetic medicines, has announced the launch of its FUEL™ manufacturing platform. This innovative platform aims to provide developers of adeno-associated virus (AAV) gene therapies with a more efficient and accelerated manufacturing foundation, enabling them to advance new programs and target a wider array of diseases.
The FUEL™ (Foundation for Unleashing Excellence in Life-Changing Therapies) platform incorporates several significant technical advancements. Notably, it features Forge’s pEMBR 2.0™ Ad helper plasmid, one of the smallest commercially available at just 8.9 kb. This small size contributes to an enhanced safety profile and increased manufacturing efficiency. Additionally, the platform includes newly modified rep/cap plasmids, which integrate a client-specific capsid sequence into Forge’s proprietary backbone plasmid. The trusted HEK293 suspension Ignition™ cell line remains a crucial element of the platform. Together, these proprietary technologies, alongside Forge’s established manufacturing processes and unique optimization packages, create a foundation for AAV production that is faster, potentially safer, and more efficient.
“Our commitment as a CDMO is to foster continuous innovation to deliver effective solutions for our groundbreaking clients, helping them advance their programs from the discovery phase to first-in-human clinical trials and beyond,” stated John Maslowski, President & CEO of Forge. “The FUEL™ platform represents years of extensive R&D on our innovative technologies and builds on our well-established manufacturing processes, emphasizing the need for product-specific flexibility with various optimization packages.”
“I am incredibly proud of our team’s exceptional collaboration that has led us to this milestone with the FUEL™ platform and the productivity gains we are witnessing,” remarked 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 dedicated to driving manufacturing excellence for our clients and the industry as it continues to expand and reach broader patient populations.
