Forge Biologics Unveils FUEL™ AAV Platform for Enhanced Gene Therapies
Introducing the FUEL™ AAV Manufacturing Platform
Forge Biologics, a prominent name in the field of genetic medicine manufacturing, has made significant strides with the announcement of its revolutionary FUEL™ (Foundation for Unleashing Excellence in Life-Changing Therapies) platform. This state-of-the-art manufacturing approach is designed specifically to propel AAV gene therapy developers towards achieving faster and more efficient production processes, enabling them to advance their innovative programs aimed at addressing a wider array of diseases.
Innovative Features of the FUEL™ Platform
The FUEL™ platform introduces several groundbreaking advancements that enhance the manufacturing process. Among these innovations is the introduction of Forge's pEMBR 2.0™ Ad helper plasmid. This plasmid is notable for being one of the smallest commercially available, measuring just 8.9kb, providing an impressive safety profile while boosting manufacturing efficiency. Additionally, the platform incorporates modified rep/cap plasmids that allow for the customization of capsid sequences, integrating these unique elements into Forge's proprietary backbone plasmid.
Commitment to Innovation
At the core of the FUEL™ platform’s success is Forge’s trusted HEK293 suspension Ignition™ cell line, a key component that ensures the reliability and scalability of the manufacturing process. By combining these proprietary technologies with Forge's established manufacturing practices, the company is positioned to offer a more effective foundational approach for AAV production. This innovation promises to significantly speed up the development of therapies that can change the lives of patients suffering from genetic conditions.
Leadership Insights
According to John Maslowski, President & CEO of Forge Biologics, the company's goal is to foster continuous innovation that delivers effective solutions to its clients. He emphasized, "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." This forward-thinking approach underlines Forge's commitment to staying at the forefront of gene therapy development.
Team Collaboration Enhancing Productivity
Dr. David Dismuke, Chief Technical Officer of Forge, expressed his pride in the collaborative efforts of the Forge team that have led to the success of the FUEL™ platform. In his words, "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." The synergy between the molecular development and process development teams has driven innovations that enhance both safety and efficiency in manufacturing.
Upcoming Presentation Details
Forge Biologics is set to introduce the FUEL™ platform at an upcoming presentation by CEO John Maslowski. This event is scheduled for October 8, 2024, at 3:15 p.m. during the Alliance for Regenerative Medicine’s Cell & Gene Meeting on the Mesa conference. This significant opportunity will allow Forge to highlight the key benefits of the FUEL™ platform to industry stakeholders.
About Forge Biologics
Forge Biologics stands as a cutting-edge hybrid gene therapy contract manufacturing and clinical-stage therapeutics development organization. Its mission is to facilitate access to life-altering gene therapies by transforming ideas into reality. Situated in a 200,000 square foot facility known as the Hearth, Forge’s operational headquarters is equipped with 20 expertly designed cGMP suites, boasting a bioreactor capacity of 20,000L. Their comprehensive manufacturing services cover everything from research-grade manufacturing to integrated regulatory support, thereby accelerating the delivery of transformative gene therapies for patients with genetic disorders. To learn more about their offerings, visit Forge Biologics.
Frequently Asked Questions
What is the primary focus of the FUEL™ platform?
The FUEL™ platform focuses on enhancing the efficiency and safety of AAV gene therapy manufacturing processes.
How does the pEMBR 2.0™ plasmid contribute to the platform?
The pEMBR 2.0™ plasmid is one of the smallest available, improving safety and manufacturing efficiency.
What are the key benefits of the collaboration at Forge Biologics?
The collaboration among teams at Forge yields innovative solutions that significantly enhance productivity and manufacturing quality.
When will the FUEL™ platform be showcased?
The FUEL™ platform will be showcased on October 8, 2024, at a presentation during the Cell & Gene Meeting on the Mesa conference.
What manufacturing services does Forge Biologics provide?
Forge offers a range of services including research-grade manufacturing, process development, cGMP manufacturing, and integrated regulatory support for gene therapies.
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