Gene therapy manufacturing and development
- Forge Biologics operates a 200,000 square foot facility called the Hearth in Columbus, Ohio, which includes 20 cGMP suites dedicated to AAV (adeno-associated virus) manufacturing.
- They offer end-to-end manufacturing services including research-grade manufacturing, process and analytical development, cGMP manufacturing, plasmid DNA manufacturing, fill and finish, and integrated regulatory support.
- Forge utilizes their proprietary FUEL™ AAV platform for manufacturing, which has demonstrated significantly increased productivity compared to industry standards. This platform includes the pEMBR 2.0™ Ad helper and modified rep/cap plasmids.
- Forge has also developed a proprietary HEK293 suspension cell line called Ignition™ Cells, and an adenovirus helper plasmid, pEMBR™, which the FDA has deemed suitable for cGMP manufacturing of clinical drug products.
Clinical programs
- Forge is developing FBX-101, a novel AAV gene therapy for Krabbe disease. They are actively recruiting patients for the RESKUE clinical trial to administer FBX-101.
- FBX-101 has received the UK's Innovation Passport Designation and the EMA's designation, aiming to make this potentially transformative therapy available to patients in Europe.
Collaborations and partnerships
- Forge has forged strategic collaborations with companies like Labcorp and Affinia Therapeutics to provide AAV gene therapy development and manufacturing services.
- They are a manufacturing partner for the California Institute for Regenerative Medicine (CIRM), supporting CIRM-funded programs with accelerated research and cGMP AAV manufacturing.
- Forge also collaborates with companies like Fractyl Health to leverage their FUEL™ platform for manufacturing AAV for gene therapy platforms targeting metabolic diseases.
Other initiatives
- Forge launched the FUEL™ AAV Manufacturing Platform in October 2024 to offer more efficient solutions for gene therapy production.
- Forge Biologics participates in and presents research at conferences such as the American Society of Gene and Cell Therapy (ASGCT) Annual Meetings.
- They also offer an internship program, providing students with meaningful projects and exposure to multiple teams.
In summary, Forge Biologics plays a significant role in advancing gene therapy through its comprehensive manufacturing services, clinical programs targeting rare diseases, strategic collaborations, and platform technologies designed to improve efficiency and scalability.
