Viral Vector Services
At Forge, better manufacturing isn’t a benchmark—it’s a mindset. Through innovative technologies and deep AAV expertise, we deliver end-to-end manufacturing services. Any stage. Any serotype. Built around your journey.
our mission is your impact
Accelerating the Future of Gene Therapy
Our mission is to enable access to life-changing therapies by helping to bring them from concept to reality. That means delivering better, more comprehensive AAV manufacturing services, technologies, and infrastructure so gene therapy developers can deliver more therapies to more patients. Period.


Services
Expert AAV Development
& cGMP Manufacturing
Gene therapy manufacturing takes more than infrastructure. It takes the right team, the right platform, and a partner at every step. Forge offers research-grade production, process development, and cGMP manufacturing alongside in-house plasmid production, molecular development, analytics, quality, fill-finish, stability, and regulatory support—all fully integrated to streamline your path forward.
The FUEL™ Platform
Still developing your process and need a manufacturing solution to streamline your path? Forge’s FUEL™ platform offers a powerful head start—an innovative AAV manufacturing foundation built to help you scale efficiently. With advanced technologies, proven processes, and flexible, product-specific optimizations, FUEL™ can increase productivity while maintaining product quality.
The hearth
Our cGMP Production Facility
To bring gene therapies to patients, you need a facility built for scale, flexibility, global readiness, and unwavering compliance. The Hearth, Forge’s 200,000+ sq. ft. GMP facility, is one of the largest manufacturing sites dedicated to AAV. With 20 GMP suites and bioreactors ranging from 50L to 5,000L, it’s intentionally designed to increase throughput and support efficient production. Built with future growth in mind, The Hearth can expand to meet rising demand. With strict adherence to GMP and safety standards, the facility has been audited by a Qualified Person (QP) and complies with EU GMP—supporting clients with global clinical and
commercial goals.

What Services Are Right For Your Program?
Connect with our experienced AAV manufacturing team for dedicated support throughout your journey.
Frequently Asked Questions
Does Forge Biologics provide AAV CRO services?
While we don’t provide traditional CRO services, like preclinical or clinical trial management, we work closely with clients to support their manufacturing strategy throughout the development lifecycle and maintain preferred partnerships with CROs that we can connect our clients to as needed.
How quickly can Forge deliver a cGMP batch?
Timelines for cGMP batch delivery are highly dependent on the specifics of your program, including vector design, process readiness, and scope of work. Connect with our Client Development team to discuss your program and receive a more detailed scope of work based on your program needs.
Can Forge help with IND filings and regulatory guidance?
Yes, Forge offers regulatory guidance and support to assist with IND filings and broader regulatory strategy. As part of our standard regulatory services, we provide:
*A Letter of Authorization to cross-reference our Drug Master File (DMF)
*A Module 3 guide outlining sponsor vs. DMF responsibilities
*Assistance with written responses to agency information requests
*A Site Master File to support regulatory submissions
We also offer regulatory strategy consulting that spans the full development program, including:
*Ad hoc consultation tailored to your specific program needs
*Review or authoring of IND and other regulatory documentation
*Participation in meetings with health authorities
*Strategic input beyond the IND stage
What differentiates Forge’s AAV manufacturing from other CDMOs?
Gene therapy developers need more than a manufacturer, they need a true partner. At Forge, we were founded by developers, for developers, with deep AAV manufacturing expertise and a commitment to solving the unique challenges of gene therapy development and manufacturing. Our focus in AAV, robust process development, and investment in manufacturing technology, set us apart.
Does Forge offer fill/finish services?
Yes, Forge offers a range of fill-finish services to meet the needs of your program. We provide customizable drug product fill options across automated, semi-automated, and manual operations, designed to accommodate varying batch sizes, container types, and fill volumes to suit your product requirements.
Do you perform all manufacturing and development work in-house?
Yes. All development and manufacturing work is performed at the Hearth, Forge’s 200,000 sq. ft. custom-designed cGMP facility dedicated to AAV viral vector manufacturing in Grove City, Ohio.
How many assays does Forge perform in-house?
Forge offers over 30 AAV assays in-house for efficient and accelerated characterization and release, including rcAAV, potency, and more.
Once signed does Forge have a dedicated client team?
Yes, each client is assigned a dedicated “client team” for their program. This client team is anchored by a Client Relations Manager, a Project Manager, and a Technical Sales & Scientific Advisor, who will support you throughout your entire manufacturing journey at Forge, streamlining communication and guiding each step of the process.
Can we transfer our technology in?
Yes, Forge offers collaborative and systematic full technology transfer capabilities. We support tech transfers for a wide range of viral vectors, including custom viral classes as well as commonly used classes like AAV, lentivirus, baculovirus, and more. Additional key advantages of partnering with Forge for tech transfer include our deep expertise, flexibility in customizing services to fit your unique needs, and access to a facility with a vast array of development and production scales for your program.
What scales do you offer across research-grade, process development, toxicology, engineering, and GMP manufacturing?
We offer AAV production across every stage, including: research-grade (1–40L), process development (1–1,000L), toxicology (50–1,000L), and engineering & GMP manufacturing (50–5,000L).
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