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.

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.

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

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.

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.

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.

Forge offers over 30 AAV assays in-house for efficient and accelerated characterization and release, including rcAAV, potency, and more.

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.

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.

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).