Expert Support from First Run to Full Scale

Whether you’re launching your AAV process or ready to scale, we’re here to help set your therapy up for manufacturing success.

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Your Collaborative Partner from Idea to Impact

We know that no two gene therapy programs are alike, which is why biotech companies need a manufacturing collaborator with deep expertise across serotypes, indications, and scales—and solutions for every stage of your program.

Fuel Your Process Development with Forge’s Robust Platform

Our FUEL™ platform offers a powerful head start with an innovative AAV manufacturing foundation built to help biotech companies scale efficiently.

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Analytics to Prepare Your Program for cGMP

We offer over 25 in-house assays for efficient and accelerated characterization and release​, including NGS, potency, and rcAAV.

aav capabilities

Scale and Support for cGMP

Our process development and cGMP scale-up and scale-down capabilities support a commercial suspension platform. From technology transfer to fill-finish—Forge has you covered.

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a partner for growth

We Help Scale Your Gene Therapies

With numerous development studies, scales, and AAV grades available to shape manufacturing pathways and reach key milestones, a common two-fold question we hear from biotech developers is: “Where do I start, and will it work?” We help navigate these decisions and scale programs with confidence — from selecting the right approach and leveraging our FUEL™ platform to optimizing for yield and driving toward commercial success.

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innovation

Innovation that Powers Your Progress

Biotech companies need a manufacturing partner that is relentlessly innovating to help them stay ahead. Our investments in manufacturing R&D have led to real advantages for developers through novel technologies in our FUEL™ platform, including our HEK293 suspension Ignition Cells™, pEMBR™ 2.0 Ad helper plasmid, and modified rep/cap plasmids. Everything is designed to help you develop, manufacture and deliver transformative therapies faster, safer, and to more patients.

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An aerial rendering of the Hearth, showing the 20 cGMP suites and room for expansion.

Designed to scale with you

State-of-the-Art cGMP CDMO Facility

Our facility offers cutting-edge technologies and ample capacity to scale as your program advances, with 20 cGMP suites and bioreactors ranging from 50 to 5,000L. We’re ready to support you from your first run through to full scale production.

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Team members at work in the offices of the Hearth.

guidance

Expert Regulatory Guidance for Biotechs

Navigating regulatory requirements can be complex and time-consuming for biotech companies advancing new therapies. Forge provides the guidance and support you need, from DMF cross-referencing and Module 3 guide to tailored consulting, documentation support, and strategic input to help streamline IND filings and strengthen your regulatory strategy across every stage of development.

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Forge Your Path

Let’s talk about how we can bring your AAV program to scale today.

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