High-yield AAV vector production built for gene therapy programs

AAV Manufacturing for Novel Gene Therapies

Forge Biologics delivers specialized AAV manufacturing designed to accelerate your gene therapy from concept to clinic, and on to commercial production.

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Specialized in AAV

Our expertise, platforms, and facility are built exclusively to support AAV developers across all stages of development.

AAV Production

End-to-End Support

From molecular and process development to cGMP manufacturing and final fill-finish, we support the complete AAV production lifecycle.

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Custom AAV Facility

20 cGMP suites and scalable bioreactor capacity up to 5,000L for efficient and reliable AAV production.

The Hearth

Why use Forge for AAV Vector Production? 

Producing high-quality AAV vectors demands more than equipment. It requires a partner with deep AAV specialization, proven processes, and the infrastructure to scale as your program advances. Our team brings decades of experience in AAV viral vector design, production, and regulatory guidance, ensuring every batch is optimized for yield, purity, safety, and regulatory compliance.

Forge was built exclusively for AAV manufacturing. Our platform technologies, analytics, and cGMP operations are purpose-built to help clients advance AAV programs more efficiently, with higher vector productivity, recovery, and consistent quality across scales.

Our AAV Manufacturing Process

Forge provides a proven AAV manufacturing process, meticulously honed over 600 runs, supporting developers from molecular design through fill-finish.

Upstream Process

  • Comprehensive upstream process includes vial thaw, seed expansion, inoculum expansion, triple transfection, lysis, and filtration.
  • Efficient upstream operations supported by a full suite of scalable bioreactors, enabling a smooth transition from process development to cGMP.
  • Our optimized upstream processes consistently deliver high-yield AAV vector production through efficient manufacturing.

Downstream Process

  • Our downstream process includes clarification, chromatography, TFF, filtration, and fill-finish.
  • Our systems ensure purity, safety, and consistency across scales.
  • Our downstream methods are designed to maintain exceptional drug substance recovery, translating upstream high-yield performance into real, scalable downstream gains.

Other AAV Services We Provide

Molecular Development Consultation

cGMP Manufacturing

  • Fully compliant cGMP manufacturing services, including DS and DP production, fill-finish, and lot release support.
  • 20 cGMP-ready suites that support scalable bioreactor systems.
  • cGMP guarantee: Environmental monitoring, validated systems, regulatory-aligned documentation, and dedicated QA oversight ensure every batch meets global quality standards.

Analytical Development & Quality Control

  • Robust analytical development and QC testing, covering potency, purity, identity, safety, and stability through all clinical phases.
  • Integrated analytics ensures testing is built into every step of the manufacturing lifecycle to help guide development and produce predictable and compliant outcomes.
  • With 30+ in-house analytical assays and fully equipped QC labs, we provide deep characterization and assessment of lot-to-lot consistency.

Our AAV Research Grade Production, FUEL™ Platform, and Tech Transfer Offerings

Whether you’re evaluating GOI for manufacturability or ready to scale, Forge offers manufacturing paths designed to meet you where you are. Blaze, our research-grade offering, accelerates early discovery and preclinical work. Our AAV platform, FUEL™, delivers predictable performance across scales. These options allow clients to progress smoothly through development and manufacturing with consistency and confidence. 

Our seamless tech transfer capabilities ensure that no matter where your process originates, you will have support all the way throughout your AAV manufacturing journey. 

Research-Grade AAV Production with Blaze

• Blaze is Forge’s research-grade AAV production offering, supporting rapid material generation for early discovery work such as identifying your lead therapeutic candidate or understanding the manufacturability of your vector.

• Blaze is best for early-stage programs requiring fast research-grade AAV material at 1-50L.

• The benefits of our Blaze platform include consistent, high-quality research-grade vector production that seamlessly scales into cGMP manufacturing.

Blaze

Optimize and Scale with our FUEL™ Platform

• FUEL™ is Forge’s AAV manufacturing platform which combines advanced technologies, proven manufacturing processes, and product-specific optimizations.

• Proprietary technologies include pEMBR 2.0™ Ad Helper, modified rep/caps, and HEK293 Ignition Cells™, designed to enhance safety and boost AAV yields.

• The FUEL™ platform has shown to boost manufacturing productivity by 6–22X, delivering higher yields compared to industry standard.

FUEL™

Seamless Tech Transfer Support

• Forge delivers collaborative, systematic tech transfer services built on deep AAV expertise.

• Robust support ensures your program integrates smoothly into Forge’s manufacturing process.

Our seamless tech transfer capabilities ensure that no matter where your process originates, you will have support all the way throughout your AAV manufacturing journey. 

 Tech Transfer

The HEarth

Facilities Dedicated to AAV Manufacturing

The Hearth is Forge’s dedicated gene therapy manufacturing facility. Key features include:

  • 200,000 sq. ft. cGMP facility dedicated to AAV.
  • Bioreactor scales from 50L to 5,000L.
  • Compliance with global regulatory standards, including QP requirements.
Our Facility

Book a Call with Our AAV Manufacturing Experts

When you engage with Forge, you’re paired with a dedicated client team solely focused on advancing your program. This team works with you to understand your goals, development stage, timelines, vector design, and manufacturing strategy, ensuring every decision aligns with your path to the clinic.

Speak to an AAV Manufacturing Expert

Frequently Asked Questions

How does Forge’s AVV production process work? 

Forge offers end-to-end AAV manufacturing and services, including plasmid production and molecular design through upstream and downstream development, cGMP manufacturing, and fill-finish. We use proprietary platforms (like FUEL™ and Blaze) to ensure high-yield, scalable, and quality-controlled AAV production across all serotypes.

Can Forge support custom AAV manufacturing? 

Yes. While most clients use our FUEL™ platform for predictable, high-yield AAV production, Forge also fully supports custom AAV manufacturing. Our tech transfer capabilities ensure that client-developed processes integrate smoothly into our AAV manufacturing capabilities.

How quickly can Forge deliver a GMP batch? 

Timelines for GMP 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 sets us apart.

Is fill-finish included in Forge’s 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.

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