Developing and Manufacturing Solutions for Gene Therapies

Manufacturing Solutions

The foundation of our business is the Hearth, a 200,000+ sq. ft. custom-designed, cGMP facility dedicated to AAV viral vector manufacturing. The Hearth has 20 cGMP suites utilizing 50L, 500L, 1,000L and 5,000L bioreactors.

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AAV Manufacturing Services

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We offer a robust platform approach wholly built for AAV production. That means you have access to a leadership team with 165+ years of industry experience, 200,000+ sq. ft. cGMP facility, proprietary technologies optimized for safety, and a company that shares our clients’ missions of advancing potential treatments for those who need them the most. Our facility has also been audited by a Qualified Person (QP) and fulfills the European Union Good Manufacturing Practices (EU GMP) for clients wishing to use or distribute their products in Europe.

Research-Scale Manufacturing

Blaze Vector Production is our turnkey, scalable, research-grade AAV production

  • Our proprietary Ignition Cells™ have a clear, well-documented history and are optimized for scalable suspension growth
  • Established process for many standard AAV serotypes
  • Upfront communication and pricing
  • Fast turnaround time

Process & Analytical Development

End-to-end capabilities from research to cGMP reduce the need for bridging studies

  • Our experienced team supports process development and scale up
  • In-house analytical assay development and performance to support cGMP-readiness
  • Process development to manufacture novel engineered capsids
  • View our analytical development assays

cGMP Production

Fully disposable, closed system processing

  • Flexible scheduling and maximization of capacity
  • Consistent process and product flow for reduction of variation
  • 50-5,000L scale. See our 5,000L bioreactor.

Regulatory Support

End-to-end regulatory consultation services for clients from pre-clinical through clinical development

  • Overall program regulatory strategy
  • Assistance responding to agency requests for information
  • Review client CMC/IMPD information

Forge will maintain a Drug Master File (DMF) for our process with the FDA for client’s CMC documentation


Plasmid DNA Manufacturing Services

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Plasmid DNA is an essential component of gene therapy development and the starting point of Forge’s idea-to-impact manufacturing services to accelerate gene therapy programs from preclinical through clinical and on to commercial manufacturing. Forge’s plasmid production with single-use systems incorporates seamlessly into our optimized AAV manufacturing process for increased efficiency and transparency. We offer a variety of scales and service levels to fit our clients’ needs for AAV production.

  • Increased efficiency through single vendor selection
  • Single-use systems for all grades
  • Document control, transparency, and full traceability
  • Animal component-free reagents for regulatory compliance and reduced risk
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Suitable for discovery, R&D, toxicology, and engineering runs

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Suitable for toxicology, engineering, phase I, and phase II clinical trial material manufacturing

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Coming in 2H 2023!

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Our foundation is hope

Our Advanced Technologies

At Forge, our platform approach employs the triple plasmid transfection method – the industry-standard method for manufacturing AAV. This method is bolstered by Forge’s proprietary technologies, our Ignition Cells™ and pEMBR™ adenovirus helper plasmid.

Ignition Cells™

  • Suspension HEK293 mammalian cell line
  • Royalty-free license for clients
  • Well documented history with regulatory feedback
  • Fully qualified Master Cell Bank and Working Cell Bank produced at Forge
  • Optimized for robust transient transfection
  • >40% full without enrichment step, often >90% full capsid post-enrichment with CsCl, with undetectable empty particles
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pEMBR™ Adenovirus Helper Plasmid

  • Custom designed ad helper plasmid
  • Improved safety profile–engineered to reduce known immunogenic elements
  • Decreased size increases efficiency in manufacturing
  • Shows equivalent AAV yields as compared to commercially available alternatives
  • Forge specific intellectual property
  • Available for licensing and pipeline use
  • pEMBR Yield Comparison
Our foundation is hope
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