Developing and Manufacturing Solutions for Gene Therapies
Services

Manufacturing Solutions

Forge offers end-to-end AAV and plasmid manufacturing services to support gene therapy developers from discovery to delivery and every need in between.

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Services

AAV Manufacturing Services

Our foundation is hope

We offer a robust platform approach wholly built for AAV production. That means you have access to a leadership team with 200+ 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.

Research-Scale Manufacturing

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

  • 1-40L
  • 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

  • 1-1,000L
  • 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

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

Integrated Regulatory Solutions

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
  • AAV and plasmid Drug Master Files maintained by Forge in the U.S. and Canada
Services

Plasmid DNA Manufacturing Services

Our foundation is hope

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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Research-Grade

Suitable for discovery, R&D, toxicology, and engineering runs

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GMP-Pathway

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

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cGMP

Suitable for phase I through commercial manufacturing

Our foundation is hope
Services

Technology

Our foundation is hope

Our Advanced Technologies

Forge’s proprietary HEK293 suspension Ignition Cells™ and pEMBR™ Ad helper plasmid help gene therapy developers accelerate their programs safely, quickly, and at scale.

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
  • >90% full capsid post-enrichment with CsCl, with undetectable empty particles
Our foundation is hope

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
The Hearth

Our Facility

Our foundation is hope

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 with room for future expansion. Our facility has 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.

Explore our world-class facility with this flythrough video of the Hearth:

5/5 (2 Reviews)