Services

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.

Request Information
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
Request Information

Research-Grade

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

Our foundation is hope

GMP Pathway™

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

Our foundation is hope

cGMP

Coming in 2023!

Our foundation is hope
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 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.

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

Services

Technology

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, and in-house plasmid production.

Ignition Cells™

  • Clonal HEK293 mammalian suspension cell line
  • Royalty-free license for clients
  • Optimized for robust transient transfection
  • Animal component free
  • Scalable production
Our foundation is hope

pEMBR™ Adenovirus Helper Plasmid

  • Adenovirus Helper Plasmid
  • Lower cost for production
  • Improved safety profile – removed unnecessary adenoviral elements
  • Forge Biologics intellectual property
  • Available for pipeline use
  • pEMBR Design Features

    pEMBR Yield Comparison
Our foundation is hope
5/5 (2 Reviews)