Services

Manufacturing Solutions

The foundation of our business is “The Hearth”, a 200,000+ ft2 custom-designed, cGMP facility, dedicated to AAV viral vector manufacturing. We offer end-to-end manufacturing and development services to accelerate gene therapy programs from preclinical, through clinical, and commercial manufacturing.

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Services

Manufacturing Services

Our foundation is hope

*5,000L bioreactors available in the second half of 2022

Blaze Vector Production

Turnkey, scalable, premier research-grade AAV production

  • Our proprietary Ignition Cells™ that 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, reducing 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.

Ignition Cells™

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

pEMBR™ Adenovirus Helper Plasmid

Our foundation is hope
5/5 (2 Reviews)