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

Our foundation is hope


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.

  • Experienced team able to support process development and scale up
  • In-house analytical assay development and performance to support cGMP-readiness
  • Production of toxicology material
  • Process development to manufacture novel engineered capsids


cGMP Production

Fully disposable, closed system processing.

  • Flexible scheduling and maximization of capacity
  • Consistent process and product flow for reduction of variation

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

pEMBR™ Adenovirus Helper Plasmid

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.

  • Lower cost for production
  • Improved safety profile – removed unnecessary adenoviral elements
  • Forge Biologics intellectual property
  • Available for pipeline use

pEMBR™ design

High Yield of AAV using pEMBR™




In-House Offerings for End-To-End Development


Regulatory Support

  • Regulatory Support
  • End-to-end regulatory consultation services for clients from pre-clinical through clinical development, including assisting with responses to agency requests for information, review client CMC/IMPD information, and program regulatory strategy

Ambr® 250

  • Single-use multi-parallel bioreactor that is fully automated for accelerated process development
  • Aseptic Filling Workcells—a standardized, closed robotic aseptic filling machine

Analytical Ultracentrifugation

  • Aseptic Filling Workcells—a standardized, closed robotic aseptic filling machine

rcAAV lab

  • Aseptic Filling Workcells—a standardized, closed robotic aseptic filling machine

Fill & Finish

  • Vanrx automated fill-finish machine
  • Aseptic Filling Workcells—a standardized, closed robotic aseptic filling machine
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