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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Manufacturing Services
*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 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
- 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
