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. The Hearth has 20 cGMP suites utilizing 50L, 500L, 1,000L and 5,000L bioreactors.
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Services
AAV Manufacturing Services
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. Our facility has also 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.
Services
Plasmid DNA Manufacturing Services
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
Research-Grade
Suitable for discovery, R&D, toxicology, and engineering runs
GMP-Pathway
Suitable for toxicology, engineering, phase I, and phase II clinical trial material manufacturing
cGMP
Coming in 2H 2023!
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™
- 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
- >40% full without enrichment step, often >90% full capsid post-enrichment with CsCl, with undetectable empty particles
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
