Wholly built for AAV Manufacturing
We offer a robust platform approach wholly built for AAV production. That means you have access to a leadership team with 250+ 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.
The Platform
Forge’s FUEL™ platform provides an accelerated foundation for AAV development and includes advanced technologies, proven manufacturing processes, and product-specific optimization packages to deliver faster, potentially safer, and more efficient manufacturing.
FUEL™ Your Program Efficiently
Advanced Technologies
pEMBR 2.0™ Ad Helper Plasmid
Modified Rep/Cap Plasmids
Ignition Cells™
Forge’s proprietary technologies deliver higher yields, >90% full-capsid enrichment, comparable recovery to industry standard, and designed to be safer.
Proven Manufacturing Processes
Proven manufacturing processes honed by our team of experts with 300+ platform runs across all serotypes including novel.
Optimization Packages
Flexibility for product-specific customizations to meet individual client needs with multiple packages designed to optimize for yield, recovery, regulatory success, and more.
Our Advanced Technologies to FUEL™ Your Breakthroughs
Ignition Cells™
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Suspension HEK293 cell line
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Royalty-free license for clients
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Fully qualified Master Cell Bank and Working
Cell Bank produced at Forge -
Optimized robust transient transfection
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Capable of >90% full capsid post-enrichment,
often with undetectable particles
pEMBR 2.0™ Ad Helper Plasmid
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One of the smallest Ad helpers commercially
available at 8.9 kb -
Increases efficiency in manufacturing
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Improved safety profile – reduction in
adenoviral components that are not
necessary for AAV production -
Forge-specific intellectual property
Modified Rep/Cap Plasmids
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Designed for safety and higher AAV yields
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No changes to protein sequences of cap
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Plug and play of client-specific capsid
sequence with Forge’s proprietary
rep/cap element -
Patent pending
Our Services
Accelerating AAV programs at any stage from preclinical through clinical, and commercial manufacturing.
AAV Manufacturing Services
Research-Scale Manufacturing
Blaze Vector Production is our turnkey, scalable, research-grade AAV production.
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1-40L production
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Our proprietary Ignition Cells™ have a clear, well-documented history and are optimized for scalable suspension growth
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Established process for many standard AAV serotypes
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Upfront communication and pricing
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Fast turnaround time
Process & Analytical Development
End-to-end capabilities from research to cGMP reduces the need for bridging studies.
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1-1,000L production
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Our experienced team supports process development and scale-up
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In-house analytical assay development and performance to support cGMP-readiness
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Process development to manufacture novel engineered capsids
cGMP Production
Fully disposable, closed system processing.
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50-5,000L production
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Flexible scheduling and maximization of capacity
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Consistent process and product flow for variation reduction
​Integrated Regulatory Services
End-to-end regulatory consultation services for clients from pre-clinical through clinical development.
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Overall program regulatory strategy
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Assistance responding to agency requests for information
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Review client CMC/IMPD information
​Forge maintains AAV and plasmid Drug Master File (DMF) for our process with the FDA for client's CMC documentation, as well as Master Files in Canada for developers looking to conduct clinical trials in that country.
Plasmid Manufacturing
Plasmid DNA is 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.
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Increased efficiency through single vendor selection
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Single-use systems for all grades
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Document control, transparency, and full traceability
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Animal component-free reagents for regulatory compliance and reduce
The AAV Experts
Over 350+ team members that embody hope – and growing!
John Maslowski
President & CEO
Frank Agbogbo, Ph.D.
Vice President, Process Development
Ashley Craddick
Senior Director, GMP Manufacturing Operations
Adam Davis, Ph.D.
Vice President, Analytical Development
David Dismuke, Ph.D.
Chief Technical Officer
Taleen Barsoumian
Vice President, Client Development
Meghan Leonard
Vice President, Quality Management
Chris McPherson
Vice President, GMP Manufacturing
Chris Shilling
Chief Regulatory Officer
Our Facility, The Hearth
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The Hearth is our 200,000+ sq. ft. custom-designed, cGMP facility, dedicated to AAV manufacturing. Our facility has been designed to optimize for throughput, ultimately saving our clients time and accelerating development so that treatments can get to those who need them the most.
We have 20 cGMP suites with room for future expansion making our facility one the largest AAV manufacturing facility in the world.
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