Gene Therapy Manufacturing
Our gene therapy services, delivered through Forge Biologics, support programs from concept to commercial with high-yield AAV manufacturing, a world-class GMP facility, proprietary technologies, and deep gene therapy expertise.
Development and Manufacturing Services
Forge provides integrated development and manufacturing services from research-grade production and process development through GMP and commercial manufacturing. These capabilities are brought together under one roof at one of the world’s largest manufacturing facilities dedicated to AAV.
Research-Grade Manufacturing
Blaze research-grade AAV production at 1 to 40L is ideal for discovery work like material generation for proof-of-concept studies or assessing vector manufacturability. With a scalable process and Forge’s proprietary technologies, it gives early-stage developers confidence in a seamless path to GMP.
Process Development
Forge takes a flexible approach to meet each program where it is, from comprehensive process development to our established platform with targeted, product-specific optimizations, or technology transfer of an existing process. Each path is designed to support performance, scalability, and GMP readiness.
GMP Manufacturing
Forge’s GMP production—ranging from 50 to 5,000L—is designed for scalability, efficiency, and repeatable manufacturing success. Backed by deep technical expertise, the team leverages single-use technologies and optimized closed-system processes to produce larger batches with high throughput and minimal variability.
Analytical Development & Quality Control
At Forge, we offer 30+ in-house AAV assays, including potency, rcAAV, mass spectrometry, and more to accelerate characterization and release. The integrated QC and QA framework, supported by GMP compliance and connected systems, ensures consistent, compliant manufacturing quality from start to finish.
Fill-Finish
Forge offers a range of fill-finish services to meet the needs of your program. We provide drug product fill options across semi-automated and automated operations, designed to accommodate varying batch sizes, container types, and fill volumes to meet your product requirements.
Supporting Services
Forge provides molecular development and regulatory expertise, from early development through GMP and beyond, including construct manufacturability guidance, program strategy, agency interactions, and CMC/IMPD documentation.
Accelerate with the FUEL™ Platform
Forge’s FUEL™ platform provides an established foundation for AAV manufacturing, combining proprietary technologies and proven processes with product-specific optimization to improve productivity and recovery while maintaining product quality.
Proprietary Technologies
Our proprietary gene therapy technologies, including the Ignition™ Cell Line, pEMBR™ 2.0 Ad Helper Plasmid, and Modified Rep Caps, support more efficient AAV manufacturing.
Product-Specific Optimizations
We’ve mapped 50+ upstream and downstream studies to help optimize yield, purity, and efficiency.
Proven Processes
With over 600 manufacturing batches completed to date across dozens of indications and every serotype, including novel, our platform manufacturing processes are well established and backed by extensive real-world experience.
A Specialized Partner
As part of Aji Bio-Pharma, Forge brings dedicated gene therapy manufacturing service built on specialized expertise, purpose-built infrastructure, and proprietary technologies to our network of specialized CDMOs and enabling technologies.
Backed by Global Scale
Forge’s dedicated gene therapy expertise is backed by the resources and commitment to rigorous quality, operational excellence, and sustainability across our global network, alongside the Ajinomoto Group’s century-long legacy of scientific innovation.
Proven Experience. Trusted Technology
These numbers reflect more than experience. They represent the trusted partnerships built by the clients who choose us.
60+
Clients Supported Across All Stages
97%
of Clients Use Our Technologies
600+
Batches Manufactured
35+
Indications We Expertly Support
Learn More at Forge Biologics
Let’s talk about how we can scale your AAV research today.