Quality System
Our team has been approved by the U.S. FDA to manufacture commercial cell therapy products and supply critical materials for multiple products. We also support bioanalytical testing for close to 30 commercial programs.
Service
Commercial Manufacturing
WuXi Advanced Therapies is one of the few CDMOs manufacturing cell and gene therapies at commercial scale. Our quality systems, infrastructure, training and hiring practices, facilities, warehouse, supply chain, and testing laboratories are all approved and ready for commercial production.
Let’s discuss your goals for commercial manufacturing
Proven Reliability
We have been supporting commercial programs in our testing division for more than a decade and manufacturing drug substance and drug products for commercial supply since 2023.
Expedited Onboarding
Our experience allows us to quickly onboard your process for commercial production.
Integrated Testing
In house bioanalytical testing services expedite batch release and reduce risk.
Flexible Capacity
Capacity is optimized to match the changing demands of your program. Scale up or scale out to best meet your needs.
Global Quality Systems
Our quality systems and site have been approved by the FDA and other regulatory agencies for commercial production.
Why Us?
Reliable integrated GMP manufacturing and testing services with a commercial-ready quality systems and experienced regulatory support.
Quality System
Our team has been approved by the U.S. FDA to manufacture commercial cell therapy products and supply critical materials for multiple products. We also support bioanalytical testing for close to 30 commercial programs.
Project Management
Timeline development, scheduling, pre- and post-production, and all other aspects of commercial product production are coordinated by our experienced team.
Commercial Infrastructure
The 400,000+ square foot campus in Philadelphia, Pennsylvania is equipped with the facilities, systems, equipment, storage, supply chain capability and expert team required to support commercial scale for your cell or gene therapy program.
Regulatory Experience
Our regulatory support services team will collaborate with you from initial submission to maintenance and will support your entry into new markets. We have worked with our clients to successfully clear dozens of INDs and multiple PLI and BLA applications.
Integrated Testing
The bioanalytical testing team at WuXi Advanced Therapies has been supporting commercial programs for more than a decade.
In-house testing reduces the time and risks associated with product release. Materials testing, in-process testing, and post-production testing services can be provided to meet the unique needs of your product or program.
Iovance Approval of AMTAGVI™
When Iovance received approval on February 16, 2024 for the commercial manufacturing of AMTAGVI™, WuXi ATU’s Philadelphia site became the first U.S. external manufacturing site and the first third-party contract testing, development, and manufacturing organization (CTDMO) to be approved by the FDA to support the commercial manufacturing and release of an individualized T cell therapy for a solid tumor cancer.
Read the Press Release
Commercial Manufacturing Infrastructure
WuXi Advanced Therapies has wide-ranging experience and expertise to support your commercial cell or gene therapy program.
Testing Services
- Analytical Development
- Method Transfer
- Raw Materials Clearance
- Viral Clearance
- Cell Characterization
- Stability Studies
- Lot Release
Materials Management
- Raw Material Sourcing
- Inventory Control
Project Management
- Timeline adherence
- Communication strategies
- Scheduling
- Shipping coordination
Cell Therapies
- CAR-T
- TCR
- TIL/MIL
- MSC/HSC/IPSC
Viral Vectors
- AAV
- LVV
- HSV
- Adeno