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

Integrated Testing

Flexible Capacity

Global Quality Systems

Why Us?

Reliable integrated GMP manufacturing and testing services with a commercial-ready quality systems and experienced regulatory support.

Quality System

Project Management

Commercial Infrastructure

Regulatory Experience

Integrated Testing

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

Materials Management

Project Management

Cell Therapies

Viral Vectors

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