Service

Commercial Manufacturing

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

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 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™, 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

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

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