Commercial Manufacturing for Cell and Gene Therapies

Expanding global capacity through our GMP commercial manufacturing and integrated testing services, we provide solutions that support commercial cell and gene therapy programs around the world.

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Your Strategic Partner – Commercial Manufacturing Partnership Benefits

Expedited Tech Transfer
Since 2004, we have been manufacturing commercial lots. Our team understands how to quickly transfer your process into our operations, either internally or from another contract provider.
Capacity - Dedicated Suite Model
Flexible terms. Ability to scale up or scale out to meet commercial demand.
Timeline Reducing Integrated Manufacturing and Testing Services
End to end solutions provides timely manufacture and release.
Raw Material Supply Assurance
We leverage our industry partnerships to ensure all required raw materials such as plasmids and Hyperstacks are in stock. For Viral Vector Supply, we utilize our proprietary platform for rapid delivery. Learn more.
Process Optimization
Process Engineering and QbD
Comprehensive Quality System
Manufacturing operation adheres to global regulatory guidelines. View our quality system.
Analytical Development
Access to our internal department of experts. Learn more.
Gateway To New Markets
Thinking about launching your product in a new geography such as China? Our Technical and Regulatory experts can help you navigate the launch.

 

Manufacturing and Testing Facilities

 

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Over 287,000 sq ft

Global Compliance – Comprehensive Quality System – Integrated Testing and Manufacturing Operations

League Island 1

LI1 – HQ/Early Phase Clinical Manufacturing and Testing – Est. 2004 – 82,000 sq ft

LI1

In addition to early phase clinical manufacturing, testing operations such as cell line characterization, QC, and viral clearance are performed here.

Commerce Center 3

CC3 – Non-Viral Cell Therapy Manufacturing – Est. 2015 – 55,000 sq ft

CC3

For autologous cell therapies, timing is everything. Located only seven miles from Philadelphia International Airport, our campus location enables us to begin processing patient materials faster.

League Island 2

LI2 -Late Phase/Commercial Viral Manufacturing and Testing – Est. 2016 – 150,000 sq ft

LI 2

LI2’s is dedicated to late-phase and commercial manufacturing of viral vectors and gene mediated cell therapies. Additional operations include QC and release testing, fill/finish, process development, and analytical development.

Expansion Plans Underway

In order to meet global demand, we are expanding capacity. More info coming soon.

Speak with our experts

Request more information on our commercial manufacturing services.

Have additional product candidates in your pipeline?

Learn more about our clinical manufacturing services by clicking the links below.

Clinical Manufacturing

Viral Vector Supply