Cellular Therapies

A leading integrated cell and gene therapy Contract Testing, Development and Manufacturing Organization (CTDMO)

Our complete portfolio of integrated development, manufacturing, and testing services for autologous, allogeneic, and gene mediated cell therapies provide rapid entry to clinical trials and support commercial programs around the world.
Service Overview:

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Technical Consultation
In order to build a manufacturing program that scales, we involve our technical team from the very beginning to understand every detail of your process and product.
Collection, Preparation, Chain of Identity
We comply with regulatory requirements by utilizing COI software to ensure that no patient materials are mislabeled during production and testing.
Assay Development/Analytics Readiness
Analytical Department experts prepare custom potency assays required for release.
Expansion - GMP Manufacturing
State of the art facilities minimizes contamination risks. Develop expansion plans tailored to your requirements.
Harvest/Formulate/Fill
Types of equipment… integrated testing.
Release/Stability Testing
Complete portfolio of assays required to release your cell therapy. Custom and Semi-custom assays can be created by our analytical development group.
Deliver to patient
Located only 7 miles from PHL international airport, we are able to rapidly ship your cell therapy product directly to the patient.
Patient Monitoring
Patient monitoring capabilites post administration.

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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.
 

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Manufacturing
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