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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Dedicated GMP manufacturing suite model
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Analytical Development – Potency and Rapid Sterility
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Process Development – Scale up or out
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Viral Vector Production Platform to ensure supply
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Regulatory Support
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.
Technical Consultation
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.
Assay Development/Analytics Readiness
State of the art facilities minimizes contamination risks. Develop expansion plans tailored to your requirements.
Harvest/Formulate/Fill
Types of equipment… integrated testing.
Harvest/Formulate/Fill
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.
Deliver to patient
Patient monitoring capabilites post administration.