Cell Therapy Characterization & Release Testing

Ensure the safety, identity, purity, and potency of your cell-based products with industry-leading expertise in GMP-compliant analytical testing. Our team combines decades of experience in regulatory science and cell therapy analytics to support your QC strategy from early-phase clinical trials through commercial manufacturing.

With scalable capacity, rapid turnaround, and proven regulatory record across global frameworks, we partner with developers and CDMOs to deliver fast, consistent and high-quality testing services for complex cell therapy platforms.

1- Recommended if using viral vector for delivery of genetic material to cells

AUTOLOGOUS PRODUCT RELEASE TESTING
Test	Design
Rapid Sterility using the BactT® /ALERT 3D system	Off-the-shelf
Mycoplasma PCR	Off-the-shelf
Endotoxin	Off-the-shelf
VSV-G or RD114 for early RCL/RCR detection1	Off-the-shelf
Vector Copy Number1	Off-the-shelf
Viable Cells	Custom
Potency	Custom
Identity	Custom

1- Recommended if using viral vector for delivery of genetic material to cells

ALLOGENEIC PRODUCT RELEASE TESTING
Test	Design
Rapid Sterility using the BactT®/ALERT 3D system	Off-the-shelf
Mycoplasma PCR	Off-the-shelf
Mycobacterium	Off-the-shelf
Endotoxin	Off-the-shelf
28-day in vitro assay for the presence of adventitious viral contaminants (3 detector cell lines) (US, WHO)	Off-the-shelf
VSV-G or RD114 for early RCL/RCR detection1	Off-the-shelf
Vector Copy Number1	Off-the-shelf
Viable Cells	Custom
Potency	Custom
Identity	Custom

CELL THERAPY TESTING INNOVATION BUILT ON A FOUNDATION OF REGULATORY EXPERTISE

Featured innovations: 

• Operating model unique for autologous drug product release
• NGS applications
• Rapid methods
• Phase-appropriate method development and validation
• Regulatory expertise

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