CMC Testing Support for Gene and Cell Therapy

Eurofins BioPharma Product Testing supports the development of ATMPs both for traditional use as well as for use in personalized medicine. We provide comprehensive GMP-compliant CMC testing support to ensure the identity, potency, purity, and safety of starting materials, intermediate products, vectors, and final drug products as well as support for manufacturing process development and validation.

Testing Capabilities include Raw Materials, Cell Banks, Virus Banks, Plasmid Vector, Harvest (Lot Release Testing), and Bulk & Finished Products. We support gene therapies, cell therapies, viral vaccines/oncolytic viral therapies, and oncolytic peptide vaccines. We offer comprehensive cell and molecular biology, biochemistry, biosafety, and microbiology testing through one testing partner. We have provided cGMP-compliant testing support to gene and cell therapy sponsors for over 10 years and also support most contract manufacturers focused on ATMPs. We have the laboratory capacity, BSL2 facilities, and state-of-the-art instrumentation to meet regulatory requirements and turnaround times for cell and gene therapy products. We provide a 3 day Certificate of Analysis of interim test results for rapid sterility, mycoplasma, and endotoxin testing. Our specialized sample delivery and receipt process ensures seamless communication between our lab and yours and expedites your samples into our laboratory. Our secure 24/7 online data portal, LabAccess.com, provides timely access to your test results.



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