Gene Therapy Testing Services

Gene therapies have made significant progress in the treatment of many diseases, including cancer, genetic and autoimmune disorders, by replacing, adding or turning off patient’s genes. With the promise to enhance treatment, greatly reduce side effects, and potentially cure many types of diseases and disorders, these therapies are in high demand, and biopharma companies are in a race to the clinic.

With BSL2 facilities and state-of-the-art instrumentation, Eurofins BioPharma Product Testing network of laboratories has vast experience supporting gene therapy manufacturing from early clinical through process validation, product optimization, and marketed release.

Eurofins BioPharma Product Testing supports testing of viral vectors, nanoparticle vectors, plasmid based and mRNA gene therapies through comprehensive cGMP-compliant testing, including:

• Potency Testing
• Infectious titer analysis (TCID50)
• Replication Competent Testing
• Empty/Full Capsid Analysis
• Residuals Testing
• ddPCR
• NexGen Sequencing
• GMP Biosafety Testing
• Viral Safety
• Raw Materials Testing
• Stability Testing
• Unprocessed Bulk Testing, including sterility, mycoplasma, in vitro viral screening, and virus specific qPCR assays
• Cell Banking
• Cell Line Characterization
• Bioassays for Gene Therapy Products
• Plasmid GMP Testing

To achieve the goal of providing comprehensive cGMP testing, Eurofins BioPharma Product Testing has invested significant capital at our Lancaster and Columbia laboratory locations.  New equipment specific to gene therapy includes; ddPCR, analytical ultracentrifugation (AUC), and transmission electron microscopy (TEM).  Our breadth of services include; phenotypic protein identity, empty capsid particles, replication recombinant viruses, transgenic expression, product/process related impurities, and safety testing all in one location.

We offer platform methods as well as the capability for method establishment and validation. Our teams can help bridge the gap from development to GMP testing for gene therapy clients.   

Our experienced project management and technical teams serve as your single-source solution for all of your testing needs and our secure 24/7 online data portal, LabAccess.com, provides timely access to your test results.