Analytical Services for Cell & Gene Therapies
Cell and gene therapies are transforming modern medicine, with modalities such as AAV (adeno-associated virus) gene therapy vectors, CAR-T cell therapies, lentiviral vectors and other engineered cell products delivering durable, often one-time treatments. Their complexity, however, demands specialized analytical characterization to ensure identity, purity, potency and safety throughout development and manufacturing.
At Biofidus, we provide an integrated portfolio of analytical services for cell and gene therapies, with particular expertise in AAV vector characterization and CAR-T cell analytics. For AAV and other viral vectors, we combine long-read next-generation sequencing (ONT) for genome integrity and sequence confirmation, qPCR for vector genome titer, TEM and biophysical methods for capsid morphology and empty/full ratio, and LC-MS/MS for capsid protein identity and post-translational modifications.
For CAR-T and other engineered cell therapies, we support cell identity and purity, phenotype and activation status, transduction efficiency, vector copy number, viability, functional potency and safety-relevant attributes using flow cytometry, cell-based functional assays and molecular methods.
Our experienced team in sequencing, vector genome analysis, capsid protein characterization and cell-based analytics will guide you through the variety of available methods and help you define a fit-for-purpose, regulator-aligned analytical strategy.
We adapt our platform methods to the properties of your drug substance, its individual formulation matrix, and your specific analytical question, and qualify them as needed according to ICH guidelines.
Get in contact with us to quickly identify the optimal analytical setup for your cell and gene therapy programs and to speak directly from expert to expert.
