GMP Biosafety Services
In Vitro Safety Studies
Adventitious agent testing plays an important role in the cell bank and bulk harvest release of recombinant biopharmaceutical, vaccine products as well as other cell- and virus-based products. ViruSure offers fully validated in vitro assays using a range of detector cell lines from different species to meet your biosafety testing needs.
A range of molecular biology services are available at ViruSure to meet your biosafety testing needs. We have an extensive list of qPCR testing for various viruses, mycoplasma and mycobacteria. In addition, qPCR testing can be performed for biodistribution studies (e.g. for gene therapy vectors).
Transmission Electron Microscopy
Transmission Electron Microscopy (TEM) allows visualization of virus particles, particle size, morphology, and location. It is possible to use TEM for quantification of virus-like particles (VLPs) in bulk harvest.
In Vivo Safety Studies
In vivo tests are important cornerstones in cell or virus bank characterization. They may also be required for lot release of vaccine products. ViruSure’s state-of-the-art animal facility offers a broad range of internationally compliant in vivo studies ensuring pathogen safety following European Pharmacopoeia and the ICH guidelines.
In Vivo Tumorigenicity + Oncogenicity Studies
Cell systems to produce or vaccines bear the risk of tumorigenicity or oncogenicity. ViruSure can assist you in the evaluation of the tumorigenic and oncogenic potential of your cells following European Pharmacopoeia and FDA requirements.
GMP Lot Release (Bulk Harvest) Testing
Bulk harvest testing of each bulk is key for GMP lot release. ViruSure will support you to develop the right testing strategy and ensure rapid turnaround time to release your lot.