Genetic stability includes the testing of cell or virus banks at the level of the Master, Working and End of Production Cell or Virus Bank to ensure that the genetic insert is stable. Such testing is a key element of the safety concept for cell-derived biopharmaceutical products and vaccines.
In vitro/in vivo GMP testing are also required for live vaccines and viral vectors. Such studies can be especially challenging when the detector cells or animals are susceptible to the virus.
Virus Permissivity Studies
If you are using an alternative expression system and you are interested in its susceptibility to virus infection, ViruSure can assist you with virus permissivity studies using a wide range of different viruses to check if they are permissive to your producer cells.
Biodistribution for ATMPs
For ATMPs such as gene therapy vectors or cell-based therapies, a demonstration of the biodistribution of the vector, kinetics of gene expression in vivo or migration potential is normally required.