Cell + Virus Banking Services
The storage of critical biological products up to their point-of-use is a fundamental aspect of the GMP cell and virus banking system. Our GMP-compliant storage area offers dedicated or shared storage in standard freezers (-80°C), ultra-low freezers (-130°C), or in cryotank for storage in liquid nitrogen vapor phase at temperature below -150°C.
The safety testing of cell or virus banks at the level of the Master, Working and End of Production Cell Bank is a key element for cell- or virus-derived biopharmaceutical products. Characterization tests aim to confirm identity, genetic stability and purity of the cell or virus bank.
Sterility and mycoplasma testing are the minimal assays to be performed as bank release testing. For both assays a method suitability (stasis testing/interference testing) is required once for each product. Method suitability must be repeated whenever there is a change in composition or in the method of manufacture that might affect mycoplasma or bacteria detection.