Size exclusion removal of model mammalian viruses using a unique membrane system, Part II: Module qualification and process simulation.

The performance of a fabricated device may be influenced by the characteristics of the fluid management within the device and reproducibility with which the device is manufactured. The performance of the Viresolve/70 membrane is not diminished when incorporated into a fabricated module. The Viresolve/70 fabricated modules are shown to reproducibly retain viruses via a sieving mechanism, independent of virus type or character, in excellent agreement with the base membrane retention coefficients reported previously. The retention coefficients measured for the Viresolve/70 modules are shown to increase with increased recirculation flow rate within the module. Mammalian virus spiked protein solutions processed through the Viresolve/70 system show that mammalian viruses can be removed from solution in accordance with the apparent membrane retention coefficients. The retained virus is recoverable on the upstream side of the membrane. Process clearance factors for murine leukemia virus is in excess of 6.7 LRV and that of human immunodeficiency virus I is 8.5 LRV.