Process interruptions, whether planned or unexpected, can happen during your viral filtration step, and may impact the virus retention performance. Several strategies can be applied to mitigate this risk, including filter selection, process design, and approaches to clearance evaluations. This presentation describes a case study using ViresolveÂ® Pro membrane filters where virus retention performance is characterized following process interruptions.
Overall, the presentation demonstrates:
- Changes in parvovirus retention by ViresolveÂ® Pro devices following process interruptions were small (0.0 - 0.5 log change)
- A model based on the size exclusion principle was developed that predicted a small decrease in LRV (~0.3 logs) following flow interruptions
- The model predicted that virus retention was insensitive to many filter, feed, and process parameters; these predictions are consistent with the experimental results
The model predictions and supporting results may simplify risk mitigation strategies and approaches to viral clearance evaluations for virus filters.
Click here to view the webinar