Parvovirus retentive filters are a commonly implemented and validated viral clearance technology within bioprocesses (mAb/recombinant and plasma fractionation). Regulatory guidance stresses that viral clearance filter validations be as representative of full scale manufacturing as possible to ensure the validity of the study results. There are a number of critical factors to consider during validation which can present challenges in maintaining this representativeness. If these factors are not properly addressed in the study design, retention and/or capacity could be negatively impacted.
This webinar will guide you through best practices to adopt for spiking studies to ensure the highest levels of success and filter performance. Specific considerations to be discussed will include: effect of freeze/thaw/aging/shipping/handling on feed, decoupling adsorptive prefilters, virus prep purity and spike percentage, constant flow vs. constant pressure operation and process interruptions.
In this webinar you will learn:
- Critical factors which can impact the success of a spiking study
- Best practices to ensure the highest levels of success and filter performance