- Continuous end to end process presents new challenges operation and validation of the viral filter operation. Higher loadings required to maximize filter utilization and decrease filter swap outs, thereby reducing process risk.
- Higher loadings and continuous operation can lead to viral clearance assessments lasting several days and potentially overloading the filters with virus causing either non-representative filter fouling or non-representative virus breakthrough
- Novel filter evaluation and assessment strategies are needed to maximize filter utilization while still demonstrating safety
Integrated, end-to-end continuous processing presents challenges to the viral filtration operation to maximize filter throughput while ensuring viral safety. Continuous virus filtration over many days requires higher loadings to maximize filter utilization and minimize system manipulations, such as filter change-outs, to reduce process risk. However, high filter loadings and long process times create challenges in evaluating the viral clearance capabilities of the viral filter. Assessment of viral clearance to support continuous viral filtration may require studies spanning over several days, as well novel virus-spiking strategies. This type of assessment is needed to adequately demonstrate a high level of viral clearance while not overloading the filters with virus in a manner not representative of manufacturing operations. This presentation will include small-scale screening data for different viral filters to identify those filters that can process large volumes over long operating times, followed by implementation of one of these filters at scale in a continuous process. Additionally, the use of virus surrogates and alternative spiking strategies demonstrating high levels of viral clearance will be presented.