(564c) Leveraging Collaboration to Develop Improved Processing Strategies for Virus Filtration in Continuous Bioprocesses

Virus filtration is a critical unit operation to ensure viral safety of biologic modalities such as monoclonal antibodies. However, as the bioprocessing industry attempts to integrate continuous processing, utilizing prolonged low flux conditions at the virus filtration step, the potential impact on virus retention performance must be considered. Processes must therefore be designed to maintain robust viral clearance in continuous processing.

Through a combination of academic collaboration to understand the underlying mechanisms of virus retention and experiments using realistic bioprocessing conditions, several strategies for virus filtration in continuous processing have been developed. For example, a method that involves cycling a single filter over several days has shown good agreement with a model for the impact of process interruption on virus retention at different flow rates. Further, an intermittent spiking approach, developed through an academic collaboration, was leveraged to demonstrate the performance of high area ratio serial virus filtration operating at low flow.

Several case studies of virus filtration performance in continuous processes will be presented and academic collaborations’ contributions to the development of these viral clearance strategies will be reviewed. The value of academic studies was enhanced by working with close guidance from industrial partners providing greater relevance and applicability into areas of active growth and interest that needed the illumination of detailed fundamental research.