There is a current trend in biomanufacturing to move from batch to continuous processing. Potential benefits of continuous processing include significant reductions in cost and footprint with improved product quality. It also facilitates the design of flexible multi-product manufacturing facility and increases the speed to market. However, significant differences exist between unit operations in continuous versus batch mode, creating challenges in how viral safety should be addressed and assured according to guidelines (ICH, 1999, 2005).<br/><br/>Traditional viral clearance study design is proven and well-suited for batch processing; but developing clearance scale models for continuous processing can be complex and may require specialized instruments not available in testing labs today. In this study, we developed alternative spiking and loading methods to evaluate the viral reduction of a flow-through AEX in the context of continuous processing using a standard ÄKTA system. The studies were designed to mimic the potential fluctuations in the feed material that might be introduced by a connected, continuous process. Results suggest that AEX is robust in viral and impurity removal despite loading high and fluctuating product and virus concentrations. The study also demonstrates the design of a batch clearance study representing a potential ‘worst-case scenario’ in continuous processing that can be readily adopted in a testing lab. This approach has the potential to evaluate other chromatography steps and harness the advantages of continuous processing.<br/>

Evaluating viral clearance in continuous processing

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.