ウイルスの不活性化のための充填層における流体力学に影響を与える設計上の考慮事項

Despite significant advances in continuous manufacturing of monoclonal antibodies, the implementation of continuous virus inactivation (CVI) remains challenging due to standardization gaps that could compromise product quality and safety. This study identified limitations in minimum residence time (mRT) prediction for packed bed reactors (PBR) utilized for CVI. This work focused on characterizing the residence time distribution (RTD) behavior of tracers with varying molecular properties in four PBR configurations. The results demonstrated that tracer molecular size impacted mRT prediction, with larger molecules showing shorter residence times than smaller molecule tracers under identical conditions. During scale-up from 16 to 26 mm diameter columns, mRT was not maintained, suggesting that traditional chromatography scale-up principles may not be directly applicable to CVI using PBRs. Overall, this work established a helpful foundational understanding of how process material properties impact mRT prediction-a critical process parameter that would directly impact virus inactivation efficacy in integrated CVI systems.