As continuous bioprocessing advances toward the opportunity of adding to the global drug supply, continuous downstream processes are now being tasked with quantifying the viral clearance capabilities of the downstream unit operations. Symptomatic of the increased complexity of the downstream unit operations, coupled with high specificity of the process equipment to a company, the ability to provide a scaled down model to a contract testing organization is not trivial.<br/><br/>This study presents the results of a low pH viral inactivation study across a three mAb panel, in which the basis of the experimental design was to provide a head-to-head comparison of a standard batch based viral inactivation study to the performance of continuous viral inactivation. The objective of this study is to provide evidence that the viral inactivation kinetics experienced in the batch scaled down model are either comparable or worst case relative to the continuous viral inactivation scale down model. The study results justify the use of a batch scaled down model to quantify the log reduction value of a continuous viral inactivation process.

Comparison of inactivation kinetics for batch and continuous viral inactivation of X-MuLV in scale down model

ACS Fall 2021

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