Understanding the Harvest Operation Using Dynamic Particle Sizing Technology

摘要

The harvest process most often used during the primary recovery of cell-based biopharmaceuticals is continuous centrifugation followed by depth filtration. While it is widely used in the industry, little attention is typically paid to this unit operation because of the lack of analytical tools to develop and monitor the performance of this step. Turbidity, which is a measure of cloudiness, has been used up to now as the common output for the performance of this step. However, this output does not provide any direct information on the number of particles removed or their size. Nevertheless, these parameters are key to understand the effectiveness of the harvest operation. In this paper we describe how a CCD-microscope can be used to develop an optimized harvest operation by determining the number of particles and their size distribution of particles present in the centrate or in the eluates of the depth filters.