Considerations In Depth Filter Scale-Up

In the biopharmaceutical industry, depth filters are commonly used due to the media thickness, pore size distribution, and adsorptive capacity, making them ideal for separating product from complex cell culture fluids during harvest applications. Recent studies have underscored the significance of capsule design in the scalability of depth filters. In this study, scalability data for depth filter capsules across process development, pilot, and manufacturing scales is presented. The analysis covers pressure profiles, turbidity and particle reduction, yields, and impurity removal. These findings aim to assist process development scientists and engineers in understanding the structure of these devices, identifying key parameters for development, and setting appropriate safety factors during scale-up.