High-Cell-Density Clarification By Single-Use Diatomaceous Earth Filtration

摘要

Single-use concepts are widespread in all unit operations of the biopharmaceutical industry. Although single-use technology is rapidly advancing and considered to be highly advantageous in many regards (l-3), in some cases it cannot (yet) compete withclassical manufacturing systems. Processes with a demanding character (e.g., high cell densities, high titers, high turbidities, increased particle/contaminant loads) especially can bring disposables to their limit of technical feasibility, especially in product harvesting (4-6).Here we focus on that step, which is defined as a removal of cells, debris, and (ideally) typical contaminants such as host-cell proteins (HCPs) and DNA from process fluid. In conventional (multiuse) facilities, a typical harvest is a multistep procedure