Qualification of a Single-Use Disk Stack Separator for Cell Separation in Mammalian Cell-Based Antibody Production

Abstract

Single-use technology is now an indispensable part of biopharmaceutical production processes. This not only applies to research and development, but also to commercial processes. The manufacturers of single-use systems are working on improving them for use in intensified processes as well as on new developments. One of the bottlenecks was the availability of single-use disk stack separators whose stainless steel variants are widely used in industry. In this study, the suitability of the new single-use disk stack separator kytero 500 was investigated for the first time for cell separation in pilot-scale Chinese hamster ovary cell-based antibody production. The cells were completely separated over a wide range of separator settings with nearly no release of intracellular substances and no loss of the antibody.