Evaluation of single‐use disk stack continuous centrifuge to harvest monoclonal antibody from cell culture fluid

Abstract Various technologies, including precipitation, flocculation, depth filtration, microfiltration, and centrifugation, have been developed to clarify mammalian cell culture fluids. For processing volumes between 2000 and 5000 L, continuous centrifugation followed by depth filtration is the preferred method. This process starts with the removal of cells and large debris through continuous centrifugation, followed by the filtration of small debris and some impurities. The newly introduced single‐use centrifuge, designed to prevent cross‐contamination and mimic traditional continuous centrifuges, was evaluated for its performance, particularly focusing on its impact on cell lysis and subsequent filtration and purification processes. The single‐use centrifuge showed better performance in reducing turbidity and lactate dehydrogenase levels (LDH) in the supernatant, indicating less cell lysis compared to the conventional centrifuge. A separation load factor range of 0.91–2.73 was identified as optimal for balancing centrifugation throughput and product quality. Both centrifuge types had a comparable impact on the performance of subsequent depth filtration, supporting a load capacity of at least 100 L/m 2 . No significant differences in product quality, including SE‐HPLC, NR/R CE‐SDS, icIEF, HCP, and rDNA, were observed between the conventional and single‐use centrifuges. These harvest strategies did not affect the subsequent purification steps. For volumes up to 5000 L, both centrifuge types are viable; however, for larger volumes, the conventional centrifuge is necessary due to the scale limitations of the single‐use centrifuge.