Integration of Single Pass Tangential Flow Filtration and High Performance Countercurrent Membrane Purification for Intensification of Monoclonal Antibody Processing.

ABSTRACT: There is increasing interest in the development of intensified processes that can provide significant reductions in manufacturing costs for monoclonal antibody (mAb) products. This study examines the performance of an integrated membrane process that combines single-pass tangential flow filtration (SPTFF) with high-performance countercurrent membrane purification (HPCMP) for the preconditioning of clarified culture fluid (CCF). The SPTFF step was operated with a single-pass concentration factor of 20x for 24 h filtration, with no evidence of membrane fouling; the transmembrane pressure remained < 30 kPa throughout the process. HPCMP was then performed on the pre-concentrated feed, resulting in a 60 ± 8% reduction in host cell proteins (HCPs) and more than a 30-fold removal of DNA while mai

SUBMITTER: Minervini M 

PROVIDER: S-EPMC12322625 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature