Development of a Next Generation Cellulose-Based High Capacity rProtein A Capture Resin for High Throughput MAb Purification in Both Batch and Continuous Purification Formats

A new product development approach will be described for the affinity capture of Mab’s from cell culture materials employing a novel base stable rProtein A ligand. Using a stable cellulose base bead with excellent flow properties coupled with a novel immobilization methodology, a next generation rProtein A capture resin has been developed with a high level of antibody binding capacity. The new Cellufine™ rProtein A resin shows _C20% dynamic binding capacity (DBC) of >50 mg/ mL with polyclonal antibodies at a residence time of 8 minutes. This resin has been shown to retain > 95% of its original binding capacity after 100 cycles of re-use with a 0.1M NaOH CIP step every 10th cycle. In continuous purification format, where more of the resin capacity is utilized > 65 mg/mL DBC has been demonstrated with shorter four-minute residence times. A high through-put screening (HTS) assay format has been developed to screen pH elution conditions. Polyclonal antibodies show efficient elution at pH 3.5 with a 0.1M Glycine HCL buffer.