Application Note

Lifetime Performance Study Of MabSelect™ PrismA During Repeated Cleaning‑In‑Place Cycles

Source: GE Healthcare Life Sciences
Cleaning‑In‑Place Cycles

This work demonstrates a lifetime performance study on MabSelect PrismA protein A chromatography resin. The study was conducted for 100 purification cycles using mAb‑containing samples, including cleaning in place (CIP) with 0.5 M NaOH at a contact time of 15 min in each cycle. Results show that dynamic binding capacity (DBC), antibody recovery, and clearance of impurities, such as antibody aggregates, host cell protein (HCP), host cell DNA (hcDNA), and leached protein A, were maintained at a similar level throughout the study. Furthermore, an alkaline‑stability study was performed for 300 cycles, using 0.5 M NaOH as cleaning agent, and for 150 cycles using 1 M NaOH as cleaning agent. Generated data indicates that the protein A ligand of MabSelect PrismA is stable and that it withstands repeated and effective CIP procedures with high concentrations of NaOH as cleaning agent over a long resin working life.