Optimization Of A Protein A Chromatography Process For A Herceptin® Biosimilar

Four Protein A resins from leading industry vendors, including AmsphereTM A3, were screened for use in a capture step for a Herceptin biosimilar. Multiple parameters were assessed for their performance against the platform resin. Initially, a dynamic binding capacity (DBC) determination was made using a standard 4-minute residence time (RT) using purified protein. Performance of the resins were then screened for recovery and purity using harvested cell culture fluid (HCCF) where the mAb load was 80% of DBC at 10% breakthrough (BT).