Summary

Comparison of a complete MAb purification process from a 100-L cell culture volume demonstrated a 50% reduction in process time using the ReadyToProcess platform instead of traditional process equipment. The decrease was made possible by elimination of column packing and testing, membrane wetting and rinsing, system cleaning, cleaning validation, and so on. Additionally, the ReadyToProcess run required less hardware and thus generated a smaller footprint. Both chromatography steps were run on one system using disposable, exchangeable flow paths. There was no difference in quality between the traditional process and the single-use process. However, using ready-to-use equipment instead of traditional process equipment contributed to increased productivity and process safety.