One resin, multiple products: A green approach to purification

Protein A affinity chromatography is a key purification step used during the purification of recombinant monoclonal antibodies (mAbs) harvested from cell culture fluid (HCCF). During this purification process typically a single Protein A resin is dedicated to purify a specific mAb of interest. For clinical manufacturing and pilot plant runs this can result in significant resin underuse, such that the Protein A resin is only used 10% of its potential lifetime. Herein we demonstrate that significant cost savings can be achieved (annually) if the Protein A resin is reused for multiple products. In this study, a cleaning procedure called the MabSelect SuRe™ Campaign Changeover Procedure (MSSCCP) was developed on lab-scale to reduce protein carryover during the reuse of the Protein A resin for purification of multiple products. Use of the MSSCCP cleaning procedure results in less than 1 ppm carryover of intact IgG into subsequent purification samples. This low protein carryover is 10³ fold less protein carryover than that set in safety margins, and demonstrates that the same Protein A resins can be used to purify multiple products. The reuse procedure was successfully implemented on lab scale, and on pilot plant scale for the production of mAb drug substances.