A Flexible Antibody Purification Process Based On ReadyToProcess™ Products

We have developed and used an efficient monoclonal antibody (MAb) purification protocol to reduce the level of aggregates from 10% to 0.4% in a two-step chromatography process giving a monomer yield of 81%. The process involved the use of MabSelect SuRe™ for the capture step and Capto™ adhere for the polishing step. In addition, we describe the transfer of a small-scale process based on prepacked HiScreen™ columns (4.7 mL) to a ReadyToProcess format based on prepacked and prequalified columns and filters suitable for clinical phase I/II production for increased speed and process flexibility.