Monoclonal antibody purification using activated carbon as a replacement for Protein A affinity chromatography

Abstract

Activated carbon (AC) is a porous solid with a higher surface area and a lower cost than chromatography resins. AC is widely used in the pharmaceutical field in applications such as the manufacturing of low-molecular and hematological drugs and as a treatment for oral poisoning and hemocatharsis. In this work, AC was employed in the purification process of therapeutic monoclonal antibodies (mAb). After screening several kinds of ACs, we investigated the selected AC used in a flow-through mode (with impurities binding) and as a replacement for Protein A affinity chromatography (PrA). The recovery, purity, and clearance of the impurities were examined compared with those obtained from the Protein A platform purification process (PrA followed by anion exchange chromatography (AEX) and cation exchange chromatography (CEX)). Comparable clearance of impurities, high-molecular-weight species (HMW), low-molecular-weight species (LMW), host cell proteins (HCP), and DNA were observed in the purification processes, which were AC followed by AEX and CEX. In addition, we designed all flow-through processes using AC. Effective HMW, LMW, and HCP clearance were also obtained in this manner. From these results, it is expected that AC can be applied to industrial mAb purification as an alternative to PrA to improve process economy.