Chromatographic Methods for the Purification of Monoclonal Antibodies and their Alternatives:A Review

Monoclonal Antibodies (mAbs) have emerged as a unique and exciting group of biological products. They represent a rapidly growing biopharmaceutical market segment with interesting and extremely useful medical applications in the treatment of numerous diseases such as cancer and immunological disorders. The monoclonal antibody purification process that is adopted should be reliable, robust and must efficiently remove various impurities such as aggregates, host cell protein, DNA, some cell culture media additives, clipped/low molecular weight species, viruses etc. The currently established purification platform typically employs three chromatography steps with Protein A chromatography as the initial capture step followed by two polishing steps which may include cation exchange chromatography, anion exchange chromatography, hydrophobic interaction chromatography etc. But conventional packed bed chromatography suffers from certain serious drawbacks. As a result, alternatives to chromatography are also becoming important. In this paper, various techniques used for the purification of monoclonal antibodies are discussed and the merits and demerits of each technique are critically analyzed besides discussing about the typical applications of each of these methods. Keywords—Aqueous two phase systems, Chromatography, Impurities, Monoclonal antibodies, Resin, Yield