Industrial Purification Strategies for Monoclonal Antibodies

Abstract

The global monoclonal antibody market in 2016 was around USD 85.4 billion and is expected to reach USD 140 billion by end of 2024 i.e., approximately 1.5 fold increase in market rate within 10 years. The therapeutics purification process monoclonal antibody through chromatography technique is expected to grow by 5% from 2011 to 2017, with a prediction of reaching to USD 9 billion by end of 2017. The global market interest is shifting from monoclonal antibody to fragmented antibody; nearly 60 fragmented antibodies have gone into clinical trials as of 2010. In this review, recovery of monoclonal antibody by centrifugation, depth filtration followed by purification by chromatography techniques i.e., capture step by affinity chromatography, intermediate step by anionic chromatography in flow through mode and polishing step by cationic chromatography is reviewed. The production of antigen binding fragment is carried out by enzymatic method followed by affinity chromatography, multimode chromatography and cationic chromatography. Monoclonal antibodies have been developed by these methods are used for targeting range of diseases. Many of such monoclonal antibodies have been approved and many such is still in development pipeline. This review gives an overview on the structure of antibody, production of monoclonal antibody and the downstream purification of monoclonal antibody. The downstream purification covers the basic techniques followed for most of the mAb purification done commercially. The downstream purification steps discussed here include centrifugation, tangential flow filtration, depth filtration and chromatographic techniques.