Orthoclone OKT3® was the first monoclonal antibody-based drug (approved in 1986). As of today, more than 100 such products are available for therapeutic use across different geographies. Recently, Margenza™ (December 2020), Danyelza® (November 2020), Adakveo® (November 2019), Beovu® (October 2019), SKYRIZI™ (April 2019) and EVENITY™ (April 2019), were approved by the USFDA. Owing to their specificity for a target biomolecule (antigen) and favorable safety profile (compared to small molecule drugs), antibody-based interventions presently make up the largest class of biologic drugs. This trend is unlikely to change as multiple advanced variants of these drugs, such as bispecific antibodies and antibody fragments-based products, have been developed and several pharmacological leads based on these relatively novel constructs, are under evaluation. However, as is the case with all biologics, the production of antibodies is also a complex process. Specifically, antibody purification, which is one of the most crucial steps downstream of the manufacturing process, is a cost intensive operation. The investment of both effort and capital at this stage of production is justified because any impurity, or unwanted antibody molecule, poses a serious threat to not only therapeutic efficacy but also to the safety of patients. A variety of physiochemical approaches, including ammonium sulphate precipitation, hydrophobic interaction chromatography, ion-exchange chromatography and size exclusion chromatography techniques, are used to purify antibodies.

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